#31: Making Sense of Digital Medicine Regulatory Pathways (with Smit Patel, Associate Director at DiMe)

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Episode Details:

What you’ll get out of this episode

Listen in as host Tim Fitzpatrick chats with Smit Patel about how the Digital Medicine Society, better known as “DiMe”, is building the professional home for digital medicine. Smit shares how DiMe and its partners are tackling the toughest digital medicine challenges, developing clinical-quality resources on a tech timeline, and delivering actionable resources to the field via open-source channels and educational programs. DiMe serves professionals at the intersection of the global healthcare and technology communities. BONUS: Smit is our very first T10 Alum to go through the Final Frontier, Tim’s 50-second gauntlet to finish all future Voyages. Enjoy! 

In this episode you’ll discover:

  • Smit’s path to clinical medicine and his decision to pursue a career in service to patients as a PharmD
  • Why Smit is passionate about advancing digital medicine and his work at DiMe
  • The power of connectedness and treating digital health as a team sport
  • How Smit and his team are supporting the adoption and deployment of digital medicine in large integrated care organizations like the Department of Veteran Affairs
  • How DiMe led its 8-month collaboration called the Digital Health Regulatory Pathways Project that brought together stakeholders from Medtech, academia, trade associations, and digital health innovators to create free, interactive resources for the community
  • How DiMe’s Reg Path Tool helps innovators from square one as they begin to navigate the landscape of digital health regulation and the FDA.
  • How many different stakeholders have a hard time navigating regulations and laws for publishing the devices that are being built, and how often that leads to products not reaching their full potential in the marketplace.

Final Frontier – 5 Questions in 50 Seconds

  1. Top ChallengeBuilding trust across stakeholders
  2. Top OpportunityEthics, equity, and accessibility
  3. Tech Trend You’re Following: AI/ML in oncology
  4. Top Media RecsExits & Outcomes (Link→); DTx Podcast (Link→)
  5. Healthcare / Tech Leader(s) You’re Following: 

Watch

Listen

Recommended Resources

  • Seek Not Sleep: Navigate health choices with technology (TEDx)
  • Catalog of Regulatory Pathway Resources (DiMe)

Join the Conversation
 

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Smit Patel on LinkedIn

DiMe on Twitter

DTA partnered with the Digital Medicine Society (DiMe) community and Smit Patel to develop resources that will help any company looking to engage with the FDA. This page is a great place to start on that journey.” @Smit Patel on LinkedIn

“Excited to share: Answering the call of The White House, DiMe and Moffitt Cancer Center will co-host #CancerX, a new public-private partnership effort to rapidly accelerate the pace of cancer innovation in the U.S., alongside the Office of the National Coordinator for Health Information Technology (ONC) and Office of the Assistant Secretary for Health.” @Smit Patel on Linkedin

About Your Host

Tim Fitzpatrick is the CEO of IKONA Health, a company using neurobiology and immersive technology to improve how patients learn about their care and treatment options. Tim co-founded IKONA based on his own patient experiences while serving in the US Navy and now in the VA health system. He has served as Principal Investigator on multiple federal research grants, has co-authored papers on learning science, VR, and mental health in the age of COVID-19, and has partnered with top healthcare investors and institutions including the National Science Foundation, Department of Defense, National Artificial Intelligence Institute, StartUp Health, On Deck, FundRx, MATTER and NVIDIA.

Sponsored by: IKONA Health

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