MDIC Holds External Evidence Methods Executive & Fellows Meeting

On April 2, 2019, MDIC’s External Evidence Methods (EEM) program hosted an Executive & Fellows meeting with about 70 subject matter experts from FDA, industry, and non-profit organizations to discuss the existing methods and identify gaps for the use of external data. MDIC’s EEM program aims to establish a more predictable pathway for use of external […]

MDIC Releases RFI on Creating Human Cell Lines

MDIC released a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically actionable […]

MDIC to Release RFI on Creating Human Cell Lines

MDIC will release a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically […]

MDIC Releases Catalog of Known SRS Products for NGS-based Oncology Tests

On March 6, 2019, MDIC released a Landscape Analysis report compiling all the currently available somatic variant reference samples for next-generation sequencing-based tests. This report, researched and assembled by MDIC’s Somatic Reference Samples Landscape Analysis working group, is a catalog of known SRS products for NGS-based oncology tests compiled in one resource, according to the […]

MDIC Blood Damage Working Group to present at BMES/FDA Frontiers in Medical Devices Conference

Dr. Marc Horner, MDIC’s Blood Damage Modeling Working Group Chair, will discuss the Blood Damage Modeling project updates and future directions at the BMES/FDA Frontiers in Medical Devices Conference: The Role of Digital Evidence to Support Personalized Patient Healthcare on March 19-21, 2019 at the College Park Marriott Hotel and Conference Center at the University of Maryland. […]

AMIA’s President and CEO Joins MDIC’s Board of Directors

The Medical Device Innovation Consortium (MDIC) is pleased to announce the addition of Doug Fridsma to the Board of Directors. Doug joins the Board to provide leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies. Doug Fridsma, MD, PhD, FACP, FACMI, is the President and Chief Executive […]

MDIC’s Newest Initiative Is Underway

The Health Economics & Patient Access (HEPA) initiative launched last summer and began evaluating projects and focusing on tools to increase predictability of payer scientific and evidentiary requirements. Under the leadership of Liz Spurgin (Vice President, HEPA) and Andrew Greenfield (Vice President and General Manager, Abiomed) a steering committee of industry and regulatory members was […]

Case for Quality: CDRH’s Pilot Program Name Change

In 2018, MDIC supported CDRH’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program which simplifies regulatory requirements for medical device manufacturers who practice and demonstrate mature quality practices.  As we’ve seen this pilot gain momentum throughout the past year, CDRH, MDIC, and CMMI aim to scale the pilot into a full program in 2019. […]

Top Medical Technology Conferences to Attend in 2019

The Medical Device Innovation Consortium (MDIC) hosts events and webinars to inform the public of the collaborative efforts we’re involved with, in an effort to increase patient access to innovative medical technologies. Our events provide an opportunity for our members and stakeholders to network and engage on topics such as clinical diagnostics, device quality, early […]