MDIC Releases Draft Blueprint for Early Feasibility Study Success

Recognizing the strategic advantages of conducting early feasibility studies in the United States, the Medical Device Innovation Consortium (MDIC) has develop a blueprint for success—a best practices guideline for planning and executing U.S.-based early feasibility studies.
 
The draft, now available for download and comment, cover topics such as interactions with the U.S. Food and Drug Administration (FDA) and institutional review boards, legal and IP considerations and patient perspectives on early feasibility studies. The blueprint is a supplement to FDA guidance on early feasibility studies (EFS). 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 percent of MDIC members surveyed in 2015 said 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 U.S.-based EFS, but wanted to see others document success with the program and expressed a desire for tools to help assure study success.
 
MDIC members are already realizing the strategic value of U.S.-based EFS. “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,” said Rick Geoffrion, president and CEO of Mitralign Inc. and MDIC board member.
 
The Center for Devices and Radiological Health (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 CDRH. “MDIC’s blueprint should spur participation in this program.”
 
“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,”MDIC President and CEO Bill Murray said.  
 
Now that it has released the draft blueprint, the MDIC early feasibility working group will integrate comments into a final document later this summer and encourage members to use the blueprint in their own U.S.-based EFS.
 
Founded in 2012, the Medical Device Innovation Consortium is the first public-private partnership created with the 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. The organization 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.