White Paper
As the research in our white paper, "How to Succeed as a Biopharma and Medtech CIO in Today’s Digital Era" shows, CIOs are facing significant challenges when building and launching digital health solutions. From the escalating security and privacy concerns, to the regulatory complexities, to the need for robust analytics capabilities, developing a digital health solution and the supporting cloud infrastructure from the ground up is no simple task. When you combine these challenges with ongoing pressures related to scaling solutions across regions, brands or increased number of patients, the costs can be eye-wateringly high.
For these reasons, biopharma and medtech companies can’t go it alone. They are in need of a fully-managed Internet of Things (IoT) platform that allows them to offload the additional regulatory headaches, security challenges and scalability issues that hamper new digital health products while also enabling them to integrate with a broader ecosystem, such as Electronic Health Records, payers or disease management programs.
This compendium will help readers understand the value of leveraging an end-to end managed service platform that accelerates time to market, reduces the cost of implementation and maintenance versus a custom solution, and scales across products and global markets.
Based in Silicon Valley with teams all over the globe, BrightInsight is backed by leading healthcare and technology VCs. Our leadership team brings over 100 years of combined digital health experience in the biopharma and medtech industries.
Our vision is to transform patient outcomes globally by bringing the power of digital technology to healthcare, and we work every day to achieve this by accelerating regulated digital health innovation for our customers through our scalable medical-grade platform.
The world’s leading biopharma and medtech companies trust BrightInsight as their regulated IoT platform, supporting transformational digital health solutions including Software as a Medical Device, connected combination products, apps and more.
Our medical-grade BrightInsight Platform is an IoT platform built under a Quality Management System to support and optimize regulated drugs, devices and software through integrated data and actionable insights to enable customers to drive increased patient adherence and engagement.
Our BrightInsight™ Platform uses software and services to capture, transmit and analyze data from CE-marked and FDA-regulated medical devices, combination products, apps, Digital Therapeutics, and Software as a Medical Device (SaMD), 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.
BrightInsight goes beyond siloed, custom-built IoT platforms by offering one of the only open, medical-grade managed service platforms for regulated connected devices and therapies.
Our team has made significant investment in the highest quality people, processes and certifications to minimize customer risk. We offer fully managed regulatory services and a modern platform architecture to accelerate speed to market, and our real-time intelligence and analytics capabilities offer actionable Clinical, Operations and Patient Engagement insights to enable our customers to improve adherence and engagement.
BrightInsight offers connectivity and management for regulated apps, algorithms, devices or combination products.
BrightInsight can aggregate data from multiple sources and can integrate with EHRs and other IT systems.
Clinical, operations and patient engagement dashboards provide valuable insights in real-time.
Biopharma and medtech companies wouldn’t accept a sub-par security, privacy, regulatory or quality system for their traditional drugs or devices, and the same rigor should be applied to their digital health offerings.
We apply the Security-by-Design principle and Defense-in-Depth best practices and built the entire BrightInsight software stack with security in mind for the whole software development lifecycle. BrightInsight has achieved the utmost privacy and security certifications to minimize customer risk and protect sensitive health information.
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 utmost privacy standards, the BrightInsight Platform is HIPAA and GDPR compliant. The BrightInsight Platform has also achieved the French HDS (“Hébergeur de Données de Santé”) certification, validating that BrightInsight ensures data confidentiality, integrity, and availability for our biopharma and medtech customers.
See our full list of certifications here >
Our managed service for data privacy includes privacy policies and procedures, implementation of automated processes to decouple sensitive personal information from other health data, operational procedures for protecting Personal Health Information (PHI) and monthly employee trainings to safeguard customer’s information.
Our platform is built from the ground up to securely manage highly regulated medical device data and personal health information and is designed to support up to Class III medical device and combination product intended uses.
We are committed to the highest quality standards and BrightInsight, Inc. is EN ISO13485:2016 certified and our software development lifecycle process follows EN / IEC 62304. As part of our managed service, we maintain all of the required documentation and processes to ensure regulatory compliance globally.
In the US, the BrightInsight Platform Device Master File has been accepted by the FDA, reducing the regulatory burden for our customers by directing any FDA questions related to the BrightInsight Platform to our team, not our customers. As a result, our regulatory managed service helps relieve the regulatory headaches that digital therapeutics carry with them related to the software system.
BrightInsight has achieved the Medical Device Single Audit Program (MDSAP) Certification, which will enable us to accelerate time to market for our customer’s medical devices or Software as a Medical Device hosted on the BrightInsight Platform in a compliant manner. MDSAP eliminates the need for country-specific audits of BrightInsight’s Quality Management System and design control documentation in participating countries, including the U.S., Canada, Japan, Brazil and Australia.
Fueled by real-time data capture and advanced Machine Learning (ML) algorithms, the platform offers robust clinical, operations and patient engagement dashboards with actionable insights. In addition to these off-the-shelf configurable dashboards, we have a best-in-class data science team as well as extended advanced analytics resources and expertise through our strategic partnership with the Google Cloud Artificial Intelligence (AI) team.
Together with the Google Cloud AI team, we are leveraging cutting edge ML and AI technologies to develop custom analytics solutions to provide actionable insights to improve patient engagement and adherence. These Google-backed analytics will help CIOs transform the data collected on the digital health platform into actionable insights.
The BrightInsight Platform is designed to scale beyond single products and regions to support customers’ market needs for hundreds of thousands, millions or tens of millions of patients. The platform offers capabilities for rapid development and a modular platform architecture to support customization.
Biopharma or medtech companies with product-specific digital health platforms often encounter major technical or regulatory challenges when they try to scale a custom platform to support new devices or products. The cost of iterating a platform to keep up with a growing user base is challenging enough and adding additional products to the platform only compounds the issue. It can become impossible to move fast enough to support evolving business needs.
Our platform is designed so our customers won’t have that problem. We built the BrightInsight Platform with a microservices architecture that supports automated scalability of its various capabilities. Not only that, the capabilities can scale independently and as needed. For example, the platform offers functionalities around managing medications, tracking symptoms, managing users and more. Instead of scaling the entire platform for growth in any one area, BrightInsight can scale performance for each one of those functions separately to match the needs of each of their customers’ digital products and patient populations.
It is important to have an open, interoperable platform that can integrate with products from different biopharma and medtech companies and also with third party health IT systems, such as Electronic Health Records or disease management programs. BrightInsight is designed to be an open platform that can integrate into the broader healthcare ecosystem.
Our team employs a best-in-class engineering team experienced with regulated environments. Our leadership team has more than 100 years of combined digital health experience, managing 80+ engineers with deep experience in building software solutions for highly regulated medical environments, balancing the need to iterate rapidly while maintaining a robust Quality Management System. The team has experience deploying regulated healthcare software products that include cardiac monitoring, telehealth, medical imaging and pharmaceuticals.
There are a number of variables biopharma and medtech companies need to consider when building a digital health platform. At the end of the day, it’s important for CIOs to invest in an IoT platform that can support the evolving needs of the Commercial and R&D sides of the business quickly – such as adding new products, entering new markets or accelerating clinical trials – in a regulated environment that meets the requirements of standards bodies globally.
One crucial difference between traditional CIO responsibilities and new ones, like creating digital products, is that making the wrong decision about a digital health product can put the company’s revenue at risk. Whether that leads to a failed product or a delay getting to market, revenue will suffer. Competitive pressure is mounting with an increasing number of companies working in the same therapeutic areas. Capturing market share quickly has never been more critical. As CIOs’ decisions around digital transformation impact product rollouts, CIOs do not want to be responsible for delaying a therapy’s entry to the market.
Today, the stakes are also higher for CIOs developing digital health platforms, because unlike traditional IT projects, these platforms are both highly regulated and collect sensitive patient data. Data breaches or compliance issues could lead to regulators shutting down a product altogether.
Instead of courting the risks, costs and delays that developing an in-house digital health platform can require, biopharma and medtech companies would do best to invest in a partner that can manage their end-to-end digital health needs, so they can focus on their core business, creating more effective therapies.
When building a digital health IoT platform, partner with BrightInsight and leverage our regulated platform to maximize your speed to market, minimize your risk and future-proof your platform.