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August 5, 2022

Five Expert Insights from the HealthXL Community

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HealthXL Team & HealthXL Community
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Over the past month, our HealthXL community members discussed digital health evidence requirements, DTx label claims, and DTx - pharma collaborations, among other topics. We’ve put together a snapshot of five expert insights from these meetings.

#1 On Evidence Generation for Standalone DTx: Randomized Control Trials (RCTs) and Real-World Evidence (RWE) are the two main practices for evidence generation in DTx. While there is no clear answer on which format is more successful, some companies have seen success with a hybrid model. A hybrid design integrates the traditional RCT trial with design aspects to collect real-world data on patients. Traditional RCT’s are what physicians are most familiar with and thus trust, but they aren’t best suited to DTx. DTx solutions are constantly updating and improving. An 18-month RCT isn’t the best fit for an evolving solution. Hybrid models could be a way to both earn physician trust and allow for ongoing changes to digital solutions.  

#2 On evidence requirements from payers and regulatory bodies in oncology digital health: For payers in general, the return of investment will be measured through a cost savings lens or a member attraction and retention lens. FDA/regulatory approval for a digital health tool is not a strict requirement for payers. However, gathering sufficient evidence for partnerships with payers is proving difficult as they want a broader array of evidence than the FDA typically requires. Payers want real world evidence; they want to see the health economics impact and adherence data, which is costly and time consuming to gather, especially for small start ups. What does this say about the state of digital health if payers are more difficult to convince than the regulators?

#3 On DTx label claims: Label claims cannot be universal for one solution due to regulatory differences across regions. A digital solution could be regulated as a prescription digital therapeutic (PDT) in one region but a non-PDT in another region. Regulations control what claims labels can make about DTx solutions. Therefore, products may not have the same label claims everywhere. This makes it hard for companies to standardize commercialization strategies across countries, which could affect scalability.

#4 On Pharma - DTx collaborations: To maintain a strong relationship with pharma, DTx companies need to find numerous stakeholders to champion them throughout the partnership. It is important to focus on ROI, endpoints (both shared and individual), and stakeholders management. Keeping stakeholders onboard with a clear problem statement and roadmap is a key component of success.

#5 On employer partnerships for DTx in mental health: Working with employers requires a different approach than with life science or medical partners. While a strong evidence base is still vital, the focus will be more on productivity and employee satisfaction and less on healthcare outcomes. That said, clinical trials remain an important way to illustrate the efficacy of a solution. Although employers may not have the required expertise to dissect clinical evidence in detail, it is often a foot in the door. Helping employers to understand and navigate clinical evidence could create more opportunities for collaboration.

Want to join the conversation? Check here for upcoming meetings and events.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

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Connect with peers and share insights

Don't miss out on the discussion of the latest insights and reports on digital health. Meet with peers and take a deep dive for 75 minutes. Unlike at webinars, you can freely exchange experiences and insights to solve challenges and design the future of DTx.

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The healthcare industry is undergoing a digital transformation and extended reality (XR) technologies such as virtual reality (VR) and augmented reality (AR) are expected to play a significant role in this change in the next few years. Apply now to join this Masterclass led by Nemanja Kovačev, MedTech Expert at HTEC Group.

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Nemanja Kovačev
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MedTech Expert, HTEC Group
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Join our Digital Health Meetings and take a deep dive for 75 minutes into topics like digital therapeutics, patient support, telehealth, clinical trials, dermatology and many more. These Meetings are not regular webinars: No audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And with a free account on our Community Hub, you stay connected and up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.

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