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.
For Roche, the path forward was clear.
“Our ability to provide a sustainable competitive advantage with our products won't be based on developing our own cloud-based solutions—that’s not our expertise,” says Paul Upham, Head of Smart Devices at Roche / Genentech.
Rather than engineer their own infrastructure, applications, and data stores, they partnered with BrightInsight.
Prior to the BrightInsight Platform, built on Google Cloud, biopharma and medtech had no other alternative but to build their own underlying platform. They found this a significantly expensive thing to do. Building that custom-bespoke solution barely meets the requirements for one solution in one country and doesn’t scale—not to mention it takes an army of engineers and several years to build that infrastructure.
You can learn more about this collaboration, and how we significantly accelerated time to market for Roche’s Software as a Medical Device (SaMD) in our latest case study.