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 […]

MDIC Initiates Pilot Study to Strengthen the Performance of Struggling Sites

MDIC | Kathryn Merrill, Pilot Study Program Chair The Medical Device Innovation Consortium (MDIC) is facilitating a collaborative effort between the medical device industry and the Food and Drug Administration (FDA) to develop an innovative pilot study that could revolutionize how sites under an enforcement action could reach and then sustain compliance. The goal of […]

MDIC Initiates CAPA Process Improvement Pilot for Medical Device Manufacturers

MDIC | Kathryn Merrill, CAPA Process Improvement Program Chair This past year the Medical Device Innovation Consortium (MDIC) facilitated a collaborative effort of the medical device industry, strategy consultants, and the Food and Drug Administration (FDA) to bring together cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) […]

Applications for cybersecurity threat modeling bootcamps now open

Technical and regulatory professionals in the medical device sector are invited to attend a free two-day intensive workshop on managing cybersecurity risks in medical devices and diagnostics. MDIC plans to offer two bootcamps this year — one in the Washington, D.C., metro area and one in California — and dates and additional information about the […]

Comment period for white paper on patient input extended to May 1

MDIC is seeking public comments on a white paper titled Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, which provides medical device developers with a compilation of best practices and approaches to enhance their ability to engage patients in clinical trial design. The final report will become part of MDIC’s […]

Materials now available from MDIC’s EFS Budgeting Best Practices Workshop

On February 26, 2020 in Arlington, VA, MDIC led a workshop of leading sponsors and sites with extensive Early Feasibility Study (EFS) experience to share EFS budgeting best practices and roundtable discussions to identify concrete improvement steps that can be taken. Materials from this workshop are now available on our website.

Patient Engagement Forum Postponed

MDIC’s Patient Engagement Forum, originally scheduled for March 26, 2020, has been postponed. Check back for more information once we confirm a new date for our event. Read our full announcement here.

MDIC releases key element of resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials

MDIC is seeking public comments on its Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be completed this year. Developing patient-centered medical product trials has the potential to improve the patient experience in clinical trials, […]

MDIC seeks feedback on use of Resource Library

The Resource Library is a valuable information-sharing service MDIC offers to the public in order to share the work that we’re doing to advance the future of healthcare for patient benefit. If you’ve downloaded one of our reports, studies, or publications for and about the device and diagnostics industry, we want to hear from you! […]