Real-time epidemiology, population health, and patient tracking.
Virtualized and distributed clinical studies with improved data collection, patient recruitment, and patient retention.
Treatment compliance with beyond-the-pill solutions for patient behavior monitoring.
Real-time monitoring and flagging of adverse events for immediate treatment.
Treatment selection, administration, and reimbursement based on measured outcomes.
Collection of high-fidelity, longitudinal data to improve treatment and value delivery.
Disease management across devices, drugs, care providers, health systems, and other stakeholders.
Patient-specific prescription selection, treatment evolution, and holistic lifestyle regimen.
Each of these trends and applications needs a trusted and regulated, cloud-connected infrastructure.
To launch and maintain digital health solutions, you need an underlying regulated infrastructure. Prior to BrightInsight, biopharma and medtech had no alternative but to build their own underlying platform. Building a custom platform introduces a number of challenges:
Speed and Scale
Developing a custom, siloed platform can take 2+ years, even without integration into the broader digital health ecosystem.
Standing up a novel solution is expensive upfront — maintaining its adaptability, scalability, and security can be exorbitant.
Creating a robust Quality Management System is resource-intensive, with added complexity from evolving global regulatory, privacy, and security regulations.
Building an in-house digital infrastructure is a competitive disadvantage for biopharma and medtech companies, given the complexity, resourcing, and market evolution. To drive speed to market, you should focus your team on specific digital health IP that is core to your business and partner on the underlying infrastructure to drive speed to market.
The medical-grade BrightInsight Platform is a regulated digital health platform built under a Quality Management System to support and optimize regulated drugs, devices, and software through integrated data and actionable insights to enable customers to drive increased patient adherence and engagement.
Connectivity and management for regulated apps, algorithms, devices or combination products.
Data aggregation from multiple sources and can integrate with EHRs and other IT systems.
Clinical, operations and patient engagement dashboards provide valuable insights in real-time.
Our BrightInsight™ Platform uses software and services to capture, transmit, and analyze data from CE-marked and FDA-regulated medical devices, combination products, apps, algorithms, Digital Therapeutics, and Software as a Medical Device (SaMD), in compliance with security, privacy, and regulatory requirements.
Our BrightInsight Platform reduces the cost of implementation and maintenance versus a custom solution, and scales across products and global markets.
We handle global regulatory compliance, so you don’t have to.
To be prepared for the future, you need a regulatory strategy for your digital health products now. Most medical Device Data Systems (MDDS) do not offer a sustainable regulatory infrastructure to support digital health solutions as they mature to regulated offerings. BrightInsight is more than just MDDS and supports up to Class III medical devices.
We accelerate your time to market while lowering costs.
Our unwavering commitment to security and privacy minimizes your risk.
Our managed service model reduces your operational burden and ensures ongoing compliance.
We provide real-time intelligence to optimize your therapies.
Based in Silicon Valley with teams all over the globe, BrightInsight is backed by leading healthcare and technology VCs. Our leadership team brings over 100 years of combined digital health experience in the biopharma and medtech industries.
Our vision is to transform patient outcomes globally by bringing the power of digital technology to healthcare, and we work every day to achieve this by accelerating regulated digital health innovation for our customers through our scalable medical-grade platform.
The world’s leading biopharma and medtech companies trust BrightInsight as their regulated digital health platform, supporting transformational digital health solutions including Software as a Medical Device, connected combination products, apps, algorithms, and more.
"We selected BrightInsight because its pre-built, compliant platform accelerates our time to market while allowing us to focus on digital health innovation and leveraging our clinical know-how to improve patient outcomes instead of the underlying infrastructure."
Karan Arora, Chief Commercial Digital Officer and Global Vice President, AstraZenecaLearn More
"After conducting a rigorous evaluation, we selected BrightInsight because it has the only regulated solution with a robust Quality Management System and a comprehensive list of privacy and security certifications. BrightInsight’s Platform allows us to focus on therapeutic innovation, rather than the underlying digital technology."
Brian Johnson, Director, Digital Health, CSL BehringLearn More
"Medical-grade digital health platforms like BrightInsight are key to helping us improve the conversation between people with diabetes and their caregivers."
Anders Dyhr Toft, Corporate Vice President, Commercial Innovation, Novo NordiskLearn More
"If you leverage a solution like BrightInsight that meets the most stringent requirements and maintains compliance as part of their managed service, you don’t have to worry about your regulated digital solutions in the U.S. versus Europe versus U.K. and so on. You just know they’re compliant."
Paul Upham, Head of Smart Devices, Roche/GenentechLearn More