Roche: How BrightInsight Accelerated Time to Market for a Software as a Medical Device Solution

We are currently living in the age of personalized healthcare, where treatments can be tailored to the individual to maximize therapeutic benefit. As medicine becomes more personalized, it becomes increasingly complex to determine the correct dosing.

This is the case for the treatment for Hemophilia A, a rare disorder that affects only 400,000 people worldwide. Roche, one of the largest biotech companies in the world, decided to leverage the power of digital technology to provide a simple and convenient solution for physicians who treat patients with Hemophilia A.

To maximize Hemlibra’s therapeutic benefits, Roche developed a digital dosage calculator to aid prescribing physicians. But given the novelty of digital health solutions, navigating the regulatory landscape was a challenge. Would the solution be regulated as a medical device?

If so, should the relevant registration strategy be 510(k), CE marking, de novo, or something else? The platform for this kind of solution must meet requirements for a multitude of global standards, regulations, and certifications with monikers like IEC 62304, ISO 13485, ISO 27001, GDPR, HIPAA, and HITRUST.