Medical device recalls are on the rise. They have increased well over 60% over the last ten years. Minimizing the risks associated with a new medical device is the manufacturer's primary responsibility. So how do manufacturers fix this? The solution, is not to fix the problem as quickly as possible but to prevent the problem or problems from ever happening in the first place. Fixing problems after the fact can cost significant amounts of money to the enterprise, can cause significant disruption to design, development, and production processes, and result in lost reputation, and increased regulatory scrutiny. Most importantly, recalls put patients and users at risk, and at the extreme, can result in serious injury or even death. This industry owes more to itself and the people that it serves.
Manufacturers must employ, at each step of the design process, product acceptance criteria that are based on the level of risk that the device poses to the human body. Being committed to a risk-based analysis approach means addressing two distinct aspects of the device: the applicable product standards for the product, and the hazards associated with its use. This approach extends to all of the materials, parts, and assemblies used to produce the device and explicitly requires that all possible failure modes be identified that relate to them. The elegance of the process is manifested in how and to what extent mitigation is required and achieved.
The challenge for manufacturers is to structure their culture to address prevention through risk evaluation and mitigation then design their processes to prevent the errors and failures that eventually can lead to device recalls.
Join this session, where expert speaker Charles H. Paul will provide you with the performance tools that are necessary to create a cultural climate that invests resources to avoid the significant costs and consequences of device recalls and to achieve the cost avoidance benefits that are realized as a successful end-result of the endeavor. The message is not to ignore the risk-based approach to device design, but rather to effectively manage risk so that you achieve both a zero sum approach to preventing recalls while at the same time cost effectively designing your medical devices and quickly bringing those products to market.
This session will be about significantly minimizing recall risk at every step of the medical device design and development process during specification writing, risk assessment and risk management, the early design and the detail design phases of development, and during validation, verification, and software design.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....
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