Medical Device Innovation Consortium Gets Government Contract

The U.S. Food and Drug Administration (FDA) has awarded the Medical Device Innovation Consortium (MDIC) a $500,000 contract to better understand patient preferences and research ways to integrate these preferences into the development of medical devices.The contract is a major milestone for MDIC, a nonprofit organization formed in 2012 to enhance regulatory science around medical devices.

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,” said Bill Murray, president and CEO of MDIC.

MDIC’s Patient-Centered Benefit-Risk Project, funded by FDA’s contract, will convene patient advocates, industry representatives, FDA staff, and academics to find valid ways to bring the patient’s perspective into such benefit-risk determinations through the use of robust assessment tools.

The contract will enable 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, FDA’s Center for Medical Devices and Radiological Health issued guidance for manufacturers on how it makes benefit-risk determinations during the pre-market review of certain medical devices. Significantly, the FDA emphasized that “patient tolerance of risk and perspective on benefits” is an important consideration.

While FDA’s guidance discusses the importance of the patient perspective in certain regulatory decisions, it does not outline how such information should be collected or used. For example, what types of patient preferences should be measured? How and when should this information be provided to inform the FDA?

These are some of the questions that the MDIC’s Patient-Centered Benefit-Risk Project intends to address. MDIC has assembled a steering committee of member organization representatives, patient advocates, other experts, and the FDA to work on the project. The FDA contract will help support their work, enabling the committee to catalogue methods of assessing patient preferences and develop a framework to help guide the use of this data.

Founded in 2012, the MDIC is the first public-private partnership created with the sole objective of advancing medical device regulatory science in an effort to improve product safety and performance while reducing cost and time to market. The MDIC functions in the pre-competitive medical device space, providing a forum for collaboration to leverage resources and share critical information. MDIC’s mission is to promote public health through science and technology, to solve issues facing the industry while enhancing safe and effective product performance through the total product lifecycle of commercialized medical devices and to enhance trust and confidence among stakeholders.