This was a big year for digital health—and for BrightInsight. There were so many big stories in digital health in 2022, from the maturing of the SaMD marketplace to evolving regulatory frameworks. We wanted to take a look back and review the top 10 pieces of content that resonated with our audiences this year.
Digital solutions were top of mind for biopharma companies in 2022, and Software as a Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Here’s why: SaMD is changing how patients and providers interact, and it’s streamlining the way data is shared, tracked and analyzed. This has huge implications for biopharma companies, whose success depends on pairing the right patients with the right treatments and making a compelling case for reimbursement with payers. In partnership with HealthXL, a digital health community and advisory company, we surveyed the pharma industry about SaMD, interviewed top digital health leaders and analyzed publicly available data for the top 30 firms over a nearly three-year period.
Since going on the market in 2020, CSL Behring’s patient app for Hizentra has been downloaded by thousands of patients, and earned a 4.6 star rating in the Apple App store. It;s also had time to deliver remarkable findings. In this case study, we detail how BrightInsight took CSL Behring from project kickoff to Hizentra app launch in six months. We examine how the app earned an adoption rate of 20% of the brand’s U.S. patient population. And we show how the app is helping patients administer Hizentra, and look at data that show how the app is providing CSL with critical insights to improve patient care.
The FDA released a draft guidance for what documentation sponsors should include in premarket submissions for software-based products. The new guidance is an update to the current guidance, which is from 2005, and it has important information for anyone operating in the digital health space. BrightInsight’s regulatory experts and Sonia Nath, Partner at Cooley LLP, provide insight into the updated guidance in this blog post.
Creating regulated digital health solutions such as Software as a Medical Device (SaMD) is complicated, no matter where you’re doing business. Each region of the world has its own set of regulatory criteria and requirements, with the US and EU being widely recognized as leading regulatory authorities. Even if you feel like you’ve mastered the regulatory framework for the US, what happens when it’s time to expand? BrightInsight’s regulatory experts explain in this blog post.
Poor patient experiences lead to worse outcomes, and bleed value from the healthcare system. Patients living with chronic and/or serious conditions are demanding seamless digital healthcare experiences. And pharma companies lose hundreds of millions a year to poor adherence. Innovative biopharma companies are investing in digital health strategies and disease management solutions to reimagine the patient journey and add value to their therapies. This white paper explains how digital disease management reimagines the patient journey and restores value to stakeholders.
It can be difficult to pair patients living with any chronic illness with the right treatment, but doctors treating autoimmune diseases face additional challenges. The diseases are complex, new treatments are hitting the market all the time, and doctors have to rely on patient self-reporting, which often gives an inaccurate picture of the patient's overall quality of life. This white paper breaks down challenges in treatment selection and digital solutions that will benefit patients and providers alike.
Biopharma and medtech executives must answer a range of complex questions when developing a regulated digital health platform. One common consideration is whether to buy or build the platform. But there is rarely a clear-cut buy vs. build choice. It's more useful to approach the choice as build vs. build, developing some digital capabilities in house and partnering on others. It's imperative to decide which teams should focus on building a platform and when to bring in an outside partner to expand your team and expertise. This white paper explores the considerations firms need to consider.
Software as a Medical Device (SaMD) is changing how patients and providers interact and streamlining the way data is shared, tracked and analyzed. This infographic breaks out the data from research BrightInsight completed in partnership with HealthXL, a digital health community and advisory company. The insights from this survey reveal the huge potential for SaMD for biopharma, as well as the potential pitfalls.
In biopharma, all the buzz is about Software as a Medical Device (SaMD) solutions. Between January 2019 and October 2021, the top five pharmaceutical companies invested a combined $270 million in SaMD initiatives. And they’re not going it alone. They’re seeking out partners to help them build, launch and maintain these regulated digital health solutions. A whole industry of vendors has sprung up around this SaMD gold rush, but not every potential partner has the expertise and real-world product launch experience required to help guide biopharma companies through a successful regulated digital health solution product launch. This brochure guides you through the questions to ask potential vendors.
Need a primer on software as a medical device (SaMD). This blog explains how Software as a Medical Device (SaMD) is at the forefront of this digital health transformation of healthcare. It shows how digital solutions like SaMD-powered apps and algorithms are revolutionizing the way patients and providers interact, as well as the way data is shared, tracked and analyzed. When we surveyed top life sciences executives, we found that over 90% of them anticipated that digital core regulated products would be central to their business within five years. SaMD is how that will happen.