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Medical Device Design Case Study: Communication is Key

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At REV.1 Engineering, we work with many types of teams looking to bring their product to feasibility. Recently we worked with a physicians’ group that found our approach a refreshing change from what they’d been experiencing.

This client was working with a “fixed bid” firm that needed product requirements clearly outlined up front, in engineering terms. This, of course, was not the physicians’ group’s specialty. Once they’d signed the contract, the firm essentially went dark for several months with very little communication. They re-emerged at the end of the promised development period with a device prototype. While it met all the requirements the physicians had outlined, it ultimately failed in testing, because the product ran into design issues that weren’t anticipated when the project was initiated.

The physicians’ group that brought us their idea (and failed prototype) for a gastric implant recognized there were significant challenges with their novel device. An innovative mechanical design and material set was required to endure delivery into the gastric system and then perform its intended function. In addition, due to the highly corrosive environment of the gastric system, traditional implant materials had simply not worked for the other firm the physicians engaged, and the product failed in feasibility.

REV.1 Engineering brought a new technical approach, as well as a refreshingly transparent relationship that this client had not experienced previously. At REV.1 we integrate ourselves with our client and work together as a team to achieve a common objective. Rather than approaching the medical device development from a mechanical perspective first, we worked to understand the problem that needed to be solved, and then solved it. In this case, our materials engineers identified 15-20 candidate material sets, acquired samples and developed a unique test regimen to further narrow the field. In the end, three materials endured the testing, and one clearly rose to the top.

Our team of mechanical engineers, designers and technicians were able to utilize these findings to design an elegant and innovative delivery system. Ultimately, REV.1 Engineering guided the physicians’ group into pre-clinical testing and assisted through the next round of fundraising once feasibility was proven.

At REV.1, we find one thing to be true in almost every project: “You don’t know what you don’t know.” Until you start the design and prototyping process, you don’t know how best to meet the product requirements. Many of our previous clients and inventors have brought us what they believed to be very advanced designs, but were unable to create a working product that could pass testing. If they had, they wouldn’t be coming to REV.1 in the first place. After all, we really aren’t just a prototype shop; we are a design and development firm dedicated to creating the best medical device to meet your needs.

REV.1 Engineering takes pride in bringing novel products to the finish line. You can trust that we will work WITH you throughout the entire process, communicating collectively to make sure a robust and thoughtful design is developed, staying close to the original intent and delivering a product with a real chance for success.

If you have a novel medical device and you’re looking for a firm that doesn’t just “build to print,” get in touch.

Our whole team thrives on solving design challenges and developing successful medical devices 2x Faster. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at, and let’s overcome your medical device design challenges.