BrightInsight – A trusted partner in the realm of digital health, creating impactful solutions across a spectrum of therapeutic domains

The Silicon Review

BrightInsight emerges as the unparalleled global platform, positioned at the forefront of biopharma and medtech regulated digital health solutions. Trusted by leading companies as the launch partner, BrightInsight plays a pivotal role in expediting time-to-market for a spectrum of regulated digital health products, encompassing apps, algorithms, medical devices, connected combination products, companion diagnostics, and Software as a Medical Device (SaMD).

In contrast to the complexities of traditional 'build from scratch' implementations, BrightInsight offers a transformative approach. The platform provides a proven foundation and configurable software modules designed to meet the most stringent global standards in security, privacy, and regulatory compliance. Beyond its role as a platform, BrightInsight is poised to serve as the Legal Manufacturer of Record, adding an extra layer of trust and reliability to digital health products.

Choosing to build digital health solutions on the BrightInsight Platform is a strategic move towards future-proofing compliance while ensuring scalability across diverse geographies. This sets the stage for a revolutionary paradigm in the realm of regulated digital health solutions, where innovation, efficiency, and compliance converge seamlessly on the BrightInsight platform.

The BrightInsight^® Platform: Revolutionizing Regulated Digital Health Solutions

BrightInsight stands as the premier global cloud platform, setting new standards for biopharma and medtech regulated digital health solutions. The platform's proven and compliant nature serves as an accelerator for organizations on their digital health journey, eliminating the need for intricate 'build from scratch' implementations. Instead, BrightInsight offers a pre-built and tested digital health platform designed under a Quality Management System, ensuring adherence to global security, privacy, and regulatory requirements.

BrightInsight has significantly expedited the digital health journey for top-tier Biopharma companies. One notable success includes launching a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in Europe within just six months. The platform has also played a crucial role in fast-tracking the development and commercialization of a remote patient platform for another leading Biopharma company, achieving this feat in less than a year. Key features contributing to this acceleration include:

Pre-built functionality covering 60-80% of requirements, reducing time to market by 6 to 24 months.
Electronic Health Record (EHR) integrations into 500+ U.S. provider networks.
Device-agnostic approach with 400+ medical device integrations across 50 manufacturers.
Deployment readiness in 64 countries globally, with additional countries in the pipeline.
Microservices architecture ensuring advanced security, scalability, and configurability.

Proven Trusted Digital Health Platform: BrightInsight has garnered the trust of top 20 biopharma companies, becoming their go-to partner for building and launching commercial regulated digital health solutions. The platform boasts expertise in launching a diverse range of regulated digital health products, including high-risk Class C Software as a Medical Device (SaMD), dosing algorithms, patient support and engagement apps, chronic disease management platforms, connected combination products, diagnostics, and more. The platform's technology is tried and tested, being utilized by patients and providers at leading healthcare systems across various therapy areas, such as diabetes, respiratory, oncology, ophthalmology, obesity, hematology, immunology, neurology, and more.

Regulatory Compliant Digital Health Infrastructure: BrightInsight takes the complexity out of global regulatory compliance. The platform supports CE-Marked and FDA-regulated Class I, II, and III medical devices, combination products, and Software as a Medical Device (SaMD). With an ISO 13485:2016 and MDSAP certified Quality Management System, the platform is equipped to handle the stringent requirements of regulatory bodies. Notably, the BrightInsight Platform Master File has been accepted by the FDA, and the platform complies with the EU MDR and IEC 82304. The unique cloud change control process, in collaboration with Google Cloud, further ensures regulatory compliance and reliability.

BrightInsight's Disease Management Solution

Empowering every facet of the patient journey, BrightInsight introduces its configurable Disease Management Solution. This transformative offering enables organizations to enhance patient and provider experiences, focusing on improved symptom management and therapy adherence. The pre-built applications expedite time to market, addressing core needs seamlessly. Moreover, it drives revenue by harnessing Real-World Data that fuels actionable insights into user engagement and clinical outcomes.

Patient-Centric Tools with the Comprehensive Patient App: BrightInsight's Patient App stands as a comprehensive solution equipped with patient-centered tools aimed at informing and engaging users, ultimately striving for improved health outcomes. The emphasis on user-centric design ensures that patients are actively involved in managing their health, fostering a collaborative and informed approach to disease management.

Enhanced Patient-Provider Communication through Healthcare Provider Interfaces: The Disease Management Solution extends its impact with Healthcare Provider Interfaces, incorporating essential elements like a clinician portal, EHR integration, and patient dashboards. These interfaces are meticulously designed to enhance communication between patients and healthcare providers, fostering a collaborative environment for more effective and personalized care.

Harnessing Actionable Insights with Real-World Data Analytics Dashboards: At the core of BrightInsight's Disease Management Solution lies the Real-World Data engine, empowering biopharma companies to leverage unique data sets for actionable insights. The Analytics Dashboards provided by BrightInsight enable organizations to not only understand patient engagement but also derive clinical insights that contribute to revenue growth. The utilization of Real-World Data elevates the solution to not only manage diseases but also proactively shape strategies based on comprehensive and real-time information.Top of Form

About | Kal Patel, MD

Kal Patel, MD has over 20 years of experience in pharma, medtech and regulated digital health. He currently serves as CEO and Co-Founder at BrightInsight, the leading global platform for biopharma and medtech regulated digital health solutions. BrightInsight has raised $166M in financing from world-renowned venture capital firms including General Catalyst, Insight Partners, New Leaf Venture Partners, and Eclipse Ventures, and attracted some of the world’s top biopharma and medtech companies as customers including Sanofi, Novo Nordisk, Roche, AstraZeneca, UCB and CSL Behring, among others.

Kal also spent several years at Novartis Pharmaceuticals in various sales, marketing and account leadership roles. He began his professional career at the Boston Consulting Group where he worked for a broad portfolio of Healthcare companies across the U.S. and Europe. He transferred to the company’s Budapest office as part of BCG’s prestigious Ambassador program and was promoted early to Principal. Kal has also served as a Senior Advisor in Digital Health to the Boston Consulting Group where he helped C-level executives at pharma and medtech companies develop and execute digital health strategies.