Biopharma and medtech companies trust BrightInsight’s compliant platform to differentiate and expand the value of their therapies with groundbreaking digital solutions. SaMD is the backbone of next-generation companion apps, dosing and treatment selection algorithms, data analytics and more. Learn how SaMD is transforming healthcare.

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Profile Brad Gescheider

Digital enables more engaging patient experiences by increasing therapy compliance, improving disease and medical tracking and as importantly, building connections among patients and with healthcare providers. The data collected with digital can be used to deliver more personalized therapies, increase reimbursement and potentially increase revenues through extended patent life."

– Brad Gescheider, Global Head, Digital Innovation and Patient Services, Immunology at Sanofi

WHITE PAPER:
Expectation vs. Reality: Cost and Time to Bring SaMD to Market

Insights from top digital health executives on how to speed time to market and lower costs for SaMD solutions.

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Everything You Need to Know About Software as a Medical Device (SaMD)

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CASE STUDY:
Roche: How BrightInsight Accelerated Time to Market for a Software as a Medical Device (SaMD) Solution

Roche developed a digital dosage calculator to aid prescribing physicians and maximize Hemlibra’s therapeutic benefits for patients with Hemophilia A. Rather than engineer their own infrastructure, applications and data stores, Roche partnered with BrightInsight and significantly accelerated time to market.

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Data Snapshot:
Promising SaMD Use Cases

While the potential applications for SaMD are myriad, a recent survey found that disease management was the most promising use case.

3 Things You Need to Know About the FDA's New Software as a Medical Device (SaMD) Guidance

This new guidance from the FDA has important information for anyone operating in the digital health space.

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3 things you need to know

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SaMD Compliance: How the US and EU Approach Regulations

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Webinar:
How to Launch Regulated Software as a Medical Device in 6 Months’ Time

Learn more about how Roche launched a CE-marked dosing calculator to treat Hemophilia A in just 6 months in this conversation with Paul Upham, Head of Smart Devices at Roche/Genentech.

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Webinar how to launch regulated software as a medical device in 6 months time

SaMD Resources

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