When a medical device or combination product is cleared or approved by FDA, can we assume it’s safe and effective?
In a word… NO!
Only 3-5% of adverse events are reported to manufactures or FDA. Spun in reverse… 95-97% of adverse events are never reported! If problems are not reported, can we conclude our devices are working perfectly? Is the absence of evidence, evidence of absence?
Post-market surveillance (PMS) is the process of watching our devices perform while on the market. PMS is a vital component of the medical device and combination product lifecycle. Yet historically, the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe. But having an effective PMS system means more than simply meeting the regulatory and quality requirements.
A strong PMS system cannot simply find problems that may have been missed as part of the pre-market development or quality assurance process. A strong PMS system can be used to add additional indications, a.k.a. label expansions, which translates to greater revenues for the manufacturer!
Having an effective PMS system is important from both a regulatory and quality perspective. But can you assume if your PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! And when companies make such assumptions, they often find themselves in trouble… not just with the FDA but with product liability attorneys as well!
In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!
This presentation will use the case study approach to take a broad look at medical device and combination product post-market surveillance in an interactive fashion including:
- What are the key elements of an effective PMS system?
- With increasing pre-market regulatory requirements, do we still need PMS?
- Is passive PMS enough? What about active PMS?
- What is the role of risk management in PMS?
- How do we integrate usability into PMS?
- What about PMS for combination products? How does device PMS compare to drugs?
- How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
- How do we meet PMS regulatory requirements without increasing product liability risk?
- How is PMS similar and different in the US vs. EU?
- What are the PMS challenges for the future, i.e., PMS for personalized devices including 3D printing?
- 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
Additional columns, articles, podcasts and webinars can be found: Global Medical Device Podcast, Mike on MedTech (Medical Product Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) here and Healthcare Packaging here or LinkedIn 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 start-ups 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.
