In our continuing series on Leaders & Influencers, we talk with Robin Martin, Chief Regulatory Strategist, and Jana Gerken, Chief Legal Strategist, co-founders of the newly formed Kinetic Compliance Solutions, which provides regulatory and legal services to emerging and mature companies specializing in the medical device and life sciences industries.
Talk a bit about Kinetic Compliance Solutions.
Jana: Our focus is on medical device and life sciences industries, which is a very specialized niche. These are highly regulated industries. You can see from the news what happens when these types of companies get into trouble, with major lawsuits and fines. This kind of high risk requires real-life expertise, and Robin and I have more than twenty years combined in-house experience in industry manufacturing at a global healthcare company with a focus in medical device and life sciences. We come in early and partner with our clients using the “ounce of prevention” strategy to help them remain successful and competitive for years to come.
Why establish your business in Wisconsin?
Robin: We both worked for GE Healthcare in Wisconsin so have been established in the healthcare industry here. We’re based in Milwaukee, which gives us access to both Madison and Chicago. There’s a great start-up culture in Madison and Milwaukee, and lots going on in medical devices and life sciences. And Wisconsin’s fantastic research universities are really interested in bridging the technology transfer piece.
Jana: We did a lot of due diligence before we founded Kinetic Compliance Solutions to get feedback from experts in the field and to make sure there was a demand for this type of service. To our knowledge, there’s not another firm in Wisconsin that provides the combination of regulatory and legal services that we offer in the medical device and life sciences space.
Tell us about your regulatory service and how that relates to the legal realm.
Robin: Emerging or smaller companies may not have an in-house regulatory or legal team, and that’s where we come in. Those emerging companies are often focused on the regulatory piece early, but we also provide ongoing compliance support as they grow and can help them think about what the competition is doing, or how that competition has gotten into trouble with FDA regulations so they can learn from that. When we work with more mature companies, they are typically looking to expand beyond the U.S. and Europe. There are massive amounts of work that can come with going global, and we are happy to provide our expertise to those companies as well.
Jana: What we’re seeing and are focused on are overcoming those barriers to entry around FDA regulations and intellectual property, so from a legal side we really want to set the tracks in the right direction from the get-go. For example, the anti-kickback statute has implications in healthcare that are not necessarily intuitive. A well-intentioned “thank-you” gift can be perceived as a kickback and a meal will likely be reportable to the public under the “Sunshine” laws. These are just a couple of the many examples of how a practice that’s customary in one industry could potentially put your company at risk in the highly regulated healthcare space. We believe that knowledge is power and work with our clients to help them navigate these choppy waters so that they can focus on growth and innovation.
What’s one piece of regulatory and/or legal advice you give to emerging companies?
Jana: What you don’t know can hurt you. Bring us in early because we’re here to help you and work with you. Our model is very flexible, so we can work with anyone from a smaller start-up to a mature company or investor. Also, don’t underestimate your leverage in negotiations and give in too quickly. You may have more power than you think.
Robin: Really understand the FDA landscape: it’s going to help immensely and save you time and money. For example, in a worst-case scenario, a company submits to the FDA with incomplete data, not realizing they needed clinical data first. Things like that can really set you back.
What’s the single most important change you’d like to see to encourage more innovation and entrepreneurship in Wisconsin?
Jana: Anecdotally, we hear about so much activity and so many great ideas coming out of our research universities, and we need to find ways to commercialize that knowledge and keep those ideas and resulting companies in Wisconsin rather than have them leave for the East or West Coasts. This would also help generate jobs in Wisconsin. Part of our business model is partnering with companies for sustainable growth, so we’d like to see more of these companies stay and grow here.
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