MDIC has released its first annual report, outlining the organization's impact in 2018 as well as opportunities for improvement moving forward. Highlights include the launch of the Health Economics and Patient Access initiative, NESTcc's Real-World Evidence Test-Cases and publication of tools and resources for stakeholders, including a medtech cybersecurity report. Learn more.
MDIC has named CVRx President and CEO Nadim Yared chairman of the MDIC Board of Directors and Executive Committee. He will serve a two-year term succeeding Abiomed President and CEO Michael Minogue, who will continue to serve on the board. Learn more.
A framework created by MDIC and myriad industry and government partners seeks to establish a foundation for the use of surrogate samples to support in vitro device product development and the regulatory process, and it will be discussed in a webcast today. The educational modules will also be available in MDIC's resource library. Learn more.
Stakeholders understand the value of patient input in the development of medical devices, but they often struggle to capture and integrate the patient perspective. MDIC is developing a tools to facilitate integration of patient perspectives, and they were discussed in this webcast, now available on demand. The content provides insight to help viewers develop clinical trials that work for patients and evaluate what matters to them. Learn more.
FDA's Early Feasibility Studies program seeks to accelerate patient access to emerging devices and treatments of significant health importance. MDIC's EFS Initiative supports these aims by creating a network of sites and sponsors willing to use available EFS tools, meet performance goals, and share best practices to achieve the "60/60/60" goal -- defined as the time to complete the EFS Clinical Trial Agreement, gain institutional review board approval and enroll the first patient. In this webcast, available on demand, learn how two sites have met this goal. Learn more.
MDIC's Case for Quality Forum of 2019, co-hosted by MDIC and the Center for Medicare & Medicaid Innovation, explored the work of the MDIC Case for Quality initiative, including conversations on topics such as:
Intersection of Quality and Cybersecurity
Intersection of Quality and Clinical Diagnostics: an opportunity for cross-collaboration at MDIC
An update on the Case for Quality Voluntary Improvement Program (CFQ VIP)
Working group updates from the CAPA, Quality as Career, and Leadership Engagement working groups
Presentations and discussion from the ISPOR Summit 2018 were published this month in Value in Health. MDIC's Vice President of Health Economics & Patient Access Liz Spurgin co-authored the paper "Specific Value Considerations," which outlined the value assessment of medical devices and the role of MDIC in aligning the differing health economics needs of regulators and payers. Learn more.
NESTcc has announced 12 new real-world evidence test cases that will examine questions of importance to a variety of medical device industry stakeholders and partners, bringing NESTcc's portfolio of test cases to 20. The latest group includes initiatives focused on patient-generated health data and active surveillance, as well as a project developed in response to request from a patient advocacy group. Learn more.
MDIC is proud to be one of the industry partners at the upcoming 2019 American Medical Device Summit! Due to this partnership, Generis Group has decided to release a handful of exclusive passes at a special rate for our members.
The summit is taking place Oct. 28-29 in Chicago. Some of the high-caliber executives speaking at the event include:
David Pacitti, President and Head of Healthcare, North America, Siemens-Healthineers
Cynthia Hougum, SVP, Global Quality Transformation, Terumo BCT
Jijo James, Chief Medical Officer, Medical Devices, Johnson & Johnson
Capt. Sean Boyd, Deputy Director for Regulatory Affairs, CDRH, FDA
Tanya Klaslo, VP, Global Regulatory Operations, Becton Dickinson
The Medical Device Innovation Consortium (MDIC) is a public-private partnership collaborating on regulatory, scientific, and patient value challenges within the medical device and diagnostic industry. Through its partnership with government, non-profit, and industry stakeholders, MDIC works to shape the future of healthcare by developing tools and resources aimed to advance approaches that promote patient access to safe and more cost-effective medical technologies.