Our HealthXL meetings in March covered everything from  ‘Navigating the DiGA Framework’ to ‘Leveraging Sources of US Government Funding for Digital Health’. 

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To make sure you’re not missing out on the topics that matter most to our communities and to keep you plugged into the conversation, here are my top five meeting takeaways from the past month: 
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1. Reframing digital health will make it a priority for pharma.

Digital will be a part of pharma’s future, as consumers demand the digital convenience they now take for granted in other industries. Pharma is learning from the past and focusing its efforts on high-potential initiatives. In our recent roundtable discussion on ‘Pharma 3.0: Doing Digital Health Better’, led by Jeremy Sohn (Managing Partner, P74 Ventures) and Martin Kelly (Founder, HealthXL), we discussed understanding the fit for digital health in pharma, choosing success metrics that resonate and rethinking resources for digital health. However, seeing the value of digital health is different from having strategic goals and KPIs that must be achieved. To date, many of these have not been defined and clearly articulated yet. Therefore, this group felt that in order to gain executive interest, and to ensure digital becomes a leadership priority, it must be framed as a way to enhance trial recruitment or development processes, for example, rather than as a stand-alone venture. Accepting failure as part of the development process, and approaching digital as a way to enhance speed to market, will help to make digital a priority for pharma.

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Ahead of the release of the HealthXL industry report on ‘Pharma 3.0: Doing Digital Health Better’, we ran a webinar in March to gain insights on what the next phase of digital health in pharma will look like, and how pharma can ‘do digital better’. Watch the webinar recording to learn the key learnings and expert projections for the future. 

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2. US government funding is available for your digital health solution - you just need to know where to look

Everyone wants free money right? And the U.S. Government is constantly looking for methods to improve the health and wellbeing of its beneficiary populations. Your digital health solution may be exactly what the Government needs, but it doesn’t even know it yet. If you can make it aware of the value of your solution, you may be able to attract non-dilutive funding that you didn’t even know existed. 

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Michael Hopmeier (President, Unconventional Concepts) is an expert in the field of sourcing funding for digital solutions and in this masterclass, he guided participants through the world of non-dilutive funding from US federal, state and local governments, the requirements and procurement process for non-dilutive government funding and how to develop a game plan and point-of-view to solve problems for the government. The most important element in securing funding from the government is to proactively engage with this entity and promote solutions that can help beneficiary populations. To identify government requirements, companies can visit SAM.gov, attend conferences hosted by government agencies (e.g. SOMA conferences), or invite Government representatives to events. By engaging with the government early and providing solutions that meet its needs, vendors can position themselves for non-dilutive funding opportunities and establish long-term partnerships with government agencies. If you missed the masterclass, read our key takeaways to find out some tips and tricks to help secure government funding here. 

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3. To qualify as a ‘DiGA’, it is imperative that the solution is a medical device and a digital therapy.

Germany’s Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) play a key role in not only providing a path to reimbursement but also in increasing provider awareness and trust in digital health solutions. The DiGA framework is the current role model for reimbursement in Europe, but how can digital health companies best avail of it? In our recent masterclass led by Jonas Albert and Hans Holger Bless from fbeta, we found out!

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To qualify as a ‘DiGA’, a solution must be a medical device (class I or IIa), and digitally focused. If the clinical decision comes from humans, rather than digital technology, it will not qualify as a DiGA. Although it sounds obvious, the digital-centricity required by these solutions is often overlooked by developers. For example, solutions should omit physician interaction components (e.g. a physician dashboard), as these transfer the clinical decision and therapy away from the digital solution, and thus will not be considered to be digital focused. Find out how to best approach the DiGA pathway through evidence and product requirements, communicating with the BfArM, and performing price negotiations here. 

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4. Extended reality (XR) companies in healthcare need to be trailblazers. 

In our recent meeting on ‘Extended-Reality (XR) Solutions in Mental Health and Substance Use Disorders’ experts who are working on XR solutions for mental health and substance use disorders brainstormed on how we can leverage XR solutions to alleviate the burden of mental health conditions in exhausted clinical systems. We discussed the potential of XR solutions to address these challenges, the barriers to adoption and how to design a trial that takes full advantage of this technology and its data. Read more takeaways on the barriers to adoption of XR solutions, how to address challenges and design a trial that takes full advantage of XR technology and its data here. 

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The digital health regulatory landscape is constantly changing, and even regulatory bodies are finding it difficult to keep pace with innovation. This challenge is particularly relevant to XR applications. However, this also presents an opportunity for XR companies to take the lead in defining evidence-based and regulatory requirements. By setting clear expectations and standards within the industry, these companies can help establish a robust and credible regulatory framework for XR in healthcare.
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5. Hospital partnerships may be most suitable for rare diseases and niche cohorts when scalability is not a pressing concern.

While pharma has been a key partner for digital health partnerships, the reality is that we have not seen many success stories come out of these collaborations yet. In our meeting on ‘Beyond Pharma: Finding the Best Commercial Partner for Digital Health in Oncology’ led by Lavi Kwiatkowsky (Founder & CEO, Canopy) and Francesca Wuttke (CEO and Founder, Nen), the participants delved into what constitutes a successful partnership for digital oncology companies and explored the potential of other partners ‘beyond pharma’ including hospital systems, payers, and MedTech. 

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A large part of the discussion was focused on the potential and limitations of hospitals as a partner in digital health. Although forming hospital partnerships can have key benefits, major hurdles are the restricted budget and incentives available to hospital systems for investing in digital health solutions. Therefore, scalability can be a limiting factor for such collaborations. For oncology companies, hospital partnerships may be most feasible in the context of rare oncology diseases that necessitate niche cohorts. In such cases, scalability across multiple hospitals may be less crucial, making hospital partnerships a more attractive option than for general oncology diseases where large cohorts are required.

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These are just a few key insights from some of our discussions last month. Head over to our platform to read through the takeaways from all our past meetings covering a great variety of digital health topics. Or even better, apply to attend an upcoming virtual meeting or in-person event. 

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See you in a HealthXL meeting soon!

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