GuideWire Devin Hubbard

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.”