Insights you Need: Key learnings from the HealthXL Community
HealthXLs digital health meetings bring the leaders in digital health together. We have run 8 interactive masterclasses so far this year, where key experts from the HealthXL community have shared their expertise in trending areas of digital health. We felt it was about time to look back at the highlights of the most noteworthy sessions over the last few months. Keep reading to learn the key takeaways from 3 of our top masterclasses.
The Regulation of Digital Therapeutics (DTx)
Regulation is an absolute essential for DTx companies who want to be incorporated into clinical and payer activities. What are the must know do’s and dont’s when attempting to take a DTx product through regulatory pathways in the US? We explored this during different masterclasses led by key HealthXL members, BlueBridge Technologies and AmalgamRx.
Here’s what we learned:
- In the US, regulations relating to Medical Devices, Software as a Medical Device (SaMD), General Wellness Products and Clinical Decision Support Software all have elements that can be applied to DTx products and inform regulatory thinking. While there are a range of regulatory classifications possible for DTx products, many are expected to be Class II devices.
- In the US, understanding the interplay between the three approval pathways, PMA/De Novo/510k, and ‘’regulatory programs’’, Breakthrough Device/Safer Technologies (STeP), is important. Regulatory programs are voluntary programs for manufacturers. The FDA is selective on which DTx are eligible for which programs, so getting into these programs means the FDA prioritizes you, which might reduce the pre-market authorization burden, study designs may be more flexible, etc. Even if you are eligible for any of these programs, you still have to go through the regulatory pathways (e.g 510k).
- In Europe, the MDR (Medical Device Regulation) recently replaced the MDD (Medical Devices Directive) which was created 25-30 years ago, when there were no smartphones. With the new MDR, there are specific sections for SaMD and remote monitoring devices (Rule 11 for software in Annex VIII). The EU is moving towards new regulatory rules for SaMD whereas the US is moving more towards the certification of company culture excellence (Pre-cert program).
- Regulatory frameworks for SaMD are a changing landscape and digital health companies should not try to get around regulators but rather engage with them. Early engagement with regulators and having data to support this engagement is key to saving time and resources and it helps in the reimbursement process.
We are running this masterclass again in September, stay tuned! You can see all our upcoming meetings here.
Trial design for digital health products
There are a broad variety of digital health solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to clinically prove their efficacy and safety. How to design trials for digital health tools so that they are rigorously validated and regulated? In this masterclass led by Akili Interactive we learned:
- As a framework to consider study design, we described the following: 1) Descriptive Trials (surveys/qualitative reports) as a means for hypothesis generation; 2) Analytical Trials that are experimental/randomized for hypothesis testing; and 3) Observational analytical trials for the generation of RWE (Real-World Evidence).
- Ideally experimental, hypothesis testing trials should have three arms, two control arms - treatment as usual and an active control. If there is a crossover element to a study, consideration needs to be given to wash out periods and the halflife of treatment effects.
- In relation to Study Participants and Recruitment, along with considerations for representativeness, enriching for responders/compilers is an important consideration for digital therapeutics trials. Allowing for roll over studies should also be considered and used where budget allows.
- There is a balance to be struck between endpoints required for regulatory approval and those that will be useful in the future to convince stakeholders of the utility of DTx. This becomes real as decisions need to be made around sample sizes and how to increase study power. However, the primary focus of the hypothesis testing trial is for regulatory approval and that should be the guiding principle for decisions on endpoints. A further consideration on data being collected is to ensure there is a good reason for collecting the data while simultaneously protecting patient privacy.
We are running this topic again in September, stay tuned! You can see all our upcoming meetings here.
How can pharma use digital education to engage HCPs?
Covid-19 has shaken up the traditional pharma model, leading to the inevitable necessity to use digital tools to have meaningful touchpoints with HCPs. In a masterclass led by Figure1 we learned:
- Time of outreach for maximum impact: the right time is perhaps outside their workday, but there are insights that might be useful at certain points in a physicians’ workflow (before they see a patient, during the patient consultation, or after).
- The shift in focus for pharma (or anyone who creates content targeted at HCPs) should be on how content is created - be genuine, meet them at a peer level.
- Engage in bite-sized content that is targeted, easy to ingest, and give them the answer quickly and effectively, perhaps delivered by a fellow physician.
- Language and communication: If something sounds like marketing jargon, doctors know it! Things that sound more personable are likely to get greater engagement.
- Pharma companies are continuing to use text and stat heavy presentations. While popular and effective two decades ago, this will not engage physicians now.
Learn more about this topic here.