The breakthrough designation program (BDP), created by Congress as part of the 21st Century Cures Act in 2016, is an extension of the expedited access program (EAP) (April, 2015 guidance) and before that the Medical Device Innovation Initiative (MDII) and before that… The BDP represents the next in a series of “special programs” to encourage companies to pursue “breakthrough technologies” often (but not always) in areas of unmet clinical need. FDA issued “draft” guidance on the BDP in 2017 and “finalized” guidance in December, 2018.
The goal of the BDP and similar programs is simple: to help patients gain timely access to breakthrough technologies that have the potential to change lives without compromising safety or effectiveness – at least in theory, but is that reality? According to recent statistics (here), CDRH has received 94 requests for breakthrough status for devices treating a variety of conditions and has granted 54 – resulting in an overall success rate of 57%.
Simply put: when used appropriately, the BDP can offer significant advantages to the manufacturer by getting their device to market sooner. But if the device doesn’t qualify, your BDP application will be rejected by FDA and you have just wasted a bunch of time and money!
This presentation will use the case study approach to present the breakthrough designation program in an interactive fashion including:
- What is the breakthrough designation program and when should it be used?
- What are the advantages and disadvantages of obtaining breakthrough designation?
- How does a manufacturer apply for BDP designation?
- Why are nearly half of BDP applications rejected and what should be done to avoid that?
- What are my options if my BDP application is rejected?
- Are there non-regulatory advantages of obtaining BDP designation, i.e., reimbursement, public relations, fund-raising, etc.?
- Q&A Session
Who should attend?
- Medical Device Industry Executives
- Quality Professionals and Management
- Regulatory Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
For additional information, check out:
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Mike on Medtech: Breakthrough Designation Program (MPO Magazine, Aug 10, 2018) here.
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What you need to know about FDA’s Progressive Programs (GreenLight.Guru, August 29, 2018 here.
About the Presenter
Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University. He works with leading medical device, pharmaceutical and biotechnology companies ranging in size from startups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.
