MINNEAPOLIS--(BUSINESS WIRE)--Recognizing the strategic advantages of conducting Early Feasibility Studies in the US, the Medical Device Innovation Consortium (MDIC) sought to develop a Blueprint for Early Feasibility Study Success, a best practices guidelines for planning and executing US-based Early Feasibility Studies. The draft, now available for download and comment at http://mdic.org/EFSblueprint, cover topics such as interactions with FDA and IRBs, legal and IP considerations and patient perspectives on Early Feasibility Studies. The Blueprint is a supplement to FDA guidance on Early Feasibility Studies. It is intended to be an overview of best practices and factors to consider for study success.
In 2013, the FDA released guidance encouraging U.S. EFS studies, yet nearly 50% of MDIC members surveyed in 2015 reported that their companies had not initiated these types of studies in the last two years. In that same survey, many companies expressed a willingness to conduct US-based Early Feasibility Studies, but wanted to see others document success with the program and expressed a desire for tools to help assure study success (For the rest of the 2015 survey results see: http://mdic.org/ctir/early-feasibility-study/).
MDIC members are already realizing the strategic value of US-based Early Feasibility Studies. “By participating in the Early Feasibility Study Program, we have been able to initiate the formal clinical research for our Percutaneous Tricuspid Valve Annuloplasty System in the United States before any other geography, and we intend to leverage that research to supplement regulatory submissions around the world. This would have been inconceivable before the advent of the EFS program,” according to Rick Geoffrion, the President and CEO of Mitralign, Inc. and MDIC Board member.
CDRH is committed to the success of the Early Feasibility program. “FDA’s focus is on improving the health and the quality of life for patients. Our Early Feasibility Program supports earlier and broader patient access to beneficial medical technology, while fostering medical device innovation in the U.S.,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “MDIC’s Blueprint should spur participation in this program.”
MDIC President and CEO Bill Murray said, “MDIC was founded to do exactly this kind of work, recognizing a strategic need to advance medical device regulatory science in a particular area and developing tools to make that happen. We will continue work to advance regulatory science with tools such as the EFS Blueprint.”
With draft Blueprint now released, the next steps for the MDIC Early Feasibility working group are to integrate comments into a final Blueprint later this summer and to encourage members to use the Blueprint in their own US-based Early Feasibility Studies.
For more information on MDIC’s Early Feasibility project and to download the MDIC Blueprint for Early Feasibility Study Success and leave your comments, visit the MDIC web site: http://mdic.org/EFSblueprint.
About 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 life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. We work 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. Our initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit www.mdic.org.