This week on Trying to Keep Up (TTKU), Allison Komiyama and Michael Nilo cover a wide range of regulatory and industry updates shaping the medtech landscape.

They discuss the FDA’s latest push to highlight real-world evidence (RWE) in regulatory decision-making, including newly shared examples of successful marketing authorizations. The conversation also explores updated guidance on patient preference information and how it may influence benefit-risk assessments moving forward.

The episode dives into practical insights on FDA hiring, including how to navigate USAJobs postings and why direct outreach can improve candidate visibility. Allison and Michael also review recent device reclassification activity and emphasize the importance of submitting public comments while proposals are still open.

Additional highlights include:

• Expansion of the TAP program into new device areas

• The role of FDA clearance in enabling global market access

• A spotlight on a solar-powered oxygen innovation improving care in underserved regions

• Reflections on FDA communication efforts and internal challenges

As always, the discussion blends technical insight with candid perspective—and a few jokes along the way.

Links

• OxyCare Uganda (Children’s Prize winner)

• Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices

• Total Product Life Cycle Advisory (TAP) Program

• Reclassifications

  • Exemptions from Premarket Notification: Class II Medical Devices

  • Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers