New Patient Initiatives May Help Neurotech Products

by Jennifer French, senior editor

November 2017 issue

Several new efforts now underway from government and nonprofit agencies to increase patient involvement in medical device design and development may help neurotech vendors get products to market sooner.

Earlier this fall, the FDA released updates to its patient engagement program and guidance policies in an effort to improve innovative medical device access and protect those who rely on these medical products. In response to the 21st Century Cures legislation, the FDA created the medical device development tool, a 23-item questionnaire designed to gain input directly from patients. The aim is to standardize the development process and make it easier for developers to comply and easier for the consumers to gain access.

According to FDA Commissioner Scott Gottlieb, “The development of more modern tools for measuring outcomes relevant to regulatory decisions is a key part of our efforts to promote innovation. Such development tools can also help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving on the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes.”

Along with the MDDT, FDA also introduced the “Breakthrough Devices Program” guidance documents. This effort extends the popular Expedited Access Pathway designed to help patients gain access to devices that will potentially halt or reduce the progression of degenerative and life-threatening diseases. Accompanying this guidance were two more guidance measures that pertain specifically to 510(k) pre-market approval, and that clarify the interaction with FDA regarding small, incremental changes to devices. That development could hasten the neurotech device commercialization process and remove a barrier to market access.

The FDA also hosted the inaugural meeting of the Patient Engagement Advisory Committee, held last month in Washington, DC. The committee was created out of 2012 federal legislation for the FDA to seek patient input and guidance during the medical product development process. PEAC is considered a forum for the voice of the consumer. This nine voting member committee has a goal to “better understand and integrate patient perspectives into our oversight, to improve communications with patients about benefits, risks, and clinical outcomes related to medical devices, and to identify new approaches, unforeseen risks or barriers, and unintended consequences from the use of medical devices.” In essence, it is an advisory committee to help FDA understand complex issues impacting medical device users.

On a similar front, the Medical Device Innovation Consortium is also engaging with FDA and industry to gain a better understanding and develop improved methods for patient participation, needs, and engagement. MDIC is hosting a series of webinars addressing these issues such as the upcoming topics of patient preference information and the regulatory process and surrogate sample use in clinical diagnostic test development.

An additional element to this mix is hosting patient engagement education sessions with FDA reviewers and compliance officers. These ad hoc sessions are designed for FDA staff to interact with consumers and clinicians on specific topics for targeted conditions. Earlier this month, the nonprofit organization, Neurotech Network organized a session addressing neuroprosthetic devices for treating spinal cord injury. The four-person panel consisted of two people living with paralysis and two clinicians who frequently treat patients with SCI.

These recent developments can help streamline neurotech product development. By enhancing consumer input and interacting with those who will benefit, vendors and end users are likely to have more successful outcomes.

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