This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA division director and current Director of Medical Affairs at Precision Neuroscience, Vivek Pinto, to talk medical device regulation, innovation, and what FDA reviewers are really thinking during submission review.

Vivek shares stories from his 12+ years at FDA, including his time leading teams in physical medicine and neuromodulation, mentoring reviewers, and helping shape decisions around emerging technologies like brain-computer interfaces (BCIs). The group dives into FDA culture, the realities of balancing risk and access, and why understanding the patient journey matters more than ever.

The episode also covers:

• FDA’s new RAPID pilot program and the future of CMS/FDA collaboration
• Key takeaways from the 2026 REdI Conference
• Why sponsors need to “tell the story” in submissions
• New PMA approvals, including Signatera™ CDx and Atellica IM free PSA II
• FDA’s growing focus on real-world evidence (RWE)
• Patient-focused drug/device development and patient-reported outcomes
• Challenges with the Office of Combination Products (OCP)
• How FDA staff think about benefit-risk and access decisions
• The emotional impact of seeing devices change patients’ lives

Plus: new CDRH Learn modules, updated ELP topics, digital health and TEMPO, and the importance of flexibility and creativity inside FDA.

As always, there are terrible medical jokes, regulatory tangents, and strong opinions about healthcare innovation.

Links

• REdI Conference Speaker Biographies
• ELP Areas of Interest
• Patient Preference Information Guidance
• TEMPO Pilot Module

Subscribe

Sign up to receive a calendar invite for weekly TTKU sessions