Did you ever have one of those days that things just didn’t seem to go right?  You ran out of milk for your morning coffee, traffic was a nightmare along your commute, the refrigerator at work broke, and nothing was going your way. You ask yourself “What’re the odds?”

All of life entails some about of risk. There is a non-zero chance that any number of things could go horribly wrong for any one of us on a given day.  Our car/bus could break down; the electricity could go out, and erase hours of hard office work; rain could start to pour out in buckets from the sky. 

The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis. We can make a point to have our car properly maintained and serviced as the manufacturer intends.  We could install back-up generators and emergency power supplies to preserve our information technology, at least for long enough for us to save our files.  We learn about the weather, and dress appropriately to the forecast, or at least have an umbrella with us.

The same goes with medical devices. An amputee could take on a more active lifestyle than before, putting a more intense load profile on their prosthetic limb than they did with their original biological limbs.  An electrical connection in an EKG could fail, preventing an accurate reading at a crucial moment.  A knee replacement could have a microscopic crack in the stainless-steel bearing structure, leading to faster failure.

Any of these things going wrong could have horrific consequences for the users, which is why the Food and Drug Administration requires manufacturers to take all these risks, and more, into account when designing any potential medical device.[1]  This way, patients and manufacturers can have a better idea of what they might be getting into. The experts at EMMA International can help you manage the risks of your company’s foray into the medical device field. Contact them at 248-987-4497, or at info@EMMAinternational.com


[1] Quality System Regulation, 21 C.F.R. § 820 (1996)

Ethan Benedict

Ethan Benedict

Mr. Benedict has experience in FDA compliance for both medical devices and pharmaceuticals. He has experience with many different elements of quality and regulatory compliance. Mr. Benedict holds a Bachelor of Science in Mechanical Engineering from York College of Pennsylvania, and a Bachelor of Science in Physics from Ursinus College.

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