A company with a medical grade light curable polymer needed a light source for their bone stabilization system.

Context

An appropriate medically approved light source was not available for our client to use with their photodynamic polymer.

Solution

Because time to market was a very important issue for our client, we worked with a vendor that had an existing commercial illuminator to modify it for medical system compliance. Our engineers did a complete review of the commercial device and provided feedback for the vendor to appropriately modify and document its product.

In addition to advising this vendor (that had never worked in the medical industry before) we created additional custom electronics that provided an updated user interface as well as provided risk mitigations to allow the device to fully comply with the IEC60601 standard.

This very successful startup is currently using this completed illumination product and has CE mark approval for market in Europe.