Kristin Havranek has worked extensively with and in the MedTech industry for the last 25 years. A trusted advisor to investors and companies alike, Ms. Havranek regularly helps startup and emerging MedTech companies build their IP portfolios in a strategic, thoughtful manner with their business goals and needs in mind. She evaluates freedom-to-operate, patentability, investor due diligence and financing IP, and conducts patent validity analyses. She advises on strategic alliances and prepares and prosecutes patent applications before the U.S. Patent and Trademark Office. Ms. Havranek’s ties in the industry run deep and is currently on the leadership team of MedtechWomen.
Martin Gomez is a partner in Goodwin’s Technology Companies group specializing in intellectual property matters. Mr. Gomez focuses his practice on advising technology and life sciences companies of all sizes (including startups), and their investors, in corporate and especially intellectual property matters throughout the business life cycle, including new company formation, IP protection, fundraising, strategic transactions and exits.
Matt Wetzel is an experienced health lawyer and provides strategic advice to life sciences companies on complex health care laws and regulations, including federal and state fraud and abuse laws, Medicare and third party billing and reimbursement regulations, patient privacy obligations, and transparency requirements, among other areas. Matt also works with clients to establish and operate effective global compliance and risk management programs.
Steven Tjoe is a partner in the firm’s Technology and Life Sciences groups and a member of the firm’s FDA practice. He focuses his practice on product development strategies and regulatory compliance counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, compounded drugs, cell and gene therapies, and other drugs and biologics. Steven advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Steven also advises on Hatch-Waxman patent listing and exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S, and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities across the medical device, drug, and biologic industries.
Stephanie Philbin, a partner in the firm’s FDA practice and a member of its Life Sciences group, concentrates on Food and Drug Administration laws. She joined Goodwin in 2007.
Medtech companies should be particularly mindful of the following legal and regulatory compliance issues. This is especially true for companies transitioning to data-based services.
Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Investor and strategic partner mindsets have shifted toward optimal ways to protect their intellectual property (IP) requirements, especially given evolving laws and social concerns.