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Compliance In Focus
Posted by John Lehmann on Tue, Apr 23, 2013

Making Medical Device Regulatory Science History

The Medical Device Innovation Consortium (MDIC) is making medical device regulatory scienceMaking Medical Device Regulatory Science History history by being the first ever public-private partnership (PPP) with the intent of being a national 501c(3) operating in partnership with the FDA. LifeScience Ally, Inc. (LSA) leads the way with the CDRH to create this group for the sole purpose of establishing research collaborations to advance medical device regulatory science and improve health through the application of shared knowledge.

MDCI is currently being funded from industry membership fees, and at this time does not plan on obtaining funds from the FDA as noted in an article titled, Medical Device Innovation Consortium Sets Priorities to Advance Reg Science published in “The Gray Sheet” on April 8, 2013. The MDIC website notes the following members, to name a few of the 21 members:

The focus of MDIC is to bring industry, non-profit organizations, and the government together to meet the public health needs of the patients in the United States in a timelier manner. This intends to be accomplished through the development of new tools, methods, standards and applied science to improve product safety, quality and effectiveness of a product through its life cycle. “The Gray Sheet” listed the three preliminary projects that MDCI will be focusing their efforts in the upcoming months:

  • Clinical Trial Reform
  • Computer Modeling and Simulation
  • Patient Centeredness and Risk Management

Once clear goals and comprehensive tasks of each of these top projects are identified, MDCI will be able to clearly identify the needs of the subcommittees in terms of potential members. If you could add a project that would improve the life cycle of a product’s development, what focus would you suggest? 

Do you think groups similar to MDCI can work to improve the timeliness of medical innovation from bench-side to bed-side? Feel free to comment below.

Photo Credit: Wyoming_Jackrabbit

Documentation in Devices





Topics: The Medical Device Innovation Consortium, LifeScience Ally, Regulatory Science


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