GuideWire

By Devin HubbardScience Technology Life Sciences Natural Sciences

GuideWire episodes

June 08, 2022Season 2 - Episode 8: Falls & Falls Prevention with Kim Young
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
Telesitter

Quotes:
“Falls is a global problem. It’s a problem for people at home.”
“Despite the pain and suffering, there are reasons why we prevent falls.”
“Leave your privacy at the door. You just have to let us help you.”
“Seeing the nursing staff when they do have a patient that falls and injures themselves, it’s deeply disturbing.”
41 min
February 02, 2022Season 2 - Episode 7: The Effects of COVID-19 on Regulatory Affairs
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
N95 Respirators, Surgical Masks, and Face Masks
Nabil Khan
Devin Hubbard
FastTraCS
FastTraCSClinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast

Quotes/Tweets:
“Up until that point, we were growing fast and furious in a good way.”
“We now have been able to open up our talent pools to markets that might have not been accessible to us.”
“Medical device - it’s the long play. It’s not the short-term thing. There will be a need for my product, my technology.”
“There were a lot of positives that have come through the pandemic. I saw the collaboration, the sharing, the openness.”
40 min
December 10, 2021Season 2 - Episode 6: Electronic Quality Management Software with Jon Speer from Greenlight.Guru
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 approach to a quality system is really about scaling it and evolving it as you go.”
“A quality system is really describing how we do business.”
40 min
November 03, 2021Season 2 - Episode 5: A Family of Healthcare Innovators
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
39 min
October 06, 2021Season 2, Episode 4: Clinician in Residence as Part of Innovation Programs (Part 2)
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.”
39 min
September 03, 2021Season 2 - Episode 3: Innovation in Medical Training with Dr. Yee Lam
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.”
37 min
August 16, 2021Special Announcement: Accelerating Health Care Innovation in North Carolina Conference
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
19 min
August 01, 2021Season 2 - Episode 2: Dr. Austin Rose, A Clinician Entrepreneur
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.”
24 min
July 01, 2021Season 2 - Episode 1: COVID-19 Follow-up & The Future of Hospital Medicine
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.”
34 min
December 02, 2020Season 1 - Episode 10: A Year in Review
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
48 min

About GuideWire

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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.

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