MDIC releases final framework on Real-World Evidence generation for In Vitro Diagnostics

MDIC’s Clinical Diagnostics program today released the final version of its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs). Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be […]

MDIC seeks applicants for Accelerate Sustainable Capability Pilot Study

The Medical Device Innovation Consortium (MDIC) is seeking medical device manufacturers to participate in the Accelerate Sustainable Capability (ASC) pilot study, which was developed in collaboration with the medical device industry, Information Systems Audit and Control Association (ISACA), and FDA. The ASC pilot study is designed to serve as a way to help manufacturers improve […]

NESTcc Announces First International Research Network Collaborator

NESTcc has announced NorthWest EHealth (NWEH) and Discover-NOW, the Health Data Research Hub for Real World Evidence, as its newest Network Collaborator partnership and first international addition to its Research Network. The Manchester, UK-based NorthWest EHealth, funded by UK Research and Innovation, are world leaders in the innovative and trustworthy use of routinely collected healthcare […]

NESTcc Announces Launch of NEST 1.0

NESTcc has announced that it has officially opened for the management of sponsor-funded research projects to advance the use of real-world data (RWD) in medical device evaluation. The public launch of NEST 1.0 is a key inflection point in the maturity of NESTcc, signifying both the demonstrated capabilities of our Research Network and the strategic […]

NESTcc announces new Governing Committee members and Executive Committee leadership

NESTcc has announced the addition of six new members of its Governing Committee. The NESTcc Governing Committee is comprised of stakeholders from across the medical device ecosystem committed to the success of NESTcc and, upon inception, was charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency. NESTcc’s new […]

MDIC Announces Two New Board Members

The Medical Device Innovation Consortium (MDIC) is pleased to announce the addition of two new members to the Board of Directors: Jody Powell and Andrew Cleeland. The Board provides leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies. Jody Powell is the Vice President, Global Regulatory Affairs […]

MDIC Releases 2019 Annual Report

MDIC is excited to announce the release of our second annual report and share the impact of our work during the 2019 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights of our 2019 Annual Report […]

NESTcc Welcomes Flora Sandra Siami, MPH as its Senior Vice President

The Medical Device Innovation Consortium (MDIC) today announced that Flora Sandra Siami, MPH, has joined the organization as Senior Vice President for NESTcc. As SVP of NESTcc, Ms. Siami will guide the strategy and operations for NESTcc programs to advance the goals of stakeholders including patients, providers, payers, industry, regulators, and others.  She will lead […]

FDA Commissioner Dr. Stephen M. Hahn to headline MDIC’s Annual Public Forum

On June 18th, FDA Commissioner Dr. Stephen M. Hahn will headline MDIC’s 2020 Annual Public Forum, to be held virtually this year. The Annual Public Forum is MDIC’s premiere event where the medical device and diagnostics community convenes to discuss current trends in regulatory science and highlight innovative regulatory science tools and industry priorities. The […]

MDIC releases draft framework on Real-World Evidence generation for In Vitro Diagnostics for public comment

MDIC is seeking public comment on its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs).  This framework was established following the release of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical […]