I recently crossed paths with Jonathon Lee, now a consultant to the medical device industry. At the time, Jonathon was making the transition from working as Medtronic’s expert in the areas of regulatory and clinical (for the company’s Surgical Technologies group) to being an independent consultant. The name of his new company is Medical Device Consulting Solutions International, or MedDev CSI.

Jonathan claims that he can help device makers take their designs from conception all the way through the product lifecycle, through the end of product life. His expertise lies in the area of risk management.

Supplier management is a subset of risk management. If you look at standard 14971, which is product lifecycle, risk management as associated with medical devices, it not only looks at the risks associated and introduced with design, but also the process control, component purchase, package sterilization, and the distribution, labeling, user education, and implant patient use. It also covers patient education and rehabilitation.

As Jonathon pointed out, these are usually quite specialized areas of expertise. “Over the last five years or so, the global tolerance of medical device failure and mal-performance by the community at large is reduced. Today, there’s an expectation that a person will return to life as usual when a medical device is used. So there must be a greater sequence of actions taken to prevent failure.”

These aspects are becoming more global as the world continually shrinks. That’s another aspect I found key to the success of someone like Jonathon, who has lived all over the world throughout his career. He gave me a good education on risk management. Maybe he can do the same for you.

Richard Nass