June 8, 2022
Medical Device Innovation Consortium (MDIC) Announces Andrew Fish, JD Appointed as President and Chief Executive Officer (CEO)

ARLINGTON, Va.–(BUSINESS WIRE)–The Medical Device Innovation Consortium (MDIC) today announced that Andrew Fish, JD has been appointed as President and Chief Executive Officer, effective July 20, 2022. Mr. Fish succeeds Pamela Goldberg who is stepping down after leading the organization for four years.

Mr. Fish joins MDIC following his most recent tenure as Executive Director, Center for Digital Health and Head of Sector Initiatives at AdvaMed, where he significantly expanded the association’s digital health membership and scope of work while supporting the Center’s Executive Leadership Group. Previously, Mr. Fish served as the first Executive Director of AdvaMedDx, AdvaMed’s corporate division focused on in vitro diagnostics, and subsequently as AdvaMed’s Chief Strategy Officer, overseeing the association’s global and domestic policy departments and providing thought leadership on the fast-evolving role of medical technology across all care delivery settings. Mr. Fish has demonstrated consistent success in developing effective public policies and achieving advocacy goals in numerous areas of healthcare regulation and delivery.

“Over the past several months the Board conducted an extensive search for a CEO with substantial experience in building and leading cross-sectional teams and a passion for medical device innovation. With his exceptional track record of leading and growing organizations with a commitment to advancing innovative patient care, Andrew is the ideal leader for MDIC as we continue to collaborate with our partners to advance science and enable transformational medical technology to shape the future,” said MDIC Board Chairman Jijo James MD, Chief Medical Officer, MedTech and External Innovation at Johnson & Johnson.

“CDRH congratulates Andy Fish on his appointment as the new President and CEO of MDIC. We look forward to working with Andy and our continued collaboration and partnership with MDIC to support medical device safety and innovation in the interest of patient health,” said Jeffrey Shuren MD, JD, Director, Center for Devices and Radiological Health (CDRH), FDA.

MDIC, through its public-private partnership among government and regulatory agencies, nonprofits, and the medical device industry, aims to advance regulatory science and bring innovative technologies to patients. MDIC coordinates the development of methods, tools, and resources used in managing the medical device lifecycle to improve patient access to cutting-edge medical technology.

“Bringing more than 20 years of experience in the industry, Andrew has the knowledge, expertise, and commitment to continue to build on MDIC’s success that Pamela Goldberg helped to establish. Among other accomplishments, Pamela helped to launch of the Health Economics and Patient Value initiative to increase the utilization of real-world evidence in healthcare decision making. We are grateful for her leadership over the past four years,” said James.

“Andy’s service at AdvaMed over the past 12 years has prepared him very well to lead MDIC,” said AdvaMed President and CEO Scott Whitaker. “While we will miss Andy, we’re glad to know he’s not going too far—MDIC has always been a great partner of AdvaMed’s, given our shared mission to improve patient care, and we look forward to continuing that good work with MDIC under his leadership.”

In accepting the position as Chief Executive Officer, Mr. Fish said, “I am grateful for the opportunity to lead MDIC by serving as President and CEO. I look forward to bringing together medical devices and diagnostics stakeholders and leveraging our collective expertise, resources, and data to create new methods, tools, approaches, and standards that will assist in developing safe and effective medical technologies for patients everywhere.”

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product lifecycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.

Contacts

Gregory Bologna, MDIC
AVP, Marketing and Communications
gbologna@mdic.org

June 3, 2022

Registration is open for the 2022 MDIC Annual Public Forum to be held in Washington, DC, on Tuesday September 13 – our first in-person APF since 2019! Join us for General Sessions on Digital Health, Health Economics & Patient Value, and NESTcc, as well as concurrent sessions across a wide range of topics and Fireside Chats with representatives from FDA and CMS. Be a part of the event that gathers industry experts, innovators, and regulators and addresses the latest issues facing the medical device community.

June 1, 2022

The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement can be found here.

A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success. Updated for 2022, the ICF throughly outlines how those conducting studies can explain the process of participating in a study, the benefits of contributing to research as participant of early feasibility studies, the risks associated with participation and the patients rights to potential participants. Click here to see the full template.