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The Starting Line: Turning the Corner with a Device Concept

Surgeons approach me with new product ideas on a near-weekly basis. I consider myself lucky to see these in the “wishes and dreams” stages of development. Orthopaedic surgeons have many great thoughts for innovative medical devices in a field where bringing a new medical device to market can be a long and arduous journey, with unexpected challenges—everything from funding to FDA approvals.

The conversations usually start at a height of about 40,000 feet before the realities of a regulated industry are presented by yours truly. The discussion’s outcome is commonly aligned with a smattering of disbelief (that this device is regulated), a hard dose of “We had better go back to the drawing board,” a spoonful of “I can’t believe that we have to comply with the Quality System Regulation for Design Controls,” and the realization that a Premarket Notification has an FDA user fee attached to it and (later on) a registration/listing fee, as well.

I find myself laying out the regulations and costs involved rather swiftly because the early-on, 40,000-foot drop to the runway should include a safe and effective landing for all parties concerned. Mind you, we sometimes never land the plane. Other times, we land the plane but can’t find the gate. In any case, the excitement and enthusiasm is contagious and the thrill of talking about the prospects for the future is energizing.

In light of my experience, I believe that design engineers might be helped by a blueprint for walking a surgeon—or a startup—or any novice—through the process of commercialization, beginning at the starting line. This article highlights the early, basic stages of regulatory and development, as well as what catches novice inventors by surprise.

Prototype/Predicate Bubble
The first bubble is usually broken when I explain how we must identify a predicate device for Premarket Notification (premarket clearance or 510(k)) purposes and how this predicate doesn’t have to be exactly like your device, but should be substantially equivalent for the intended use or have either the same technological characteristics, or technological differences that do not change its safety and effectiveness. “Do you mean that there is another device like mine out there?” My answer is always, “hopefully.” Hopefully, substantially equivalent to the conceptual prototype you’ve made, because that would, in fact, make this journey much smoother. Breaking fresh ground with new indications for use or new technology could mean having to file a Premarket Approval (PMA) submission, which is far more inclusive, time-consuming and more expensive than you could ever imagine.

Some surgeons and manufacturers have difficulty determining where research ends and design and development begins. Research activities may be undertaken in an effort to determine basic characteristics for a new product. It may be necessary to develop a prototype to explore the feasibility of a concept or design approach. But, the inventor and the manufacturer should avoid tripping into the maze of equating the prototype design with a finished product design. Prototypes at this stage lack safety features and ancillary functions necessary for a finished product. They are commonly developed under conditions which preclude adequate consideration of product variability due to manufacturing. The safety and efficacy of the device becomes entwined in the manufacturing process without engineering-aligned acceptance criteria.

How Much Does it Cost to File
This is where the rubber hits the road. For fiscal year 2014, the user fee for a 510(k) is $5,170, whether you succeed or not. In other words, this is a non-refundable, up-front fee paid directly to FDA. The registration and listing user fee is $3,313 for fiscal year 2014. You have 30 days after 510(k) clearance to pay that bill.