BrightInsight – Providing the leading global regulated digital health platform for BioPharma and medtech sector

With longer life expectancies, the increasing number of people living with chronic diseases and the rising costs of healthcare, there is an ever-growing pressure on healthcare systems around the world. There is also a growing shift towards digital health approaches to healthcare. With digital health platforms, patients have quicker access to health services, improving the quality of care provided to them.  Simultaneously, these platforms help reduce burdens on health care facilities by pioneering the idea of self-care for patients. Digital health technologies help patients self-manage their health conditions through regular monitoring and tracking of symptoms. More importantly, it is a tool for the early detection of significant changes to disease progression in a patient, before lung health has been irreversibly compromised.

BrightInsight is one such firm, whose data can help deliver on that promise, cutting trial timelines, while improving data accuracy. Its device-agnostic platform also supports inclusion of off-the-shelf and custom medical devices in clinical trials. The firm uses software and services to capture, transmit and analyze data from CE-marked and FDA-regulated medical devices, combination products, apps and Software as a Medical Device, in compliance with security, privacy and regulatory requirements. Deployed as a managed service, the platform accelerates the time to market for BioPharma and medtech companies, reduces the cost of implementation and maintenance versus a custom solution, and scales across products and global markets. 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, and more. Whether it’s personalized patient engagement analytics, market intelligence on drug and device usage, or building blocks for patient-facing apps, BrightInsight Platform offers comprehensive solutions that can improve patient adherence.

“Our mission is to accelerate regulated digital health innovation for our BioPharma and medtech customers through scalable medical-grade platform.”

Most reliable digital health services offered by BrightInsight

The BrightInsight Platform: Built under a Quality Management System to support regulated products, its medical-grade BrightInsight™ Platform uses software and services to capture, transmit, and analyze data from connected medical devices and surgical equipment, combination products, apps, Digital Therapeutics and Software as a Medical Device-all in compliance with security, privacy,  and regulatory requirements.  BrightInsight also offers connectivity and management for regulated apps, algorithms, surgical equipment and medical devices, combination products, or Digital Therapeutics. It can aggregate data from multiple sources and can integrate with EHRs and other IT systems. Its clinical, operations, and patient engagement dashboards provide a valuable insights in real-time.

Starter Assets: The company’s configurable, pre-built software assets provide capabilities for participants, sponsors and investigators right out of the box. It offers seamless regulatory path from trial to commercialization with the necessary documentation, Quality Management System, testing and more. It provides fully customizable Participant App that increases engagement through eCOAs (ePROs, ePerfO), instructions, therapy management, predictive interventions, and more. Clinical Trial Sponsor Portal enabling Sponsors to setup and customize trials by adding new Sites and Investigators, creating ePRO Instruments, creating ePerfO measurements, monitoring key de-identified patient metrics, and more. Clinical Trial Site Portal enables investigators and clinicians to onboard participants, generate participant schedules, complete ClinROs, and manage participant progress, study metrics, and more.

Platform Managed Service: Included in the platform license, it’s managed service means less cost, less stress, and accelerated time to market. Its team of experts conducts ongoing privacy, security, and regulatory monitoring to stay up to date on the evolving regulations and ensure your digital health solutions are compliant. The managed service also includes platform performance monitoring and Level II and III support for the BrightInsight Platform. The firm also offers global performance, usability, and compatibility maintenance and support for their custom solutions.

Medical-grade device and data protection: Medtech CISOs and privacy officers have more sensitive data today than they have historically had, with more potential risk of a breach than ever before. According to research, 96 percent of IT professionals believe cyber-attackers are outpacing the security capabilities of medical organizations. With BrightInsight’s defense-in-depth infrastructure, security and privacy tools, and processes, you can minimize your risk. This white paper offers recommendations for a path forward to launching a scalable, intelligent digital health platform that meets your company’s needs.

The valiant leader behind the success of BrightInsight

Kal Patel is the Co-Founder and serves as the Chief Executive Officer of BrightInsight. He has an overall experience of 20 years in pharma, medtech, and regulated digital health. Prior to joining BrightInsight he was Chief Commercial Officer for Doctor on Demand, now the nation’s largest video-medicine provider, with backing from Andreessen Horowitz, Venrock, Google Ventures, and Qualcomm. Mr. Kal founded and built Amgen’s Digital Health business unit where he had end-to-end responsibility for developing and commercializing a portfolio of digital products in connected devices, advanced algorithms/decision making and next-generation marketing, where he launched multiple regulated devices.

He 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. Mr. 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.

“Our BrightInsight Platform regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications against global standards to earn your trust.”

“To help our biopharma and medtech customers with compliance and reporting, we share information, best practices, and easy access to documentation.”