Addressing this challenge with its leading, SaaS-based platform for biopharma and medtech’s regulated digital health solutions is California based BrightInsight. The company’s compliant platform leverages innovative software and services to capture, transmit, and analyze data from CE-marked and FDA-regulated apps, algorithms, medical devices, combination products, companion diagnostics, and Software as a Medical Device (SaMD) to help its clients scale their regulated digital health products across regions. To eliminate complexity with respect to updating the feature-set of a digital health solution, BrightInsight is built with a microservices-based architecture, enabling rapid iterations of functionalities while maintaining compliance to a continuously changing regulatory landscape. “Our platform monitors the latest developments in the evolving healthcare compliance arena and assists clients in remaining in lockstep with them to accelerate time-to-market and ultimately drive better patient outcomes,” says Ferry Tamtoro, co-founder and CTO at BrightInsight.
Speed is paramount, and building compliant digital health products from scratch is complicated and timeconsuming. BrightInsight helps clients cut down their solution development efforts by 70 percent and accelerate goto- market with its configurable software’s Accelerator Modules on the BrightInsight® Platform. Biopharma Commercial teams use BrightInsight’s Accelerator Modules to speed the launch of digital health solutions for everything from patient diagnosis and selection to dose calculation and disease management. Clinical development teams use the robust capabilities of our software modules to quickly stand up clinical trials of digital health products. “By cutting down the time and efforts for app development, our pre-built technology accelerators allow our clients to focus on more critical aspects of their digital health solution such as clinical benefits,” explains Tamtoro.
Further discussing the core competencies of the BrightInsight Platform, Tamtoro mentions his company’s collaboration with a global pharma company, AstraZeneca. In this instance, AstraZeneca leveraged BrightInsight to monitor and maintain the compliance requirements of both the consumer-facing and clinical portals of their AMAZE Disease Management Platform.
BrightInsight took AstraZeneca’s AMAZE Disease Management Platform from project kick off to commercialization in less than a year. In a similar case, leading pharma company Roche/Genentech also approached BrightInsight during the development of their dosing calculator for treating Haemophilia A, a rare disorder that affects 400,000 people worldwide. BrightInsight helped Roche/Genentech build its regulated Software as a Medical Device (SaMD) dosing calculator in less than 6 months. “In both cases BrightInsight ensured that the building blocks of our clients’ digital health solution were compliant, thereby future-proofing their delivery and impact on patient health,” adds Tamtoro.
Our platform monitors the latest developments in the evolving healthcare compliance arena and assists clients in remaining in lockstep with them to accelerate go-to-market times and reduce risk
At the heart of BrightInsight’s success is its ability to boost go-to-market times for digital health solutions across a plethora of therapy areas and use cases, including patient diagnosis and selection to dose calculation, adherence and disease management. At the same time, the company’s proven track record, robust Quality Management System that’s ISO 13485 certified, and comprehensive list of certifications including MDSAP, HDS, ISO 62304:2015, ISO 27001:2013, HIPAA, GDPR, and more, has also helped to establish its leadership position in the digital health market. Tamtoro explained that BrightInsight regularly undergoes customer and third-party audits to support recertifications and verification of procedures, ensuring that they are always ready to support their clients’ regulated digital health products in a compliant manner.
BrightInsight is focused on its vision of transforming patient outcomes globally by bringing the power of digital technology to healthcare. Looking ahead, BrightInsight continues to develop additional Accelerator Modules to support its biopharma clients in Oncology and Autoimmune disease use cases, two indications that are seeing increased need globally. From a geographical standpoint, BrightInsight plans to strengthen its footprint in the U.S. while expanding operations into additional territories where its clients are launching products, including Canada, Australia, Japan, and more. To conclude, Tamtoro reiterates the roadmap of his company, “We will continue to incorporate emerging technologies into the BrightInsight Platform to accelerate time to market for our customer’s game changing digital health solutions that aim to improve patient outcomes.”