Managing Regulatory Risks Through Medical Device Transactions: Best Practices for Regulatory and Compliance Diligence

Philip R. Desjardins, Partner

Philip Desjardins 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.

Hemmie Chang, Partner

Hemmie Chang, head of the firm’s newly launched Boston office, is a leading lawyer in the life sciences industry. She regularly advises life sciences companies on high-profile intellectual property transactions, finding creative solutions for their complex needs, and helping them navigate the legal landscape as they develop their innovative IP and look to commercialize it globally.

Hemmie is recognized by clients and within the legal community as an experienced advisor with a keen and strategic business sense, deep substantive knowledge and sharp strategic business perspective and legal acumen, developed more than two decades of experience representing innovators and investors in the biopharmaceutical, medical device, diagnostics, gene and cell therapy, and genomics sectors. She advises both established and emerging companies on a wide variety of licensing matters — from development to marketing deals — all of which involve a broad range of intellectual property assets, including patents, trade secrets, brand names, and copyright.

In recent years, Hemmie has closed more than $20 billion in deals across diverse therapeutic areas on behalf of such clients as Alexion*, Daewoong, Dicerna*, Genevant*, HiFiBiO*, H.I.G. Capital*, LegoChem Biosciences, and Tiger Management*. She also has an active pro bono practice, including work for the Asian American Legal Defense and Education Fund and Franklin Square House Foundation, which serves homeless women and children in the Greater Boston area.

Phillip V. DeFedele, Senior Associate

Phillip DeFedele counsels clients in the life sciences industry on regulatory, transactional, compliance, and enforcement matters. His areas of focus include FDA regulation of drugs, devices, and biologics, fraud and abuse, research and development, advertising and promotion, and compliance programs. Phil assists life sciences companies with regulatory matters throughout the entire product life cycle, including FDA inspections and enforcement and advisory actions as well as matters that are essential for FDA approval, clearance, or licensure.  Phil also conducts regulatory due diligence in connection with business transactions and assists in drafting and negotiating various contractual arrangements.  He has worked on a significant number of life sciences transactions at, and prior to joining, Arnold & Porter that have collectively exceeded US$100 billion in value. His experience in this area includes applying and analyzing applicable FDA requirements while accounting for general contractual, practical, and business considerations in order to draft contractual provisions and revise agreements from a regulatory perspective.