Often when an entrepreneurial company is struggling to get their first product to market, the focus is on clinical trials, regulatory approval, production startup, and sales. The farthest thing from their mind is the issue of reliability. This is dangerous.

Chet Haibel, principal consultant at Haibel Consulting, LLC, advises reliability should never be forgotten. If a latent reliability issue emerges, it could conceivably invalidate clinical data, forcing a company to repeat clinical trials. Reliability issues cost money, delay schedules, and can damage company reputations.

To protect his clients from encountering reliability issues with new product, Haibel developed a Generic Medical Device Reliability Plan. It describes key activities you should undertake, beginning in the requirements phase and carrying through production, to make sure a new product won’t be hampered by latent reliability problems.

The generic plan is designed to spur discussion of product reliability issues. Haibel says it can be customized for a specific product to form the basis of a robust reliability plan.

We’re pleased to be make the generic plan available to Medical Devices Group members. Let us know if it’s helpful for you.

About The Contributor: Chet Haibel has spent twenty-three years as manager, coach, and mentor in quality, reliability, and risk management in computer peripherals and Class III medical devices. Mr. Haibel is an international lecturer and consultant through Haibel Consulting LLC and also through Hobbs Engineering Corporation of Thornton, Colorado, delivering custom in-house seminars or standard seminars ranging from one-half to three days in length.

Jim Schulz
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Your reliability plan is akin to “qualifying” a device for suitability. Institute of Electrical and Electronic Engineers (IEEE) Std 323 talks about main variables that should be looked at: temperature, pressure, aging, seismic, radiation, EMI/RFI. In addition the design engineers should look at the application for the product, determine the “critical characteristics” and test those as well. Electrical Power Research Institute (EPRI) document #5652 gives much guidance, and identifying critical characteristics is one.