SPOT Radio: Recent Episodes
Charlie Webb
Welcome to Sterile Device Packaging on Track podcast. Listen in as we speak with the nation’s leading experts in medical device packaging.The goal of this Podcast is to engender a community of packaging and manufacturing engineers that can pose questions to our panel of SME’s. We will cover all corners of medical device packaging from trending medical device packaging regulatory issues, new packaging technologies, and techniques as well as a host of case studies designed to make your medical device packaging program more robust.We would love to hear your feedback about our program and receive your input and suggestions on how we may improve this podcast. We are working to build a community of enlightened medical device packaging professionals. If you would like to be included in an upcoming episode please feel free to contact us at our website - www.spotradiopodcast.com, or send us an email to info@spotradiopodcast.com.
In this thought-provoking episode of SPOT Radio, host Charlie Webb, CPPL, sits down with sustainability advocate Samantha Smith to explore the critical intersection of healthcare and environmental responsibility. Together, they unpack the growing urgency to make hospitals and clinics more sustainable—without compromising patient care or regulatory compliance.
They also dive into the cultural and institutional hurdles that often slow progress, and how a possible shift towards a data-driven decision-making can open new possibilities for long-term impact.
If you’ve ever wondered how medical facilities can reduce their environmental footprint while maintaining safety and sterility, this episode will leave you inspired—and armed with insights to make a difference.
About Samantha Smith: DIRECTOR, SUSTAINABILITY AND PRODUCT STEWARDSHIP
Senior MedTech leader in Sustainability, ESG, and Product Stewardship, shaping corporate strategy, securing executive alignment, and delivering measurable business and environmental impact. Selected by Medtronic’s Executive Leadership Team to build and scale the first R&D function focused on Sustainability, securing $4M+ in funding. Defined and reported to investors Medtronic’s first external-facing Sustainability Product and Packaging goals. Trusted voice in MedTech Sustainability, representing the company in key industry and customer forums.
CAREER HIGHLIGHTS
Sustainability Strategy & External Reporting: Secured $4M+ in executive-approved funding to build Medtronic’s first R&D function focused on Sustainability and defined external product and packaging ESG goals reported to investors, embedding ESG into product innovation and driving investor confidence.
Cost Savings & Risk Mitigation:
Negotiated $100M+ in Master Supply Agreements for packaging, delivering 5% year-over-year cost savings and protecting Medtronic from COVID-related supply chain price surges, saving $10M+.
Operational Excellence & Circularity:
Integrated circularity and eco-design criteria into Medtronic’s New Product Development process, advancing FY30 sustainability commitments
Samantha Smith Email: samanthakeeneysmith@gmail.com
Linkedin: linkedin.com/in/samanthakeeneysmith
On this episode of SPOT Radio, Charlie Webb, CPPL, speaks with Karen Goelst. Karen and Charlie dive into strategies for building consensus across departments. By presenting a multi-benefit sales proposition—one that speaks to the priorities of clinical teams, procurement officers, and risk managers alike—they explore how layering value can break through resistance and foster collaborative buy-in.
About Karen Goelst:
As CEO of KleenEdge, a company specializing in privacy curtain compliance software and patented “no-ladder” exchange solutions, our focus is on empowering hospitals with cost-saving, innovations that get patient curtains exchanged on time.
With over 14 years in architectural specialties we leverage lean, safe workflows along with technology to mitigate healthcare-acquired infections ensuring patient and staff safety.
KleenEdge has pioneered software that empowers on-time curtain exchanges while providing actionable data. Our mission centers on delivering safety-driven, cost-saving, tools that address compliance and infection control challenges while supporting hospitals in optimizing their resources effectively.
Karen Goelst Email: kgoelst@KleenEdge.com
Roadtrip webpage: www.kleenedge.com
Linkedin: https://www.linkedin.com/in/kleenedge/
On this episode of SPOT Radio, Charlie Webb, CPPL, discusses the Sterile Summer Patient Safety Road Trip 2025—an outreach initiative designed to raise awareness about sterile packaging practices and awareness. Joined by his wife, Lisa Webb, General Manager of Van der Stähl Scientific, the duo will actively support the Sterile Aware initiative, engaging medical device manufacturers by distributing awareness bracelets and posters while demonstrating advanced medical device packaging machinery.
Beyond their mission to promote patient safety, Charlie and Lisa are also weaving moments of vacation and exploration into their journey, striking a balance between industry advocacy and personal adventure.
Tune in to hear more about this unique road trip blending education, engagement, and a bit of summer fun!
About Charlie Webb CPPL:
Charlie Webb CPPL is the founder and President of Van der Stahl Scientific; a medical device packaging and testing machine provider and packaging testing and calibration laboratories.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, he is a former co-PM in the Kiip group and voting ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testers.
His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination.
About Lisa Webb:
As the General manager of Van der Stähl Scientific she has grown the company sales by double in her 15-year tenure. Her technical acumen is impressive as there is not a packaging machine in Van der Stähl Scientific’s offering that she does not know every nut and bolt and its placement.
Beyond understand the medical device packaging and testing machines operation and build she also understands the ISO 11607 processes for which they are held under. Lisa also oversees many of the functions in Van der Stähl Scientific’s ISO/IEC 17025 medical device pouch test and calibration laboratory. She is Kaizen trained and certified and continues to improve Van der Stähl Scientific’s operation from product development to market reach.
Team Email: info@vanderstahl.com
Roadtrip webpage: https://www.linkedin.com/in/missy-travis-b8588b45/
Roadtrip Video: https://youtu.be/s58_ih8G7IM?si=Vglm3Nm60M5-3EmW
Storyteller Hilt: https://www.storytelleroverland.com/pages/hilt
On this episode of the Spot Radio Podcast, host Charlie Webb CPPL sits down with Elon Goldbaum from the Network Partner Group to delve into the intricacies of performing a Corrective and Preventive Action (CAPA). They discuss the framework that underpins the CAPA process, highlighting its crucial role in ensuring product quality and compliance in the medical device industry.
Charlie and Elon explore the vital importance of the CAPA process, shedding light on how it helps organizations identify, address, and prevent potential issues. They also share valuable tips and strategies to make the CAPA process more manageable and effective, ensuring that businesses can maintain high standards of safety and quality.
Tune in to gain insights from industry experts and learn practical advice that can be applied to your own CAPA initiatives. This episode is a must-listen for anyone involved in quality assurance, regulatory affairs, or medical device manufacturing.
About our guest:
As Vice President, Client Solutions for Network Partners Group, Elon (Lon) brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality management systems, CAPA and sterilization.
Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice Leadership Program.
Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, Endologix and Danaher with a wide range of responsibilities. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
Elon Goldbaum e-mail: elon.goldbaum@onenpg.com
On this episode of the Spot Radio Podcast, Charlie Webb, CPPL, speaks with Michael Geanous and Doug Stallard both experts in VHP ( vaporized hydrogen peroxide) The discussion is centered around the movement to perform in-house sterilization at the MDM's location in order to streamline distribution.
About Our Guests:
Michael Geanous
Michael Geanous has worked in the industry for 42 years, the last 20 of which have been using Hydrogen Peroxide technology. Michael has developed several commercially successful pieces of DECON equipment with STERIS and his current independent company. He has been the lead engineering manager in developing DECON chambers, Deep Vacuum hydrogen peroxide sterilizers, and the interface of VHP with freeze dryers. His expertise is in steam, Eto, chemical sterilization, and decontamination methods.
Doug StallardFor the past 25 years Doug Stallard has been working as an independent consultant in business development, marketing, and sales management. Doug represented and consulted with several companies over his career primarily in the pharmaceutical, biotech, and medical device industries. Many of his clients over the years have been start-ups, smaller domestic manufacturers without internal sales and marketing resources, or companies based in Europe wanting to penetrate the US market.
His experience and expertise have been with capital equipment such as H202 decontamination, liquid and powder aseptic fill finish machines, WFI water systems, sterilization and autoclave equipment, inspection equipment, cleanrooms, isolators, and material handling.
For more information on VHP e-mail me: info@vanderstahl.com
On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with Cord Burnham CKF about his observations of both healthy and unhealthy cleanroom cultures. Over the past 10 years, Cord has visited hundreds of cleanrooms throughout the United States and abroad.
About Cord Burnham:
As a Van der Stahl Scientific's ISO 17025 laboratory manager, Cord oversees all of the functions of the calibration and their empirical Laboratory. Cord is certified as a CKF (certified kaizen facilitator) and he co-authored the quality system manual for Van der Stahl Scientific. Cord is hands-on with all of the machinery that Van der Stahl Scientific offers and is also an SME for regulatory processes surrounding the ISO 17025 standards
Email: Cord@vanderstahl.com
Website: www.vanderstahl.com
On this episode of the Spot Radio and the Sterile Aware Podcast Charlie Webb CPPL speaks with Missy Travis a certified Infection Preventionist about her role in managing contaminants and healthcare-acquired infections.
About Missy Travis:
As a certified Infection Preventionist with over two decades of experience in acute care, long-term care, public health, and professional sports, but most importantly being a wife, mother, sister, daughter, and friend, She has learned the importance of living the life you want while doing something you love.
She is passionate about spreading the message of creating a safe environment for people, young and old, using infection prevention principles. I use evidence to support my recommendations while applying Her own experience, including some interesting stories, for application.
Missy specializes in helping new Infection Preventionists develop an Infection Prevention Plan while managing their busy schedule. She also work with health departments, healthcare facilities (acute, post-acute, and long-term care), and sports teams to develop an Infection Prevention Program that promotes safety and excellence.
Email: missytravis@ipandcconsulting.com
Linkedin: https://www.linkedin.com/in/missy-travis-b8588b45/
On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with Stan Gibson, JD. Listen in as Stan Uncovers the secrets to securing your medical device or packaging innovations. Stan Gibson is a leader in patent litigation and Chairman of the Patent Litigation Group at Jeffer Mangels Butler & Mitchell LLP.
About the Stan Gibson:
Stan is a seasoned trial attorney dedicated to helping innovators and entrepreneurs protect and monetize their ideas, transforming them into valuable business assets. With 30 years of experience and victories in dozens of trials, he has developed a specific strategy to shield clients' intellectual property from theft, ensuring they truly own their envisioned assets. His approach provides early peace of mind, allowing clients to focus on business growth. Stan's mission is to help 10,000 innovators secure and enhance the value of their intellectual property while avoiding costly trials and litigation.
Contact Stan: www.ip-checklist.com
On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with biomedical engineer Emily Graba about her scoring system for the visual features of a medical device Pouch or Tray sealing.
About the Emily Graba:
Emily Graba is a biomedical engineering graduate from the University of Minnesota and a Process Development Engineer at QTS. Prior to joining QTS as a full-time engineer, Emily completed an R&D Co-op with the Cardiac Surgery group at Medtronic and a Project Engineering Co-op at QTS. At QTS Emily is heavily involved in the development and improvement of the sealing characterization and validation process for medical devices. Outside of work, Emily enjoys going to Society of Women Engineers (SWE) events and spending time outdoors!
Guest Email: egraba5736@gmail.com
Visual seal inspection app: https://vanderstahl.com/viu-system/
Visual seal inspection device: https://vanderstahl.com/seal-stats/
On this episode of the SPOT® Radio Podcast Charlie Webb CPPL speaks with Justin Paur the president of Achates about when and why to use a contract medical device packaging and consultancy firm.
About Justin Paur:
Justin Paur is the president of Achates (A-kate-ees), a medical device contract manufacturing and product development company in the Twin Cities focused on startup medical device technologies. Justin has undergraduate degrees in Mechanical Engineering and Aerospace Engineering from West Virginia University, and an MBA from the Carlson Medical Industry Leadership Institute at the University of Minnesota in the Twin Cities, where Justin is now a senior lecturer. Justin authored “The Core Chain”, a book on lean medical device development, which is available now on Amazon.
Email: Justin@achates.com
Link to The Core Chain Book: https://a.co/d/7vBnVeu
Link to Achates: www.achates.com
Link to Biodesign Book: https://a.co/d/hPq9Aun
On this episode of the Spot Radio Podcast Charlie Webb CPPL speaks with the Pack-Out founding members Sarah Rosenblum-Ptach and
Kiley Djupstrom about what to expect at this years event. The event this year will be held in Coronado California.
About the Pack-Out
This is not your average healthcare packaging conference. the PACK-Out is built for the industry, by the industry. Whether you are new to healthcare packaging or a seasoned healthcare packaging professional, join us to grow your expertise and knowledge of the industry.
Email: info@thepackout.com
Website: https://thepackout.com
Linkedin: https://www.linkedin.com/company/thepackout/about/
On this episode of the SPOT® Radio Podcast Charlie Webb CPPL speaks on the topic of medical device packaging system innovation. Charlie asks the question, can we do better as innovators in sterile device packaging?
About Charlie Webb CPPL:
Charlie Webb CPPL is the founder and President of Van der Stahl Scientific; a medical device packaging and testing machine provider and packaging testing and calibration laboratories. He also hosts the popular Podcast "SPOT Radio" (sterile packaging on track)
www.spotradiopodcast.com Charlie was recognized in the Rode Podcast awards as the top 100 ‘Highly Commended Podcasts for his Podcast "Antidote to Despair" Charlie earned his BS degree in Management at the University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of Packaging Professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 26 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system, his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, the Kiip group, and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.
His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. His patented seal-through HTIP system isolates the donor tissue during the packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increase packaging machine component life cycles, saving money while managing infection risks to donor recipients.
His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.
E-mail: Charlie@vanderstahl.com
Website: www.vanderstal.com
PTT-500-AV Video: https://vanderstahl.com/wp-content/uploads/2024/02/PTT-500-AV.webm
On this episode of SPOT Radio Podcast Charlie Webb CPPL speaks with Megan Frost PhD the founder and Chief Technology Officer and Kurt Yockey the CEO of Sterile State about their exciting new technology. Could this sterilant be the future of medical device sterilization? Listen in and learn more about the emerging technology.
Guest bio's:
Megan Frost PhD is the founder and Chief Technology Officer for Sterile State. She has worked on the development of medical polymers and their applications to devices for over 20 years. She earned a BS in Biological Sciences from the University of Notre Dame, a BS in Chemistry with a minor in Mathematics and an MS in Analytical Chemistry from Purdue University - Indianapolis, and a PhD in Chemistry with a Graduate Certificate in Cellular Biotechnology from the University of Michigan - Ann Arbor. She was a post-doctoral researcher in the Department of Surgery at the University of Michigan Medical School. Her dissertation work focused on the development of implantable, real-time sensors for medical analytes such as oxygen, carbon dioxide, pH, glucose, etc. Industrial experience gained prior to completion of graduate studies includes working at Dow Elanco (Indianapolis, IN) in the Technology Applications Group. She also has experience as an analytical chemist at Eli Lilly and Company (Indianapolis, IN) and was a professor for 16 years and department head for Michigan Technological University.
Kurt Yockey is the CEO of Sterile State, LLC and has worked extensively with physicians, hospitals, medical product manufacturers, and other healthcare professionals and entities for over 40 years. While practicing law, he was preferred counsel in complex litigation involving orthopedic surgery, emergency medicine, obstetrics, cardiology, and medical device matters. Kurt has been general counsel for innovative medical product development companies including Zip Pak Inc., J.M. Longyear, Pioneer Surgical, Frontier Medical Products, Samaritan Medical and Sterile State LLC. In 2005, Kurt was named a Michigan "Lawyer of the Year" by Michigan Lawyers Weekly for his role as hospital counsel in finding a defect in a medical device, leading to the manufacturer making a design change which avoided patient injury worldwide. He is AV rated by Martindale-Hubble. Kurt received his undergraduate degree from Michigan State University in 1977 and graduated with honors from the Detroit College of Law in 1981.
E-mail: info@sterilestate.com
Website: www.sterilestate.com
Phone: (906) 295-5250
On this episode of SPOT Radio Podcast Charlie Webb CPPL speaks with Jeff Meleville from Mini Mover about how conveyance systems can increase packaging workflows and improve worker ergonomics. In this episode, Charlie speaks with Jeff about utilizing companies that deeply understand the clients needs.
Guest bio:
Jeff Melville is the National Sales Director for Mini-Mover Conveyors. Mini-Mover Conveyors specializes in creating personalized conveying solutions in industrial automation applications. Jeff credits the success of Mini-Mover Conveyor to the dedicated team behind the scenes whom he says are “focused on the same goal and achieves this by an unwavering commitment to a team mentality”.
Jeff uses an optimistic attitude and positive energy to encourage others to work hard and succeed. He is inspired daily by his wife and three children. In his free time, he likes to be outdoors, hunting, fishing, and playing sports with his kids.
E-mail: jmelville@mini-mover.com
Website: https://mini-mover.com/
Phone: 800-586-4585
LinkedIn profile: https://www.linkedin.com/in/jeff-melville-57171732/
Movement efficiency kaizen dishwasher unloading and loading: https://youtu.be/E6rRHqb5MV0
Listen in as Charlie Webb CPPL speaks with Malinda Elammari Clinical Education Specialist at Healthmark Industries. Today's discussion speaks to the different packaging workflows of medical device manufacturers versus hospitals and clinics. During this discussion, Charlie and Malinda cover the topic of the critical importance of preventative and predictive maintenance.
Guest Description:
Malinda Elammari, CST, CSPM, CSPDT, CFER, CSIS, CRCST, CIS, CHL, CER, CLSSGB
Malinda Elammari is a Clinical Education Specialist for Healthmark Industries. She began her career in the medical field as a Certified Surgical Technologist specializing in Open-Heart surgery. Throughout her career, Malinda has served in a variety of positions within SPD, such as Interim Director of Education and Quality, Sterile Processing Educator and Quality Control Manager, Clinical Operations Manager, OR Liaison, and an Endoscopic Service Rep. In addition, Malinda was the lead instructor for the Central Sterile program at Durham Technical Community College. She holds several certifications in sterile processing through CBSPD and HSPA. Malinda is a TeamSTEPPS Master trainer and is certified as a Lean Six Sigma Green Belt. She is an active member of AAMI and sits on multiple national standard writing committees. Malinda sits on the Editorial Board for AAMI Publications and is a project manager for KiiP’s Aseptic Presentation subgroup. She is a graduate of Duke’s Innovation & Entrepreneurship program and Duke’s Technical Excellence Program. She currently serves as president for the North Carolina HSPA chapter.
Contact: melammari@hmark.com
On this episode of the SPOT™ Radio Podcast Charlie Webb CPPL speaks with Chris Danek CEO of Bessel about human-centered design and agile teamwork. Chris speaks on using advanced technology like artificial intelligence, additive manufacturing, and digital engineering and their support to medical device manufacturers.
Guest bio
Chris Danek, CEO of Bessel, is an entrepreneur and life sciences industry veteran. Chris believes in empowering technical teams. Trained in business and engineering, he has worked with dozens of teams in industry and at universities across the US. He helps them speed time-to-market with agile teamwork and human-centered design while using advanced technology like artificial intelligence, additive manufacturing, and digital engineering. Bessel clients and Powered by Bessel startups are located nationwide.
Chris is a visiting professor at the University of Texas at El Paso. This leading Hispanic-serving research university has adopted the Bessel Origin program in its Department of Aerospace and Mechanical Engineering. Chris is also a visiting professor at the W.M. Keck Center for 3D Innovation at UTEP.
Chris was co-founder and CEO of AtheroMed (now Philips AtheroMed), and before that was V.P. R&D of Asthmatx (Boston Scientific). Chris is an advisor to the Santa Clara University Healthcare Innovation and Design Lab. He has a Ph.D. in mechanical engineering from Stanford University and an M.B.A. with a concentration in finance from the Wharton School - University of Pennsylvania. He is an inventor of over 85 U.S. patents.
About Bessel
Bessel's roots are in product lifecycle support for medical device and diagnostic products. With a foundation of more than 20 years of experience designing and developing medical devices, Chris Danek and Bessel have provided full-service support for over 5 years to diverse organizations ranging from startup companies to Fortune 50. We bring innovation throughout the product lifecycle -- from a clean sheet of paper through commercial release.
We combine human-centered design and agile teamwork (scrum) in our approach to work, with a dual focus on results and on improving the capabilities of our clients' teams.
Mentoring startup teams reminded me of my love of teaching. It was natural to step from putting the patient first as a medical device developer to putting the student first as a teacher. The core of the Bessel Origin program stems from my work helping students transform into excellent team members ready for the workforce.
My co-founder, Carolyn Danek, inspired the start of Bessel. Trained as an architect, Carolyn is professionally versed in human-centered design. Her deep-rooted empathy sparked the creation of Bessel. I'm fortunate to be her co-founder.
We saw the broad applicability of the Bessel Origin program and its mindsets, methods, and discipline to train the next generation of innovative thinkers and high-performance team members. Now we deliver corporate critical innovation projects and our Bessel Origin program.
Website: www.bessel.co
On this episode of the SPOT Radio® Podcast Charlie Webb CPPL speaks with Elon Goldbaum about the value of medical device packaging inspection and testing in order to monitor process value.
Guest bio
Elon Goldbaum isVice President, Packaging Engineering & Client Solutions, Lon has over 20 years of experience in the MedTech and Pharmaceutical industries, specializing in packaging, labeling, quality, CAPA systems, and sterilization.
Lon is focused on business development for growing the Network Partners packaging engineering organization and commercial sales.
Prior to joining Network Partners, Lon held various roles with Beckman Coulter, Baxter Healthcare, Edwards Lifesciences, Endologix, and Danaher with a wide range of responsibilities. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
E-mail: elon.goldbaum@networkpartners.com
Website: http://www.networkpartners.com/
Linkedin: https://www.linkedin.com/company/network-packaging-partners/
On this episode of the SPOT™ Radio Podcast Charlie Webb CPPL speaks with Roy Morgan about new ways medical device manufacturers can streamline the process of sterilization and medical device packaging through Eagle Medical's PATH (packaging accelerated timeline help) program.
Guest bio
Roy Morgan is best known for his work in electrochemistry; the inventor of the world's first orthopedic device to upregulate genetic progenitor compounds in the healing process of osteoarthritis of the joints. His skills in R&D team building and fast-paced project execution, requiring FDA product acceptance are well known in the med-device community. Mr. Morgan possesses expert know-how in regulatory submission drafting, platform strategy, intellectual property, and project management.
Mr. Morgan is currently expanding Eagle's growth strategy; requiring new business methods for improving volume, speed-to-market and customer service. These are adjunct areas to which Mr. Morgan has consistently excelled having launched many medical devices with companies such as: Abbott Laboratories, Meditrina, and Stryker. Using his "advantage maker" leadership approach, he has brought to market episodic blood glucose meters; wireless continuous glucose monitoring systems; drug infusion pumps; and several electrosurgical systems.
His product design skills are highly sought after as are his engineering skills in both electromechanical-engineering and injection molding. Educated at Brown University, Providence, Rhode Island, Mr. Morgan gained a BSc. in Mechanical Engineering and a BA in Semiotics. At the University of California at Berkeley he became a Registered Professional Engineer and was awarded a Certificate in Project management. In 2000 Mr. Morgan was also awarded Project Management Professional designation from the Project Management Institute. At Eagle Medical, he leads with efficient and FDA compliant manufacturing, sterilization, packaging & packaging design service options for the medical device industry.
E-mail: info@eaglemed.com
Website: www.eaglemed.com
Phone: 1 (805) 238-7401
On this short episode of the Spot Radio Podcast Charlie Webb CPPL speaks about his visit to the HSPA (healthcare sterile processing association) conference in Nashville Tennessee. Charlie also looks ahead to upcoming discussions on spot radio...
Host bio:
Charlie A. Webb CPPL | Founder & CEO of Van der Stähl Scientific
Charlie Webb CPPL is the founder and President of Van der Stahl Scientific; a medical device packaging and testing machine provider and packaging testing and calibration laboratories. He also hosts the popular Podcast "SPOT Radio" (sterile packaging on track) www.spotradiopodcast.com Charlie was recognized in the Rode Podcast awards as the top 100 ‘Highly Commended Podcast for his Podcast "Antidote to Despair" Charlie earned his BS degree in Management at University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 26 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, he is a co-PM in the Kiip group and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.
His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. His patented seal-through HTIP system isolates the donor tissue during packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increases packaging machine component life cycles, saving money while managing infection risks to donor recipients.
His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.
E-mail:
Charlie@vanderstahl.com
Website:
www.vanderstahl.com
www.spotradiopodcast.com
On this episode of SPOT radio Charlie Webb speaks with members of the Pack-Out conference that will be held in Austin Texas, May 9-11. This is the 2nd year of the Pack-Out and this healthcare packaging conference promises to bring exciting new additions to the attendee. Built into the architecture of this conference will be experiences designed to facilitate peer connection and foster industry learning. Listen in and learn more about the exciting plans for this year's healthcare packaging conference, the Pack-Out.
About: The Pack-Out conference:
To advance the industry and continue building a strong community, we need a new, single-industry event that meets the needs of both packaging engineers and suppliers – we’re ready for [out]standing!
The problem is that there are limited options available for our specialized profession. The content and accommodations of legacy events have not kept pace with expectations, leaving the healthcare packaging community without an acceptable forum to come together and share ideas that advance the industry and build strong networks.
We came together and created the[PACK]out because we believe the future of healthcare packaging shouldn’t be left in the hands of event planners. As industry packaging professionals and suppliers, we understand how frustrating it can be to spend precious marketing dollars at conferences that don’t produce the results you’d hoped for and lack consistent technical content, which is why a team of industry professionals came together to change the model. (description from the Pack-Out website)
LinkedIn connections for today's guests:
Sarah Rosenblum: https://www.linkedin.com/in/sarahrosenblum/
Karen Polkinghorne: https://www.linkedin.com/in/karen-polkinghorne/
Kiley Djupstrom: https://www.linkedin.com/in/kileydjupstrom/
Cassandra Ladd: https://www.linkedin.com/in/cassandra-ladd-7b138241/
Websites: https://www.thepackout.com
E-mail: info@thepackout.com
On this episode of the SPOT radio Podcast, Charlie Webb CPPL speaks with Sarah Deputy CKF from Van der Stähl Scientific about preventive maintenance of critical medical device packaging equipment. Learn how PMs can help save a medical device company from a potential packaging recall.
Guest bio: Sarah Deputy
Sarah is a skilled Service technician in Van der Stahl Scientific's ISO 17025 calibration and service center. She performs laboratory studies for medical device pouch seal strength and integrity for validating the sterile barrier system. Sarah is also a skilled calibration technician and calibrates force, time, and thermal environments under Van der Stahl Scientific's ISO 17025 scope of accreditation. Sarah is Kaizen and Six Sigma Green & Black Belt certified, and is currently working towards a CPP certification through the IOPP.
About Van der Stähl Scientific
Van der Stähl Scientific has helped thousands of medical device manufacturers deliver their devices safe and sterile to the point of care. We provide advanced microprocessor-controlled medical device pouch-sealing machinery to deliver seal-to-seal consistency. With a host of medical device validation support options, you can choose from a selected area of support or a complete end-to-end validation
E-mail: Sarah@vanderstahl.com
Website: www.vanderstahl.com
On this episode of SPOT radio Charlie Webb CPPL speaks with Karen Goelst CEO of KleenEdge about their technology that helps manage patient curtain exchange cycles with the aim of preventing patient infections.
Guest bio's:
Karen Goelst | Founder & CEO of KleenEdge
With a 20-year background in architectural specialties and textiles, Karen Goelst became passionate about solving the issues surrounding privacy curtains following her 15-year-old son’s hospital stay with MRSA.
Staying at his bedside she noticed everybody touched the fabric privacy curtain, but the label showed that it hadn’t been exchanged for 14 months. Thankfully her son recovered, but this realization started her journey in trying to understand why curtains weren’t getting exchanged when other touchpoints in the room were thoroughly disinfected. Karen founded KleenEdge to ensure this infection risk did not impact other families.
About KleenEdge
Launched in 2018, the company received early accolades for its innovative Protocol Compliance Software, receiving AHE’s Product Innovation Award, as well as getting patents for the QuickLoad and TeleTrack “no ladder” curtain exchange cubicle track solutions. KleenEdge’s solutions have helped many healthcare facilities dramatically reduce operational costs while having peace of mind knowing that their curtain exchanges are compliant and deliver the highest standard of care for their patient’s safety.
KleenEdge builds its privacy curtain solutions on 4 pillars:
· Protocol software that monitors curtain exchange compliance
· Sustainable cost-saving recyclable curtains
· No-ladder solutions to promote lean workflows and safety
· Patient and staff safety
E-mail: kgoelst@KleenEdge.com
Website: www.kleenedge.com
On this episode of SPOT radio, Charlie Webb CPPL speaks with Jennifer Benolken, Sarah Rosenblum, Dannette Casper, Cassandra Ladd, and Arthur Castronovo from the Medical Device Packaging Technical Committee (MDPTC) about the success of the inaugural "Fundamentals of Medical Device Packaging" course. Listen in and learn about this valuable course as well as the big news that the course will also be available at the MD&M West meeting in Anaheim California in February.
Jennifer Benolken CPPL, is a Medical Device and Regulatory Package Engineering Specialist with DuPont Tyvek® Medical Packaging. Jennifer works with DuPont Tyvek®’s medical and pharmaceutical downstream customers. For the past 30 years, Jennifer has played an active role in the medical device packaging community through industry organizations, speaking engagements, and by holding a variety of different roles in the value chain, including packaging, labeling, and sterilization. Currently, Co-Chair and DuPont’s Primary Member for AAMI’s ST/WG7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7, Jen also represents the U.S. as a delegate to the ISO Packaging Working Group. Additionally, Jen is the Sub-Committee Chairperson for ASTM F02.50, Package Design, and Development. Jen has been a long-term member of the Institute of Packaging Professionals, currently serving on the National Board of Directors. She also is Chairperson for IoPP’s Medical Device Packaging Technical Committee.
Arthur Castronovo CPPL is a Packaging Engineering professional who has over 32 years of experience working in R&D, Operations, and Supply Chain organizations. In addition to Medical Devices, he has also worked in the Consumer Products and Personal Care Industries. Art's specialties include strategically developing, resourcing, and leading Packaging Engineering and Global labeling departments. His strengths include technical problem-solving, change management, cross-functional collaboration, packaging development, labeling systems, validation, and operations management.
Sarah Rosenblum is the Senior Director of Sales & Marketing at Packaging Compliance Labs (PCL). Currently, she is co-leading initiatives for Kilmer Innovations (KiiP) in Aseptic Presentation and serving as a board member for the Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals (IoPP). After starting her career at an advertising agency in Chicago, she had the desire to make a difference with her work. Following her father being diagnosis of Parkinson’s, she decided to take her talents to PCL in 2016 with the initiative to help advance the medical and pharmaceutical industries through packaging. Sarah is a continuous student in the field of packaging engineering and always looks for new opportunities to learn from her mentors, peers, and colleagues.
Cassie Ladd is the Sr. Marketing Manager at Packaging Compliance Labs (PCL). Cassie’s primary roles at PCL are managing and building the public reputation of PCL through marketing and assisting the sales team by creating funnels to generate qualified leads. Cassie is one of the founding members of thePACKout and assists with graphic design and marketing efforts for the Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals (IoPP). After starting her career at a marketing agency and working freelance as a graphic designer in Grand Rapids, she realized clients weren’t fulfilling her desire to help others. She listed the qualities that she wanted her next job to have which quickly led her to PCL. Working at PCL and in the sterile medical device packaging industry feeds her desire to do work that matters and help others by keeping patients safe.
Registration Link: https://lnkd.in/gt2JRkyP
LinkedIn page: https://www.linkedin.com/company/iopp-mdptc
On this episode of SPOT radio, Charlie Webb CPPL and Pieter Van Gool speak with Eddy van den Berg of Pharmafilter B.V. about their company's amazing technology that provides a much deeper solution for hospital waste stream management. The centralization of the waste stream holds incredible promise for reducing the expanding burden of hospital waste.
Guest bio's:
Pieter Van GoolStrong product development professional with demonstrated capabilities in leadership, strategy, innovation management, product development and industrial design, and significant experience in the medical device packaging industry. Focused on including patient safety till the point of care and improving patient outcomes. Formerly worked at Nelipak Healthcare Packaging with multiple international leadership roles in packaging design, development, and innovation management. Active member in Kilmer innovations in Packaging; Co-Chair Education committee, Sustainability Program member, Marketing and Communication and Branding committee member. Active member of the Sterile Barrier Association; Co-Chair Education Committee.
About SÜDPACK MEDICAServed the global medical device, pharmaceutical and diagnostics industries for over 30 years. Our company’s mission and passion are to help to improve people's lives with safe and reliable sterile packaging at the point of use. SÜDPACK Medica is a specialist in co-extrusion of plastic films, and we convert sterile barrier systems in cleanrooms, such as pouches, bags, die-cut lidding, to name a few. Environmental, economic, and social responsibility are deeply rooted in our DNA, combined with product protection and patient safety as top priority. With a plant for biopolymers and compounding, SÜDPACK Medica is a competent partner for forward-looking, sustainable packaging concepts.
E-mail: Pieter.vanGool@suedpack-medica.com
Website: www.suedpack-medica.com
Eddy van den Berg
Eduardo previously held senior management posts at the Hilton Group
Benelux. In 2001 he founded EcoVase International a company focused on
developing single use disposal environmental products for use in
hospitals. He successfully introduced his first product a disposable flower
vase into hospitals in the Benelux and Germany.
The idea for Pharmafilter originated in 2005 as result of his observations
and daily consultation with hospital staff. He applied his findings and
combined with his previous years experience in hotel management to the
development of Pharmafilter. Pharmafilter today is being introduced to
hospital across Europe and this is as a result of his passion, vision,
creativity, skill and entrepreneurial drive.
Website: www.pharmafilter.nl
E-mail: info@pharmafilter.nl
On this episode of SPOT radio, Charlie Webb CPPL speaks with Don Alip and Randall Troutman from the SPMC (sterilization packaging manufacturers council) on this episode of SPOT radio you will learn the history as well as future plans for sterile packaging days events.
Guest bio's:
Don Alip is the Director of Product Excellence, Healthcare with Amcor and is responsible for driving the product growth strategy and leading Amcor’s product management and field service teams. Since 2019, Don has served as Marketing Committee Chairman for the Sterilization Packaging Manufacturer’s Council (SPMC), an industry organization dedicated to developing consensus on test methodology among industry-leading sterilization packaging manufacturers and publishing guidance documents for healthcare packaging validations. He can be reached at https://www.sterilizationpackaging.org/members/amcor.
Randall Troutman is a Senior Executive business leader with a history of building and empowering high-performance teams in the packaging industry. 20 plus years of advancing technical, commercial, and business leadership roles driving market expansion, revenue growth, profit enhancement and overall enterprise value creation strategies.
Excelled in roles accountable for Strategic Planning, International Expansions, M&A Assessment/ Integrations, and P&L responsibility. Worked in various business ownership structures under Public, Private Family Owned, and Private Equity funded enterprises.
Expertly skilled in Business Development, Sales/ Marketing Leadership, Research and Development, U.S. Food and Drug Administration (FDA)/ EU MDR Regulations, Antitrust related matters (DOJ), Third Party (external consultant) Operational Improvement Programs, and Value Creation Strategic Plan Execution.
Website: https://www.sterilizationpackaging.org/
On this episode of SPOT radio, Charlie Webb CPPL speaks with Brian Nissen, Jennifer Benolken, and Amy Stewart from the IOPP's
Medical Device Packaging Technical Committee (MDPTC) about the upcoming "Fundamentals of Medical Device Packaging" course. Listen in and learn about this exciting new event.
Guest bio's:
Brian Nissen, CPP received his Bachelor of Science in Mechanical Engineering from the University of Minnesota. He has been with QTS for twelve years and currently holds the position of Project Engineering Manager. Brian has over twenty years of experience in the medical device industry and has previously held positions at Medtronic, St. Jude Medical, American Medical Systems, and Lifecore Biomedical. Brian holds current certifications as a Certified Packaging Professional (CPP) and Six-Sigma Green Belt (CSSGB) Certified Lean Practitioner and has previously held certifications as a Certified Quality Engineer (ASQ-CQE) and Certified Quality Auditor (ASQ-CQA)
Amy Stewart, Product Development Manager - Printpack Medical, has 25 years of experience in the flexible packaging industry in operations and technical roles for healthcare and various other markets including food, health and beauty and industrial. Amy is committed to impacting patient safety through her work and with industry organizations in medical device packaging. She serves as program leader for the IoPP Medical Device Packaging Technical Committee Fundamentals of Medical Device Packaging course and formerly served as Chairperson of MDPTC, named 2020 Technical Committee of the Year. Also, Amy serves on the FPA Sterilization Packaging Manufacturers Council (SPMC), which established the annual Sterile Packaging Day and promotes patient safety awareness and celebrates the supply chain organizations dedicated to patient safety. Additionally, Amy supports leadership programs as a mentor within her organization and specifically, women's leadership in the Greater Atlanta business community.
Jen Benolken, CPPL, is a Medical Device and Regulatory Package Engineering Specialist with DuPont Tyvek® Medical Packaging. Jennifer works with DuPont Tyvek®’s medical and pharmaceutical downstream customers. For the past 30 years, Jennifer has played an active role in the medical device packaging community through industry organizations, speaking engagements and by holding a variety of different roles in the value chain, including packaging, labeling and sterilization. Currently Co-Chair and DuPont’s Primary Member for AAMI’s ST/WG7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7, Jen also represents the U.S. as a delegate to the ISO Packaging Working Group. Additionally, Jen is the Sub-Committee Chairperson for ASTM F02.50, Package Design and Development. Jen has been a long-term member of the Institute of Packaging Professionals, currently serving on the National Board of Directors. She also is Chairperson for IoPP’s Medical Device Packaging Technical Committee.
Registration Link: https://www.iopp.org/i4a/pages/index.cfm?pageid=4833
LinkedIn page: https://www.linkedin.com/company/iopp-mdptc
e-mail: jennifer.a.benolken@dupont.com
In this two-part episode of SPOT radio, Charlie Webb CPPL speaks with Carol Barnum Ph.D. from the UX firm about the human connection piece for medical devices and medical device packaging to the clinician. Carole provides insight during this engaging conversation on how the UX Firm guides clients through comprehensive user research projects and single usability studies. UX Firm’s toolkit of usability services includes usability testing, human factors validation testing, and a wide variety of UX research tools to uncover user experience at every stage of development.
About: Carol Barnum
Carol Barnum brings her academic background and years of teaching and research to her work with clients to deliver the best research approaches that have proven to produce practical solutions. Carol’s many publications (6 books and more than 50 articles) have made a substantial contribution to the body of knowledge in the UX field. Her latest book Usability Testing Essentials: Ready, Set…Test!(2nd edition, 2021) is used by professionals and students around the world.
Carol has received top honors, awards, and recognition for her work in many ways. The Society for Technical Communication has awarded her the designation of Fellow and the distinction of the Rainey Award for Research and the Gould Award for Excellence in Teaching. IEEE Professional Communication Society has honored her with the 2013 Blicq Award for Distinction in Technical Communication Education. Also in 2013, Carol was named one of the Top 20 Women Professors in Georgia.
Websites: www.uxfirm.com
e-mail: carolbarnum@uxfirm.com
Phone: 404.881.8136 or 404.680.0329 (cell)
In this two-part episode of SPOT radio, Charlie Webb CPPL speaks with Carol Barnum Ph.D. from the UX firm about the human connection piece for medical devices and medical device packaging to the clinician. Carole provides insight during this engaging conversation on how the UX Firm guides clients through comprehensive user research projects and single usability studies. UX Firm’s toolkit of usability services includes usability testing, human factors validation testing, and a wide variety of UX research tools to uncover user experience at every stage of development.
About: Carol Barnum
Carol Barnum brings her academic background and years of teaching and research to her work with clients to deliver the best research approaches that have proven to produce practical solutions. Carol’s many publications (6 books and more than 50 articles) have made a substantial contribution to the body of knowledge in the UX field. Her latest book Usability Testing Essentials: Ready, Set…Test!(2nd edition, 2021) is used by professionals and students around the world.
Carol has received top honors, awards, and recognition for her work in many ways. The Society for Technical Communication has awarded her the designation of Fellow and the distinction of the Rainey Award for Research and the Gould Award for Excellence in Teaching. IEEE Professional Communication Society has honored her with the 2013 Blicq Award for Distinction in Technical Communication Education. Also in 2013, Carol was named one of the Top 20 Women Professors in Georgia.
Websites: www.uxfirm.com
e-mail: carolbarnum@uxfirm.com
Phone: 404.881.8136 or 404.680.0329 (cell)
On this episode of SPOT Radio Charlie Webb CPPL speaks with Karen Greene CPPL about the ASTM F-88 medical device pouch testing method. As laboratory owners Charlie Webb CPPL and Karen Greene CPPL provide a fresh optic to the discussion developed from their voice of the customer insight.
Guest Description:
Karen Greene is a tenured packaging professional, A CPPL certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.
30+ years of professional experience in package engineering. 22 years in medical device and pharmaceutical package engineering and engineering services. Leadership experience, 20+ years.
Specialties: Sterile barrier packaging, structural packaging, films, cushioning, and regulatory compliance for the medical device industry. ISO 11607, ASTM, and ISTA standards. IQ, OQ, and PQ for packaging designs and packaging equipment. DOE experience, test method development, accelerated aging, and pkg design qualifications. Package design and prototyping for sterile medical packaging(sterilization) and all types of structural packaging designs. Thermal package design, development, and validation.
Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.
You can learn more about her package engineering services which include package design, prototyping, as well as validation consulting by visiting her website.
Contact: www.lifepacklabs.com
On this episode of SPOT radio, Charlie Webb speaks with Cord Burnham regarding needless regulatory and packaging process risks due to inaccurate calibrations and poorly maintained medical device packaging machinery. Cord Burnham highlights process failures from his experience as the service Director and calibration laboratory manager at Van der Stahl Scientific's ISO 17025 laboratories.
About: Cord Burnham CKF Cord Burnham is the director of laboratory services for Van der Stahl Scientific's ISO-17025 accredited calibration laboratory. Cord has traveled throughout the country providing technical and calibration services to the largest and smallest medical device manufacturers. He is Six Sigma trained and a Kaizen trainer.
Websites: http://www.vanderstahl.com
E-mail: Cord@vanderstahl.com
Phone:800-550-3854
On this episode of SPOT radio, Charlie Webb speaks with Jeff Barrett President and CEO of J-Pac Medical. Jeff gives keen insight from the point of view of a contract provider of assembly, packaging, and sterilization. Because contract packagers see a variety of packaging configurations, materials, and sterile delivery requirements, their global vista often can provide fast solutions for a host of healthcare packaging challenges.
About: Jeff Barrett
Jeff Barrett is the President and CEO of J-Pac Medical. Jeff has more than 25 years of experience building high-growth medical product-based companies. He leads the advancement of J-Pac’s growth strategy, pursuing opportunities to further drive adoption of the company’s offerings and optimizing capabilities to better serve customers.
Prior to joining J-Pac Medical, Barrett held CEO positions at GI Supply and Optim LLC and Vice President of Operations roles at Haemonetics and Aspect Medical Systems. He is also a successful entrepreneur. By applying his operational and engineering aptitude, Barrett founded Eggrock Modular Solutions, which became a disruptive business in the building technology industry. Barrett has proven expertise building and managing high-performance management teams, developing and implementing optimized operating infrastructure and manufacturing processes, and both improving existing product pipelines and growing new ones.
Barrett holds an MBA from Boston University’s Graduate School of Management, a B.S. in industrial engineering, and a B.A. in economics from Rutgers University.
Websites: https://www.J-pacmedical.com
E-mail: JBarrett@j-pacmedical.com
Phone: 603-692-9955
On this episode of SPOT radio, Charlie Webb has an edifying conversation with Jeremy Stackawitz from Senzo about the future of at-home diagnostics systems. As this new market grows in healthcare it is a great time to ponder how medical device packaging will support this new end-point. This new paradigm will surely launch new growth for medical device and diagnostic packaging machines and material providers.
About Jeremy Stackawitz:
Jeremy holds a science degree from Dartmouth and earned his MBA in Healthcare management from Wharton. He has 25+ years in healthcare with 15 of those years in diagnostics. At present Jeremy is CEO of Senzo, he resides in Pennsylvania with his wife and 3 kids and loves bringing innovative products to market.
About Senzo:
Senzo, is a leading in vitro diagnostics company, that recently announced the successful development, and completion of a new 7-minute Covid-19 lateral flow rapid antigen Self-Test with the same accuracy as professional laboratory PCR tests, the industry’s gold standard. In an operator-blind study of 59 positive and 101 negative Covid-19 test samples, across all major variants, the Senzo Amplified Lateral Flow (ALF) test achieved 98.3% positive percent agreement (PPA) and 99.0% negative percent agreement (NPA) with PCR results, and 100.0% positive percent agreement (PPA) for samples with a Ct value between 33 - 38, representing very low levels of target nucleic acid in the sample.
LinkedIn:
https://www.linkedin.com/in/jeremystackawitz/
Websites:http://www.senzo.com
https://www.emdevicelab.com
E-mail:
Jeremy@senzo.com
On this episode of SPOT radio, Charlie Webb speaks with founding members of the Pack-Out conference that will be held in Austin Texas, May 10-12. The Pack-Out promises to bring an exciting new attendee experience designed to facilitate peer connection and foster industry learning. Listen in and learn more about this exciting new medical device packaging professional conference.
About: The Pack-Out conference:
To advance the industry and continue building a strong community, we need a new, single-industry event that meets the needs of both packaging engineers and suppliers – we’re ready for [out]standing!
The problem is, there are limited options available for our specialized profession, the content and accommodations of legacy events have not kept pace with expectations, which leaves the healthcare packaging community without an acceptable forum to come together and share ideas that advance the industry and build strong networks.
We came together and created the[PACK]out because we believe the future of healthcare packaging shouldn’t be left in the hands of event planners. As industry packaging professionals and suppliers, we understand how frustrating it can be to spend precious marketing dollars at conferences that don’t produce the results you’d hoped for and lack consistent technical content, which is why a team of industry professionals came together to change the model. (description from the Pack-Out website)
LinkedIn connections for today's guests:
Rod Patch: https://www.linkedin.com/in/rod-patch-756227a/
Sarah Rosenblum: https://www.linkedin.com/in/sarahrosenblum/
Jenn Goff : https://www.linkedin.com/in/jenn-goff-8714785/
Karen Polkinghorne: https://www.linkedin.com/in/karen-polkinghorne/
Kiley Djupstrom: https://www.linkedin.com/in/kileydjupstrom/
Websites: https://www.thepackout.com
E-mail: info@thepackout.com
On this episode of SPOT radio, Charlie Webb continues his conversation with Pat Kothe a medical device innovator and host of the mastering medical device Podcast. On this two-part podcast, they cover a gambit of issues surrounding medical device and packaging development including sustainability, innovation hierarchies, and balancing the voice of the customer with product development.
About SPOT Radio guest Pat Kothe
Pat Kothe has spent his entire career in the Medical Device industry and is currently the CEO of EM Device Lab, Inc., an early-stage company that provides a breakthrough product for treating abscesses. During his career, he and his teams have successfully launched over 50 implantable and external hardware and software devices, including brain health assessment devices, ECG algorithms, heart valves, and interventional and diagnostic cardiology products. He was founding CEO at NeuroChaos Solutions and contributed to Marketing and Sales leadership roles at Monebo Technologies, Sulzer CarboMedics, Mallinckrodt Medical, and American Hospital Supply Corporation. Pat earned a B.S. in Business Administration from Carroll University.
LinkedIn:
www.linkedin.com/in/patrick-kothe
Websites:
https://www.masteringmedicaldevice.com
https://www.emdevicelab.com
pkothe@emdevicelab.com
On this episode of SPOT radio, Charlie Webb speaks with Pat Kothe a medical device innovator and host of the mastering medical device Podcast. On this two-part podcast, they cover a gambit of issues surrounding medical device and packaging development including sustainability, innovation hierarchies, and balancing the voice of the customer with product development.
About SPOT Radio guest Pat Kothe
Pat Kothe has spent his entire career in the Medical Device industry and is currently the CEO of EM Device Lab, Inc., an early-stage company that provides a breakthrough product for treating abscesses. During his career, he and his teams have successfully launched over 50 implantable and external hardware and software devices, including brain health assessment devices, ECG algorithms, heart valves, and interventional and diagnostic cardiology products. He was founding CEO at NeuroChaos Solutions and contributed to Marketing and Sales leadership roles at Monebo Technologies, Sulzer CarboMedics, Mallinckrodt Medical, and American Hospital Supply Corporation. Pat earned a B.S. in Business Administration from Carroll University.
LinkedIn:
www.linkedin.com/in/patrick-kothe
Websites:
https://www.masteringmedicaldevice.com
https://www.emdevicelab.com
pkothe@emdevicelab.com
On this episode of SPOT radio, Charlie Webb speaks with Pieter Van Gool with SÜDPACK MEDICA AG in Zürich Switzerland about a host of subject-centered around industrial design for medical device packaging. Charlie and Pieter chat casually about their own experiences with VOC "voice of the customer" data collection and highlight new ways our industry may collect data about subjects such as medical pouch opening challenges.
About SPOT Radio guest Pieter Van Gool
Pieter is a product development professional that has demonstrated capabilities in leadership, strategy, innovation management, product development, industrial design, and significant experience in the medical device packaging industry. He is focused on patient safety with his attention on better sterile barrier containment systems to deliver devices safe and sterile to the point of care with the aim of improving patient outcomes. Pieter has held multiple leadership roles in both the United States and Europe, acquiring different international cultural skills. These skills include lead Design, Development Management, and Innovation Management to name a few, working closely with global leading Medical Device companies. Pieter is experienced in using the power of collaboration and innovative thinking to meet the ambitions of both internal and external customers and he creates a positive atmosphere with an enthusiastic and disciplined project approach built on trust and strength. Pieter is a member of the KiiP (Kilmer innovation in packaging) for both the Sustainability and Education Group.
E-mail: pieter.vangool@suedpack-medica.com
Website: www.suedpack-medica.com
Podcast Episode Description:
In this episode of SPOT radio, Charlie Webb talks about what is coming up on SPOT radio for the year ahead. Charlie also talks about machine innovation from his point of view from his 30 years in Healthcare innovation and marketing. He explains a new mobile app for medical device packaging engineers and quality managers that he strongly believes will forever change the way packaging engineers will interact with their packaging systems.
About SPOT Radio Host Charlie Webb CPPL
Charlie Webb is the founder and President of Van der Stahl Scientific; A medical device packaging and testing machine provider. He also hosts the popular Podcast "SPOT Radio" (sterile packaging on track) www.spotradiopodcast.com Charlie was recognized in the Rode Podcast awards as the top 100 ‘Highly Commended Podcast for his Podcast "Antidote to Despair" Charlie earned his BS degree in Management at the University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 26 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.
His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. His patented seal-through HTIP system isolates the donor tissue during the packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increase packaging machine component life cycles, saving money while managing infection risks to donor recipients.
His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.
www.vanderstahl.com
Charlie@vanderstahl.com
On this episode of SPOT radio, we speak with best-selling author Nicholas Webb about his mission surrounding employee happiness. The quality and value of your product or service are driven by employee morale. With mission-critical companies that develop medical devices, tainted outcomes can risk patient health and safety. A Gallup poll finds that 22 million dissatisfied and disengaged employees will cost the US economy nearly $350 billion each year in lost productivity from absenteeism as well as other problems due to an unhappy workplace.
Guest Description:
Nick captivates audiences worldwide as an engaging speaker, speaking with tens of thousands of people each year at live events. As an inventor, Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industrial and consumer products, including one of the world’s smallest medical device implants.
A prolific writer and bestselling author, his current breakthrough books include The Innovation Mandate. What Customers Crave, Hey Day, and What Customers Hate. These books are used by top brands to design their customer experience and innovation strategies. Nick works closely with Fortune 500 companies throughout the world to help them lead their industries in innovation, strategy, and growth.
As one of the world’s leading innovation futurists, Nick Webb, is the CEO of LeaderLogic, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.
www.nickwebb.com
https://www.goleaderlogic.com/
On this episode of SPOT radio, Charlie Webb speaks with Dr. Julie Suggs about online learning and certification programs from Packagingschool.com. With so much evaluation and innovation in the packaging industry, continuing education will play an important role in moving stakeholder's knowledge forward. These affordable and flexible courses designed for working professionals will help keep the packaging industry strong.
Guest Description:
Julie Rice Suggs Ph.D. obtained her Ph.D. in Food Technology at Clemson University. She is currently the Academic Director for The Packaging School, which offers 100% online and affordable specialized certificate programs and courses in the packaging industry. She is the lead instructor for the Certificate of Mastery in Packaging Management Program run through Clemson Center for Corporate Learning and works closely with the creative team to build instructional content for various companies. Julie has published ten papers in various prestigious packaging journals. During her time at Clemson, Julie has traveled to Campinas, Sao Paulo, Brazil to present her research at the International Association of Packaging Research Institutes Conference. In her spare time, Julie takes part in the Big Brothers Big Sisters Program.
Contact:
Website: www.packagingschool.com
E-mail: info@packagingschool.com
Phone: 864-412-5000
On this episode of SPOT radio, Charlie Webb speaks with Ehsan Mokhbery from FUTEK about the wide range of force and torque sensing systems that FUTEX offers. With smaller sensing system, many new opportunities to utilize this technology is opening up for a medical device developers.
Guest Description:
Ehsan Mokhberi joined FUTEK in 2005, focused on the development of FUTEK's organizational systems and sales. He has spearheaded various successful internal and customer relations programs and is the main liaison between FUTEK’s headquarters and its national and global customers and representatives.
About FUTEK:
FUTEK Advanced Sensor Technology is a leading provider of strain gauge sensor solutions (force, torque, pressure), instrumentation, software, and calibration services that are at the forefront of sensor technology.
With its headquarters and manufacturing facilities located in Irvine, Southern California, FUTEK products are designed and manufactured under one umbrella, allowing for a highly efficient and innovative ecosystem that includes multidisciplinary engineering teams, a high precision machining center, exceptionally advanced calibration facilities, and state of the art quality assurance systems.
The company was founded in 1988 by Javad Mokhbery, who left his career as a senior engineer at Rockwell to fulfill his ambition to create high-quality sensor solutions that would help advance the future of technology. Three decades later, his American dream has come to fruition. FUTEK has grown from a one-man operation in a small apartment to an industry powerhouse with 150 team members, 100,000 sq ft manufacturing space, 3,400 off-the-shelf products, and a client roster that includes the likes of NASA, Google, MIT, and J&J. With offerings that include standard catalog items, OEM sensors, and fully custom solutions, FUTEK employs unparalleled and all-encompassing quality assurance processes that meet and exceed stringent ISO certification standards. “Failure is not an option” is a popular expression among team members.
Another cornerstone of FUTEK’s culture is the confidence and drive to take on challenging and unique applications, giving the team a greater appreciation of potential sensor capabilities, pushing them to continuously find new areas to innovate, and motivating each member to perform to their fullest potential.
Contact:
Website: www.futek.com
On this episode of SPOT radio, Charlie Webb speaks with Ehsan Mokhbery from FUTEK about the wide range of force and torque sensing systems that FUTEX offers. With smaller sensing system, many new opportunities to utilize this technology is opening up for a medical device developers.
Guest Description:
Ehsan Mokhberi joined FUTEK in 2005, focused on the development of FUTEK's organizational systems and sales. He has spearheaded various successful internal and customer relations programs and is the main liaison between FUTEK’s headquarters and its national and global customers and representatives.
About FUTEK:
FUTEK Advanced Sensor Technology is a leading provider of strain gauge sensor solutions (force, torque, pressure), instrumentation, software, and calibration services that are at the forefront of sensor technology.
With its headquarters and manufacturing facilities located in Irvine, Southern California, FUTEK products are designed and manufactured under one umbrella, allowing for a highly efficient and innovative ecosystem that includes multidisciplinary engineering teams, a high precision machining center, exceptionally advanced calibration facilities, and state of the art quality assurance systems.
The company was founded in 1988 by Javad Mokhbery, who left his career as a senior engineer at Rockwell to fulfill his ambition to create high-quality sensor solutions that would help advance the future of technology. Three decades later, his American dream has come to fruition. FUTEK has grown from a one-man operation in a small apartment to an industry powerhouse with 150 team members, 100,000 sq ft manufacturing space, 3,400 off-the-shelf products, and a client roster that includes the likes of NASA, Google, MIT, and J&J. With offerings that include standard catalog items, OEM sensors, and fully custom solutions, FUTEK employs unparalleled and all-encompassing quality assurance processes that meet and exceed stringent ISO certification standards. “Failure is not an option” is a popular expression among team members.
Another cornerstone of FUTEK’s culture is the confidence and drive to take on challenging and unique applications, giving the team a greater appreciation of potential sensor capabilities, pushing them to continuously find new areas to innovate, and motivating each member to perform to their fullest potential.
Contact:
Website: www.futek.com
On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the one-pound peel value for medical device packaging validation. Does your packaging validation plan rest on the one-pound seal strength standard? Listen in and learn why this may be an arbitrary value that could be a process risk.
Guest Description:
As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems, and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of 483, and 90 CAPAs, while rebuilding the CAPA system.
Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
Elon Golbaum
Contact:
Website: http://www.networkpartners.com/
e-mail: elon.goldbaum@networkpartners.com
On this episode of SPOT radio, Charlie Webb speaks with Julio G. Martinez-Clark about the expansion of trade in medical devices and pharmaceuticals from Latin America. We will discuss the possibility of Latin America being a sleeping giant for med-tech.
Guest Descriptions:
Julio G. Martinez-Clark believes that Colombia represents an untapped destination for medical device manufacturers to do clinical research and one of the perfect country gateways to enter the Latin American market. Julio is the CEO of bioaccess™ –a contract research organization (CRO) and market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Colombia and the rest of Latin America. Julio is a recognized medical device expert, and his insights on the medical device industry have a voice in industry-leading publications such as Med Device Online and Clinical Leader. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. Julio currently serves as an advisory board member for Stetson University's Leading Disruptive Innovation program. His past experiences include technology consultant for Johns Hopkins Hospital, a co-founder and president of a successful real estate investment firm, startup ventures in the telecom and computer industries, and technical and business positions at global telecom and networking companies, including Lucent and Nortel. Julio has a bachelor's degree in electronics engineering from Saint Thomas University in Bogota, Colombia, and a master's degree in business administration (M.B.A.) from Western New England University in Springfield, MA. Julio lives in Orlando, FL.
Contact Information:
Email: jmclark@bioaccessla.com
Phone number: +1 (954) 903-7210
LinkedIn: https://www.linkedin.com/in/juliomartinezclark/
vCard: http://bit.ly/julio-martinez-clark-digital-card
Website: www.bioaccessla.com
Additional Links:
The Pacific Alliance: https://alianzapacifico.net/en/what-is-the-pacific-alliance/
OECD: https://www.oecd.org/latin-america/
PROCOLOMBIA: https://investincolombia.com.co/en/sectors/healthcare-services-and-life-sciences/pharmaceutical-sector
On this episode of SPOT radio, Charlie Webb speaks with Adam Peek about the good and the bad news regarding packaging sustainability. Listen in as Charlie and Adams discuss the unique challenges in medical device packaging sustainability and how these challenges have been addressed. Adam Peek also chats about exciting new technologies that will provide sustainability solutions for a growing population.
Guest Descriptions:
Adam Peek is an MBA and a consultative sales professional with over 14 years in the printed packaging world, Adam digs in with packaging engineers, designers, supply chain personnel, financial analysts, sales, marketing, operations, logistics, and product people to help them figure out where they are and where they want to be. Sometimes the goal is better functioning packaging. Sometimes it's more sustainable packaging. Sometimes it's better-looking packaging. Whether it's personal care, CPG, pharmaceutical, med device, home care, food, beverage, cannabis/healthcare, or industrial, he is there to help.
Adam also co-hosts the "People of Packaging" Podcast.
Ted-Talk: https://youtu.be/-WOBqfJM2lk
Linkedin: linkedin.com/in/adampeek
Website: adampeek.com
Phone: 719-551-2374 (Mobile)
Email: adam@peopleofpackaging.com
On this episode of SPOT radio, Charlie Webb speaks with Lindsay Lannelli a candidate connection Specialist for the Adept Group about her experience working from home. Many people turned their time at home into gains on domestic projects and they sharpened their work skills. Listen in on how Lindsay approached the shutdown era.
Guest Descriptions:
Lindsay Iannelli is a Candidate Connection Specialist for Adept Group, where she connects the leading brands in the Life Science, Food, Beverage, and CPG industries to elite packaging talent to unlock opportunities and create solutions. The Adept Group delivers best-in-class engineering, consulting, talent, and digital solutions for the packaging world.
Website:
www.adeptpackaging.com
Phone: 610-739-7347
Email: Lindsay.iannelli@adeptpackaging.com
Linkedin: www.linkedin.com/in/lindsay-iannelli-7a56a4b7
On this episode of SPOT radio Charlie Webb speaks with Tom Widroe from the Tom Widroe Group on the future of dispersed employees. We also chat about key motivators that will attract better employee candidates by expanding flexible work location options.
Guest Descriptions:
Thomas Widroe is the founder and principal of The Widroe Group, since 1998, T-W-G has been helping public, private, and non-profit organizations win the war for talent. Tom Widroe's placement expertise in a host of industries including technology, healthcare, professional services, finance, manufacturing, and government agencies.
Tom worked as an operation executive at Bargain Network, a $75 million subscription-based information service with over 700 employees. Tom’s education includes two degrees from the University of California, Santa Barbara.
Contact:
Website: www.practiceinparadise.com
email: tomwidroe@icloud.com
Phone: 805.680.7772
On this episode of SPOT radio, Charlie Webb speaks with Mark Escobedo a Senior Sales Engineer at Westpak about the process of accelerated aging. This podcast provides a solid overview from the vista of a medical device packaging testing laboratory. Westpak is an ISO 17025 Accredited Independent test laboratory. Their Laboratory covers a variety of testing processes including Environmental conditioning, Package Performance testing, as well as Accelerated and real-time aging.
Guest Descriptions:
Mark Escobedo is a Senior Sales Engineer at Westpak providing technical expertise in the medical device and pharmaceutical industries. Mark holds a degree in Package Engineering from San Jose State University. Mark is also a member of ASTM Committees D10 and F02 where he participates in the development of standards. In addition to writing articles for industry publications, Mark has also conducted seminars on a variety of testing-related topics. His goal is to provide the guidance necessary for a successful regulatory submission as it pertains to packaging.
Contact:
Website:
www.westpak.com
email:
mark@wastpak.com
Phone:
1 (800) 830-8020
On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their upcoming Packaging Validation 101 Webinar. This online event will cover topics such as: determining the appropriate sample size for testing, writing the validation protocol, developing the test plan, selecting appropriate tests, family grouping and worst-case considerations, and creating the appropriate samples.
Guest Descriptions:
Wendy Mach is with Nelson labs, she has over 27 years of medical device manufacturing and laboratory experience. She is a known expert in the MedTech packaging industry, a sought-after speaker, and actively contributes to industry publications.
In her role as Consulting Manager, Wendy works with clients to address their unique needs in order to meet the requirements for packaging validations.
Wendy is a participating member of the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is chairperson of the Packaging & Sterile Barrier SystemsWorking Group for the Society for Sterilization Assurance Professionals (SfSAP). Wendy's participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the demands of the future."
Event link for more information and to register:
https://www.nelsonlabs.com/events/packaging-validation-101/
Contact:
Website: www.nelsonlabs.com
email: wmach@nelsonlabs.com
Phone: 1 (800) 826-2088
On this episode of SPOT radio, Charlie Webb speaks with the technical sales team at Merrill's Packaging. Dan Kelly, Andy D'Esposito CPP, and Kevin Scott provide insight on the process of custom medical thermoforming. This year Merrill's is celebrating its 60th year and is a custom thermoformer based in the California Bay Area with a second location in Costa Rica. They have a custom medical thermoforming focus plus also form food, retail, and electronic packaging. Through the years, they have become a trusted leader in thermoforming, supplying many of the world's largest medical companies.
Guest Descriptions:
Dan Kelly Soon after graduating college in the mid-'90s with a BS in Engineering, Dan moved into a project management/application's engineering role with a top packaging machinery manufacturer in Cape Cod, MA. Soon thereafter he transitioned to a sales role and promoted their business in Europe. In the early 2000's Dan moved back to the states and has been in the custom thermoforming environment ever since. Dan enjoys the healthcare side of packaging as it continuously evolving to better serve the patient. In his spare time, Dan enjoys coaching youth basketball, boating, running road races, and spending time with his wife and their 2 children. dan@merrills.com
Andy D'Esposito CPP graduated from Cal Poly San Luis Obispo in 1981 with a degree in Marketing. After that, he started working in the packaging industry and has been for 40 years with the last 11 years in Medical Packaging. He is on the board for IOPP in Southern California and also on the board for the ASTM F-02 group. Andy received his Certified Packaging Professional certificate about 10 years ago and remains active in his local chapter. His knowledge and experience in various packaging industries allow him to offer customers and prospects a myriad of advice and assistance in their efforts to develop various types of packaging. Having worked for companies large and small he has developed a sales style that fits any sized company. Andy was also part owner in a medium-sized retail thermoforming company in Southern California for 10 years and fully grasps the intricacies of running a business including accounting, human relations, marketing, production, quality control, and inventory management. In his spare time, Andy enjoys boating, skiing, backpacking, golf, travel, and spending time with his family. andy@merrills.com
Kevin Scott has been in custom thermoforming for close to 15 years with a short stint in pharmaceutical packaging. For the past ten years, his primary focus has been on medical & pharma packaging. Since graduating from NC State with an accounting degree in 2000, he has worked in plastics, starting with an injection molder in the accounting department and finding his calling in sales. When he isn't traveling for work or pleasure, he is an avid runner and enjoys professional boxing in his free time. He lives in Raleigh, NC, with his family. kscott@merrills.com
Contact:
Website: merrills.com
email: info@merrills.com
Phone: 800-284-5910
On this episode of SPOT radio, Charlie Webb speaks with Curtis Gippe the director of the Life Science practice at Adept Packaging. In this discussion, we talk about the end-to-end challenges of pre-filled syringe packaging development.
Guest Description:
Curtis Gippe is the director of the Life Science practice at Adept Packaging, which delivers best-in-class engineering, consulting, talent, and digital solutions for the packaging world. He is a driven, highly accomplished Packaging Engineer with expertise in packaging design and development and more than 15 years' experience in pharmaceutical (over the counter and prescription), medical device (auto-injectors, pre-filled syringes, and other injectables), and consumer products (Oral Care, Beauty, Intimate health, and Women's healthcare packaging goods). He is a strong leader and accustomed to working in highly regulated industries. His other specialties include working with IM, IBM, EBM processes, mold qualifications, thermoforming, new packaging development, and platform development.
- ASTM committee member for F02, D10, & D37
- Lean six sigma certified
- Hazmat and Dangerous Goods Certified- Holds a bottle design patent for a class 2 medical device
Curtis Gippe
Contact:
Website: www.adeptpackaging.com
Contact: Curtis Gippe
Director of Life Sciences
Adept Group
c: +1.585.703.4022
o: +1.484.373.2504
www.adeptpackaging.com
On this episode of SPOT radio, Charlie Webb speaks with Don Alip about "Sterile Packaging Day" Listen and learn about this exciting day of awareness that takes place on March 10th, 2021. Please follow the link at the bottom of this Podcast description to view valuable infographics that highlight this event. Don also shares ways that you and/or your company can participate.
Guest Description:
Don Alip is currently Director of Product Excellence, at Amcor, and is responsible for driving the product growth strategy and leading Amcor’s product management and field service teams. Since 2019, Don has served as Marketing Committee Chairman for the Sterilization Packaging Manufacturer’s Council (SPMC), an industry organization dedicated to developing consensus on test methodology among industry-leading sterilization packaging manufacturers and publishing guidance documents for healthcare packaging validations.
Under Don’s leadership, the SPMC will be sponsoring the inaugural Sterile Packaging Day event on March 10, 2021, to create awareness of sterile packaging’s vital role in healthcare and keeping patients safe.
Don Alip
Contact:
Website: https://www.sterilizationpackaging.org/sterile-packaging-day
Contact: https://www.sterilizationpackaging.org/members/amcor.
Podcast Episode Description:
On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.
Guest Description:
Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging.
Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.
Contact:
Website: https://pkgcompliance.com
e-mail: rerickson@pkgcompliance.com
Ryan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits.
Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.
Website: https://pkgcompliance.com
e-mail: rott@pkgcompliance.com
UDI Links for reference:Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here):
https://www.gs1.org/
Download the GS1 General Specifications Guide here:
https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…
FDA website for UDI:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…
Podcast Episode Description:
On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.
Guest Description:
Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging.
Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.
Contact:
Website: https://pkgcompliance.com
e-mail: rerickson@pkgcompliance.com
Ryan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits.
Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.
Website: https://pkgcompliance.com
e-mail: rott@pkgcompliance.com
UDI Links for reference:Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here):
https://www.gs1.org/
Download the GS1 General Specifications Guide here:
https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…
FDA website for UDI:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…
On this episode of SPOT radio, Charlie Webb talks about expanding the show to cover topics deeper within medical device manufacturing as well as discussions surrounding challenges in the sterile processing departments at hospitals and clinics. As SPOT radio podcast expands the scope of the show packaging engineers will gain valuable insight into all aspects that affect their mission to deliver medical devices safe and sterile to the point of care. Welcome to season three.
Host Description:
Charlie Webb is the founder and President of Van der Stahl Scientific; He also hosts SPOT Radio (sterile packaging on track) www.spotradiopodcast.com
Charlie earn his BS degree in Management at the University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 25 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.
He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 accreditation. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.
His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is the HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. The seal-through HTIP system isolates the donor tissue during the packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increases packaging machine component life cycles, saving money while managing infection risks to donor recipients.
His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.
Contact:
charlie@vanderstahl.com
On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.
Guest Description:As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.
Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
**Elon Golbaum
Contact:**
Website: http://www.networkpartners.com/
e-mail: elon.goldbaum@networkpartners.com
On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.
Guest Description:
As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.
Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.
Elon Golbaum
Contact:
Website: http://www.networkpartners.com/
e-mail: elon.goldbaum@networkpartners.com
In this episode of SPOT radio, Charlie Webb speaks with Laura Palker about the future of tradeshows and Expos post-COVID. When will we come together again in close proximity to each other, or will human distancing be a constant to better manage the risk of infectious Disease? The tradeshow and expo industry is developing solutions that will make venues safer and will also develop virtual meetups as a stopgap as the pandemic risk slowly wanes.
Guest Description:
Laura Palker is an accomplished business executive with more than 25 years of experience in the Trade Show Sales and Marketing industry. She is the founder and managing director of Trade Show Solution Center/Trade Show Studio and the Solution Center Network.
Palker has developed a distinguished career working for some of the region’s top companies in the trade show industry where she was able to hone her marketing, logistics, and analytical acumen. Some of the firms that benefitted from her efforts include Exhibit Corporation of America, Exhibit Graphics, and Display Presentations.
In 2002, she branched out on her own with a vision of building a company that did more than simply sell trade show displays – one that supported the entire sales cycle with tools that worked in tandem to grow her clients’ business. That resulted in the founding of Trade Show Solution Center, a full-service agency that offers sales and lead generation tools, marketing collateral, corporate communications, trade show displays and management, and promotional items – all with an eye to presenting a clear, consistent, and compelling message that drives sales and effectively builds your brand.
Palker’s management style emphasizes strong communication, strategic planning, and internal controls to build relationships, revenues, and profits. And, with a reputation for being able to provide creative solutions for even the most complex problems, coupled with her commitment to exceptional customer service, Palker has amassed a loyal following of satisfied customers.
Giving back to the community has always been a priority to Palker as evidenced by her involvement with a variety of philanthropic and professional organizations. Palker serves as President of the Moxxie Mentoring Foundation. She proudly supports her husband as First Lady of the Global Board of Directors for the Institute of Management Accountants. Palker sits on the EAC Network Board and served as former Marketing Chair and the 2014 EAC Spring Luncheon Chair. She served on the EAC Spring Luncheon Committee in 2010, 2011, and 2012 and the EAC Golf Committee in 2011. Finishing her term on the Board of Directors of the Executive Women’s Golf Association, Long Island, NY Chapter as the Sponsorship Chair and former Communications Chair; Palker is now co-site director for LPGA Girls Golf in Long Island.
Leading the way in an annual fundraiser for the American Cancer Society, she chaired the Island Hills Golf Club Babe Zaharias Tournament in 2008 and 2009 and served on the Executive Committee in 2011. Previous to that she served on the Board of the Foundation Fighting Blindness and worked with the Long Island Foundation for Hospice Care and Research where she lobbied in both Albany and Washington D.C. to help build awareness and support for hospice as an alternative to traditional cancer treatment in the late 1980s. Palker continues to offer seminars and webinars on profitable trade show exhibiting and smart selling. She is a regular columnist in Golfing Magazine, Networking Magazine, and hosted the FIOS1 My LI Show “Golfing on Long Island in 2011. Laura Palker and her husband Marc P. Palker reside in South Huntington, NY.
Laura Palker
Contact:
Website: www.tssolutioncenter.com
E-mail: Laura@tssolutioncenter.com
In this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson Vice President of Packaging Compliance labs about the value of outsourcing medical device packaging validation, engineering, and testing lab services. As we develop more complicated medical devices with embedded drugs, packaging systems will continue to become more complex. SME's can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019.
Guest Description:
Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging.
Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.
Ryan Erickson
Contact:
Website: https://pkgcompliance.com
e-mail: rerickson@pkgcompliance.com
In this episode of SPOT radio, Charlie Webb speaks with Lisa Wassberg general manager of Van der Stahl Scientific about the importance of proper machine care. Siloed quality departments often seem unaware of maintenance issues that could risk their sterile packaging program. Listen in and hear the perspective of a medical device packaging machine provider regarding the proper care of the critical equipment.
Guest Description:
Lisa Wassberg is the General manager of Van der Stahl Scientific, she has worked as the general manager of an industrial caster company overseeing the process from development to distribution. She worked as a marketing manager from one of the nation's oldest custom metal fabrication companies developing key national accounts in a highly competitive industry. Lisa is certified as a Kaizen facilitator and co-manages Van der Stahl Scientific's busy ISO-17025 calibration and testing Laboratory.
Lisa Wassberg
Linkedin:
https://www.linkedin.com/in/lisa-wassberg-webb-07769bb/
In this episode of SPOT radio we ask the question, how are medical device manufacturing and packaging engineers managing with the new connection tools such as videoconferencing during this pandemic event? The COVID event continues to make collaboration difficult as packaging validation requires many hands-on steps and connections. In this episode we speak with medical device packaging engineer Swandand Kuuawar from Abbott to learn about his workflow during the challenging COVID event.
Guest Description:
Swanand Kullarwar is a packaging engineer at Abbott and was previously a packaging engineer at Zimmer Biomet. Sawnand holds a master's in packaging science degree from RIT and a bachelors degree in printing engineering from India. Swanand is currently working on his CPP (certified packaging professional) certification.
Swanand Kullarwar
Linkedin:
https://www.linkedin.com/in/swanand-kullarwar-45540716/?msgControlName=reply_to_sender&msgConversationId=6636453303867756544&msgOverlay=true
On this episode of SPOT radio, we discuss protecting our brands and products from counterfeiters with our guest Robert Sherwood from Veritrace. Worldwide sales of counterfeit medications could top $75 billion this year. This is a 90% rise in five years according to an estimate published by the Center for Medicine in the Public Interest of the United States of America. This influx of counterfeit medicines into the marketplace poses huge risks to consumers. Robert speaks to solutions that Veritrace has created to combat this threat.
Guest Description:
Robert Sherwood, CPP, is a security print and software technology specialist with 25 years of Brand protection experience. He designs security solutions to protect IP, products, revenue, customers, and to reduce liability. He applies a total approach to brand protection solutions by analyzing counterfeiting, diversion, supply chain security, packaging, and stakeholder concerns.
His packaging and labeling expertise includes security design, anti-counterfeit print technologies, substrates, adhesives, specialty converting, and authentication/track & trace software systems.
Robert holds certification as an ASIS Certified Protection Professional. He is a past chairman and current board member of NASPO International and contributed to the writing and publishing of the 2015 ANSI/NASPO International Security Management Standard.VeriTrace Inc.
Robert Sherwood
513.673.1576
rsherwood@veritrace.com
Websitewww.veritrace.com
On this episode of SPOT radio, we discuss automated handwashing systems with our guest Paul Barnhill from Meritech. Mr. Barnhill speaks on best practices in hand hygiene and how automated technologies can greatly improve Hand Washing outcomes. Medical device manufacturing will benefit from these automated technologies as they can now better control bioburden in the cleanroom.
Guest Description:
Paul Barnhill is Chief Technology Officer and Head Engineer at Meritech, the leader in automated employee hygiene. He has over 28 years of experience working with professionals in food manufacturing, healthcare, and food service to understand the challenges they face when creating hygiene programs and how to overcome these obstacles through education and automated technologies.
Mr. Barnhill often speaks on best practices in hand hygiene, footwear sanitation, and the science behind pathogen removal. Helping food processing and packaging facilities produce safe and healthy products through hygiene excellence is a passion for him. Prior to joining Meritech, Mr. Barnhill worked at Medtronic, Inc. a leader in cardiovascular equipment and implantable devices, in their Hemostasis division as a Mechanical Designer within the R&D department.
Mr. Barnhill earned his accreditation degree from the A.I.D.D. (American Institute for Design & Drafting). When he's not inventing a new method for guaranteeing effective hygiene, you can find Mr. Barnhill spending time with his loving wife Ann of 26 years, son Josh, daughter-in-law-to-be Emily, and dog Beau at his home in Aurora, Colorado.
Website:https://www.meritech.com/
Phone:+1 800-932-7707
On this episode of SPOT radio, we speak once again with medical device packaging influencers Rod Patch and Jennifer Benolken about the progress of the "Kilmer innovations in packaging" group. This group hopes to imagine best practices in sterile packaging and will pose questions to colleagues that will spark innovations that will shape the future of medical device sterility and delivery.
Guest Description:
Rod Patch is Senior Director, Package Engineering & Product Labeling for Johnson & Johnson Vision. In his role, Rod serves the needs of J&J’s Vision Franchise with packaging strategies, innovation programs, talent, regulations and supply chain improvements. Rod is responsible for both J&J Vision Care and J&J Surgical Vision within the J&J Vision Franchise.
Rod is an accomplished leader with a broad base of experience in sterile barrier package design and labeling systems. Rod has supported packaging his entire career working in operations, supply chain, and R&D functions where he has led and managed teams supporting the package design, package process, package delivery as well as product label designs.
Rod is an industry-recognized expert in sterile barrier packaging. Rod is J&J’s primary delegate to ISO/TC198 WG7 Packaging and is an approved consensus U.S. Expert at international meetings. Rod is also J&J’s primary voting member for ASTM F02 and D10, supporting packaging standards.
Our 2nd guest:
Jennifer Benolken, CPPL, is the Western Region Medical Device and Pharmaceutical Manufacturer and Regulatory Specialist with DuPont Tyvek® Medical Packaging; she works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization. Jen has worked in the medical device community since 1991 in a variety of packaging related roles - packaging/labeling/sterilization engineer (in both operations and R&D roles), flexible packaging sales representative, and manager of packaging engineering and labeling groups.
While Jen earned her undergraduate degree in Manufacturing Systems Engineering at Kettering University (Flint, MI), she came to love packaging through her collegiate co-operative work experience at CPI/Guidant. Jen furthered her education by obtaining a Master of International Management degree from St. Thomas University (St. Paul, MN). She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7.
Jen is also an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification in 2012. As part of IoPP, Jennifer has recently been elected to the Board of Directors and is also Vice-Chair on its Medical Device Packaging Technical Committee (MDPTC) board.
Kilmer Innovation in Packaging
https://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=true
Rod Patch
https://www.linkedin.com/in/rod-patch-756227a/?msgConversationId=6592084813891596289&msgOverlay=true
Jennifer Benolken, CPPL
https://www.linkedin.com/in/jbenolken/?msgConversationId=
This episode our host Charlie Webb speaks with Larry Nichols From Next Thermal on the process of Integrating heating and temperature sensing systems to medical devices.
Guest Description:
Larry Nichols is a Technical Manager with Next Thermal, he is an MBA and with 24 years of industrial sales experience. Larry shares his skills with his students as an adjunct professor at Baker College.
(269) 964-0271
www.nexthermal.com
Listen in as we speak again with Bruce Anthenat founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of modular cleanrooms are specked out and delivered. We will also hear about emerging technology from AWS Bio-Pharma Technologies that will allow for the conversion of office space into a cleanroom.
Guest Description:
Bruce Anthenat earned his BS degree from the College of Engineering and Technology of Southern Illinois University. He has also obtained the status of Certified Plant Engineer as recognized by the Association of Facilities Engineers (AFE). He is Past-President of AFE Chapter 126 and has made several presentations on a variety of topics to various professional organizations including AFE, ISPE, and the PDA.
Bruce has over 40 years of experience in facilities and process engineering, and management with the last 30+ years in pharmaceutical engineering and manufacturing management for a variety of well-known injectable drug manufacturers. In February of 2000 he received the Engineer of the Year award from his peers in AFE Chapter 126. He has been a past member of the Board of Directors for the International Society of Lyophilization, a member of PDA Glass Handling Task Force, project manager, and lead technical authority for a number of new and renovated pharmaceutical manufacturing facilities.
He is the primary patent holder of US Patent# 831667 [a method and apparatus for high-velocity electromagnetic sealing of containers (primarily for Parenteral vials and cartridges]. Mr. Anthenat entered into the entrepreneurial world by founding AWS Bio-Pharma Technologies in 2005, where he continues to provide leadership to this growing company. He is a proven leader, with a keen sense of observation and analytical skills, which provides him with the knowledge to administer and inspire others while developing a genuine understanding of their point of view. His vision includes helping others achieve very memorable accomplishments in his related areas of expertise.
877-297-7763
https://www.awsbiopharma.com
Best selling author and speaker Nick Webb discusses the art and science of managing a collaborative workgroup. Nick, a prolific writer and event speaker turns to digital platforms to reach out to his scattered and remote audience. Nick talks about the systems he uses to keep his innovation staff at a southern California medical School on task by focusing on the individual which he believes can foster better team performance.
Guest Description:
Nick serves as the Chief Innovation Officer as well as an adjunct Professor of Health Sciences at Western University of Health Sciences in Pomona, California,
As an inventor, Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industrial and consumer products, including one of the world’s smallest medical device implants.
A prolific writer and bestselling author, his current breakthrough books include “The Innovation Mandate” and “What Customers Crave,” these books are used by top brands to design their customer experience and innovation strategies. Nick works closely with Fortune 500 companies throughout the world to help them lead their industries in innovation, strategy, and growth.
As one of the world’s leading innovation futurists, Nick Webb, is the CEO of LeaderLogic, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.
Take a peek at his virtual event space: https://www.nickwebb.com/virtual-events/
Nick's Website: www.nickwebb.com
Our guest Gavin Smith a Chromatography scientist at SGS Polymer Solutions speaks on the role of independent Chromatography laboratory's in medical device manufacturing and packaging development. As medicinal embedded drugs seem to expand in our industry, Chromatography will help us understand the interplay and compatibility of drug chemistry in the presents of our delivery polymers.
Guest Description:
Gavin Smith is a Chromatography scientist at SGS Polymer Solutions Incorporated with 6 years of experience in polymer and pharmaceutical testing in a laboratory setting. Gavin holds degrees in chemistry and biology from Radford University and Leads the size exclusion chromatography group at SGS PSI. Polymer Solutions is an independent testing laboratory specializing in polymers and pharmaceutical products, including medical devices, packaging, consumer product, and characterization and analysis.
https://www.polymersolutions.com
(877) 961-4341
As the medical device industry continues to speak the new mantra of "Patient Outcomes", device safety and sterility has become an enhanced topic of discussion. In this episode, our guest Michael Matthews of the Beyond Clean Podcast speaks on issues that must be addressed in the SPD departments in order to assure the safe and sterile delivery of surgical instruments to the OR. The interplay of People, Processes and Products must be understood to better manage the complicated work environment in the SPD.
Guest Description:
Michael Matthews, MBA, CLSSGB, CRCST, CIS, CHL currently serves as the Director for Clinical Education and Training for Northfield Medical, where he previously served as a Territory Manager for the Little Rock, Arkansas area, and a Clinical Education Manager for the southeast region. Before working at Northfield, Michael served as the manager for sterile processing at Baptist-Health Medical Center-Conway, a new $200 million facility in Arkansas.
During this time Michael also served as an Infection Preventionist on a PRN basis to consult on reprocessing services throughout the Baptist-Health system. Michael has previously served as a Sterile Processing Technician at Jewish Hospital & St. Mary’s Healthcare (Catholic Health Initiatives) (2012-2013), Baptist East Hospital (2011-2012), both in Louisville, KY, and system manager for sterilization and high-level disinfection at Conway Regional Medical Center (2013-2016).
He holds three International Association of Healthcare Central Service Materiel Management (IAHCSMM) certifications for sterile processing. Michael has also served as a subject matter expert and participated in exam development for IAHCSMM. Michael holds an MBA and has also been certified as a Lean Six Sigma Greenbelt. He has published articles in Infection Control Today, Becker’s Hospital Review, Healthcare Purchasing News, as well as several LinkedIn articles in the sterile processing community.
Michael is a co-host of the Beyond Clean podcast, the premier podcast for sterile processing professionals throughout the world, and the lead host for Beyond the Headlines, which examines news related to the medical device reprocessing industry.
https://www.beyondclean.net/
Shifting trends in medical product innovation may mean that innovation will come from unexpected organizations like Google and Amazon. Healthcare based on patient contributions to treatment may shape 3rd partly reimbursements as we move to the next level of managed care. As we move to a prevention model of healthcare, device makers will likely focus on wellness devices. Listen in as our Guest Nick Webb speaks on the future of Healthcare Innovation.
Guest Description:
Nick serves as the Chief Innovation Officer as well as an adjunct Professor of Health Sciences at Western University of Health Sciences in Pomona, California,
As an inventor, Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industrial and consumer products, including one of the world’s smallest medical device implants.
A prolific writer and bestselling author, his current breakthrough books include “The Innovation Mandate” and “What Customers Crave,” these books are used by top brands to design their customer experience and innovation strategies. Nick works closely with Fortune 500 companies throughout the world to help them lead their industries in innovation, strategy, and growth.
As one of the world’s leading innovation futurists, Nick Webb, is the CEO of LeaderLogic, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.
www.nickwebb.com
https://www.goleaderlogic.com/
In this episode, we speak with sterile packaging influencers Rod Patch and Jennifer Benolken, CPPL from the Kilmer group. The Kilmer Conference community is a forum for select sterility assurance professionals. This group shares knowledge and best practices, poses questions to colleagues, and through their conversations, they spark the innovations that will shape the future of sterility assurance. Listen and learn about the valuable charter of the Kilmer innovation in packaging group.
Guest Description:
Rod Patch is Senior Director, Package Engineering & Product Labeling for Johnson & Johnson Vision. In his role, Rod serves the needs of J&J’s Vision Franchise with packaging strategies, innovation programs, talent, regulations and supply chain improvements. Rod is responsible for both J&J Vision Care and J&J Surgical Vision within the J&J Vision Franchise.
Rod is an accomplished leader with a broad base of experience in sterile barrier package design and labeling systems. He has a track record of implementing innovative packaging systems and packaging strategies that elevate the quality; compliance, and business value as well as improving the customer delight experiences for Johnson & Johnson products. Rod has supported packaging his entire career working in operations, supply chain, and R&D functions where he has led and managed teams supporting the package design, package process, package delivery as well as product label designs.
Rod is an industry-recognized expert in sterile barrier packaging. Rod is J&J’s primary delegate to ISO/TC198 WG7 Packaging and is an approved consensus U.S. Expert at international meetings. Rod is also J&J’s primary voting member for ASTM F02 and D10, supporting packaging standards.
Our 2nd guest:
Jennifer Benolken, CPPL, is the Western Region Medical Device and Pharmaceutical Manufacturer and Regulatory Specialist with DuPont Tyvek® Medical Packaging; she works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization. Jen has worked in the medical device community since 1991 in a variety of packaging related roles - packaging/labeling/sterilization engineer (in both operations and R&D roles), flexible packaging sales representative, and manager of packaging engineering and labeling groups.
While Jen earned her undergraduate degree in Manufacturing Systems Engineering at Kettering University (Flint, MI), she came to love packaging through her collegiate co-operative work experience at CPI/Guidant. Jen furthered her education by obtaining a Masters of International Management degree from St. Thomas University (St. Paul, MN). She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7.
Jen is also an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification in 2012. As part of IoPP, Jennifer has recently been elected to the Board of Directors and is also Vice Chair on its Medical Device Packaging Technical Committee (MDPTC) board. Jennifer is currently working with industry leaders as the editor for the upcoming 3rd edition of the Medical Device Packaging Handbook.
kilmer innovation in Packaging
https://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=true
Rod Patch
Human error is known to be the primary cause of quality and production losses in many industries including medical device manufacturing and medical packaging. In this episode of Sterile Packaging on Track (SPOT) radio host Charlie Webb speaks with Dr. Ginette Collazo a leading Industrial-Organizational Psychologist about how human errors develop and what can be done to manage the human failure risks.
Guest Description:
Ginette Collazo, Ph.D is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.
Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.
Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.
Contact Dr. Collazo
info@humanerrorsolutions.com
Professor Michael Cima chats with host Charlie Webb about his Drug and Medical device development course offered through the xPRO program at MIT. The course goals are to help participants gain a “big picture” perspective of the entire drug and medical device development process, from day one strategic planning through product commercialization. Also, students will understand the critical interplay between strategy and development and how they affect each other. This online program helps you explore the process of discovering, developing, testing, and bringing a medical product to market.
Guest Description:
Dr. Michael J. Cima is a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology and has an appointment at the David H. Koch Institute for Integrative Cancer Research. He earned a B.S. in chemistry in 1982 (phi beta kappa) and a Ph.D. in chemical engineering in 1986, both from the University of California at Berkeley. Prof. Cima joined the MIT faculty in 1986 as an Assistant Professor. He was promoted to full Professor in 1995. He was elected a Fellow of the American Ceramics Society in 1997. Prof.
Cima was elected to the National Academy of Engineering in 2011. He now holds the David H. Koch Chair of Engineering at MIT. He was appointed faculty director of the Lemelson-MIT Program in 2009 which is a program to inspire youth to be inventive and has a nationwide reach.
Prof. Cima is author or co-author of over two hundred and fifty peer-reviewed scientific publications, fifty-eight US patents, and is a recognized expert in the field of materials processing. more on his Bio https://cima-lab.mit.edu/people/cima
Learn more about the Drug and Medical device development course.
We visit with Greg Jones from SGS North America and gain insight into the ISO 13485 certification process from a seasoned auditor. Start-ups or established medical device manufacturers can benefit from this discussion as we speak about potential pitfalls that could jeopardize accreditation.
Guest Description:
Greg Jones is the Technical Director at SGS in North America. In that capacity, Greg is responsible for all technical and operational aspects of medical device certification including ISO 13485, MDSAP, MDR and IVDR. Greg brings over 15 years of experience in Medical Device Certification and prior to that spent over 10 years in Research & Development as a Process Engineer with a leading Medical Device manufacturer. He is a certified lead auditor for ISO 9001 and ISO 13485. Greg earned his Bachelors at Belmont University.
201.296.5353
www.sgs.com
Email Joseph.Jones@SGS.com
Listen in as we speak with the founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of a modular cleanroom is specked out and delivered. Bruce has great insight into the process of controlled environments from his 40 years of experience in facilities and process engineering, and management.
Guest Description:
Bruce Anthenat earned his BS degree from the College of Engineering and Technology of Southern Illinois University. He has also obtained the status of Certified Plant Engineer as recognized by the Association of Facilities Engineers (AFE). He is Past-President of AFE Chapter 126 and has made several presentations on a variety of topics to various professional organizations including AFE, ISPE, and the PDA.
Bruce has over 40 years of experience in facilities and process engineering, and management with the last 30+ years in pharmaceutical engineering and manufacturing management for a variety of well-known injectable drug manufacturers. In February of 2000, he received the Engineer of the Year award from his peers in AFE Chapter 126. He has been a past member of the Board of Directors for the International Society of Lyophilization, a member of PDA Glass Handling Task Force, project manager and lead technical authority for a number of new and renovated pharmaceutical manufacturing facilities.
He is the primary patent holder of US Patent# 831667 [a method and apparatus for high-velocity electromagnetic sealing of containers (primarily for Parenteral vials and cartridges]. Mr. Anthenat entered into the entrepreneurial world by founding AWS Bio-Pharma Technologies in 2005, where he continues to provide leadership to this growing company. He is a proven leader, with a keen sense of observation and analytical skills, which provides him with the knowledge to administer and inspire others while developing a genuine understanding of their point of view. His vision includes helping others achieve very memorable accomplishments in his related areas of expertise.
877-297-7763
https://www.awsbiopharma.com
On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.
Guest Description:
Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry. Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel. Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept. Joe has also consulted to the industry on strategy, marketing, M&A and product development.
Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation. Joe and his family live in Birmingham, MI.
https://www.universal-robots.com
On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.
Guest Description:
Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry. Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel. Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept. Joe has also consulted to the industry on strategy, marketing, M&A and product development.
Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation. Joe and his family live in Birmingham, MI.
https://www.universal-robots.com
Accurate regulatory-compliant packaging machine calibrations are the headwater to a rounded medical device packaging program. Many medical device makers are falling short with their calibration, is your company at risk. On this episode of SPOT radio our guess Cord Burnham CKF speaks to the 5 common mistakes in packaging machine calibrations.
Guest Description:
Cord Burnham CKF Cord Burnham is the director of laboratory services for Van der Stahl Scientific's ISO-17025 accredited calibration laboratory. Cord has traveled throughout the country providing technical and calibration services to the largest and smallest medical device manufacturers. He is Six Sigma trained and a Kaizen trainer.
www.vanderstahl.com
Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.
Guest Description:
Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability.
She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.
Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing.
She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president.
Contact: Jan Gates
ph-650.743.5780
packwiseconsulting.com or Adeptpackaging.com
Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.
Guest Description:
Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability.
She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.
Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing.
She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president.
Contact: Jan Gates
ph-650.743.5780
packwiseconsulting.com or Adeptpackaging.com
David Cocke MBA, offers insight on delivering medical devices to the point of care from his 25 years of managing a contract packaging company. Charlie Webb and David speak to the challenges of medical device packaging from regulatory science, cost containment as well as managing cleanroom staff.
Guest Description:
David Cocke David is an MBA and he has spent the past 27 years in medical device manufacturing at the executive level. Currently, David is the VP of Manufacturing at NuPak Medical an ISO 13485 certified contract manufacturer that specializes in thermoplastic injection molding, silicone molding and assembly and packaging in controlled environments.
We were interviewed on the Podcast "Beyond Clean" and spoke on the contrasting approach of medical device packaging OEM's and SPD groups. Also, Charlie gives a brief talk on the growth and challenges of the "Sterile Packaging on Track" Podcast.
**Guest Description:
Beyond Clean** Podcast takes a creative look into the inner workings of the healthcare industry at the Hospital level, which is surrounded by challenges and disrupted by change. The team at Beyond Clean brings on the biggest names in surgical instrument reprocessing and provide commentary on the biggest issues facing sterile processing professionals, facilities, administrators, manufacturers, and vendors.
www.beyondclean.net
Our host Charlie Webb CPP interviews Richard Hogan of ISO budgets and learns about his 7 step approach to estimating measurement uncertainty. Listen in on this informative conversation and gain a clearer view of this often challenging process.
Guest Description:
Richard Hogan holds a bachelors and master’s degree in Engineering and his consultancy ISO budgets, specializes in measurement uncertainty analysis for ISO 17025 accredited laboratories. His process for estimating measurement uncertainty has helped more than 9,000 laboratories worldwide get accredited. He combines his cross-functional competencies in all phases of Metrology, including calibration, quality management, and research.
www.isobudgets.com
In this episode, Karen Greene CPP speaks on the verity of medical device pouch testing methods. Charlie Webb CPP gains clarity on the ASTM F-88 test method and learns how her company (life pack labs) approaches medical device package testing.
Guest Description:
Karen Greene is a tenured packaging professional, A CPP certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.
The first seven years of her 30+ year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.
Her medical device and pharmaceutical packaging experience included leadership positions with IMED Corporation (now Cardinal Health), Edwards Lifesciences, and Allergan.
She has led teams of individuals responsible for medical device and pharmaceutical package development, validation, and production implementation. She has also led teams responsible for documentation, configuration management, and label development and control.
Karen has published several articles in her area of specialization, (the packaging of terminally sterilized medical devices) and she presents frequently at industry conferences such as Medical Design and Manufacturing conference.
Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.
You can learn more about her package engineering services that include package design, prototyping, as well as validation consulting by visiting her website.
www.lifepacklabs.com
Charlie A. Webb CPP asks. "Is it time to upgrade your medical device packaging machinery? Charlie points out: "My advice is don’t get duped with the pointless bells and whistles that are really at the end of the day just marketing pitches that may add no value in creating better/stronger seals on your pouches. On the flip side don’t hang onto outdated equipment because you fear re-validation, this is a recipe for disaster. Re-validation can feel like a herculean task however if new packaging machinery better manages potential "Infection risk to patients" than it is time to push into better equipment and refresh your validation plan…
Guest Description:
Charlie Webb is the founder and President of Van der Stahl Scientific he manages the company’s new technology development through the company’s vendor partners. Charlie is a certified packaging professional “CPP” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. Charlie has been in sterile device packaging for 25 years and has been involved in numerous FDA and ISO audits as a regulatory advisor. Charlie has multiple granted and pending patents on medical device packaging machinery and pouch testing systems. His current patent-pending technologies include a sterile containment system for the processing of human donor tissue as well as a 100% inspection system for medical device trays.
In this episode, Nick Webb the nations leading technology futurist and best selling author speaks about innovation pitfalls in medical device development. Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industries including consumer products, as well as one of the world’s smallest medical device implants.
Nicholas Webb calls out disruptive innovation as the leading way to break away from traditional innovation methodology that bogs down the product and device development. He also calls out invalid VOC (voice of the customer) data collection that may miss what the customer truly desires.
Guest Description:
A prolific writer and bestselling author, his most recent book, “What Customers Crave,” is used by top brands to design their customer experience and innovation strategies. “What Customers Crave” was featured as Mashable’s “Top 50 Marketing Books to Read” in 2017 and LinkedIn’s “Top Summer Read” for 2017. His other groundbreaking books include “The Innovation Playbook” and “The Digital Innovation Playbook.”
His next breakthrough book, “The Innovation Mandate,” will be published by HarperCollins Leadership in 2019.
In recognition of his contributions to healthcare innovation and policy, Nick Webb was awarded his Doctorate from Western University of Health Sciences, where he serves as an adjunct professor and the director of Innovation.
Nick is also the founder of WebbLogic®, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.
Charlie discusses the "lifecycle approach" to medical device packaging. Some medical device manufacturers do not continue to watch the arc of their sterile packaging validation plan and failures, therefore, happen as a result. Validation is a living process that needs constant monitoring at all levels to thwart potential packaging failures that could result in a sterility loss of the device. Also on this episode guest Rod Jennings a nuclear power plant field engineer discusses human systems like checklists and acronyms. These systems help guide critical process to better control expected outcomes.
This episode we speak with Andy D'Esposito a technical account executive for Merrill’s Packaging. He is a CPP (certified packaging professional) he is certified through the Institute of packaging professionals where he is an active member of his local chapter. Andy provides a look into the process of developing a packaging program with thermoformed trays. Andy discusses the human factors in tray design as well as particulate control and material options.
Charlie Webb and Cord Burnham talks about the critical value of medical device packaging machine service and maintenance. Medical device package failures have been traced back to poorly maintained packaging machines. Listen in on this important conversation centered around the essential steps on staying on track with your maintenance plan.
Charlie Webb explains what will be covered on the Sterile packaging on track podcasting on upcoming episodes.
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