Valuing the Patient

Earlier this year, the FDA's Center for Devices and Radiological Health launched the Patient and Caregiver Connection Program in an effort to gain a better understanding of end users' perspectives. There have been similar efforts such as Faster Cures, a watchdog of the 21st Century Cures Act, or the Patient-Centered Outcomes Research Institute, which funds patient-centered research. These initiatives are welcome additions to the medical device landscape. But we have to ask whether this is all a facade.

In other industries, consumer preferences are studied in distinct detail. Mobile devices vendors spare no expense incorporating the end user experience into product design. Commercial aviation manufacturers design their cockpits based on pilot workflow. Yet this concept seems foreign to many in the medical device industry. Perhaps this stems from the paternalistic roots of our clinical culture or perhaps it's the result of the healthcare industry's complex distribution system.

One might think that clinical trials could offer an opportunity to discern user preferences but unfortunately, our healthcare system prioritizes safety and efficacy in clinical trials. Neither attribute addresses the critical end-user perspective of risk versus benefit.

If medical device vendors need any more motivation to prioritize patient engagement, they should consider the costs of clinical trials that fail to reach their recruitment targets, or their dependence on patient communities when they need help lobbying for reimbursement. The Parkinson's community played a key role in advancing DBS therapy, while the deaf community initially put up roadblocks to cochlear implants.

Unlike drugs, implanted devices raise complex ethical issues like failure rates, explantation surgeries, and what happens when a device is discontinued or the manufacturer goes out of business. At some point, the primary customer shifts from the implanting surgeon to the end user.

The choice is ours. The neurotech industry can have a front row seat to the daily lives of its end users in the form of mobile diagnostics and data monitoring that could revolutionize the doctor/patient experience. We applaud neurotech vendors like NeuroPace and ElectroCore who have embraced the end-user as a partner not only to aid in the individual’s treatment but in guiding future product development.

Calling on the patient community only in times of need like reimbursement or trial recruitment is no longer a viable strategy. Nor is paying lip service to patient-centricity. Successful vendors will embrace patients as valuable partners throughout the research and product design process and continuing through marketing and distribution. There is a definite value to patient engagement just as there is for legal, regulatory, and reimbursement consultants. We encourage neurotech vendors to recognize that value up front.

Jennifer French
Senior Editor and Associate Publisher


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