Find and Fix Defects Before Your Devices Go to Market
Recently, a medical device manufacturer posted a $20 million bond to guarantee its infusion pumps would be brought into compliance with FDA cGMP requirements, and will spend an estimated $65 million in repairs. On top of these costs, the company faces lost sales, potential lawsuits and damage to its reputation.
Design problems can be caught earlier — so your company can prevent warning letters, potential recalls, lawsuits and patient deaths.
Get a clear understanding of how to conduct a Failure Modes and Effects Analysis (FMEA) to reduce risks of design problems. In this 90-minute audio CD/transcript, Marta Villarraga, Ph.D., and Dan Mazzucco, Ph.D. show you how FMEA can provide a systematic way to address potential pitfalls of a new device, enable objective evaluation with a clear end point, establish risk-based criteria for various failure modes, and keep you in compliance with the Safe Medical Devices Act.
Order now for your entire team to listen in and discover:
- Four types of Failure Modes Effects Analysis (FMEA), and their respective objectives
- How to conduct an FMEA
- How to conduct a Fault Tree Analysis (FTA)
- When to conduct an FMEA or an FTA
- Strategies for identifying causes and effects for each failure mode
- How to develop "risk priority numbers" and prioritize problems for CAPA
- Potential failure modes, possible effects of failure modes, and the occurrence of failure modes, using a hypothetical medical device design for an "artificial eye"
A major device recall can mean losses of billions of dollars to your company. Take steps now to catch design problems before your devices reach the market.
Dr. Marta Villarraga is a principal engineer in Exponent's Biomechanics practice and is based in Philadelphia, Pennsylvania. She specializes in spine biomechanics and in failure analysis of medical devices, and has experience with orthopedic, spinal, reconstructive surgery, and diagnostic medical devices from product liability, intellectual property, regulatory compliance, and product development perspectives. Marta also has experience in evaluating quality control issues as applied to medical devices and pharmaceuticals, with an emphasis in contamination, manufacturing compliance and finished device evaluations.
Dr. Dan Mazzucco is a Senior Engineer in Exponent's Biomechanics practice and is based in Philadelphia, Pennsylvania. He has expertise in the lubrication, friction, and wear of medical implants; he also has expertise in the chemical and mechanical analysis of biological materials. Dan has experience with orthopedic, cardiovascular, genitourinary, and diagnostic medical devices from product liability, intellectual property, regulatory compliance, and product development perspectives. He has overseen numerous series of laboratory experiments evaluating and characterizing candidate biomaterials and medical devices.
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