BrighInsight has built a powerful platform to solve these challenges and help MedTech and Pharma companies run and scale their digital health initiatives successfully.
BrightInsight's platform acts as the functional springboard for companies to launch their solutions and integrate them with the relevant source of data. The solution can be an app, an algorithm, a connected drug delivery device, a regulated wearable or implant, or any other type of medical device. BrightInsight integrates the source data from these devices and takes the responsibility of all the privacy, security, and regulatory aspects of moving that data to the cloud. It then provides an environment that turns data into insights. BrightInsight can redeploy these insights back to the provider and the patient. "We are the plumbing, the infrastructure that enables regulated healthcare data to move around in a private, secure, and compliant manner, while enabling the more specific, and regulated use cases. That's the core offering of the BrightInsight platform," Patel says.
While helping companies to roll out innovative digital health solutions, BrightInsight's platform solves another challenge that's inherent in the Pharma/MedTech landscape: The speed of solution development. "Companies in this sector are very good at innovating from a drug and device perspective, but they are generally not very good at developing regulated software. Companies should not be focusing their resources in building the platform, but on the solutions and how those solutions support their specific Pharma or Medtech objectives," says Patel. As a result, they end up building software products in the same way they build drug or devices. This is not fast enough to address the challenges in a rapidly evolving digital world. "Drug and medical device development are on a multi-year life cycle, whereas software, including regulated software, needs to be on a quarterly lifecycle, if not faster ," Patel adds.
We are the plumbing, the infrastructure that enables regulated health care data to move around in a private, secure and compliant manner
So the question is how companies can achieve this? How can they build and deploy software and its patches, or how they can add new functionalities to enhance the product, quickly?
"At BrightInsight we build regulated software at the speed of non-regulated software," states Patel, "we are accelerating and scaling digital health innovation." Roche, a multinational healthcare company, were trying to move their product HEMLIBRA into the market quickly. As the drug went on sale, Roche wanted to support physicians with drug dosing and personalizing the dosing for the patients as soon as possible. With their skills in drug and device development, they were looking for the ideal partner, who could offer the best solution to move fast on the regulated software side as well. They selected BrightInsight to be this partner. BrightInsight launched the CE-marked Dosing Calculator that helped physicians in determining the correct dose to be administered based on dosing recommendations and biometrics. Thus, while it can take 3 to 5 years for a client to get products to market, BrightInsight can help launch digital products in less than 9 months.
One Step at a Time, Joining Hands with BrightInsight
BrightInsight takes away the responsibility from a CIO in terms of sourcing and implementing a compliant solution, collaborating to leverage the competencies of both organizations involved. When a client partners with BrightInsight, their regulated solution becomes a part of the product that the FDA or other regulatory bodies will review. The first in a multi-step engagement process, BrightInsight starts with a Quality Management System review. Within the review, the same compliance team audits BrightInsight as well as the drug components or device suppliers. BrightInsight operates, keeping the bar at where it is set—at the pace of drug development. Where BrightInsight’s edge shines through, is in its capacity to rival that pace with its own in software development, so that clients need not ever look back. “Almost all our projects go from defining the requirements to being completed typically within a nine-month period. This includes all the testing, validation, verification, the design history file, all the documentation that will go to the regulatory body and so on,” Patel re-emphasizes.
BrightInsight’s engagement with the client also helps design solutions that are customized to the needs of their business, which means that regardless of disease categorization or source of the data, they get the same speed to market as any client. Not only that, but the company is equally at ease when it comes to the broad spectrum of regulation levels that various use cases are subject to.
Leading by Example
The company's reputation is as impressive as their work ethic, which is visible from how BrightInsight helped one of their clients move into digital health. The client had several innovative capabilities to engage patients with algorithms for drug dosing and customization. They had the capacity in terms of bringing connectivity into their devices and skills on the data and analytic side. But when they approached the digital health space, they realized that they didn't have the underlying platform or the infrastructure to move their data around from a privacy, security, and regulatory perspective. BrightInsight worked with the client on a portfolio of projects that covered the whole spectrum, from apps to algorithms to connected drug delivery devices. The client has since dramatically accelerated their time to market. The company also expanded into other disease and therapeutic areas with BrightInsight, and in the coming months, they are set to launch multiple regulated digital health products globally. Evidently, BrightInsight was a major inflection point in the client's digital health journey and now, a critical partner for their ongoing success.
"At BrightInsight, we build regulated software at the speed of non-regulated software"
"We are a very agile organization on all the projects we work on, both for our own platform, as well as on our customers' projects," says Patel. BrightInsight has a new internal release every two weeks that comes with all the testing and supporting documentation, while being compliant to design control. "This allows us to deliver regulated software in the same way that traditional non-regulated companies do," he adds.
For the road ahead, BrightInsight plans to focus more on geographic expansion, and over the next 18 months, the company expects to have the platform launched in all the key global Pharma and MedTech markets. "The technology is already available from a product perspective, and it will soon be fully compliant with all the local regulatory, security, and privacy requirements," says Patel. Another focus for BrightInsight will be on supporting payers and providers, and various disease management programs. In a way, Patel and his team at BrightInsight are on a constant pursuit—to maximize the benefit of digital transformation for their clients.