Bringing a Novel Medical Device or IVD to Market

In Regulatory by Chris Mullin

The product development process can be long and confusing. What are the regulatory requirements to bring your novel medical device or IVD to market? Regulatory authorities provide guidance on these requirements that can easily be read and digested.

While it can be difficult to fully anticipate the path to market and all the bumps that will occur along the way, this is even more true for novel devices than for devices for which there is past experience. This the nature of something novel; by definition, something “novel” is new and doesn’t resemble things previously seen so it is not surprising that it is more difficult to predict how things will go.

Given this uncertainty, it is important to consider the role of planning and human factors in the path to market. Additionally, as medical devices are used by, used for, and approved by humans, they are subject to the foibles of dealing with humans. Because of these two sources of uncertainty, the uncertainty inherent with novel situations, and the unpredictability of human nature, guidelines for both planning and conduct to understand and deal with them are valuable.

Here’s an overview of some keys to success for bringing a number of novel devices to market.

  • Leverage past experiencesEven for novel devices, past experiences can be utilized. This may include leveraging past regulatory paths for novel but similar devices, borrowing innovative study designs from other areas of medicine, or creating even novel devices by combining disparate ideas or technologies into one that is novel.
  • Make a device that worksWhile regulatory professionals don’t often get a chance to provide direct input into the design of devices, it can be important to consider how device modifications may change the benefit/risk profile of the device; swinging this balance one way or the other can have a large impact on the difficulty of obtaining regulatory approval. For example, if a device change can greatly improve the safety profile at the expense of some degree of efficacy, it may be a worthwhile consideration as safety concerns often trump efficacy concerns. On the other hand, when there is a novel device that may fulfill a strong but unmet clinical need, less evidence of effectiveness may be acceptable than if there were alternative treatments. Thus, choosing the population for where the device might work relative to the alternatives can help speed the path to market.
  • Go slow to go fast.

This is the adage of the tortoise and the hare; slow but steady wins the race. Too often, start-up companies with truly novel devices push timelines to extremes but neglect important steps along the way. Proceeding carefully with sufficient thought and foresight can lead to a much faster approval than blindly charging ahead down a particular pathway.

You can learn more about these and other keys to bringing your novel device to market, as well as what to do when the inevitable challenges do occur, at RAPS 2014.  NAMSA will be part of a panel discussing key points in the novel device development process. Our experts will also be available for consultations during the conference.

If you would like to schedule a meeting, please email us.

You can also learn more about our Regulatory Services and other offerings.

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