Pushing the limits of medical device design

Our multi-disciplinary team has extensive experience in medical device research and development, including but not limited to peer reviewed publications on MRI, Regenerative Medicine, Fatigue, Boundary Conditions and Corrosion. Leveraging the thought process developed during these experiences has proven beneficial to helping our clients through novel device development challenges (e.g., doing the right kind of test to answer a clinical question).

One of our many physician group interactions highlights an example of pushing the limits of design.  This physician group wanted to understand stenting in their clinical pediatric practice from an engineering perspective. The specific question to be answered was, “Can stents implanted in infants and children be serially dilated to significantly larger diameters without losing integrity and important mechanical characteristics?” We were tasked with developing a comprehensive strategy to mimic clinical practice on the bench to better understand the boundaries associated with this off‑label use of the stent. The patient population under review was very small and the design considerations for treating this population were large.  Collaborating with the physicians by asking thoughtful clinically relevant questions is one way to transition from clinical to bench and back in a safe and effective way. Specifically, when a device is designed to operate in an 8 to 10 mm diameter range, consideration is not generally given to what will happen when the device is dilated to 24 mm in diameter. As engineers, we enjoy understanding all we can about a device, and understanding failure points of a given device before they occur clinically is very important to our patients.

Ultimately, developing a strategy using strong first principles of engineering and validated, repeatable methods can be of great benefit to patients and physicians when a novel concept is under investigation, especially, as we see today, when the need is great and the time is short.  Making decisions based on state of the art science and engineering is the cornerstone of what MED does.

For more information about how we can partner with you, please visit medinstitute.com or contact us at 855.463.1633.