Device Innovation Consortium Plans To Finish Patient-Centered Project This Year

Article preview from "The Gray Sheet"- January 29, 2014

The public-private partnership created to advance medical device regulatory science is starting 2014 with a renewed focus on its three projects and plans to possibly add a fourth to the mix.

Device Innovation Consortium Plans To Finish Patient-Centered Project This Year

Article preview from "The Gray Sheet"- January 29, 2014

The Medical Device Innovation Consortium expects to complete its patient-centered benefit-risk assessment project this year and continue to move forward with its other projects intended to help advance medical device regulatory science in the pre-competitive space.

The consortium was founded in December 2012 as a public-private partnership consisting of representatives from the device industry and federal agencies, including FDA and CMS, and currently has 36 member organizations. (See "Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013" — "The Gray Sheet," Dec. 10, 2012.) The group has been working on three priority projects since they were announced last fall focused on patient-centered benefit-risk assessment, computer modeling and simulation and clinical trial reform. 

This year, our focus is on really gaining traction on these three projects,” William Murray, president and CEO of MDIC, told “The Gray Sheet.”

“While we may add another project, our primary focus for the year is to validate the vision of MDIC: that we can make progress in regulatory science and improve the overall tools and methods that are used by both the companies and the regulatory agencies for development, assessment and review,” he said.

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