At the leading edge of scientific discovery, medical devices are capturing the public imagination – and explosive revenue – at a breakneck pace. Just two years ago, the notion that global populations could access at-home testing for deadly viruses would have been unthinkable; today, innovators in medical device technology are continuing to redefine possibilities in the field. At Foley, we boost their protection and their profit, helping medical device manufacturers, distributors, and digital health companies maneuver through a vast regulatory regime and manage compliance with advertising, promotion, and other policies.
The pandemic supercharged activity in the medical device space and countless companies in the field, producing everything from COVID test kits to ventilators to PPE operating under FDA emergency use authorization. Navigating this new normal presents considerable challenges, as does anticipating what the regulatory landscape will look like once the dust settles and the pandemic has receded from view. Planning for that uncertain future is critical to medical device companies’ long-term viability – and Foley stands ready to counsel.
The expertise of our 1,100 attorneys runs vast and deep. Start-up to mid-size clients – whether in research and development, the clinical trial space, or beyond – look to Foley for seasoned guidance in determining the applicability of federal oversight; drafting corporate compliance policies; negotiating licensing and master services agreements; executing patents; overseeing reimbursement (from both the federal and private payor side); advancing CLIA certification; and more. We provide the counsel to sustain and enhance their success.
A drive to devise and monetize tools for digital health is pushing the field in new directions. Products that were historically seen as consumer goods (watches, tablets, phones) are increasingly capturing personal medical information and enabling a deeper reliance on the provision of medical care via telehealth. With the rise of remote patient monitoring devices that communicate with clinicians, at-home tests that require the use of your cell phone camera for data uploads, and other home-based technologies, medical device companies can turn to Foley, which does more digital health work than any other firm nationwide, as a one-stop shop for targeted, strategic advice.
Clients seek us out for more than just our knowledge and experience; they also leverage an integrated legal and business practice that encompasses, and anticipates, diverse client needs. With the robust resources of a large firm and the nimbleness to pivot quickly in response to a shifting regulatory environment, we’ve got all your medical device bases covered and every option explored.