Life sciences’ biggest innovations are often developed by young, first-time entrants to the marketplace. But promising product or not, many of these companies struggle in navigating a vast and complex legal and regulatory landscape, as well as changing requirements and expectations from key regulators, such as the U.S. FDA. While many emerging medical device companies seek less expensive legal and regulatory advice from small, local law firms or non-legal consultants, those that choose to work with a larger firm often enjoy distinct advantages.
Pat Shrader, Senior Counsel and previously Senior Vice President of Regulatory and External Affairs at Becton Dickinson and Vice President of Regulatory Affairs at Medtronic, and Mike Heyl, Partner in the Medical Device and Technology regulatory practice at Hogan Lovells, share three key reasons why choosing an established, globally-focused law firm, like Hogan Lovells, can deliver benefits that go far beyond basic legal expertise.
1. Building a sound legal strategy begins with understanding regulatory expectations
Heyl: “One major benefit we provide our clients is perspective borne out of a long relationship with FDA. Starting with the product development process, there's a need to understand not only FDA's requirements, but also their expectations and how they’re changing. There is often a belief with young companies that the shortest pathway to market is the easiest way. Unfortunately, that's not really the way FDA regulates products.”
Shrader: “We often see a lack of objectivity (from clients) around compliance. A lot of times companies believe so much in their product that they assume everything about the product meets regulation and is perfect. But chances are really good that FDA won’t see it that way. One of the biggest ways we assist [our clients] is in helping them understand the tough questions they’re likely to face when working with regulators for the first time.”
2. A successful legal partner offers expertise that goes beyond what’s expected
Shrader: “(A company) might consider using a consultant simply because they’re not fully aware of the capabilities you can find within a large law firm. While individual lawyers and consultants have their place, a large interconnected firm with offices around the world provides benefits that go beyond legal advice. A lot of the work that Mike and I do in the medical device area isn't what people would think of strictly as ‘legal’ work. There's often a lot of consulting in what we do, too.”
Heyl: “In addition to lawyers, we have scientists, engineers, and MDs that can weigh in on health hazard evaluations or risk analyses for new products. I do think it is a big advantage for companies to use a large firm because of the deep bench they have access to. Not just in the legal space, but in the regulatory space as well.”
3: Reputation is everything
Shrader: “Reputation with regulators is really fundamental in helping clients proceed through the regulatory pathway, particularly when it comes to compliance (with new products). I believe large firms like ours have earned a great reputation with regulators because we always come armed with knowledge and the right facts. Regulators know us for our ability to find resolution of an issue, rather than fighting for the sake of fighting.”
Heyl: “I also think the experience we offer comes from the sheer volume of clients we’ve helped. Our firm has represented hundreds of clients in the medical device space alone, meaning we offer a distinct advantage when it comes to negotiations with FDA. Reputation with regulators can go a long way, and that's something that you don't get from reading regulations, or FDA guidances. It’s something you gain by working with [FDA] on a very regular basis.”