Ahead of the Healthcare Information & Management Systems Society (HIMSS), manufacturer Flex has announced its partnership with Google Cloud, and subsequent launch of BrightInsight.
A healthtech solution developed to provide drug and device data, BrightInsight will produce real-time insights. Built on a Google Cloud Platform, it enables customers to continually improve patient outcomes.
Set to be showcased at HIMSS, the technology has been developed with a robust Quality Management System that is designed for ISO 13485 and HIPAA compliance. Flex is also applying for HITRUST certification.
The McKinsey Global Institute estimates that applying big-data strategies to better inform healthcare-related decision making could generate up to $100bn in value annually across the US healthcare system.
Medical devices collect massive amounts of data, creating enormous potential for a rapid feedback loop that can help improve patient care and enhance drug therapy delivery and management. However, in order to make an impact, the data needs to be aggregated from a myriad of apps and stand-alone devices, as well as analysed to provide actionable insights.
BrightInsight works to solve such challenges and helps patients and health care professionals to better understand medical device usage and medication adherence and streamline the product development and certification process.
"We saw the need for a secure cloud platform designed to support highly-regulated connected drug delivery and medical devices, going beyond simple connectivity to deliver real-time intelligence and actionable insights," explained Kal Patel, MD, Senior Vice President of Digital Health for Flex.
"With our 20 years of experience operating in global regulated medical environments and having deployed more than 75 regulated hardware and software medical products, Flex can combine our cross-industry capabilities to simplify our customers' digital transformation."
By collaborating with Google Cloud, Flex will gain the ability to deliver insights through customisable analytics dashboards fuelled by the company’s advanced machine learning and artificial intelligence (AI) capabilities.
Selected as a result of its exceptional track record for data security, Google’s Cloud Platform will enable BrightInsight to successfully securely store, analyse and gain insights from health information, without pharmaceutical and medical technology customers having to manage the underlying infrastructure. Advanced use may include controlling connected devices, drug dosing, decision support, personalised patient interventions, trend analysis and AI-driven insights.
"With a partner like Flex, we will enable our customers to develop innovative solutions and leverage machine learning-based analytics that can turn new data sets from wearables, medical devices, therapies and apps into actionable information for patients and providers," explained Gregory Moore, MD, PhD, Vice President, Healthcare, Google Cloud.
BrightInsight is designed to support CE-marked and FDA-regulated Class I, II and III medical devices, combination products and Software as a Medical Device requirements, enabling automated interventions. Deployed as a managed service, the BrightInsight platform allows pharmaceutical and medical technology companies to accelerate their time to market, reduce the cost of implementation and maintenance across multiple products, and scale for global markets.
Featuring foundational capabilities for rapid development and a modular platform architecture to support customisation and worldwide implementation, BrightInsight is built to securely manage highly regulated medical device data and personal health information.
Flex has put processes in place to monitor security and threat prevention to meet global compliance standards, where BrightInsight eliminates regulatory bottlenecks that can lead to costly delays by offering turnkey regulatory design control and file management of master files with the FDA. This service enables pharmaceutical and medical technology companies to focus on their drug, device or combination product submissions without the burden of documenting the software platform.