Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.
Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally.
He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University.
Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
The biggest misconception is that many people believe they can successfully navigate the regulatory process without the guidance of a seasoned expert. Often, this results in either a failed attempt at getting through the process, an extended timeline, or a product with labeling restrictions that do not support commercialization. We often inherit good to train wreck submissions and have the challenge of getting the product cleared or approved where the client is stuck within FDA’s regulatory processes or the product did not obtain clearance or approval. Another misconception is that when FDA suggests a Pre-Sub meeting, or that a submission be withdrawn, this is done for the benefit of the company. Companies must establish their regulatory strategy independent of these suggestions, which may prolong the path to market and limit company options for appeal. Often, the only party that benefits from these suggestions is FDA, who uses these as opportunities to improve their user fee metrics. Finally, there is often a significant misconception that an earlier submission date results in an earlier commercialization date. Not true. The key is in the quality of the submission. The most effective way to ensure the earliest commercialization date is to put a good quality submission together, even if this results in a delay of the initial submission, supported by appropriately developed data which will garner you a clearance/approval.
We always tell our clients to “begin with the end in mind.” They should consider what they need out of the product commercialization. At the product level, what do the sales reps need to say to a physician and what do marketers need to put on the websites, sales collateral materials, and medical convention booth panels, to differentiate the device. At the enterprise level, clients also have to meet their business goals, e.g., do they need to: hit certain milestones to meet sales projections; advance the regulatory and/or clinical plan to qualify for additional venture-backed funding; get a relatively quick clearance/approval to be able to raise capital; or sell the technology or business? Or do they want to commercialize the product themselves?
Clients then need to ensure the intended use for the product matches those goals and meets the need for an acceptable level of private and governmental reimbursement. This will depend on the data developed (clinical or otherwise) to support marketing and reimbursement. Some intended use statements will be limited to a pedestrian, commodity-like reimbursement code, but will involve a simpler, less expensive regulatory path. Other intended use statements allow for a higher amount of reimbursement, but will involve a longer, more complex and expensive regulatory path. We recommend brainstorming a range of intended use statements that can be assessed to show the claims that are desired, the regulatory paths that are available, the data needed to bring the product to market, and the possible reimbursement scenarios.
As part of this exercise, companies must consider what technologies or procedures the product will be competing against to understand what is most critical to product success. It is frustrating to see a company spend millions of dollars and years of resources to bring a product to market only to have it fail to be competitive or widely adopted. Companies should not underestimate the value of a well-thought regulatory and reimbursement strategy to ensure that the right product with the right labeling, reimbursement and clinical support is available to market the product to the intended customer base.
Our firm has well over 100 years of experience in the medtech industry combined working with and for some of the biggest and smallest companies in industry. This level of experience allows us to witness and adapt to the changing tide of regulatory body requirements. Our stock in trade is our relationship with FDA and our deep knowledge of the laws, regulations and guidance documents. We are at FDA or on the phone with them many times each month. Our experience allows us to develop sound strategies for our clients success, rescue clients who come to us after they have become stuck with FDA (either by trying to go the road themselves or with subpar guidance). We have had over 900 clients and actively work with an average of 40 clients each month. Because we are a fixture at FDA, we are able to respectfully challenge the FDA to benefit our clients and influence positive change in the regulatory environment.
The biggest blind spot in healthcare today is probably the lack of access to quality, affordable healthcare to all. New drugs and devices can help reduce costs. FDA’s inability to recognize that its mission is not only to protect patients, but to expedite to the market technologies that are beneficial to patients, results in an over-emphasis on risk. This translates into the endless creation of guidance documents and the mindless escalation of data requirements which threatens innovation. These regulatory burdens have an incredible impact on the cost of healthcare solutions, but FDA gets away with it because they can always wave the banner of patient safety. It is politically difficult to second-guess the agency. We need the Administration and Congress to revisit seriously FDA’s budget, priorities and performance to determine if FDA is earning their user fees.
The biggest blindspot in the medtech industry today is probably the lack of understanding, or underestimation of or failure to accept, what is really required to successfully navigate the FDA clearance/approval process, to obtain reimbursement and to commercialize a device. Additionally, the increasingly academic and, as a result, impractical FDA is producing an ever-expanding sea of FDA guidance documents that drowns companies in information overload. This causes many companies to unwittingly acquiesce to never-ending Pre-Sub meetings and overly burdensome and unnecessary data requests. Although FDA often appears to collaborate on the surface, it often stagnates the process by escalating data requirements by asking for what they want, not what they need to make a regulatory decision of “substantial equivalence” for a 510(k) or “reasonable assurance of safety and effectiveness” for a de novo or PMA. FDA requests information far above what is required by statute to be considered “Least Burdensome” (i.e., the “minimum necessary”) to make those regulatory decisions.
The medtech industry, while it seems large, is actually a small interconnected community ecosystem. That ecosystem is rich and serves a lot of needs. Medical Alley connects us for the betterment of the membership, but ultimately patients, their providers and FDA and CMS benefit as well. Our firm is proud to be part of that ecosystem and our clients depend on vendors and consultants like us and we depend on them. DuVal & Associates happens to be in the high-end regulatory space. We help medical device companies and other non-legal regulatory affairs shops alike. Medical Alley enables us to socialize and network with, and inform, educate and train members. In doing so we serve the membership and they rely on our services.
Grandchildren. I am blessed to already have 6 with 1 more on the way. They are the best!
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