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 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 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.”

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.”

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: Methodologies: Mining and discovering unmet needs Medical Device Design: How it’s done at large academic centers Motivation: Learn effectively from others vs. bridging literacy gap to identify unmet needs Changes: No shadowing, but sprints featuring engaged providers with domain expertise Components: Providers, discussion leader, conference room, supplies to capture ideas Sprint Technique: Introduce idea and process to participants Collect names and contact information for attendees Provide training to introduce concept of unmet need Identify goal, objectives, and structure for session Brainstorm for five minutes (no talking allowed to empower providers) Participants prioritize and rank top three most compelling problems/unmet needs Provide participants with fixed number of votes to allocate for prioritized problems Goals: Increase efficiency capturing unmet needs and create new medical technologies 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. Martin Medical Device Innovation as a Provider FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: Needle in a Haystack: Traditional ways of medical device innovation rely on immersion and/or shadowing. Power, Influence, Experience: We value diverse perspectives and diverse stakeholders. Working Alone, Together: Don’t control quality, but quantity of unmet needs and problems. Sprint: Activity by design is hurried to maximize time with providers and promote quick decision making.

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: Methodologies: Mining and discovering unmet needs Medical Device Design: How it’s done at large academic centers Motivation: Learn effectively from others vs. bridging literacy gap to identify unmet needs Changes: No shadowing, but sprints featuring engaged providers with domain expertise Components: Providers, discussion leader, conference room, supplies to capture ideas Sprint Technique: Introduce idea and process to participants Collect names and contact information for attendees Provide training to introduce concept of unmet need Identify goal, objectives, and structure for session Brainstorm for five minutes (no talking allowed to empower providers) Participants prioritize and rank top three most compelling problems/unmet needs Provide participants with fixed number of votes to allocate for prioritized problems Goals: Increase efficiency capturing unmet needs and create new medical technologies 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. Martin Medical Device Innovation as a Provider FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: Needle in a Haystack: Traditional ways of medical device innovation rely on immersion and/or shadowing. Power, Influence, Experience: We value diverse perspectives and diverse stakeholders. Working Alone, Together: Don’t control quality, but quantity of unmet needs and problems. Sprint: Activity by design is hurried to maximize time with providers and promote quick decision making.

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: Roles and Responsibilities: Providers need to give clinical perspective Goal: Assess and reflect on best ways for FastTraCS to use providers to solve problems Challenges: Knowledge and terminology to be included and integrated Entrepreneurship Startup Pitfalls: Create crosstalk, not compartmentalize I- and T-Shaped Teams: Communicate to work together and understand each other Benefits: Continue to work on biodesign teams to add value in different spheres “Right” Providers: Medicine is moving toward multidisciplinary teams, ideas, opinions Technology: How to drive adoption and manage unmet needs Bias: Based on where innovation begins—hospitals, academic programs, or clinics Consultation Concerns: Pigeonhole or leverage providers? 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 by partnering with providers. T-Shaped Team: Communicate effectively and build off everyone’s strengths. What are the right kind of providers? There’s value in more voices rather than few. There are innovators in all fields of medicine.

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: Roles and Responsibilities: Providers need to give clinical perspective Goal: Assess and reflect on best ways for FastTraCS to use providers to solve problems Challenges: Knowledge and terminology to be included and integrated Entrepreneurship Startup Pitfalls: Create crosstalk, not compartmentalize I- and T-Shaped Teams: Communicate to work together and understand each other Benefits: Continue to work on biodesign teams to add value in different spheres “Right” Providers: Medicine is moving toward multidisciplinary teams, ideas, opinions Technology: How to drive adoption and manage unmet needs Bias: Based on where innovation begins—hospitals, academic programs, or clinics Consultation Concerns: Pigeonhole or leverage providers? 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 by partnering with providers. T-Shaped Team: Communicate effectively and build off everyone’s strengths. What are the right kind of providers? There’s value in more voices rather than few. There are innovators in all fields of medicine.

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: Innovative Approach: Solve complex problems by using and evaluating new devices Championing Collaboration: What can be improved, made more efficient and effective? Medical Device Design: Innovation driven by like-minded professionals and providers Learn from Mistakes: Avoid pitfalls by focusing on problem to develop a solution Education vs. Experience: Medical training may create hostile or necessary environment Clinical Impact: Consider all potential financial and useful benefits of device innovation Intellectual Property Ignorance: How business and entrepreneurship should be done 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 (IR) field. Mistakes are invaluable learning opportunities. Credit Sharing: Check your title at the door and be open to equal contributions of expertise. Be collaborative. Build bridges. Be open minded. Make the most of every opportunity and idea.

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: Innovative Approach: Solve complex problems by using and evaluating new devices Championing Collaboration: What can be improved, made more efficient and effective? Medical Device Design: Innovation driven by like-minded professionals and providers Learn from Mistakes: Avoid pitfalls by focusing on problem to develop a solution Education vs. Experience: Medical training may create hostile or necessary environment Clinical Impact: Consider all potential financial and useful benefits of device innovation Intellectual Property Ignorance: How business and entrepreneurship should be done 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 (IR) field. Mistakes are invaluable learning opportunities. Credit Sharing: Check your title at the door and be open to equal contributions of expertise. Be collaborative. Build bridges. Be open minded. Make the most of every opportunity and idea.

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: COVID-19: Heterogeneous effect on IR practice both nationally and internationally IR Practice: Encompasses 80 minimally invasive procedures Procedure Volume: Elective procedures deferred, but emergent/urgent cases continued Outpatient Procedures: Performed without general anesthesia or admission to hospital COVID Concerns: People who need care stay at home instead of going to hospital COVID: IR innovation shifts from what can be done to how to protect patients/providers Regulatory Pathways: Routes remain to get products on the market Risk/Benefit Analysis: IR indications and procedures depend on situation/circumstances Infection Control Challenges: Tech equipment performance not functioning correctly IR Options: Half-staff with tiered responsibility, telehealth, and education/information IR Specialty: Opportunity to improve and increase public awareness of procedures Recommendations: Room for improvement in IR practice by adapting to new paradigm COVID Response: Share experiences for improved prep/planning to address necessities Ideal IR: Lightweight, flawless, seamlessly integrated augmented reality glasses that respond to voice commands 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.” - Dr. Jon Martin “The impact of COVID really depends on what category of procedure we’re talking about.” Dr. Jon Martin “There’s people and individuals that have unstable conditions that may not show up to the hospital when they need to.” - Devin Hubbard “With COVID-19, there may be some more thinking about approaching things from a societal level and what’s sort of the greatest good for the greatest number.” - Dr. Jon Martin

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: COVID-19: Heterogeneous effect on IR practice both nationally and internationally IR Practice: Encompasses 80 minimally invasive procedures Procedure Volume: Elective procedures deferred, but emergent/urgent cases continued Outpatient Procedures: Performed without general anesthesia or admission to hospital COVID Concerns: People who need care stay at home instead of going to hospital COVID: IR innovation shifts from what can be done to how to protect patients/providers Regulatory Pathways: Routes remain to get products on the market Risk/Benefit Analysis: IR indications and procedures depend on situation/circumstances Infection Control Challenges: Tech equipment performance not functioning correctly IR Options: Half-staff with tiered responsibility, telehealth, and education/information IR Specialty: Opportunity to improve and increase public awareness of procedures Recommendations: Room for improvement in IR practice by adapting to new paradigm COVID Response: Share experiences for improved prep/planning to address necessities Ideal IR: Lightweight, flawless, seamlessly integrated augmented reality glasses that respond to voice commands 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.” - Dr. Jon Martin “The impact of COVID really depends on what category of procedure we’re talking about.” Dr. Jon Martin “There’s people and individuals that have unstable conditions that may not show up to the hospital when they need to.” - Devin Hubbard “With COVID-19, there may be some more thinking about approaching things from a societal level and what’s sort of the greatest good for the greatest number.” - Dr. Jon Martin

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: Primary COVID-19 Concerns: Access to and shortage of PPE and ventilation equipment Potential Pitfalls: Anticipate long-term hospital medicine needs for patients and providers Physical Space: How to retrofit existing hospital rooms to care for and contain patients? Variables and Complications: From mild to severe symptoms, identify high-risk people Everyday Care vs. Performing Procedures: Preserve PPE to protect workers Innovative Ideas: Make masks, gowns, tests, and equipment effective and comfortable Teamwork: Ways for patients and healthcare providers to be cohorts to do more Logistics and Locations: Be open, available, and refresh skills for other emergencies Hardest Hit and Weakest Link? Emergency Room (ER) Links and Resources: Centers for Disease Control and Prevention (CDC) #MedTwitter Society of Hospital Medicine (SHM) Learning Portal Fluid Resuscitation In The Critically Ill Course Devin Hubbard FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: How do you prevent and spread infection? Personal Protective Equipment (PPE) - Rob Lampman Early Stratification: How can people be identified as being at higher risk? - Nicholas Piazza “The face shields are a nightmare.” - Chris Kahl “The fear of running out of PPE is high, and it’s justified.” - Ria Dancel

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: Primary COVID-19 Concerns: Access to and shortage of PPE and ventilation equipment Potential Pitfalls: Anticipate long-term hospital medicine needs for patients and providers Physical Space: How to retrofit existing hospital rooms to care for and contain patients? Variables and Complications: From mild to severe symptoms, identify high-risk people Everyday Care vs. Performing Procedures: Preserve PPE to protect workers Innovative Ideas: Make masks, gowns, tests, and equipment effective and comfortable Teamwork: Ways for patients and healthcare providers to be cohorts to do more Logistics and Locations: Be open, available, and refresh skills for other emergencies Hardest Hit and Weakest Link? Emergency Room (ER) Links and Resources: Centers for Disease Control and Prevention (CDC) #MedTwitter Society of Hospital Medicine (SHM) Learning Portal Fluid Resuscitation In The Critically Ill Course Devin Hubbard FastTraCS GuideWire Podcast on Twitter GuideWire Podcast Quotes: How do you prevent and spread infection? Personal Protective Equipment (PPE) - Rob Lampman Early Stratification: How can people be identified as being at higher risk? - Nicholas Piazza “The face shields are a nightmare.” - Chris Kahl “The fear of running out of PPE is high, and it’s justified.” - Ria Dancel

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: Purpose: Create relationships with clinicians and innovative medical technologies Strange Shadowing: Shapes the way they do things now Shattered Relationship: Irreplaceable and important award comes crashing down Interview Questions: Stagefright leads to awkward and adorable first impression Stomach of Steel: First time in OR stapling sternum to ribs while listening to Willie Hungry for More: Sweet barbecue smell of cauterized flesh YouTube: Be careful of what you watch; don’t spoil best practices Prep, not Pester: Know where to go and what to wear (scrubs, ID badges, etc.) Links and Resources: Devin Hubbard FastTraCS GuideWire Podcast on Twitter GuideWire Podcast

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: Purpose: Create relationships with clinicians and innovative medical technologies Strange Shadowing: Shapes the way they do things now Shattered Relationship: Irreplaceable and important award comes crashing down Interview Questions: Stagefright leads to awkward and adorable first impression Stomach of Steel: First time in OR stapling sternum to ribs while listening to Willie Hungry for More: Sweet barbecue smell of cauterized flesh YouTube: Be careful of what you watch; don’t spoil best practices Prep, not Pester: Know where to go and what to wear (scrubs, ID badges, etc.) 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: Where to begin? Shadow existing contacts in network and departments of interest Nicole’s Background:Small-scale medical devices and biomechanics research Nabil’s Background: Biomedical engineering for medical device and development Learning Point: Discover, gather, explore, and mine problems before thinking of solutions How to select a clinician to work with? Find a spark connection—someone who is enthusiastic, energized, and passionate Pros and Cons of Problem Discovery Techniques: Shadowing, focus groups, and sprint method to identify, track, and solve problems or parts of problems quickly 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 intangibles, as I was the tangibles.” Nicole Wiley “Don’t think about solutions first. Try to discover, gather, explore, mine novel problems.” Nabil Khan “The spark connection is critical.” Nabil Khan “The best way to get in touch with folks is to work your network.” Devin Hubbard

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: Where to begin? Shadow existing contacts in network and departments of interest Nicole’s Background:Small-scale medical devices and biomechanics research Nabil’s Background: Biomedical engineering for medical device and development Learning Point: Discover, gather, explore, and mine problems before thinking of solutions How to select a clinician to work with? Find a spark connection—someone who is enthusiastic, energized, and passionate Pros and Cons of Problem Discovery Techniques: Shadowing, focus groups, and sprint method to identify, track, and solve problems or parts of problems quickly 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 intangibles, as I was the tangibles.” Nicole Wiley “Don’t think about solutions first. Try to discover, gather, explore, mine novel problems.” Nabil Khan “The spark connection is critical.” Nabil Khan “The best way to get in touch with folks is to work your network.” Devin Hubbard

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: What is IR? Minimally invasive procedures using image guidance to treat various disorders/conditions, including vascular abnormalities, women’s health, certain cancers How IR works from head to toe? Focuses on everything through small incisions in skin IR Procedures: Everything from handling abscesses and biopsies to pain control Novel vs. Incremental Medical Device Innovation: No special balloons back in the day for angioplasty and stents Nimble Ninjas: Pros and cons of IR’s public relations (PR) problem being known for inventing procedures for other specialities Big Ticket Problems: Challenges with IR continue depending on user experience and clinical needs to pursue solutions Biodesign vs. Sprints: Mining for unmet clinical needs leads to improved efficiency Urgent Unmet Needs: Problems with implanted devices and length of time they remain in body can be a death sentence Links and Resources: Dr. Jessica Stewart Angioplasty Balloon Expandable Stent Charles Theodore Dotter: The Father of Intervention Devin Hubbard FastTraCS Guidewire