We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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In this episode, we dive into the essentials of branding with expert Howie Chan, founder of Healthy Brand Consulting. The discussion covers the critical role of understanding and managing one's brand, both for companies and individuals. Howie shares insights from his journey from biomedical engineering to branding, offers practical advice for building and differentiating a brand, and highlights the importance of company values and leadership in navigating external events. Whether you're responsible for your company's brand or interested in personal branding, this episode provides valuable lessons on aligning brand strategy with business goals and values.
00:00 Introduction to Branding and Guest Speaker
02:28 Howie Chan's Journey from Biomedical Engineering to Branding
04:10 Field Experience and Transition to Marketing
09:06 Understanding and Managing a Brand
12:40 Brand Differentiation and Value
16:50 Challenges in Brand Management
23:00 Branding in the Medical Device Industry
31:02 Navigating Social Issues in the Marketplace
32:36 The Importance of Self-Awareness for Companies
33:37 Aligning Company Actions with Core Values
34:52 The Cost of Silence vs. Taking a Stand
35:33 Timeliness and Crisis Communication
36:56 Personal Beliefs vs. Company Beliefs
43:10 The Role of Leadership in Decision Making
48:05 Applying Company Branding Lessons to Personal Branding
53:35 Howie’s Insights on Branding and Consulting
57:12 Final Thoughts and Takeaways
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In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and managing advisory boards, emphasizing the importance of team involvement and maintaining high-quality standards. Paul shares his extensive career journey across different companies, detailing how advisory boards have provided key insights and contributed to successful product innovations. The episode also explores the fight against obesity and how ReShape is working to deliver effective solutions. Key takeaways include the strategic formation of advisory boards, the need for cross-functional collaboration, and the pursuit of unarticulated customer needs for innovation.
00:00 Welcome and Introduction to Advisory Boards
01:15 Meet Paul Hickey: Career Journey and Insights
02:17 Transitioning from Aerospace to Medical Devices
09:41 The Importance of Quality in Medical Devices
17:17 Forming and Managing Effective Advisory Boards
40:06 Reshape Life Sciences: Tackling Obesity
47:13 Career Advice and Final Thoughts
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Joe Steele is Head of Commercialization at Hemosonics, where they are providing point-of-care solutions to help clinicians make more informed decisions on blood product usage. In this episode Joe shares why moving up the ladder too fast may not be the best way to go, why experiencing failure will help in the long-run, how to use wisdom from past experiences and apply it to new situations, the challenges of hiring, training and managing a group of hard-charging people, getting into the C suite, and how Hemosonics is helping doctors make blood product usage decisions quicker and better.
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Stuart Simpson is CEO of Think Surgical. During his stellar 24-year career at Stryker he led an orthopedic industry transformation that established surgical robotic joint replacement as a standard of care, beginning with the acquisition of Mako Surgical in 2013. In this episode he shares his roots in medical device and how orthopedics became his passion, how competition is deeply imbedded in him, the challenges surgeons and hospitals face with the proliferation of robotics in the OR, how Think Surgical is trying to solve clinical, logistical and monetary issues, and his thoughts on how you can become a stronger leader.
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Dave Rosa is CEO of NeuroOne Medical Technologies, a company that has developed high-definition, minimally invasive diagnostic and treatment devices based on a unique thin film electrode technology, with an initial focus on epilepsy and the fast-growing neurostimulation market. In this episode he shares some times when tough feedback helped him grow as a leader, why taking the stretch assignment was the better choice, structuring a marketing group, key criteria when evaluating distribution options in a start-up company, and how NeuroOne is providing technology helpful to patients and clinicians.
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Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.
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Scott Wolf, MD is the Founder & Chief Medical Officer of Aerin Medical, where they are providing products to bring relief from nasal airway obstruction and chronic rhinitis. Scott is a prolific medical device entrepreneur across a broad range of therapeutic areas, and has also been a venture capitalist. In this episode we discuss how he identifies ideas, what criteria he uses to select ideas to work on, how VC’s evaluate opportunities, what entrepreneurs should know before they meet with investors, the problems Aerin is addressing, and how they are serving the ENT community.
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Rollie Calrson is the CEO of Immunexpress, a company that is pioneering technology that can rapidly detect sepsis. Rollie contributed to the success of Abbott Laboratories for 20 years, starting off in R&D, then transitioning to leadership positions in global businesses and start-up ventures. His attraction to start-ups led him to become CEO of Asuragen and then WaferGen Biosystems. In this episode we discuss how he prepared for new opportunities, the benefits of extreme ownership, balancing company vision and mission, alignment of everyone in a company, why sepsis is such a big problem, and what Immunexpress is doing to help clinicians better manage sepsis patients.
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Weronika Michaluk is Digital Health Principal and SaMD Lead at HTD Health, a company dedicated to planning, designing and developing custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. In this episode she shares the differences between the waterfall and agile methodologies, what sprints and scrums are, controlling scope creep, working with a company that does not have agile experience, assuring regulatory compliance, and the tools and tech stack that are used in today’s software development environment.
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Keith Smith is President of Vonco Products, a medical device contract manufacturer that works with some of the largest companies in the industry. In the first part of this episode Keith shares why companies decide to use contract manufacturers, what they look for when choosing one, the importance of transparency, and how Vonco transitioned from a job-shop serving many industries to focusing on high value industries, like medical device. The second half of the conversation goes deep into his personal story about the cost of going all-in on business, what he learned and how he has reprioritized his life, while maintaining a strong growth mindset in business.
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Milton Yarberry is Director of Project Management at Integrated Computer Solutions. Milton has developed or managed software development for Motorola, Lucent, Cognex, Inktomi, and FEI, before moving into the medical software sector in 2006 with Foliage, Ivenix and now ICS. In this episode he shares about the Protecting and Transforming Cyber Health Care, or Patch Act, which FDA implemented in October 2023, including what software is impacted, the key take-aways from this regulation, if this effects legacy devices, and how medical device companies will be impacted.
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Rich Walsh is CEO of Corvent, a company that is focused on providing solutions in the ventilator market. Rich has a long history in sales and sales management, and has transitioned from sales to become a first-time CEO. At the same time, Rich and the team are transitioning from providing a ventilator for COVID, to a full-featured product. In this episode Rich shares about the foundation of his career and the importance of discipline, openness and leader engagement, how direct feedback can make or break a career, locating a company in a non-traditional city and state, building an internship program that benefits the company and interns, and leadership lessons learned from legends in our industry.
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Joe Landolina is CEO of Cresilon, a company that has developed a technology and product intended to stop bleeding quickly and reliably. In this episode Joe shares how he began his journey at age 17, how a short project has turned into more than a decade of hard work, the impact pivots made on his team and investors, why open communication is best for the team and the well-being of the founder, and the importance of doing things the right way - even if it means delays and more investment.
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Jordan Griffin is a Field Clinical Specialist at Boston Scientific. Jordan’s no stranger to the medical device field, as her dad owns a distributorship focused on spinal implants. In this episode she shares what it was like to be a daughter of a busy, successful surgical distributor, product and sales education and how it differs in direct and distributor companies, managing a rural territory, how a clinical specialist differs from a sales rep, and what it’s like to interview and break into a large company.
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Marty Gauvin is CEO of Fertilis, a company focused on helping prospective parents have a better experience with in-vitro fertilization. Marty is a serial entrepreneur and Fertilis is his first in medical device. In this episode Marty shares his views on entrepreneurship, where ideas come from, the differences and similarities between industries, what we can learn from outside medical device, and how the Fertilis products are aiming to increase the chance of people becoming parents.
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Zach Champeau is Sr. Director of Operations at Saleytics, an inside sales organization that has a program focused on DTC strategy. In this episode he shares the objectives companies have with DTC, where DTC activities have the most influence, types of programs that can help with lead generation, the main reasons why patients who need care drop out before receiving it, and how to measure the success of your program.
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Johannes Schaeferhoff is CEO of ROPCA, a company focused on an autonomous robotic solution to aid in the diagnosis and monitoring of Rheumatoid Arthritis. In this episode, Johannes shares some of the cultural differences in the countries he has lived in and what he learned, trends in medicine that led their team to develop their innovative solution, how efficiency in medicine can be as important as efficacy, and how the ROPCA system may help solve issues with patient access and the timely and accurate diagnosis and monitoring of patients with Rheumatoid Arthritis.
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Zach Selch is CEO of Global Sales Mentor, and has decades of experience selling medical products in over 135 countries. He has authored books on international sales and has some great free resources that you can access from his website. In this episode he shares why you should consider international sales, whether direct or a distributor model is preferred, key buying influences in different countries, setting up a distributor for success, contract considerations, and managing a distributor sales process.
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Dr. Jay Shah is Chief Medical Officer at Aktii, where they are developing technology focused on identifying and monitoring hypertension. Dr. Shah is a practicing Cardiologist who pivoted his career from strictly patent care, to becoming the CMO of a start-up. In this episode he shares his thoughts on career pivots, how he researched options that were the right fit for him, what it is like to be a CMO in a start-up, what hypertension is and the difficulty of diagnosis, and how wearables can change the way hypertension is managed.
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Steve Gielda is President and Co-founder of Ignite Selling, a global sales training, simulation and consulting organization. He’s co-authored two books – Ignite Your Sales Strategy: A Field Guide to Accelerating Your Pipeline, and Premeditated Selling: Tools for Developing the Right Strategy for Every Opportunity. In this episode we discuss the changing medical device environment, why strategic planning is vital in today’s environment, what a sales simulation is and how it clarifies strategy and aligns your internal resources, tips for managers to make them more effective with their reps, and considerations in hiring your sales team.
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Lucas Piandegonda is Managing Director of Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing, and training. In this episode he shares the challenge and opportunity of becoming a consultant, considerations in choosing a plastic, how additives and manufacturing processes changes plastics, the importance of supplier choice and management, and options for making our devices more sustainable.
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Kevin Hardage is President and General Manager at Teleflex Interventional Urology. They’re treating a common problem males face as we age - Benign Prostatic Hyperplasia, or BPH. Their minimally invasive treatment provides relief for patients, and an effective way for physicians to better treat the disease. In this Episode Kevin shares the issues with BPH, educating physicians who use the product, direct to consumer marketing, metrics and objectives within DTC, how to involve referring physicians, and team development.
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Rich Wintersteller is VP Global Sales and Marketing Cardiopulmonary at LivaNova. In this episode Rich shares why market leaders need to change their approach to product design, how LivaNova moved to embrace customer-centric design, the benefits to this approach, why software and interoperability are keys in their new product, how to manage change, and how LivaNova’s new technology is helping perfusionists deliver better patient care.
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Tim Sullivan is CEO of Zeteo Biomedical, a company dedicated to providing drug and biologic delivery systems. In this episode Tim shares how an enabling technology effects the efficacy of treatment, understanding each stakeholders needs, a systematic approach for gathering stakeholder input, working with pharma companies on combination products, and the future of vaccine administration.
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Chris Idelson is Co-Founder and Chief Technology Officer at ClearCam, a company dedicated to developing technology to improve surgeons visual field during minimally invasive procedures. In this episode we discuss what a Mechanical Engineering Ph.D. program is like, the importance of hands-on education, how the NSF I-Corps program has informed his view on product development, IP development and ownership in a University, how ClearCam is helping to solve a common problem with laparoscopes, and what universities can do to better educate aspiring medical device developers.
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Brady Shirley is President and Chief Operating Officer of Enovis, an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. The Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. In this episode Brady shares the history of the company, how they are leveraging market leadership in one segment into a broader vision, why they decided to rebrand, the importance of divesting and acquiring companies and technologies to align with vision, how outcomes are a key driver in their strategy, and why team development is key to their growth and future.
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John Gumas is the Founder and CEO of Gumas Advertising, a full service advertising agency based in San Francisco. John is recognized as one of the country’s foremost authorities on Challenger Brand Marketing®. He is the author of the popular books “Marketing Smart” and “Challenger Brand Marketing”. In this episode John shares how the medical device market is the same and different than other markets, selling without selling, positioning to be a go-to, trusted resource, the importance of messaging, interviewing your external and internal customers to develop your messaging, common promotional mistakes, and the Challenger Brand Marketing approach.
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Dean Gray is a Partner at PA Consulting, a company with over 4,000 employees that operates globally, and helps companies in several industries become more effective. Dean also has has significant experience within industry at Pfizer, BD, Boston Scientific, Sanofi Genzyme, and Heidelberg Engineering. In this episode he shares how consulting is utilized, what a good or bad engagement looks like, best practices for consultants and what you should expect, how to begin a project correctly, the importance of building relationships and how you can be a good partner.
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Karen Zaderej is CEO of Axogen, where they provide technology solutions to help restore feeling and functionality to damaged peripheral nerves. After a 17-year career at the Ethicon Division of Johnson and Johnson, Karen took on the challenge of a start-up, and has built a successful company that is delivering much-needed solutions to clinicians and patients. In this episode she shares what nerve repair is, why it is important to bodily function and the quality of life of patients, why regulatory excellence is one of their key strategies, building a successful career, and the unique way they funded their company.
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Scott Nelson is Co-Founder and CEO of FastWave Medical. He is also the host of the Medsider Podcast, as well as the Founding Partner and Managing Director of Big Sky Biomedical, a leading medtech accelerator. Scott is a medical device veteran, and has held leadership roles at Medtronic, Covidien, Boston Scientific, C.R. Bard and ConMed. He also co-founded Joovv, a popular health and wellness brand. His unique background moving from traditional medical device to the consumer market and back again, opened his eyes to challenge some of his old mindsets. In this episode he shares what he learned at big companies, the differences in working in start-ups and how he applied his big-company experience, speed of iteration in the consumer space, the key drivers in evaluating early product ideas, and the importance of curiosity and developing your own learning plan.
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Richard Vincent is CEO and Co-founder of FundamentalVR, a company that is focused on improving patient outcomes by revolutionizing medical training through virtual learning platforms. Richard is experienced in building international businesses and has a keen interest in seeking out opportunities to disrupt markets through development and adoption of new technology. In this episode Richard shares insights into past medical training methods, where they excel and the limitations of the different methods, what virtual training is and its benefits, the data supporting VR learning, what haptics are and why they matter, and how medical device companies can get involved.
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Lori Harada is Senior Manager of Commercial Technical Excellence at Terumo Blood and Cell Technologies. Starting out as a nurse, Lori found that education was her passion and she’s been involved in it ever since. In this episode she shares the importance of education, what types of people are drawn to it and how to prepare them for success, considerations for designing an education program, and how Terumo Blood and Cell Technologies is changing the lives of patients.
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David Smith is President and Chief Revenue Officer of Ilumivu, a company that is taking data from common smartwatches and using AI and machine learning to gain insights into the early detection of certain medical conditions. In this episode he shares how health plans are evolving, how physician perceptions of the plans are changing, how well care and early disease detection is good for their bottom line, and how Ilumivu can help individual patients and large populations.
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Dr. Laura Cazier is a Board Certified emergency medicine physician who is also helping other doctors deal with burnout and other challenges through life skills coaching. She co-founded The Whole Physician with two other board-certified ED doctors, providing mindset and wellness coaching for physicians, by physicians. In this episode Dr. Cazier shares the reasons why physicians feel burnout, what specialties are most impacted, the issues and reasons why burnout is different between men and women, why physicians don’t seek help, the differences between mental health care and coaching, and what you should do if you or someone you know is struggling.
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Ohad Arazi is President & CEO of Clarius, a company that provides a high-definition wireless ultrasound system that includes AI to help reduce the complexity of ultrasound. In this episode he shares about his time in the Israeli military and the surprising environment that encourages entrepreneurship, what you can learn while working in large and small companies, where AI is and where it’s going, how point-of-care ultrasound can benefit clinicians and patients, and how Clarius and their high definition, wireless ultrasound system is putting a powerful tool in the hands of all types of clinicians.
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David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents and has authored or co-authored over 50 scientific abstracts and publications. In this episode David shares what makes ECG such useful tool, how the idea for personalized ECG came about, ECG regulatory strategy, technology development, the importance of robust clinical data, and the challenge of managing massive amounts of data.
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Patrick Jamnik is President of Episurf Medical, an orthopedic company who provides individualized technology for the treatment of painful joint injuries. In this episode Patrick shares why a company personal development plan may not be the best for your career, why you need to be a lifelong learner, how to seek out mentors and where to find them, what a mastermind group is and how it can benefit you, some of the things to do when importing a technology to the US, and what Episurf is doing to help an underserved orthopedic patient community.
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Dr. Agim Beshiri is the Chief Medical Officer at Nutromics, where they have developed technology for continuous diagnostic monitoring through a ‘lab-on-a-patch’ approach. Dr. Beshiri is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining Nutromics, he contributed at Abbott Laboratories for over 16 years, serving as Senior Medical Director. In this episode he shares about earning a medical degree and applying it inside industry, what doctors and companies need to recognize about each other, what Medical Affairs is and how it is structured, the long-term objectives of a company and how medical affairs can drive massive growth, and how Nutromics is positioned to help change how monitoring of critical parameters is performed.
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Ethan Drower is the Founder and Operating Partner at CiteMed Solutions, who provide full Clinical Evaluation Report services for EU MDR. Ethan is a software engineer and entrepreneur, trained to identify problems and implement solutions. In this episode Ethan shares how to listen for new ideas, R&D differences and similarities in industries, building early prototypes and capturing customer feedback, scoping a project, pricing for value, and how CiteMed has positioned itself.
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Andrew Buckler is the Founder, President and CTO of Elucid, a company that is focused on characterizing placque, with the goal of providing clinicians better information on placque stability, vessel structure, treatment options, and risk factors for cardiac events. In this episode, Andrew shares how to found a company when you have a significant amount of research ahead of you, the importance of understanding biology when designing devices, the evolution of coronary angioplasty, translating research into a product, the importance of staging a project, and the problems Elucid is targeting.
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Scott Alexander is the CEO of iVelocity Marketing, and has been on the leading edge of identifying market shifts and building strategies and programs to embrace a new and improved go-to-market strategy. In this episode he shares what providers don’t understand about medical device companies, what we don’t understand about providers, the reasons why the old go-to-market strategy no longer works in medical device, the benefits of using a digital strategy, and why sales will love – and prosper – from embracing this change.
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Stephen Mariano is Vice President of Global Endosurgical R&D at FUJIFILM Healthcare Americas Corporation. Stephen has a long history of success in research and development for the medical device industry and has helped bring numerous innovative technologies to market. In this episode Stephen shares how a company chooses the types of problems to solve, how to choose a specific problem, leveraging capabilities and core technologies, strategic direction and planning, what to do when a technology you own doesn’t fit in your portfolio, and an overview of FUJIFILM and how they’ve grown their helathcare segment.
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Amit Vohra is the Founder and CEO of Promaxo, a medical technology company that is commercializing an office-based MRI system. In this episode he shares why entrepreneurs need a support system around them, how culture is really built in a company, identifying good start-up team members, why everyone needs to be a salesperson, working with advisors, the balance between being flexible and holding true to what you believe, and what Promaxo does and why the technology is a game changer.
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Frank Fornari is the Founder and Chairman of BioMech, a leading company in motion analytics. In this episode Frank shares information on how our movement can indicate health, injury, decline, disease or neglect; why assessing motion can help to understand if we are getting better or worse over time, or after an intervention or surgery; the BioMech system; options for commercializing a platform technology; and the future of motion analytics.
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Amber Schiada is the Head of Americas Work Dynamic Research at JLL, one of the largest real estate services firms in the world. In this episode she shares the results of their 2022 Patient Consumer Survey and other topics, including the most important consideration in choosing a health care facility, generational differences in healthcare choices, attitudes toward tele-health, differences by geographical region and if you reside in an urban, suburban or rural location, life science hot spots in the US and globally, and trends in the short and mid-term.
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Skylar Talley is CEO of MedScout, a company that provides life science companies data and insights to help sales reps and sales managers be more targeted and effective. In this episode Skyler discusses upstream and downstream marketing, bootstrapping a company, why inside sales is becoming more popular, leveraging distributor organizations, why digital marketing should be moving higher on your radar, using data to design territories and target customers, surprising things medical device companies don’t do that are common in other industries, aligning the sales team targets, and how sharing data to with providers can lead to stronger relationships.
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Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation. In this episode Jim shares the sales process, including translating engineering language into customer language, aligning the company behind customer messaging, building a learning culture, question-based selling, setting sales targets for a new product, and identifying and segmenting buyer types.
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Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation. In this episode Jim shares how medical sales has changed, why reps have evolved into enterprise salespeople, his mindset of helping to heal our healthcare system, developing a value proposition for a multi-headed customer, commercialization as an initiative, the importance of sales skills, sales training based on real customer knowledge, and how to begin a salesforce in a start-up.
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Vivek Thakkar has over a dozen years of experience in regulatory affairs for Class II and III medical devices, while at Roche, JUUL, Cardinal Health, and Abbott Vascular. He is also a frequent speaker on software, artificial intelligence, and machine learning. Vivek is now focused on start-ups and consults with medical device companies to identify and refine their regulatory strategies in the software as a medical device space.
In this episodeVivek shares the definition of software as a medical device, the regulatory requirements during product development, how hardware and software programs are similar and different, working with teams that do not have a medical device background, how changes are made to software products, AI and machine learning and what is being done today vs. what will be coming, and the challenges specific to software products that the industry and regulatory bodies are attempting to overcome.
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Wearable devices have become common for a number of applications – from fitness tracking to tracking medical parameters for people with conditions like diabetes or heart arrhythmias. The overlap between consumer and regulated medical device wearables is becoming very fuzzy, but has a bright future. In this episode, Andrew Rickman, the CEO of Rockley Photonics, discusses why wearables have taken off, the differences in consumer and medical wearables, how multi-parameter data can lead to better healthcare, the benefits of longitudinal data, the products Rockley is introducing, how medical device companies may benefit from this emerging technology, and the future of wearables.
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Meilan Han, MD is a Professor of Medicine and Chief of the Division of Pulmonary and Critical Care at the University of Michigan, and a spokesperson for the American Lung Association. She is the author of a recently released book, “Breathing Lessons, A Doctor’s Guide to Lung Health.” In this episode Dr. Han describes how the lungs function, what can go wrong with them, lung development and why we need to pay attention to how we treat our lungs during their development phases, what medical devices she uses, her advice for companies developing technology, and why we should be testing and monitoring a fifth vital sign.
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Bryon Bhagwandin is CEO of Recalibrate Solutions, a Denver Startup that is developing a system to monitor a child’s response to stress. Brian also has decades of experience managing development projects. In this episode Bryon shares the challenges of managing a medical device project, different models of project management, when to go to an outside development firm, what to look for when choosing one, and his advice for new project managers. He also shares a very interesting test his company is working on to help children be more successful.
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Scott Carson is the Founder and CEO of MRP, a new kind of marketplace for medical products. Scott has been involved in several ventures that have innovated and developed new distribution models. He was part of the team that built the eBay Healthcare Marketplace strategy and structure, and was the Founder of US Medical, the first internet distributor of new and pre-owned capital medical equipment to the healthcare industry. In this episode Scott shares why early attempts to apply the internet to healthcare failed, how to build a successful marketplace, why the solo practitioner is at a disadvantage when purchasing medical products, the evolving role of salespeople, why marketing is becoming more important, and what people within the industry need to do to prepare for potential disruption.
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Nestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares who works in the SPD, what training, education and certifications are required, what devices should and shouldn’t be processed though SPD, what vendors should do to build a relationship, what the best reps do that others don’t, how to communicate with an upset surgeon who is in surgery, and the future of SPD. This is part 2 of a 2-part conversation.
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Nestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares how he entered SPD, a detailed description of what SPD does, teamwork within the hospital and educating hospital staff, and how to manage hospital acquired infection. This is part 1 of a 2-part conversation.
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Charlie Webb is the founder of Van der Stähl Scientific, a company that provides medical device packaging systems and services. In this episode Charlie shares information on the types of packaging systems available, materials used, considerations for choosing the correct system for your device, understanding user needs, what packaging sealers do and how they have evolved, why verification and validation are equally important, and packaging sustainability.
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Jon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.
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The concept of creating your own personal brand has been around for years, but it is garbage advice. In this episode Pat Kothe shares how product and company branding differs from personal branding, the origins of branding, how a brand manager creates and manages a company or product brand, why fake-it-till-you-make-it is garbage advice, why focusing on reputation is the right strategy, and some tips for understanding and enhancing your reputation.
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Patricia Zilliox has devoted her career to solving problems with the eyes. She had a very successful career at Alcon, then at the Foundation Fighting Blindness Clinical Research Institute, before joining Eyevensys as CEO. Eyevensys is working on a technology that has the potential to solve a big problem. In this episode Patricia shares how a biologics company approaches device design and manufacture, combination product development, the regulatory pathway, funding challenges, how device differs but is similar to pharma and biologics, and how great companies retain great people.
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Scott Anderson is a recognized concussion expert having spent 4 years at St. Mary’s University and 10 years at Stanford as the Director of Athletic Training. He is currently Chief Clinical Officer at SyncThink and is also a Medical Observer for the NFL. In this episode Scott describes what a concussion is, the symptoms, who should diagnose and treat the injury, medical devices used for concussion monitoring, why objective test data is vital, how the SyncThink technology is contributing to concussion management, and the future of eye tracking technology.
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Tammy Gilon is the Founder and CEO of Laminate Medical Technologies, where they are developing solutions for improving vascular access for dialysis patients. In this episode she shares why she became interested in medical device, the systematic and thorough process she followed in choosing a project to pursue, finding a partner, what it is like to found a company and raise money as a young female, the start-up culture in Israel, and the long journey of designing an implantable medical device.
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Kent Dicks has been involved in providing technology for remote patient monitoring or RPM since 2006. Kent is a thought leader in the space and is currently CEO of Life365, a leader in RPM. Prior to that he founded MedApps, which was sold to Alere in 2012. In this episode Kent shares some common terms used in connected health and their definitions, how the segment has evolved, how consumer choice is effecting where medicine is and will be delivered, the role of remote patient monitoring, how RPM works from patient enrollment and training to use, how it’s implemented in a physician’s office, and the future of connected health.
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Dr. Arun Nagdev is one of the leading international authorities on Point of Care Ultrasound, or POCUS. He practices clinically and also is the Senior Director of Clinical Education at Exo, a company that is on a mission to modernize medical imaging through its high-performance handheld ultrasound platform and artificial intelligence. In this episode Dr. Nagdev discusses the evolution of ultrasound in the practice of medicine, how point-of care ultrasound impacts procedural success and patient care, the challenges with educating established physicians, changing the curriculum of residencies, POCUS reimbursement, the differences between clinical medical teams and a medical device start-up, and his vision for a connected, low-cost, ubiquitous point-of-care ultrasound technology.
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Trades shows are slowly coming back on line. What can you expect? In this episode Pat Kothe describes his experience with making the decision to attend the largest trade show in his market segment, including decision criteria, costs, attendance of clinicians and exhibitors, COVID safety protocols, and attendee attitudes.
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Hannah Zerphy is a Managing Member of Orlaithe Consulting, a firm specializing in federal contracting. Hannah worked inside the VA as a Warranted Contracting Officer and a Training Coordinator for VA FSS, so she knows how the process works and how companies should present their products and opportunities. In this episode Hannah shares how to register on sam.gov, why a Federal Supply Schedule or FSS contract is usually your best option, choosing your product category, completing the FSS application, customer pricing disclosure, working with a contracting officer, and ongoing reporting.
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Jordan Chase has seen hiring from inside a company, as well as from a recruiter’s perspective. Jordan spent over a decade at Medtronic, in human resources and talent acquisition. He’s spent the last decade as an outside search consultant with his group, Chase Medsearch. They focus primarily on customer facing positions in sales & marketing with a specialty in the neuromodulation space. In this episode Jordan shares what you need to know about recruiters, the difference between contingency and retained search, the challenges of an inside recruiter, how inside and outside recruiting differ, why your online presence is important, how a company triages candidates, what you should and shouldn’t do when you hear about a job you are interested in, and how to choose a recruiter to work with.
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Shelly O’Donovan is a recognized expert in persuasive communication who helps people in medical device and pharma communicate more effectively. Shelly is CEO of Authentic Influence Group and also a lecturer at Wharton. The first part of her career was in government, before she made the move to industry, spending 9 years at GSK. In this episode Shelly shares key communication factors, verbal and non-verbal communication, how to stand out in a meeting, how to build trust, the importance of being clear and concise while including proof sources, and why confidence is so important. She also discusses strategies and tips for being more persuasive in one-on-ones, group meetings, when you’re the presenter, and during an online meeting.
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When he was 25 years old, Jacob McLaughlin moved from being an athletic trainer to a surgical sales representative for one of the top medical device companies in the world. He used some traditional techniques for breaking in, but also some that were very non-traditional, including documenting his journey in his podcast, New to Medical Device Sales and his presence on YouTube, TikToK and Instagram. In this episode Jacob shares the similarities and differences between athletic training and medical device sales, advanced networking techniques, what the interview process is like from a candidate’s perspective, how to make yourself stand out, what 99% of candidates don’t do, and what the first year in medical device sales is like.
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Barbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), and a past president. She earned the Brooke Berson Founders award from AHVAP in 2019, and in 2021 was honored to enter the Bellwether League Foundation Hall of Fame for Healthcare Supply Chain Leadership. In episode 2 of a 2-part series, Barbara discusses the role of the value analysis team in making decisions, whether all products go through the same process, what makes a good supplier relationship, what the components are in a good value analysis presentation, and why you may want to become a member of AHVAP.
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Barbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), and a past president. She earned the Brooke Berson Founders award from AHVAP in 2019, and in 2021 was honored to enter the Bellwether League Foundation Hall of Fame for Healthcare Supply Chain Leadership. In episode 1 of a 2-part series, Barbara discusses the evolution of value analysis, managing deal flow and how projects are prioritized, what a committee or group looks like, and what questions you need to ask to get to the right people.
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Dr. Nishi Viswanathan is the Director of Texas Health Catalyst, a program inside Dell Medical School at The University of Texas at Austin that provides researchers, innovators and entrepreneurs customized guidance on product development from industry and clinical experts as well as milestone-based seed funding. In this episode Nishi shares the problems that needed to be solved, the vetting process new ideas go through, what financial and non-financial resources are available, the importance of clinicians and engineers working together, and how industry experts are utilized as advisors to help fill in the gaps.
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Cheryl Nagowski is an expert in Federal Market Access. She runs a consulting firm, Middleton Market Access, and her team helps companies with their federal market strategy and helps them obtain access to the federal markets. In this episode Cheryl shares the size of the federal markets, how they’re organized, the steps to successful access and implementation, and best practices. Having spent eight years working for the US Department of Defense, Cheryl provides unique insights and a framework on how to successfully navigate the federal procurement process.
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John Dayton is an Emergency Medicine Physician who has practiced in settings as diverse as the University of Utah Hospital and the Navajo Nation Reservation. In this episode John shares what it’s like to practice medicine on a reservation, how he built his company, Medforums, which is a Yelp for medical education, what he has learned as an angel investor, preventing physician burnout, and pursuing dreams. John discusses how multiple passions keeps him invigorated, refreshed and motivated, and why he believes it is a good model for others to follow to lead to more productive careers.
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John Keane is the Co-Founder and CEO of MindRhythm where they are developing an interesting technology to help diagnose stroke early, when treatment decisions can have a big impact on patient outcomes. In this episode, John discusses why emerging technology is his true calling, what types of people are drawn to it and how he identifies them for his teams, how someone giving him a break made all the difference in his career, what it’s like to be a first-time CEO, how his two companies, in completely different industries, have so much in common, and his philosophy on serving customers.
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Soft launches are an important tool when introducing any new product to the market. In this episode Pat discusses why you do a soft launch, what you are trying to learn, some key issues related to the types of customers who buy in the early phases, and setting expectations. He shares why Key Performance Indicators are important to establish up front, best practices for conducting a successful soft launch, and how what you learn in this phase prepares you for a successful full launch of your product.
Mastering Medical Device:
Laura Yecies is the CEO of Bone Health Technologies and has a fascinating career arc. Laura had an extensive, and successful career working in tech in the Bay area, before crossing over into medical device. Coming up primarily from the marketing and sales track, she held positions of increasing responsibility, including becoming the CEO of several venture-backed companies, in both the tech and medical device spaces. In this episode we discuss her tech experiences including what she learned that applies to medical device, her move into medical device and how she prepared to do so, how Bone Health is poised to tackle a big problem, and what it’s like to be a female entrepreneur.
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Dr. Michael Gorn is a Pediatric Emergency Medicine physician who was inspired to develop a medical device for treating a common ailment - an abscess. Mike is also the partner of your host, Pat Kothe! Our company is call EM Device Lab and the product Mike was inspired to invent is the Quickloop Abscess Treatment Device. In this episode Mike shares how he became interested in the problem, how he built a team and company, sought expertise in areas he was unfamiliar with, and how the team developed the product and are in the early days of launching it in the US.
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Andrew Mead is a successful orthopedic device sales rep who sells products used in the OR for Smith+Nephew. In this episode Andrew describes the intensity of the training he received and sought out, what separates the consistently good reps, a unique team approach to sales, why putting your customer's needs above yours is the only way to success and redefining what value is. He learned the value of the grind from his days as a baseball player in the minor leagues, preparing him for mastering all of the little things necessary for his role supporting his customers in surgery and with their businesses.
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Mike Langlois is a Supply Chain expert, working his way up from the bottom to become Senior VP of Supply Chain for two large and widely recognized Integrated Delivery Networks (IDNs), Ascension Healthcare and Beaumont Health. He helped develop the strategies and tactics for the groups and introduced some truly innovative programs. In this episode Mike takes us inside the world of supply chain in an IDN and helps us understand their challenges and opportunities, and how medical device companies fit in. Some of the things covered were the best way to introduce a product, how to build an effective relationship, what you should be asking your customers, if your customers are talking to each other, and what happens in the middle of a contract when things change.
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Ted Newill is an expert in medical device sales and marketing. In this episode we examine why some technologies are adopted while others are not - even if there is clinical proof that they should be. We explore issues impacting long-term adoption in the pre-product release, product release, and post-release phases along with how people react to change. We discuss a number of issues that can make or break the success of a product, including product life cycle, regulatory and clinical strategy, buyer types, physician education, pricing and reimbursement. We also offer tips on what should be done to increase a product's probability of success.
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Dr. Wouter van Furth is a neurosurgeon at Leiden University Medical Center in the Netherlands who is interested in better clinical results with the help of evolving surgical techniques and technological advancements. In this episode he shares information on the education and healthcare systems in the Netherlands, medical technology breakthroughs and challenges in neurosurgery, breaking habits and the difficulty of change, why education when any change to a device is critical, and a burning question he asked the Mastering Medical Device community to explore.
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Mike Morton has over thirty years of regulatory, clinical and quality experience in the medical device industry, including serving as Vice President for Corporate Regulatory Affairs at Medtronic, on the Board of Directors for the Regulatory Affairs Professionals Society, and serving on FDA and other regulatory body working groups . In this episode we explore regulatory pathways for devices in the US, Europe and other countries, building relationships with regulators, how things have changed with regulatory agencies worldwide, where companies are launching first and why, what a regulatory affairs professional does throughout the product life cycle, and the importance of regulatory strategy.
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Paul Harkness has spent his career in hearing care, helping patients and providers. In this episode Paul explains the prevalence of hearing loss, why it occurs, how hearing loss actually effects patients, the newest trends in hearing care technology, how care is delivered and by whom, and what the business models are. He also shares how his company, Lantos Technologies, is providing a new product that can benefit hearing-loss patients and providers initially, with the promise of delivering a better experience for any device that is inserted in the ear. He also discusses his management philosophy, and the company culture he is living and building.
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Dr. Aaron Ali and Dr. John Schlitt are experts in translating world-class physician education into customer loyalty. In this episode they discuss how to deliver educational experiences that allow clinicians to learn, practice and experiment, leading to better clinical outcomes, more efficient procedures and satisfied customers. Medical device companies benefit by getting closer to their customers by providing an invaluable and memorable experience. Their facility, MedtoMarket, blends a state-of-the-art bioskills lab, conference facilities and co-working space to provide an environment where innovation thrives.
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Renee Rogers has managed through several large acquisitions as VP of Human Resources and VP of Leadership and Organizational Development at Zimmer Biomet, Zimmer, and Sulzer Orthopedics. In this episode we discuss the human side of an acquisition and how to handle it and thrive amongst the uncertainty and chaos. We discuss who makes the decisions, personnel choice, timing of decisions, culture clashes and how to deal with them, what you can do if you find yourself in this situation, what leaders should do, and how you have more leverage than you may think.
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Doctors Grayson and Dustin Moore are practicing orthopedic surgeons, who also happen to be brothers and partners. In this episode they share their unique hybrid practice model, how they built their practice, why they choose a medical device, and what good sales reps do. They also cover how they, along with their Dad who is also a partner in their practice, rely on each other to learn and deliver top-notch medical care. Many of the things they discuss about their practice can be directly applied by people working within medical device companies. Grayson and Dustin practice in the Austin area, and are co-owners of Legacy Bone & Joint Orthopedics, along with their Dad, Dr. Frosty Moore.
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Are you itching to join a startup? Before you do, ask yourself these ten questions to give yourself a greater probability of success - personally and professionally. In this episode Pat Kothe explains what a startup is, the risks that need to be mitigated along the way to becoming a company, and ten questions every aspiring entrepreneur needs to answer for themselves before jumping into a startup.
Mastering Medical Device:
Bob Beck is one of the pioneers in national accounts and has helped shape how industry manages our most important customers. In this episode Bob describes what a national account is, how to work with group purchasing organizations, integrated health delivery networks and other strategic accounts. He also shares how to best work internally with the sales and marketing team and management to achieve company objectives. Bob talks extensively about the importance of communication, personal relationships and contract structure and how each affects the short and long-term success of the relationship between the company and customer. Bob had a sales and sales management background before transitioning to national accounts at Abbott, and has worked in corporate accounts at Stryker Orthopedics, RTI Surgical, SiNTX, and Instrumentation Laboratory. He currently consults with companies on strategies and tactics in National Accounts as the Founder of Capstone Consulting.
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Mike Eriksen has over 30 years of experience in medical device marketing, and he shares his views on what makes a successful marketing executive. Mike is currently Senior Global Marketing Manager at Smith+Nephew, a leading medical device company. In this episode we discuss issues in marketing and Mike draws from his experiences at RTI Surgical, KCI Medical, Encore Medical, Carbomedics, Synthes, and Sulzer Orthopedics. He shares his views on upstream and downstream marketing, what to do when a product development project goes off the rails, how to work with others in the organization, why customer discovery is so important, and what he enjoys about working in the industry.
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Chris Hermann is the CEO of Clean Hands – Safe Hands, a company dedicated to reducing healthcare associated infections through better hand hygiene. In this episode Chris shares what his company is tackling, and the road they have taken from idea, to development, to clinical study to sales. He discusses his take on the customer discovery process and what he refers to as Clinician Centered Innovation, and how what he learned led to changes in the product, along some of the mistakes they made along the way. Also, we discuss their regulatory pathway, and disclose wether their device is a medical device or not.
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Daniel Powell is the CEO of Spark Biomedical, a startup company that developed, and as in the process of launching, a neurostimulation device to provide patients relief during opioid withdrawal. Daniel and his team have developed a solution, based on a proven technology. Daniel discusses Spark and some of the challenges they faced including product and technology, reimbursement, business model, clinical, and regulatory. We also discuss the product development process, specifically customer discovery. Daniel shares how in the past 25 years, in two separate industries, he has been involved in customer discovery in large and small companies and how his philosophy was shaped based on different systems he was taught, but modified, based on his hard-earned experience.
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In this episode Pat Kothe recaps five critical customer motives that emerged from the first 10 episodes of the podcast and discusses why it is important for people within medical device companies to unravel them. He also discusses some of the issues we will begin to explore in future episodes, broadening out to include interviews with industry people, and why it is important to share the podcast with others you feel could benefit from the content, and how to best do so.
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Dr. David Nelson is an anesthesiologist practicing in Austin, TX. With over 30 years of experience in the field, he shares how his practice has changed with outpatient surgery and the emergence of ambulatory surgery centers, what medical devices he uses and why, what documentation really is and why it’s vital for reimbursement, and his message for people in the medical device industry. He has also founded a medical device company and is working on a very interesting technology to change the way unused drugs are discarded in the hospital setting.
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Dr. Paul Davidson is an emergency medicine physician with over 30 years of experience, ranging from Level I trauma centers, to free-standing ER’s, to Urgent Care centers, to small town facilities with very little backup. He explains living through the challenges of the pandemic, what a typical day is like, who he works for and how that’s changed over the years, and products that have had massive impact on patient care. He is also an angel investor and he shares what he looks for when investing in a company, some of the companies he is currently involved with, and past investment successes and failures.
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Sarah Hermsdorf is a Surgical PA, specializing in neurosurgery, which encompasses surgical intervention in the brain and spine. Sarah discusses the details of her practice from the surgical suite, to hospital rounds, and in the clinic pre and post-surgery. She tells why she values good company representation in the OR, and what the best reps do to provide value to her, the physician and the patient. Additionally she shares why she loves her profession, the challenges, why patient education is so important, and what a typical surgery entails.
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Dr. Randy Kunik has a successful orthodontic practice built on high-quality results, stellar customer service, and sound business practices. But his loyalty to one medical device company has also been critical to getting him to the top of a competitive market - and keeping him there. In this episode, he explains business strategies for his practice, how he works with medical device companies and what is important in maintaining a long-term relationship, and a new technology he has implemented that makes orthodontic care more convenient for his patients, and better for his bottom line.
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Dr. Chester Koh discusses how the challenges with pediatric device development are being overcome through the development and coordination of several ground-breaking programs. The smaller size of the pediatric market has often led to a lack of device development, but the patient needs persist. Dr. Koh explains how pediatric device development can be accelerated through a University engineering program Capstone Project, the FDA-sponsored Pediatric Device Consortium, NIH SBIR and STTR programs, and private funding.
Links from this episode:
Chester Koh, MD Bio
Texas Children's Hospital
Baylor College of Medicine
Texas Medical Center
TMCx
TMC Venture Fund
Fannin Innovation Studio
Pediatric Device Consortia Grants Program
Philadelphia Pediatric Medical Device Consortium
National Capital Consortium for Pediatric Device Innovation 2.0
Southwest National Pediatric Device Consortium
UCSF-Stanford Pediatric Device Consortium
The West Coast Consortium for Technology & Innovation in Pediatrics
Pediatric Medical Device Development by Surgeons via Capstone Engineering Programs
Nicholas Alana is a fourth-year medical student at the University of Texas Health Science Center in San Antonio. He describes what medical school is really like - the way lectures are consumed, what you do in anatomy labs, how clinical rotations work and what you learn, and details on all of the tests and applications. He also discusses his pathway to a medical career, and how his and his father's injuries and the care they received influenced him on the specialty he is pursuing.
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Danny McIntyre is a fourth-year medical student and he describes his experience at the New York Institute of Technology College of Osteopathic Medicine's Arkansas State campus. He is also a recipient of a scholarship from the US Health Professions Scholarship Program of the US Military, and he describes the benefits and obligations of that program. He tells how he became interested in medicine, how he prepared in high school and college, the medical school application process, and the challenges throughout.
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Dr. Jessica Brown shares insights into her practice as a Cardiologist, specializing in Advanced Heart Failure and Transplant Cardiology. The conversation includes a description of advanced heart failure, devices used, how referrals work, how reimbursement does or does not impact patient management decisions, and physician compensation. Additionally, she shares how she obtains information on medical devices, what sales reps do right and wrong, what works best on the floor of a medical device congress and more.
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Jessica Brown, M.D., F.A.C.C
Tom Andersen shares what it is like to be a patient undergoing total hip replacement during a global pandemic. He describes how his life was impacted by a failing hip, what surgery was like, what he brought home from the hospital, and how he views his post-surgery future. Tom also shares how he chooses physicians and how the choice of a medical device for him is made. He tells about the devices that have been instrumental in his healthcare, along with a message to the people who work in the medical device industry.
Dr. Alejandro Berenstein is a visionary physician who helped develop a whole new field of medicine - interventional neuroradiology or endo-vascular surgery. In this episode Dr. Berenstein discusses how he became interested in medicine and what prompted him to transform radiology from a diagnostic to a therapeutic specialty. After initially developing his own devices, he established great relationships with industry to jointly develop tools that would allow a growing number of clinicians to treat patients with neurological issues. He also shares valuable tips for companies and representatives on the best ways to work with visionary physicians.
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This episode introduces you to the Mastering Medical Device Podcast and explains how it will help you become more effective in your current role, and put your career on the fast-track. The host, Pat Kothe, shares how the podcast is structured and some of the topics to be covered, along with his background. Welcome to Mastering Medical Device!