GuideWire

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 problemFiscal Year: Out of 850 falls, ~20% were injured and had to be treated because of fallFall Defined: Anytime somebody hits the floor when assisted or notFinancial Impact: Extending length of stay and who covers costs is a concernWho falls? Assessment is conducted for patient factors that predispose them to fallsWhere do patients fall in hospitals? All over, but mostly when going to the bathroomWhy do patients fall then? Want to maintain independence, mobility, and privacyWays to proactively prevent falls: Accompany and assess patient, use of alarms/aidsRounds/Telesitter: Ask, remind patients if they want help; time consuming and laboriousWhat’s needed? Some type of technology or way patients don’t get injured due to fallsFuture 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Links and Resources: Devin Hubbard Jackie Quay CRISPR FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: “All things tech...

In this episode of GuideWire, Devin Hubbard and Nabil Khan with FastTraCS talk about its newest problem discovery technique. The modified sprint technique translates well to video and remote settings because it does not use shadowing. Today’s Topics Include: Links and Resources: Devin Hubbard Nabil Khan Sprint: How to Solve Big Problems and Test New Ideas in Just Five Days by Jake Knapp, John Zeratsky, and Braden Kowitz Google Ventures (GV): The Design Sprint Miro Zoom Ep.6 Dr....

In this episode of GuideWire, Devin Hubbard and Gabe Li with FastTraCS talk to Dr. Alan Rosenbaum, the new clinician in residence for FastTraCS. Alan provides a sneak peek into how the FastTraCS program continues medical device innovation in the academic setting. Today’s Topics Include: Links and Resources: Devin Hubbard Gabe Li Dr. Alan Rosenbaum FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: FastTraCS: Innovate solutions to high-impact unmet medical needs...

In this episode of GuideWire, Devin Hubbard and Gabe Li with FastTraCS talk to Dr. Jon Martin from Duke University about his design experience with interventional radiology (IR) procedures, as well as mentoring and coaching medical device innovation teams. Today’s Topics Include: Links and Resources: Devin Hubbard Gabe Li Dr. Jon Martin Medtronic FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: Innovation is part and parcel with the interventional radiology...

In this episode of GuideWire, Devin Hubbard and Gabe Li with FastTraCS, along with Dr. Jon Martin from Duke University, discuss unintended and unseen consequences and effects of the COVID-19 outbreak on interventional radiology (IR) practice. Today’s Topics Include: Links and Resources: Devin Hubbard Gabe Li Dr. Jon Martin FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: “There’s been a really heterogeneous effect on the practice of interventional radiology.”...

Have you been practicing social isolation? Don’t panic, and stay safe! In this episode of GuideWire, Devin Hubbard and fellow FastTraCS team member, Nabil Khan, talk to UNC Health Care’s hospital medicine experts, Rob Lampman, Nicholas Piazza, Chris Kahl, and Ria Dancel, about anticipated needs related to the Coronavirus (COVID-19) outbreak. Today’s Topics Include: Links and Resources: Centers for Disease Control and Prevention (CDC) #MedTwitter Society of Hospital Medicine (SHM)...

In this episode of GuideWire, FastTraCS team members Devin Hubbard, Nabil Khan, and Nicole Wiley recall some of their more memorable and embarrassing experiences over the years while working with healthcare providers to identify unmet medical needs. They reflect on how sights, sounds, and smells informed their own practices. Today’s Topics Include: Links and Resources: Devin Hubbard FastTraCS GuideWire Podcast on Twitter GuideWire Podcast

In this episode of GuideWire, Devin Hubbard and fellow FastTraCS engineers, Nicole Wiley and Nabil Khan, discuss problem discovery techniques they use to identify unmet medical needs. One of their goals at FastTraCS is to not only discover problems, but find them quickly and optimally. Today’s Topics Include: Links and Resources: Sprint by Jake Knapp Google Ventures Devin Hubbard FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: “I was not as attracted to the...

As a patient, would you prefer a trip to the operating room for major surgery or a minimally invasive procedure? Cheaper, safer, faster. The younger stage of interventional radiology (IR) attracts us because of its cool gadgets and opportunity for medical device innovation. Today’s guest is Dr. Jessica Stewart from UNC Hospitals. We discuss medical technology innovation in the field of vascular IR. Today’s Topics Include: Links and Resources: Dr. Jessica Stewart Angioplasty Balloon...

Here’s a sneak peek of GuideWire—a direct line to medical device innovation. Hosted by Devin Hubbard, lead design engineer for FastTraCS, the GuideWire Podcast will launch on March 1, 2020. Until then, enjoy a special audio clip featuring some of our funny experiences while shadowing and finding unmet medical needs.