Digital Health Drives Next-Gen Dose Management

BrightInsight Powers Roche’s Hemlibra Software as a Medical Device (SaMD) Dose Calculator

BrightInsight sees huge potential for digital to transform dose management, ultimately benefiting countless patients and reducing the burden on their caregivers. Take Roche’s dose management solution for treating patients with hemophilia A, for example:

400,000 people across the globe live with hemophilia A, a rare disorder that involves genetic mutations causing a deficiency in factors supporting normal coagulation that can result in bleeding into soft tissue, joints and organs. Diagnosis and disease management for this disease can be highly challenging. Data suggests that up to 20% of people with hemophilia do not follow their prescribed treatment.¹ Long-term optimal patient health outcomes depend on a comprehensive approach by a coordinated team of specialists. Digital health can play an important role, including enabling more accurate dosing.

Roche’s Hemlibra dose calculator, powered by BrightInsight

Roche’s Hemlibra requires a subcutaneous injection that physicians must tailor to each individual using complex weight-based calculations. As Roche prepared to begin work on their digital dose management solution for treating Hemophilia A, they had to decide whether to build a digital health platform to support their regulated use case from scratch, or to select a partner. Faced with the challenge of developing a regulated, accessible dose management solution for use by physicians, Roche turned to BrightInsight, and we were able to help them launch a CE-marked SaMD dose calculator in less than six months.

“Our ability to provide a sustainable competitive advantage with our products won’t be based on our own cloud-based solutions—that’s not our expertise,” says Paul Upham, Head of Smart Devices at Roche/Genentech. “Where we can generate new competitive advantages is in how we analyze and use the new data being generated by all of these digital health solutions.”

Real-world data powers digital health solution innovation

Real-world data generated by digital health solutions creates a feedback loop to enhance biopharma teams’ understanding of a disease state, disease progression, patient outcomes and quality of life. There is an opportunity to combine a variety of data sources, such as actively collected, patient-reported outcomes, and passively collected person-generated data from wearables and other connected devices.

BrightInsight is dedicated to supporting our biopharma clients in launching cutting-edge tools that address dose management challenges across a variety of therapeutic areas. 

BrightInsight to support your digital dose management use cases

BrightInsight’s product portfolio accelerates time to market for biopharma regulated digital health solutions while ensuring compliance. Our BrightInsight®️ Platform is the leading global platform for regulated digital health apps, algorithms, medical devices, combination products, companion diagnostics and Software as a Medical Device (SaMD). This proven platform is the foundation for the BrightInsight pre-built software Accelerator Modules. Our Accelerator Modules’ robust capabilities accelerate time to market for our customers’ most innovative and valuable regulated digital health use cases, including patient diagnosis, selection, adherence, personalized dosing and disease management.

If you’re interested in learning more about how Roche and BrightInsight worked together to bring the Hemlibra® Dose Calculator to market so quickly, read the case study. Then, reach out to us directly so we can figure out how BrightInsight can help your team meet its dose management goals.

¹https://www.tandfonline.com/doi/full/10.1080/10245332.2018.1505225


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