Medical Device Innovation Consortium (MDIC)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2012
  • Initiating Organization: LifeScience Alley
  • Initiator Type: Government
  • No disease focus
  • Location: North America

Abstract

The Medical Device Innovation Consortium (MDIC) is a public-private partnership created with the sole objective of advancing medical device regulatory science. It is a nonprofit 501(c)3 organization that operates in partnership with the U.S. Food and Drug Administration (FDA) to improve the medical technology environment. Participation in MDIC is open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; that are involved in the promotion of public health; or that have expertise in regulatory science.

Mission

MDIC, through its public-private partnership, aims to advance regulatory science in the medical device industry. MDIC will coordinate the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

MDIC has been designed to pursue several strategies to support its mission:

Consortium History

The FDA’s Center for Devices and Radiological Health (CDRH) and LifeScience Alley, Inc., a Minnesota trade association, executed a Memorandum of Understanding in December 2011 to work together to establish research collaborations in regulatory science. LifeScience Alley filed Articles of Incorporation with the state of Minnesota in August 2012 to create an independent entity focused on advancing medical device regulatory science at an industry level.

Structure & Governance

MDIC is an independent organization governed by a Board of Directors representing the public and private sectors and patient advocacy groups. The Board will oversee MDIC subcommittee activity.
Subcommittees will be formed to lead programs that advance specific areas of regulatory science.
Each subcommittee will be responsible for establishing working groups and project plans to advance individual programs.

Points of Contact

Medical Device Innovation Consortium
1550 Utica Avenue South, Suite 740
St. Louis Park, MN 55416
phone: 952-314-1255 

Sponsors & Partners

Abbott Vascular

Abiomed

AdvaMed

Advanced Bionics

American Institute for Medical and Biological Engineering

ANSYS

Association of Clinical Research Professionals

B. Braun

Becton, Dickinson and Co.

Boston Scientific

Cardiovascular Research Foundation (CRF)

CD-adapco

Centers for Medicare & Medicaid Services (CMS)

Cook Group, Inc.

Creganna-Tactx Medical

CVRx

Cyberonics

Edwards Lifesciences Foundation

Exponent, Inc.

FasterCures

Focused Ultrasound Foundation

Global Center for Medical Innovation (GCMI)

HeartFlow, Inc.

Holaira

ICON

Immucor, Inc.

Integra Lifesciences

IT’IS – USA

Johnson & Johnson

LifeScience Alley

Medical Device Manufacturers Association (MDMA)

Medtronic, Inc.

National Institutes of Health (NIH)

National Organization for Rare Disorders (NORD)

National Venture Capital Association (NVCA)

North American Science Associates, Inc. (NAMSA)

NxThera, Inc.

Patient-Centered Outcomes Research Institute (PCORI)

SIMULIA/Dassault Systemes

Southern Research Institute

St. Jude Medical

Stryker Corporation

Sysmex America, Inc.

Terumo BCT

The Pew Charitable Trusts

U.S. Food and Drug Administration

Vital Images

W.L. Gore & Associates


Last Updated: 04/08/2016

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