The new collaborative path in medical device development: the medical device innovation consortium

Clin Biochem. 2013 Oct;46(15):1320-2. doi: 10.1016/j.clinbiochem.2013.03.021. Epub 2013 Apr 8.

Abstract

The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development.

Keywords: Approval process; Development; FDA; MDIC; Medical devices.

MeSH terms

  • Cooperative Behavior*
  • Device Approval
  • Equipment Safety
  • Equipment and Supplies*
  • Humans
  • United States
  • United States Food and Drug Administration