BrightInsight Named 2020 Global Entrepreneurial Company of the Year by Frost & Sullivan for Advancing Digital Health Innovation in Biopharma and Medtech

BrightInsight adds more value to its biopharma and medtech customers' digital health products through its modern and customizable platform architecture,pre-built software assets,and managed service

SANTA CLARA,Calif.,Sept. 29,2020 -- Based on its recent analysis of the global healthcare Internet of Things (IoT) solutionsmarket,Frost & Sullivan recognizes BrightInsight,Inc.with the 2020 Global Entrepreneurial Company of the Year Award. The BrightInsight Platform is a leading IoT platform that accelerates regulated digital health innovation for biopharma and medtech through a common technology SaaS infrastructure. Flexible,fast,and secure,it offers end-to-end data management,hosting and integration that dramatically reduces risks and costs while ensuring privacy and regulatory compliance at every step.

"A few years ago,biopharma and medtech companies looking to launch digital health solutions had no choice but to build their custom platform from the ground up and handle all of the regulatory,security,and infrastructure requirements to comply with each market's regulations. This effort would take years and cost $10 million to $20 million. This approach required duplication of costs and efforts with each new region launched," said Norma Vela,Best Practices Research Analyst at Frost & Sullivan. "BrightInsight solves this problem with a pre-built,unified platform that meets biopharma and medtech companies' security,privacy,quality,and regulatory needs."

Customers leverage the BrightInsight platform for various regulated intended uses including personalized adherence interventions,personalized drug dosing algorithms,patient identification for therapies and adverse event detection as examples from current customer programs. Biopharma and medtech customers can develop,host,and manage connected,innovative digital health products and various data sources at scale on the platform. Furthermore,BrightInsight conforms to global security,and regulatory standards,such as a Quality Management System (QMS) that is ISO 13485:2016 certified,HITRUST CSF® v9.1 certified,and GDPR and HIPAA compliant. Beyond the United States and European Union,its solution is available and cleared from a privacy perspective in more than 30 countries. BrightInsight has also achievedMedical Device Single Audit Program (MDSAP) certification,which enables a single regulatory audit of a medical device manufacturer to satisfy the relevant requirements ofregulatory authorities in the U.S.,Canada,Japan,Brazil and Australia.

BrightInsight based its platform on the four critical pillars of a robust QMS,modular architecture,privacy and security compliance,and a fully managed service. It is the only platform built on an ISO 13485:2016-certified QMS supporting the highest risk of intended use. The first-of-its-kind regulated IoT platform in biopharma and medtech also allows for a common technology infrastructure that can integrate data across device types and manufacturers. Significantly,the company bridges the gaps in complex integrations and end-to-end infrastructure management while performing ongoing maintenance and management,allowing biopharma and medtech innovators to remain compliant even after the product launch.

"BrightInsight has projects across disease areas,including diabetes,obesity,oncology,respiratory,ophthalmology,neurology,and hematology,as well as modalities such as devices,wearables,algorithms,digital therapeutics and patient- and physician-facing apps. All projects use the same underlying IoT platform infrastructure but are configured and customized for a specific application,"noted Nitin Naik,Vice President at Frost & Sullivan. "BrightInsight provides a sustainable competitive advantage,strengthening the software-as-a-service model and its status as the leading global regulated IoT solution provider. Overall,it is well positioned to capture significant market share in this fast-growing segment."

Each year,Frost & Sullivan presents this award to the company that demonstrates excellence in devising a strong growth strategy and robustly implementing it. The recipient has shown strength in terms of innovation in products and technologies,leadership in customer value,as well as speed in response to market needs. The award looks at the emerging market players in the industry and recognizes their best practices that are positioned for future growth excellence.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership,technological innovation,customer service,and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews,analyses,and extensive secondary research to identify best practices in the industry.

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Contact:

Kristen Moore

P: 210.247.3823

E: kristen.moore@frost.com

About BrightInsight,Inc.

BrightInsight provides the leading global regulated digital health platform for biopharma and medtech. Every line of code of our BrightInsight Platform is built under a Quality Management System to support and optimize regulated drugs,devices and software through integrated data and actionable insights. The Platform can enable our customers to drive increased patient adherence and engagement across therapeutic areas,with active projects in diabetes,hematology,immunology,neurology and more. The BrightInsight™ Platform 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 global security,privacy and regulatory requirements. Deployed as a managed service,the platform accelerates 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. For more information,visit BrightInsight's website,our blog,Twitter and LinkedIn pages.

Committed to the highest quality standards,BrightInsight,Inc. is ISO13485:2016 certified and its software development lifecycle process conforms to IEC 62304. From a security perspective,the BrightInsight Platform is HITRUST CSF® v9.1 Certified and HITRUST Certified of the NIST Cybersecurity Framework to manage risk,improve security posture and meet compliance requirements. The Platform is also ISO/IEC 27001:2013 certified. To support our commitment to the upmost privacy standards,the BrightInsight Platform is HIPAA and GDPR compliant,certified under both the EU-U.S. and Swiss-U.S. Privacy Shield frameworks and has also achieved the French HDS ("Hebergeur de Donnees de Sante") certification.

The BrightInsight Platform was selected as Google Cloud's Technology Partner of the Year for Healthcarefor the past two years,was named to CB Insights Digital Health 150,was selected as the "Best IoT Healthcare Platform" in the 2019 MedTech Breakthrough Awards,was featured as the cover story for CIOReview Magazine's "20 Most Promising Biotech Solution Providers 2019," and was included in The Journal of mHealth's "2020 Global Digital Health 100."

Contact:

Jamie Burgess

P: +1.831.915.0295

E: jamie.burgess@brightinsight.com

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