Industry Brief
The transformation healthcare delivery has experienced over the past decade accelerated to lightning speed in 2020. Telemedicine, once limited to rural communities, is now everywhere. Gene sequencing is helping researchers develop vaccines in record time. And patients have turned to digital health apps and wearables not only to count calories and track workouts but also to monitor heart rhythm and blood oxygen.
The pharmaceutical industry is a major player in healthcare’s digital transformation, developing clinical-grade digital health solutions that support its products and/or target a specific therapeutic area. Whether they provide education, medication reminders, or something more, all digital health apps and solutions must exist on some type of infrastructure.
Medical-grade solutions, however, need a more robust infrastructure—one that can not only transfer data but also analyze and process that data. For regulated software, that means an advanced, regulated Software as a Service platform.
Developers can build low-risk digital health apps on a medical device data system (MDDS). A MDDS transfers, stores, converts formats and displays data but doesn’t modify the data.
For example, an app that allows patients to view their prescriptions on their mobile devices may not require regulatory oversight. However, if the app developer adds an algorithm that tracks medication adherence and provides reminders, the app becomes subject to regulation.
It becomes a regulated intended use because you’re reminding a specific patient based on their specific data to take a specific action," said BrightInsight CEO and Co-Founder Kal Patel, MD. "The algorithm is practicing medicine."
In the heavily regulated pharmaceutical industry, a digital health app might get by on an unregulated platform; however, it’s not recommended, because the intended use of the data will likely evolve.
It’s underutilizing what software can do," said Bradley Merrill Thompson, who leads the medical-device-regulatory and digital-health practices at Epstein Becker & Green P.C. and a leading voice on regulatory issues around medical-device software. "Ultimately, the value is not in being generic, but in being specific."
As digital-health technology becomes more sophisticated, medical-device and pharmaceutical companies are turning more attention to clinical-grade mobile apps to enhance existing products. If they build those apps on an infrastructure that can’t manage the data, the company would have to invest significant time and resources on remediation.
Software architecture would need a complete redesign. Developers would need to add a Quality Management System that aligns with U.S., EU and other medical-device regulations. And that’s only the beginning.
Under GMP Good Manufacturing Practices [GMP], you have to have extensive systems and processes in place to show the development of your product is likely to lead to a product that’s safe and effective," Thompson said. "When you don’t do that the first time around, it’s essentially impossible to reinvent parameters that weren’t there before. And if you develop these systems and processes too casually, you won’t meet the criteria required as part of FDA’s design input and ultimate validation processes."
Teva Pharmaceuticals, one of the largest manufacturers of generic drugs and specialty pharmaceuticals, recently launched a family of digital inhalers—called Digihalers—that track inhaler use and measure respiratory flow. The inhalers pair with a Digihaler app that lets users view and share data with their doctors. The ProAir Digihaler launched in the United States in July 2020. The AirDuo and ArmonAir followed in September.
Prasad Peri, Senior Director of Global Regulatory Affairs CMC for Teva Pharmaceuticals, said the company worked with the Food and Drug Administration (FDA) on approvals for its Digihaler app as the agency’s guidance around digital health evolved.*
I don’t think I’d be inaccurate in saying part of what we did, and our conversations with the FDA, caused them to rethink their guidance documents around what is a mobile medical app, what is Software as a Medical Device and what is clinical software," he said. "It was a long journey—the goal posts moved each time we talked to them. But in every situation, the FDA was consistent in what they were looking for—they wanted to know the product met the intended use."
Peri stressed that pharmaceutical companies considering software development should remain clear in their intended use, which will help facilitate more productive discussions with the FDA.
*Views expressed by Prasad Peri are his own and not that of Teva Pharmaceuticals.
Building apps on an IoT infrastructure that is regulated by the FDA offers a host of advantages. A regulated platform is designed to manage regulated device data and protected health information.
The BrightInsight Platform supports up to Class III medical-device and combination-product intended uses. If you need real-world data, data for post-market studies or data integration from sensors, a regulated platform can handle the task.
BrightInsight also has a device master file accepted by the FDA. A device master file is required when a pharmaceutical or medical-device company partners with a third party when manufacturing the device. The device master file essentially preserves the trade secrets of both parties while working with the FDA. When building a solution on top of BrightInsight’s digital health platform, you can simply reference its master file in your FDA submission and move on.
Building on a regulated infrastructure also helps ease the minds of anyone involved in obtaining FDA approval.
Using a regulated infrastructure alleviates regulatory concerns as you’re developing your product over years and years," Thompson said. "You can be confident that from an infrastructure standpoint, you’ll be compliant."
With wearable medical devices, Software as a Medical Device, algorithms and other digital health products showing strong growth through 2020, regulated software will likely become a key focus for a growing number of medical-device and pharmaceutical companies.
The train has left the station," Peri said. "Everyone is thinking outside the box in terms of digital health and AI. Traditional medicine will continue to flourish, but ultimately, digital technology will benefit the practice of medicine."
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