FDA/CDRH Changes: How MedTech Companies Can Prepare Webinar

Randy Horton
Randy Horton
Published on: March 6th, 2025

Significant changes are underway at the FDA, with recent shifts in staff and policy creating uncertainty for MedTech companies. With updates continuing through 2029, proactive medical device manufacturers should rethink their regulatory strategies to stay ahead of a winding curve that may take unexpected sharp turns along the way.

The challenge? Knowing what’s changing, what remains unclear, and what actions to take now.

Orthogonal and a panel of former FDA regulatory staff turned industry experts broke down the latest updates from HHS, the FDA, and CDRH into clear, practical takeaways. Moderated by Randy Horton, Chief Solutions Officer, Orthogonal, this discussion featured expert insights from Steve Silverman, President, The Silverman Group, Kwame Ulmer, Managing Partner, MedTech Impact Partners, Philip Desjardins, Partner, Arnold & Porter, Megan Graham, VP, Regulatory & Quality, Orthogonal and Bernhard Kappe, CEO & Founder, Orthogonal. They shared insights on navigating regulatory shifts while continuing to develop clinically and commercially successful digitally enabled medical devices.

What You’ll Learn:

  • What’s Happening at the FDA?: Breaking down what we know, what we suspect, and what remains uncertain.
  • Implications for Digitally-Enabled Devices: How shifts impact SaMD, AI/ML-enabled devices, and connected devices, plus steps companies should take now regarding regulatory pathways, market access strategies, and ongoing programs.
  • HHS Rulemaking Changes: Understanding the impact of eliminating public comment periods for certain administrative rules.
  • Potential QMSr (Quality Management System Regulation) Changes: What could change with QMSr and how to prepare.
  • Breakthrough Device Program Impact: Examining potential effects on this program and what it means for future approvals.
  • Post-Market Regulation Changes: How evolving policies could change the predictability, consequences, and impact of inspections.
  • Maintaining FDA as the Regulator-of-Choice: Are manufacturers shifting to the EU or other global markets first?
  • Finding Opportunities In Uncertainty: How manufacturers can adapt and uncover new opportunities for clinical and commercial success.

Who Should Attend?

  • Regulatory Affairs & Quality Leaders: Get expert-backed strategies to stay ahead of changing FDA requirements and compliance expectations.
  • Executives & Business Leaders: Understand how regulatory changes impact market access, approval pathways, and commercial success.
  • Product & Engineering Teams: Learn how to align AI/ML-enabled, connected, or SaMD products with new regulatory expectations.
silverman headshot2023

President, The Silverman Group

Steve Silverman

Steve Silverman has extensive experience in regulatory strategy, compliance, and policy for medical products. He advises companies on FDA matters and previously held leadership roles at AdvaMed and McKinsey & Co. He spent nearly 20 years in federal service, including senior FDA roles overseeing compliance, enforcement, and stakeholder engagement. His background also includes positions at the DOJ and FTC.

Kwame Ulmer Headshot

Managing Partner, MedTech Impact Partners

Kwame Ulmer

Kwame Ulmer has 20+ years of experience in medtech leadership, compliance, FDA policy, and M&A due diligence. He has guided 50+ companies through FDA approval and driven 89% CAGR growth at a regulatory consulting firm. As a Venture Partner at Wavemaker Three-Sixty Health, he leads medtech investments. He serves on multiple boards, including Essenvia and California Life Sciences.

Phil Desjardins

Partner, Arnold & Porter

Philip Desjardins

Philip Desjardins has 20 years of experience with the FDA’s CDRH and leadership roles in Johnson & Johnson’s MedTech businesses. A regulatory expert, he has guided startups and global firms to success. As CDRH Associate Director for Policy, he shaped key FDA regulations and advised agency leaders on compliance, enforcement, and litigation before rejoining his firm’s Life Sciences practice.

Megan Graham Headshot (1)

VP or Regulatory & Quality, Orthogonal

Megan Graham

Megan Graham has 25+ years of experience in software engineering and regulatory affairs. She has worked with Medtronic, Mayo Clinic, and founded a digital health consulting practice. Her expertise includes AI/ML, product development, risk management, and compliance. An adjunct professor at the University of Minnesota, she is active in RAPS, HIMSS, and AAMI.

Bernhard Kappe orthogonal software as medical device

CEO and Founder, Orthogonal

Bernhard Kappe

Bernhard Kappe, Founder and CEO of Orthogonal, has driven innovation in SaMD, DTx, and connected medical systems for over a decade. He helps companies launch impactful medical device software and optimize innovation pipelines. He co-authored an AAMI Consensus Report on cloud computing, founded ChiPMA, and holds degrees in mathematics and economics from Penn and Wharton.

Randy Horton, VP of Solutions and Partnerships, Orthogonal

Chief Solutions Officer, Orthogonal

Randy Horton

Randy Horton, Chief Solutions Officer at Orthogonal, helps MedTech firms speed up SaMD, DTx, and connected device development by merging modern software practices with regulatory focus. He co-chairs AAMI’s Cloud Computing Working Group and contributes to key reports on cloud-based medical devices. A frequent speaker, he presents at events by AdvaMed, AAMI, RAPS, HLTH, and HFES.

Related Posts

Talk

Understanding PCCP for AI/ML Medical Devices: Webinar

Talk

Harnessing the Value of Data & Digital for MedTech: Webinar

Talk

Insights into New Quality Benchmark for MedTech: Webinar

Talk

Understanding Medical Device Users Through PPI: Webinar

Back to Insights
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2025 Orthogonal