January 10, 2018

NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested in responding to this Call for Concepts, be aware that the deadline for submissions has been extended to January 31, 2018. Submissions are due at 5p.m. EST.

A full description is available here. Please direct all questions to the NESTcc team at NESTcc@mdic.org. The required template is provided here.

*Please note that this update extends only to the NESTcc Call for Concepts and is NOT applicable for anyone wishing to submit a response to separate NESTcc opportunities.

December 7, 2017

Read MDIC Computational Modeling a Simulation Working Group Chair Marc Horner’s article on how CM&S can accelerate orthopedic medical device product lifecycles.

December 4, 2017

NESTcc News: NESTcc announces three new opportunities for engagement and launches the new www.nestcc.org. There are two open Requests for Proposals (RFPs) for contractor support and an open Call for Concepts from medical device manufacturers. All final deadlines are January 17, 2018 with interim deadlines in December.

November 17, 2017

Jeff Shuren on the MDIC Case for Quality: “Ultimately what we’re looking for is value to patients – that we have better product out on the market, and we’re rewarding those companies that have that greater focus on quality.” View slides from the November 15 Forum here and read more from MedTech Insight.

November 16, 2017

Can partnering with patients help advance focused ultrasound? Jessica L. Foley, PhD, Chief Scientific Officer of the Focused Ultrasound Foundation discusses this and MDIC’s work in her blog.

October 3, 2017

The Medical Device Innovation Consortium Virtual Patient Mock Submission Team received the CDRH Director’s Special Citation on August 7, 2017. Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, CDRH, FDA presented the award to Dr. Kyle Myers, Director, Division of Imaging, Diagnostics, and Software Reliability, CDRH, FDA, Dr. Dawn Bardot, Vice President, Technology Innovation, MDIC and MDIC Board Member Randy Schiestl on behalf of The MDIC Virtual Patient Mock Submission Team.

October 3, 2017

Susan Alpert, M.D., Ph.D, and Gregory Molnar, Ph.D were recognized as MDIC Fellows during the Annual Public Forum on October 3, 2017. MDIC Fellows have an honorary affiliation with MDIC in recognition of the regulatory science thought leadership provided on behalf of MDIC. MDIC Fellows have an ongoing commitment to serve MDIC’s mission externally and provide periodic strategic guidance to MDIC projects.

October 2, 2017

NESTcc News: Initial Demonstration Projects Address Key Use Cases for the NESTcc

August 22, 2017

Editorial: The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States