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 […]

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:  Shacey Petrovic and Dana McMahon. The Board provides leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies. Shacey Petrovic has served has served on Insulet’s Board of […]

MDIC Releases Report on Medical Device Cybersecurity, Advancing Coordinated Vulnerability Disclosure

ARLINGTON, Va.–The Medical Device Innovation Consortium (MDIC) today released a report encouraging the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety. “This paper advances an incredibly important topic in medical device cybersecurity—the adoption of coordinated vulnerability disclosure policies and processes,” […]

Case for Quality Working Groups

MDIC is currently looking for volunteers to participate in four new working groups aimed to continue the advancement of the Case for Quality. Since 2015, MDIC has been supporting FDA’s launch of the Case for Quality which was developed to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical […]

NESTcc Funding Opportunities

The National Evaluation System for health Technology Coordinating Center (NESTcc) has announced two new funding opportunities, including a call for concepts for its second round of test-cases as well as an opportunity to submit targeted test-case concepts leveraging patient-generated health data for regulatory purposes. NESTcc is soliciting test-case concepts from medical device stakeholders to further develop and […]

New Resources: Surrogate Samples Education

Upon creation of the Surrogate Sample Framework, MDIC’s working group developed a comprehensive set of educational materials to assist with shared terminology and principles for the acceptable use of surrogate samples between FDA reviewers and IVD test developers. The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for […]

FDA releases guidance to promote IVD device data interoperability and RWE efforts

On June 15th, 2018, FDA released the Guidance for Industry and FDA Staff “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” IVD LOINC Guidance to encourage consistency in the coding of IVD tests by addressing questions regarding the distribution of LOINC codes by IVD test manufacturers to users. This guidance helps provide regulatory […]