FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices – FDA Watch
In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden’s Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden’s Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private financing or other transaction; the intersection of FDA regulation, privacy law, and cybersecurity in AI for wellness and medical devices; cybersecurity False Claims Act risk for technology and life sciences companies; privacy considerations for those who collect information from wellness and medical devices; what companies in the space should watch for; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Rachel Turow
Rachel Turow leverages nearly two decades of experience in food and drug law to guide clients through a full range of FDA regulatory issues, with a focus on product development and regulatory strategy.
A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. She utilizes her extensive experience in advising on corporate transactions and litigation, as well as on developing regulatory risk management strategies and defending against regulatory enforcement actions.
Prior to joining Skadden, Ms. Turow oversaw regulatory strategy and compliance in various in-house counsel roles for major pharmaceutical manufacturers. Her regulatory work spans new drug development, from preclinical through post-market, and she has direct experience gaining FDA approval and launching new products. She has also worked extensively on developing and securing FDA approval of generic drugs, 505(b)(2)s and biosimilars, and has in-depth knowledge of exclusivity and other complex regulatory issues unique to those product categories. Ms. Turow also has medical device regulatory experience, with a particular focus on drug-led combination and digital health products.
Most recently, she led the regulatory legal team at one of the world’s largest retailers. During this time, she directed a team of lawyers focused on a variety of regulatory issues related to consumer products, reduced legal risks across diverse product categories, developed policies and processes to safeguard business operations, handled regulatory inquires and enforcement actions and coordinated with the government affairs and litigation teams on high-priority FDA-related issues. In this capacity, Ms. Turow leveraged her knowledge of common regulatory issues that arise regarding over-the-counter drugs, dietary supplements, cosmetics and consumer medical devices.
At FDA, Ms. Turow developed and implemented guidance and regulations, responded to citizen petitions, and advised on issues relating to the approvals of drugs and biological products as part of the Center for Drug Evaluation and Research (CDER) and medical devices at the Center for Devices and Radiological Health (CDRH).
Bill Ridgway
William E. Ridgway is co-head of Skadden’s global Cybersecurity and Data Privacy Practice. He is a former federal prosecutor with extensive trial and investigations experience who advises companies on their most sensitive cybersecurity, data privacy, artificial intelligence and white collar matters.
Mr. Ridgway has been recognized as a leading lawyer for crisis management, cybersecurity, data privacy, artificial intelligence and high-stakes white collar matters by several industry outlets. He regularly leads the defense of investigations conducted by the U.S. Department of Justice, the Securities and Exchange Commission, state attorneys general, the California Privacy Protection Agency and other U.S. and foreign regulators. These investigations frequently involve matters related to cybersecurity, data privacy, artificial intelligence, the False Claims Act, financial fraud and trade secret theft.
Mr. Ridgway has led the incident response and associated investigations for some of the most high-profile cybersecurity incidents in recent years, and his clients include financial institutions; technology, energy, insurance and health care companies; defense contractors; data brokers; and e-commerce retailers. He also often leads privacy and data security investigations and litigations around the country.
Michelle Gasaway
Michelle Gasaway represents corporate and REIT clients, public and private companies, private equity sponsors, investment banks and other investors in their most significant capital markets transactions.
In nearly 30 years of practice at Skadden and on over 500 transactions, Ms. Gasaway has cultivated extensive experience leading the full range of capital markets transactions, from traditional public and private debt and equity offerings, to more innovative, customized financing capital raising and balance sheet-related transactions.
Ms. Gasaway has particularly extensive experience advising clients in the biotechnology, pharmaceutical and life sciences; energy and natural resources; technology, including defense tech, aerospace, energy tech and digital assets; gaming and entertainment; consumer/retail and real estate (REITs) sectors.
Ms. Gasaway’s full-service capital markets practice allows her to build strong, long-lasting relationships with clients, partnering with them as they grow and their businesses change over time. She has also represented all of the major investment banks.
Leveraging in-depth knowledge of financing alternatives and the latest trends in the capital markets, Ms. Gasaway is able to effectively provide her clients with a comprehensive understanding of financing strategies, as well as practical, commercial and strategic advice customized to each client’s business, industry, objectives and culture.
Carolyn Bruguera
Carolyn M. Bruguera has extensive experience in the design, implementation and management of global compliance programs for medical device manufacturers. She serves as General Counsel and Vice President of Consulting Services to R-Squared Services and Solutions, Inc., a software company that provides software and consulting services to companies seeking efficient and effective healthcare compliance solutions.
She previously served as General Counsel to Hansen Medical, Inc., a manufacturer of robots for intravascular procedures, and to Micrus Endovascular, a manufacturer of neurovascular devices (acquired by Johnson & Johnson in 2010). Prior to joining Micrus, Ms. Bruguera was a partner with Montgomery Hansen LLP, where she specialized in corporate and securities law.
She received her undergraduate degree from Harvard University and her law degree from the University of California, Berkeley’s Boalt Hall School of Law. Ms. Bruguera is a member of the California Bar.
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