The FDA is providing the Medical Device Innovation Consortium (MDIC) with nearly $500,000 to conduct research to better understand patient preferences, and how to integrate such preferences into the development of medical devices, the group said Monday.
The Consortium lauds this new contract as "a major milestone." The funding will be used for MDIC's Patient-Centered Benefit-Risk Project, which will convene patient advocates, industry representatives, FDA staff, and academics in an effort to find valid ways to bring the patient's perspective into benefit-risk determinations through the use of robust assessment tools.
An MDIC news release explains that the medical device industry and the FDA are trying to find scientifically valid ways to reliably assess patient views on the potential benefits and risks of specific devices. Developers, regulators, and patient groups see the value in weighing device benefits and risks from the perspective of patients, but there aren't any current guidelines on how to collect and use this data.
"The comparison of benefits and risks that is critical to the regulatory process should? include the perspective of patients, since they're the ones taking the risks of a medical? intervention to achieve clinical benefits," Bill Murray, president and CEO of MDIC, said in a news release.
The contract will provide funding for MDIC and its partners to complete a one-year research project with three goals:?a catalog of methods for assessing patient preferences about medical devices, a framework for incorporating that information into device development and benefit-risk assessments, and an agenda for further research.
In 2012,CDRH issued guidance for manufacturers on how it makes benefit-risk determinations during its premarket review of certain medical devices. Significantly, the guidance emphasized that "patient tolerance of risk and perspective on benefits" is an important consideration. While the guidance discusses the importance of the patient perspective in certain regulatory decisions, it does not outline how such information should be collected or used.?
The project intends to address questions such as what types of patient preferences should be measured, and how and when this information should be provided to FDA. MDIC has assembled a steering committee of member organization representatives, patient advocates, other experts, and the FDA to work on the project. The committee will catalog methods of assessing patient preferences and develop a framework to help guide the use of this data.
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The MDIC is an independent nonprofit formed in 2012 as a public-private partnership by CDRH and LifeScience Alley. The goal of the MDIC is to foster collaborations between industry, non-profit organizations, and government agencies. This cooperation is intended to advance regulatory science in the medical device industry and lead to efficient and effective advances in both medical device research and the needs of patients.
