Initiatives

The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. These subcommittees will develop data quality and methodological standards for NESTcc Network Collaborators – the organizations partnering with NESTcc to generate and analyze real-world data (RWD). Subcommittees will also be charged with designing processes for demonstrating conformance to the standards and will make recommendations for their implementation. Standards will build upon existing bodies of work and will leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.

The subcommittees are comprised of members with a diverse set of stakeholder perspectives, including FDA, academia, industry, and society registries, who bring expertise from other national data initiatives and device-specific partnerships.

Read more about these subcommittees in NESTcc’s most recent press release or visit nestcc.org/subcommittee-announcement.

Join MDIC at the 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from May 19 – 23 in Baltimore, Maryland. MDIC initiatives will be featured throughout the conference, including a patient-focused workshop, What Is Patient-Centered and Fit-For-Purpose Patient Preference Information? on May 22 from 3:45-4:45p.m. EST. MDIC Program Director Stephanie Christopher, MA, along with Anindita Saha, BSE (CDRH),  Brett Hauber, PhD (RTI Health Solutions), and Margaret Sheehan, JD (Michael J. Fox Foundation Patient Council) will present a case study from a recently completed project using patient preference information to inform the statistical design of clinical trials to treat Parkinson’s disease.

The second MDIC initiative featured throughout the conference will be the National Evaluation System for health Technology Coordinating Center (NESTcc). A NESTcc panel, moderated by NESTcc Executive Director Rachael Fleurence, PhD (co-chair of the 2018 ISPOR Conference), will feature Owen Faris, PhD (CDRH, FDA), Naomi Aronson, PhD (Blue Cross & Blue Shield Association), and Kathleen Blake, MD, MPH (American Medical Association) on The Changing Landscape of Health Care Decision-Making. Dr. Fleurence will moderate the discussion on May 21 from 5:00-6:00p.m EST that will focus on how the rise of digital and health technologies is changing the landscape of decision-making in the health care system and the role NESTcc can play in enhancing RWE generation to improve decision-making. For a full list of NESTcc related activities at ISPOR and other events, please see https://nestcc.org/events/.

Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?

What if FDA and Medtech Worked Together on Quality? An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.