What's Ahead for FDA and MedTech – FDA Watch
Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Dr. Rusty Segan, CEO of Medical Scientific Advisors. You’ll hear their takeaways from AdvaMed’s MedTech Conference and emerging FDA issues, plus their thoughts on CDRH priorities under Dr. Michelle Tarver and the evolution of risk-based device regulation; MDUFA reauthorization and potential device policy changes; QMSR implementation and FDA compliance and enforcement expectations; FDA oversight of AI-enabled medical devices; the RAPID pathway and alignment of FDA authorization with Medicare coverage and reimbursement; and much more.
Headlines
Pharma: FDA launches Rare Disease Framework Initiative to streamline drug development while allowing flexibility
Pharma: FDA finalizes guidance for software and apps used alongside prescription drugs
Devices: Medtech industry outlines top policy priorities ahead of MDUFA VI
Food: FDA finalizes guidance on new dietary ingredient notification requirements
Cosmetics: FDA flags misleading social media promotion of Evolus’ Jeuveau
About Our Guests
Philip Desjardins
Philip Desjardins is a Partner at Arnold & Porter. He brings nearly two decades of experience working with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. His comprehensive insights into the intricacies of the FDA’s operational framework and regulatory expectations and broad knowledge of the MedTech ecosystem position Phil as a leading authority on MedTech regulatory affairs and compliance. He has consistently delivered successful outcomes to a broad spectrum of clients, from emergent biotech startups to established global healthcare giants.
As CDRH Associate Director for Policy, Phil was key in formulating the FDA’s current policies on medical devices and drug-device combinations, including legislation, regulations, and enforcement actions. He helped develop and implement CDRH policies in the MedTech space on clinical trials and audits. As Regulatory Counsel, Phil advised FDA leaders on the legal implications of potential compliance actions, pending litigation, enforcing post-market regulatory requirements, and responses to congressional inquiries.
Phil rejoined the firm’s Life Sciences & Healthcare Regulatory practice after serving as counsel earlier in his career.
Sean Boyd
Sean Boyd, a 31-year veteran of the US FDA, serves as Corporate Vice President for QualityHub’s, a MedTech consulting firm providing Quality and Compliance services to the medical device and pharmaceutical industries. He is responsible for establishing corporate vision, culture and providing best-in-class services for clients and their customers – patients across the globe. In this role, Sean provides strategic oversight and direction for business development, recruiting, client engagement, professional services, communication & marketing, and finance & administration functions across the company.
Sean previously served as Director of the Office of Regulatory Programs in the Office of Product Evaluation and Quality, within the agency’s Center for Devices and Radiological Health (CDRH). In that post he was responsible for leading all device review programs across the total product lifecycle to promote device innovation and patient safety. Prior to that Sean held leadership positions that included Deputy Director for Regulatory Affairs in CDRH’s former Office of Compliance and many components of the Center’s Radiological Health Program. He is well versed in all aspects of pre-market, post-market surveillance, and compliance programs across the full spectrum of medical, industrial, commercial, and consumer products.
A now-retired Flag Officer in the US Public Health Service (USPHS) Commissioned Corps, RDML (ret) Boyd led preparedness and response efforts that impacted national and global public health needs, providing care to people who had no one else to turn to and nowhere else to go. Sean, who resides in Monrovia, MD, is married to his high school sweetheart and is father to two sons and a daughter. He’s an outdoorsman who enjoys camping and boating, and loves cooking for family and friends. Sean holds a Bachelor’s in Biomedical Engineering from Boston University and a Master’s in Public Health from Uniformed Services University of the Health Sciences.
Dr. Rusty Segan
Ross “Rusty” Segan, MD, MBA, FACS, is a physician executive, surgeon, MedTech leader, and former senior official at the U.S. Food and Drug Administration. He served as director of the Office of Product Evaluation and Quality (OPEQ) within FDA’s Center for Devices and Radiological Health (CDRH), where he led one of the agency’s largest medical device oversight organizations.
Before joining FDA, Segan held senior leadership positions across the medical technology industry. He served as global chief medical officer of Olympus Corporation and previously held executive roles at Johnson & Johnson MedTech and Covidien Surgical Solutions. His responsibilities have spanned medical and scientific affairs, clinical and preclinical strategy, evidence generation, health economics and market access, patient safety, quality, and product innovation. He has also worked in venture investment, including as a venture partner with Vensana Capital.
Segan began his career as a practicing surgeon and served as a U.S. Army officer and chief of minimally invasive surgery at Tripler Army Medical Center in Hawaii. During Operation Enduring Freedom, he performed the first laparoscopic surgery in Afghanistan and helped establish a multinational surgical training program in Kabul.
Today, Segan is founder and CEO of Medical & Scientific Advisors, LLC, where he advises companies, boards, investors, and other healthcare and MedTech leaders. He joined the RQM+ board of directors in 2026 and is a founding partner of White Oak 66 Capital. He also joined the Wounded Warrior Project board of directors in 2026, bringing both his professional healthcare experience and his perspective as a post-9/11 wounded warrior to the organization.
Segan earned his medical degree from Rutgers Robert Wood Johnson Medical School and an MBA from New York University’s Stern School of Business. He is a Fellow of the American College of Surgeons.
