Putting the Patient First

One of the hallmarks of successful product marketing is a customer focus that prioritizes the needs and desires of the product’s intended user. In the medical device industry, manufacturers have often conducted focus groups to discern aesthetic or usability preferences for particular device designs.

But focus groups or user surveys are of little use if the product cannot obtain regulatory approval. In the past, there have been many cases where individuals with a particular neurological disease or disorder have had little say in a device’s design because of regulatory hurdles confronting the manufacturer. Even worse, devices that patients might have wanted have never seen the light of day because regulators formed risk/benefit analyses without considering the needs and desires of the particular patient community.

Fortunately, this situation is now changing. The FDA earlier this month published new guidance on considering patient preferences when evaluating new medical devices for approval. Indeed, the draft version of this guidance, published last year, proved instrumental in the approval of at least one neurotech device, EnteroMedics’ Maestro Rechargeable system for treatment of obesity.

At the recent meeting of the IEEE Engineering in Medicine and Biology Conference in Orlando, FL [see Jennifer French’s conference report on p7 of this issue], Heather Benz from the FDA’s Center for Devices and Radiological Health highlighted the impact of the patient perspective initiative on neuroprosthetic devices. The example she provided was recent work to assess the benefit-risk preferences of upper limb amputees using prosthetic arms. The pilot approach began with qualitative interviews of current prosthesis users who expressed common themes like discomfort or pain, overuse syndrome, difficulty with precision movements, and feeling a lack of wholeness. They also identified novel benefits for an advanced upper limb prosthesis with features like lightweight, comfortable, functional, and easy to control.

With this information, they then moved to a focus group format to further understand risks and benefits for this population. Surgical procedures brought the highest perceived risk—but a risk that was more acceptable to users if the benefits gained include robustness, precision, speed, and reduced weight. Later this fall, CDRH will begin the next phase of this study in the form of a questionnaire distributed through the VA and other medical systems. The concluded information may then be used to drive prosthetic development.

We’re pleased to see this new guidance from the FDA come to bear on the neurotech industry and its customers.

James Cavuoto

Editor and Publisher

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