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BrightInsight CEO Kal Patel M.D. discusses the future of regulated digital health for biopharma and medtech 

In order to benefit from the Virtual1Care trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations.

In the past 21 months since Covid-19 became a public health crisis, adoption of virtual health solutions has accelerated in an effort to mitigate risk. Although once regarded as a useful companion to in-patient visits, virtual care as a default starting point for healthcare delivery is becoming increasingly common, thanks to CMS reimbursement. And that’s becoming the norm not only for many primary and some urgent care delivery, but also for specialty areas such as behavioral health. National retail chains such as CVS Health and Walgreens have adopted platforms to support Virtual First Care (Virtual1Care). Amazon Care embraces Virtual1Care – it’s made the service available to its employees across the country and other companies are beginning to use it as well, particularly Hilton.

Virtual1Care is part of a wider trend we’re seeing in the restructuring of healthcare. In order to benefit from this trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations. In an interview, BrightInsight CEO and Founder, Dr. Kal Patel discussed how Virtual1Care is shaping digital health adoption, some of the regulatory shifts underway in digital health and how BrightInsight is collaborating with companies to fulfill this new vision of healthcare.

One deal that underscores this trend is the digital health collaboration between Fitbit, owned by Google, and Verily’s virtual clinic – Onduo. The collaboration pairs Onduo’s chronic condition platform with Fitbit’s devices and Fitbit Premium as part of the company’s approach to whole person health. It seeks to provide a comprehensive view of how the different aspects of health and wellbeing fit together, including activity, sleep and stress, to help participants better manage their health and build a routine that works for them, according to the September announcement.

These kinds of collaborations are also taking place in life sciences, for the same reasons. 

“How do you leverage continuous data sources in ways that drive intervention with the patient that go beyond a patient interaction having to be a face to face clinical visit?” Patel asked.  

“Our whole portfolio speaks to the potential and the power of what you can do by wrapping regulated software around traditional drugs and devices.”

Digital health investment soared to new heights in 2021, particularly for companies developing virtual care tech. As a company that provides the infrastructure for pharma and medtech companies to develop and scale regulated digital health programs, BrightInsight benefited from this investment trend as well. In the first quarter, it closed a $101 million Series C round led by General Catalyst.

Patel’s background in digital health in pharma at Amgen, with telemedicine provider Doctor on Demand and more recent experience as president of Flex Digital Health makes him well suited to lead these collaborations. One example of how BrightInsight is helping life science companies execute on their digital care ambitions is its collaboration with Novo Nordisk to support people with Type 2 diabetes. 

The pharma company needed a regulated digital health platform to help it build and operate a suite of digital health products and services to improve diabetes care. In addition to an open, device-agnostic platform that could capture data from continuous blood glucose meters and insulin pens, Novo Nordisk required a regulated platform designed to satisfy the stringent privacy, security, regulatory and quality requirements of US and European healthcare regulatory bodies. One of the challenges that companies seek to address is to improve the way patients manage their chronic conditions. At least 45% of people with type 2 diabetes have a tough time managing their blood sugar levels and medication adherence is one contributing factor.

The collaboration with BrightInsight helps people with diabetes unlock real world data. By integrating user’s blood glucose data with automatically recorded insulin dose data from Novo Nordisk’s smart insulin pens, users can better understand how their activities, diet, and insulin intake play a role in their levels and make more informed decisions to keep their glucose levels within safe parameters. 

Although there are numerous companies developing digital health solutions, if they can’t adapt to regulatory shifts, they risk falling behind or becoming irrelevant. Earlier this year, the EU regulatory body mandated a series of changes directing how companies need to manage software medical devices, which went into effect May 26. The changes were designed to ensure a high standard of safety and quality as regulators try to keep up with the pace of health tech innovation while maintaining the need for safety and efficacy. The FDA shared draft guidance for planned changes to premarket submission of digital health technology – the original version dates back to 2005.

The FDA has indicated that it’s updating software medical device guidance so that each software device will fall into one of two buckets: basic or enhanced, according to a blog post on BrightInsight’s website. The updated draft guidance is the FDA’s attempt to keep up with the influx of cutting-edge submissions.  By focusing on basic and enhanced risk, they eliminate the middle ground and streamline the submission process.

“This is reflective of the FDA’s view of low risk/high risk when it comes to devices,” said Sonia Nath, a partner with Cooley law firm in a BrightInsight blog post. “This may be announced as a simpler risk-based approach to viewing software devices generally…The thinking behind this guidance is, if we tell you more explicitly what we need, you can get through the approval process more quickly because there’s not going to be so much back and forth. Technology is always faster than the law and the guidance documents.”

The new draft guidelines will require that submissions for “high risk” software devices are accompanied by more design documentation spelling out the technical design details of how the software functions, how the software design implements all the requirements of the Software Requirement Specification (SRS) and how the Software Design Specification (SDS) traces to the SRS in terms of intended use, functionality, safety, and effectiveness. 

The convergence of pharma, medtech and providers through digital health data over the past few years has been a fascinating transformation. Pharma companies such as Takeda and Sanofi are developing specialty practices to gain greater insights on market dynamics and what patients need. Patel noted that health data has become a critical commodity.

“For pharma and medical device companies, there will continue to be a tremendous expansion and focus of their resources going into software,” Patel said. “You will have multiple sources of health data that can answer questions from disease diagnosis to matching patients with the right therapies.”

He added: “I think all disease areas are amenable to digital solutions.”

Virtual health visits are poised to increase in 2022 as will the need for regulated connected devices and Software as a Medical Device (SaMD) to monitor patient health between medical appointments. Collecting and analyzing data from these devices is not only critical for spotting potential problems with dosages, device usage and the overall health of patients; they can also make the interaction between patients and their clinicians more meaningful with the insights they can provide to them. The digital health offerings across pharma and medtech will continue to expand and become more robust across chronic conditions and specialized areas such as oncology and rare diseases. It will be interesting to see the form these collaborations take in the new year. 

Photo: NicoElNinom, Getty Images