GuideWire: Recent Episodes
Devin Hubbard
Guidewire is a behind-the-scenes peek into the world of medical device innovation and problem discovery. Our team of medical device design engineers dive into the nuances, challenges and considerations that go into finding and solving high-impact unmet medical needs at a large university hospital.
Hosted by Devin Hubbard of FastTraCS and the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. The project described was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
What if you or a loved one goes into the hospital for a treatable condition only to end up with a completely unrelated health problem while admitted? It happens and is a perennial issue. Almost one-million Americans experience falls in the healthcare systems every year.
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Kim Young, Clinical Senior Management Engineer in the Office of Quality Excellence and Performance Improvement at UNC Health, about falls and preventing them.
Today’s Topics Include:
- Quality Coach: Why falls matter to Kim - it’s a really big, persistent problem
- Fiscal Year: Out of 850 falls, ~20% were injured and had to be treated because of fall
- Fall Defined: Anytime somebody hits the floor when assisted or not
- Financial Impact: Extending length of stay and who covers costs is a concern
- Who falls? Assessment is conducted for patient factors that predispose them to falls
- Where do patients fall in hospitals? All over, but mostly when going to the bathroom
- Why do patients fall then? Want to maintain independence, mobility, and privacy
- Ways to proactively prevent falls: Accompany and assess patient, use of alarms/aids
- Rounds/Telesitter: Ask, remind patients if they want help; time consuming and laborious
- What’s needed? Some type of technology or way patients don’t get injured due to falls
- Future of Falls: Improvement and innovation is needed for more elegant solutions
Links and Resources:
Devin Hubbard
Kim Young - FastTraCS Clinical Advisory Group
FastTraCS
GuideWire Podcast on Twitter
GuideWire Podcast
U.S. Food and Drug Administration (FDA)
National Database of Nursing Health Quality Indicators
In this episode of GuideWire, Devin Hubbard and Nabil Khan with FastTraCS talk to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
Jon discusses how the COVID-19 pandemic and shutdown affected the quality and regulatory affairs industry and specifically, Greenlight Guru as a company and quality management system (QMS).
Today’s Topics Include:
- Greenlight Guru’s QMS: Needed now more than ever for to access documents, records
- Rules Change: Why Greenlight Guru decided to allow remote work to continue growing
- Greenlight Growth: Expected, forecasted, and planned for but faster because of COVID
- Industry Impact: Companies struggled, shut down, or shifted development efforts
- Clinical Trials/Investigations: COVID changed how these are being conducted
- New Types of Med Device Companies: Naive about requirements and regulations
- Positive Outcomes: In this together, so collaborate and share knowledge, feedback
- Emergency Use Authorization (EUA): FDA’s criteria for risk tolerance and assessment
- Side Effects: Longer lead times but faster standard practice to develop medical devices
Links and Resources:
Greenlight Guru
Greenlight Guru Podcasts
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices
Greenlight Guru - Ultimate Guide to 21 CFR Part 820
Greenlight Guru - The Ultimate Guide to Design Controls
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
FDA - 510(k) Submission Process
FDA - Premarket Approval (PMA)
FDA - Case for Quality Initiative
National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx Program)
ASTM International
F3502 Mask Standard
IEC 60601 Standard
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
Jon discusses the origins of his company, electronic quality management software (QMS), and entrepreneurship experiences in the startup world.
Today’s Topics Include:
- Greenlight Guru: Medical device success platform helps meet quality/regulatory needs
- Greenlight Guru provides workflows to navigate/manage design/development process
- Design Controls: Evidence demonstrates safe and effective products that actually work
- Why electronic quality systems are easier to manage, maintain than paper-based ones
- Primary Processes: Design controls, risk management, documentation, management
- Quality system intent is to describe how business is conducted w/ regulatory compliance
- Free Resources: How and where to learn about quality systems and regulatory affairs
- Entrepreneurial Experiences: Got a good idea? Be patient, wait for conditions to be right
- Guru: Story behind the business name, brand, and domain to be differentiator
- Trends: COVID-19 created choice to grow and hire talent without relocating
Links and Resources:
Jon Speer on LinkedIn
Greenlight Guru
Greenlight Guru Podcasts
Greenlight Guru Medical Device Blog
Greenlight Guru YouTube Channel
Greenlight Guru - The Ultimate Guide to Design Controls
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices
U.S. Food and Drug Administration (FDA)
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
HubSpot
Devin Hubbard
FastTraCS
FastTraCS Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes/Tweets:
“Prior to Greenlight, there was no software solution designed specifically for the medical device industry.”
“My appro
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jim and Audrey Larson, a father-daughter duo from a family of healthcare innovators—one is a physician and the other is a medical device engineer.
Jim and Audrey discuss their journeys into medical careers and focus on everything from emergency medicine to design, research, and development of devices. You don’t have to have the ultimate solution in mind, but what is the problem? Find somebody you can work with.
Today’s Topics Include:
- FastTraCS: Jim joined Clinical Advisory Group to provide input, innovate, solve problems
- Bedside Calculations: Engineering background in medicine offers ability to do math
- No One Knows It All: Communication between engineers, non-engineering physicians
- Innovation: Clinical shift causes challenge to carve out time to create awareness
- Alarm Fatigue: Mitigate beeps, taps, and similar sounds that go off all the time
- Academia vs. Industry: Match manufacturers, clinicians to use expertise for unmet needs
Links and Resources:
Devin Hubbard
Jim Larson
Audrey Larson on LinkedIn
Cinnamon Larson on LinkedIn
Tim Brown of IDEO
U.S. Food and Drug Administration (FDA)
FastTraCS
FastTraCS Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes/Tweets:
“My engineering education was way harder than medical school.” - Jim Larson
“Having an engineering background in medicine, the ability to do math at the bedside is something that you take for granted.” - Jim Larson
“There can be this dynamic where engineers can have a tendency to be sort of know it alls or cynics.” - Audrey Larson
“Getting to a solution that works is more important when it’s time-critical for patients.” - Jim Larson
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Dr. Alan Rosenbaum, founder and first of six team members to join the FastTraCS Clinical Advisory Group (CAG).
Alan gives an update on CAG, which offers unfiltered, critical input and feedback from participating clinicians and non-physician providers on ideas, projects, diseases, and unmet needs. Is he happy with where things are and where he wanted them to go? It’s still too new and early to know.
Today’s Topics Include:
- DiverseTeam: Individuals with different clinical specialties, expertise, experiences
- Recruitment Criteria: FastTraCS picked various, under-represented specialties
- Compensation: NC TraCS and FastTraCS contributes FTE to participants’ salaries
- Practice Areas: ER, family, hospitalist medicine; engineering; pediatric ENT; OB/GYN
- Valuable Perspectives: When research/literature don’t match provider/patient settings
- Problems/Solutions: Determine where to spend time/resources to utilize skills/expertise
- Improvement Areas: Agenda/presentation leads to productive meetings, better outcomes
- Best Practices: Manage team dynamics, culture, and experience to allow all opinions
Links and Resources:
Devin Hubbard
Dr. Alan Rosenbaum
FastTraCS Clinical Advisory Group
FastTraCS
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
“These are folks who are able to critically analyze and communicate effectively.”
“We tried to capture a broad diversity of clinical settings, and patient populations, and clinical problems.”
“That’s probably the most important part of the CAG group is determining where to spend time and resources because those are finite.”
If you want to be the best at innovating and what you are doing, you have to be up to speed on what’s going on to be viewed as an expert. In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Dr. Yee Lam about innovation instruction in medical training.
Dr. Lam is a family medicine provider at the University of North Carolina (UNC), member of the Clinical Advisory Group for FastTraCS, and innovation instructor for medical students. She earned a PhD at Duke University before completing medical school at UNC. Then, Dr. Lam did a residency in Family Medicine at UNC at Chapel Hill. As a family medicine practitioner, Dr. Lam provides care to patients throughout their life span. She works in several different settings, including outpatient clinics and hospital services.
Today’s Topics Include:
- FastTraCS Fit: Chance connection and background in innovation led to recommendation
- Lifelong Learner and Teacher: Dr. Lam earned her PhD before going to medical school
- Engineer Trend: Mutually innovative tech thinkers seek out Dr. Lam as their provider
- Capstone Course: Social and Health System Science 5 - make something better
- Techniques: Break problems down and seek advice from mentors to think critically
- Individualization: What do you care about most, interested in, and makes an impact?
- Team Sport: Students, stakeholders, and collaborators complement skill sets
- Innovation Investment: Takes too long or too little time to teach and improve outcomes
- Clinical Advisory Group: Who’s information is most important when? MD, NP, PA, PT...?
- Pave Path to Passion: Build and seek out collaboration, awareness, and expertise
Links and Resources:
Devin Hubbard
FastTraCS
Dr. Yee Lam
Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
“I was always interested in how technology can impact health and improve health.”
“I want to empower the students to think about what is something you want to make better.”
Some Medical Students: “They already have a passion to address a need.”
“Celebrate the small successes.”
“Knowing to reach out and create these collaborative teams is the best way to innovate and provide the best care at the same time.”
In this episode, host of the GuideWire podcast, Devin Hubbard, shares some big news! On September 23 and 24, FastTraCS is partnering with the North Carolina Biotechnology Center (NCBiotech) to host the first ever Accelerating Health Care Innovation in North Carolina Conference: Charting the Course.
If you are interested in design or healthcare innovation, register for the virtual conference. NCBiotech and FastTraCS are collaborating with health systems across North Carolina to provide a foundation for clinician innovation. The two-day virtual event emphasizes taking action by connecting attendees with people, insights, and strategies to systematically tackle the innovation process from ideation through execution.
In the meantime, Devin asks FastTraCS’ 11 North Carolina Health System Partners participating in the conference to share how they are supporting innovation in their healthcare system.
Today’s Topics Include:
- Where healthcare systems are located, number of employees, and who they serve
- Examples of how participating healthcare systems support and foster innovation
- Power of Partnerships: Innovation is a capability and responsibility of many, not few
- Internal and External Innovators: Embrace everybody because anybody can be one
Links and Resources:
Devin Hubbard
FastTraCS
GuideWire Podcast on Twitter
GuideWire Podcast
Accelerating Health Care Innovation in North Carolina Conference: Charting the Course
North Carolina Biotechnology Center (NCBiotech)
Lindsay Deneault with Atrium Health on LinkedIn
Ken Russell with Wake Forest University on LinkedIn
Casey Granack with WakeMed Innovations on LinkedIn
Carol Lewis with UNC Health Enterprises on LinkedIn
Michael Schotzinger with Cne Health Ventures on LinkedIn
Paula Kranz with Novant Health on LinkedIn
Quotes/Tweets:
“Our mission, overall, is to improve health, elevate hope, and advance healing for all.” - Lindsay Deneault
“One of the key differentiators we have is we provide funding.” - Ken Russell
"Anybody is capable of being an innovator." - Casey Garack
In this episode of GuideWire, Devin Hubbard and Nicole Wiley with FastTraCS talk to Dr. Austin Rose, MD, MBA, who discusses his experience as a clinician, innovator, and entrepreneur.
Austin is a pediatric ear, nose, and throat (ENT) surgeon at UNC - Chapel Hill. Also, he is a member of FastTraCS’s Clinical Advisory Group and Clinical Advisory Board.
Today’s Topics Include:
- MD, MBA: Why and how Austin combines interests in worlds of science and business
- OR vs. Clinic: How Austin’s MBA makes a difference in different provider settings
- Austin’s Home Otoscope: Device used on iPhone for families to be involved in their care
- Customers’ constructive feedback is necessary to make rapid iterations, improvements
- S. Patent Process: Complicated to understand similar and competitors’ submissions
- A/R Technology: How Hololens led to most embarrassing moment for Nicole with Austin
- Austin’s Advice: Use available resources to identify, validate, understand unmet needs
Links and Resources:
Devin Hubbard
Nicole Wiley
Dr. Austin Rose
OtoscopeApp
U.S. Patent and Trademark Office
SBIR
Augmented Reality and Healthcare: Dr. Austin Rose
UNC Center for Health Innovation
Ep.3 Embarrassing Stories from Clinical Immersion
FastTraCS
FastTraCS Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
Overall Goal for Otoscope: Help families be more involved in their own health care, reduce costs, and improve access.
“I haven’t thought of anything that no one has thought of at all before.”
“My research and other interests have sort of been in technology and the ways in which new technologies might be useful or applicable to what we do.”
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Dr. Rob Lampman about his experiences managing COVID-19 patients and the directions of hospital medicine post-COVID. What was in short supply and what changes in practice are expected?
Dr. Lampman is a hospitalist at UNC and member of the FastTraCS Clinical Advisory Group. He reflects on predictions he set for medical supplies, such as disposable stethoscopes, masks, and face shields.
Today’s Topics Include:
- PPE: Sometimes there were enough masks and gowns, sometimes not—wash, reuse
- Masks: About 90% of people fit into standard N95, and 10% wear a non-traditional size
- Hot Zone Containment Area: Different hospitals did different things to adapt
- Unexpected Shortages: Different every day/week—testing swabs, wipes, OR gowns
- Kudos to College Kids: Chapel Hill hit less hard because community wore masks
- Organizational and Operational Changes: Willingness toward telehealth, other barriers
- Capacity: Exposed limitations when population grew, but number of hospital beds did not
- Mobile and Home Healthcare: Shrink, package, and make technologies easier to use
- Policy and Licensing: Federal and local laws should change because of pandemic
- Turnaround Time: Tests/results were disrupted due to direction, trajectory of stressors
- Haves and Have Nots: COVID highlighted disparities in access and quality in everything
- COVID Changes: Medicare and other payers need to support medical care in U.S.
Links and Resources:
Devin Hubbard
Dr. Rob Lampman - FastTraCS Clinical Advisory Group
U.S. Food and Drug Administration (FDA)
FastTraCS
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
“On the inpatient side, it felt like we were kind of living on the edge. It felt like some days we had enough N95s that fit and sometimes we didn’t.”
“Inside the hospital, honestly, it seemed like we were playing Whac-A-Mole.”
“Don’t waste your crisis.”
“You’re going to have to change the model of how we deliver some of this care, and I think it’s going to have to create some flexibility.”
In this episode of GuideWire, Devin Hubbard and other FastTraCS team members reflect on what they have tried in the past that worked well or not, and things that are still works in progress to uncover and solve high-impact, unmet medical needs. Also, they predict what’s coming in 2021 for medical device innovation.
Today’s Topics Include:
- What has worked, was better than expected, or abandoned to move onto next idea?
- Clinical Advisory Group: Enriching to get direct, constant engagement and feedback
- Growing Pains: Engineers and physicians learn to work together and communicate
- Sprints to Solutions: Simply try, accept different outcomes, and avoid analysis paralysis
- COVID: Push processes outside traditional comfort zone to deal w/ less ideal situations
- Observation Collaboration: When’s the right time and place to use it?
- What needs to be done? How quickly and crappy? Data collecting, positioning devices
- What’s worth pursuing? Intermediate projects, products, achievements, unmet needs
- Hippocratic Oath: Have no fear, be safe, avoid risks, even if you don’t know everything
Links and Resources:
Devin Hubbard
FastTraCS Team
Gabe Li on LinkedIn
Dr. Alan Rosenbaum
FastTraCS
GuideWire Email
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
“Embrace the crappiness.” Director Shawn Gomez
“What is good enough? Lessen your threshold for action.” Prototype and Design Engineer Nabil Khan
COVID/PPE Space: “Just do it mentality.” Devin Hubbard
“Having people who are willing to sort of discuss and argue and sort of push why things are done the way they are is really helpful.” Director Shawn Gomez
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jackie Quay, Director of Licensing and Innovation Support at the UNC Office of Technology Commercialization, about the basics of technology transfer. Moving good ideas out into the world where they can help others is core to the mission of FastTraCS.
Today’s Topics Include:
- Research and Academia: Jackie’s background in biology to law school and tech transfer
- Tech Range: Biotech, medical devices, vaccines, pharmaceuticals, diagnostics, software
- Tech Transfer: Ask questions, conduct research, and seek answers to solve problems
- New Idea Process: Conversations, action, publication, evaluate, and decision
- Invention Evaluation: Is it patentable and/or commercializable?
- Conflict: Publish research and graduate or commercialize and reveal trade secret
- Valley of Death: Most inventions never go far enough down one side to get up other side
- Portfolio or Startup? Best or only ways to get invention and technology to move forward
- Gap Funding: Pursue manufacturers, universities, nonprofits, and government grants
- Team Assembly: COVID may make entrepreneurs/investors consider new technologies
- Networking: Find the right people at the right time to de-risk ideas and technologies
Links and Resources:
Devin Hubbard
Jackie Quay
CRISPR
FastTraCS
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes:
“All things tech transfer are driven by the economy.”
“In tech transfer, our goal is to transfer the technology that we developed, so that somebody will pick it up (usually a company) and turn it into a product that somebody can buy.”
“Protecting a trade secret in academia is a problem because if you’re going to publish your work, it’s no longer a trade secret.”
“An awful lot of inventions never make the leap across what’s called the valley of death because they haven’t gone far enough down one side to get up the other side.”