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Stories of Medical Device Success: The Opportunity in Failure

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“Don’t bury your failures, let them inspire you.” – Robert Kityosaki

As we all know, medical device development is not always a smooth process. In fact, we like to say that there are no bumps in the road… it’s just the road. Everything doesn’t always go as expected, but it’s how you handle design failures that separates the good development teams from the great ones.

When faced with a failure, how do you turn it into success? Do you become frustrated and stuck, unable to see the solution? Or do you become inspired by the challenge the problem presents, working hard, focused on building an even better design?

At Rev.1 Engineering, we’ve encountered our share of fascinating problems, and we love taking up the gauntlet to find a solution. One memorable situation occurred when two of our developers were attending an in-vivo pre-clinical validation study, accompanied by our inventor client and his chief medical officer. Despite extensive bench testing, the in-vivo study uncovered problems with the design which arose to everyone’s surprise, and it was clear that the design needed to be re-worked.

After any type of study or trial, our practice is to immediately report on all the results, good or bad, to the rest of the team while the data is fresh in our minds. Even when there are no immediate actions to be taken, there is usually something to learn… improvements that can be made… and even take-aways that might speed the next project’s success.

In this instance, the negative report came back to the team by phone from the study, and before the developers had even boarded the plane to return home, the team in the office was in motion working toward a solution. We generally follow a consistent protocol when addressing device failures:

  • Dissect and inspect
  • Identify root cause
  • Repeat the failure mode to confirm it
  • Design a solution

In this case, a specific failure mode was already suspected and discussed by the team over the phone, which set the design team at home into motion. The team’s immediate action turned into an all-nighter, and by morning the developers returned to not only find the failure mode confirmed on the bench, but a new innovative design solution developed. This design ultimately ran the remainder of the development gauntlet and is in safe and successful clinical use today, improving the lives of people suffering from chronic disease.

Our response to failure is a choice. We can see it as a frustrating roadblock, or an inspiring opportunity to come up with an even better device solution.

At REV.1 Engineering, our team is committed to do whatever it takes to find successful solutions to meet every challenge in your medical device development. When you are ready to put your device development on hyper-speed, give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at info@rev1engineering.com.