The digital therapeutics (DTx) market is rapidly evolving. New regulations, like the European Medical Device Regulation (MDR), mean significant resources and expertise are required to launch and run Class II medical devices. Regulatory approaches around the world are increasingly diverging, making global ambitions tougher and more expensive to implement. Last but not least, users - meaning patients, doctors, and nurses - are ever more unforgiving when it comes to bad user experience (UX). And without user acceptance, it will be hard to deliver meaningful outcome impact.

Digital therapeutics platforms promise to solve this challenge. At smartpatient, we operate MyTherapy, an 'Operating System for Digital Therapeutics'. Large entrants with global ambitions can benefit from such platforms thanks to faster product development, easier regulatory submission, a faster gathering of clinical evidence, and economies of scale in DTx operation.

While often smooth in their early days, platform partnerships can become challenging, in particular, when things go well: Scaling to additional regulatory environments brings new technical and regulatory requirements, which can be difficult or impossible to fulfill if not planned for from the outset. Also, there have been cases where platform providers started to compete with their former principal once the product-market fit was validated.

Does this mean that digital therapeutics platforms are a strategically risky choice? Certainly not. However, we see five questions that pharma should be asking to ensure they choose the best platform upon which to develop their digital therapeutics.

1. Can the platform reliably cut time-to-market without cutting corners?

Time-to-market is usually of critical importance for digital health projects. Still, when building digital therapeutics from scratch, some activities take their time: User retention requires a smooth user experience, which typically not only needs an experienced design team, but also rigorous testing and countless iterations. Cutting corners during this process will most likely have its price in terms of efficacy.

Similarly, building technical documentation that lives up to ISO 13485 (Quality Management for Medical Devices) is important, but not enough. From the outset, the documentation needs to be modular and development standards should anticipate the coverage of additional regulatory environments. Otherwise, time-to-market today comes at the expense of time-to-market during roll-out.

As damaging as delays are, however, releasing a digital therapeutic that does not deliver on its outcome promise or does not live up to safety standards risks doing permanent damage to its credibility in the eyes of HCPs and patients, if it ever even makes it into their hands.

Choosing the right platform means that development time can be spent on the specific value driver of your DTx, rather than getting UX or regulatory requirements right. We have gone through over 300 releases of MyTherapy to reach the stage where we can confidently assure prospective partners of what they will get.

2. Is the platform accepted by patients?

For any digital therapeutic, the true test of usability and functionality is whether it is accepted by patients. Going through 300+ iterations is one thing, but being able to show the resulting impact in terms of active users and engagement is what really counts.

The efficacy of digital therapeutics tends to rely on their ability to enact behavior changes, such as improving medication adherence, effective self-care, or lifestyle improvements, which can only be achieved by engaging patients.

Additionally, this engagement needs to be sustained over time if the effects are going to provide long-term health benefits. MyTherapy has built up a user base that is now counted in the millions, earning exemplary levels of satisfaction. While each DTx requires a unique approach to individual elements, embedding them in an environment with several touchpoints a day can be a valuable tailwind.

3. Is the platform scalable and able to fulfill our global ambitions?

Pharma companies tend to think globally, as must their partners. The investment required to develop a digital therapeutic is going to generate a far more attractive return if the possibility to expand to markets around the world – either at launch or further down the line – exists.

When selecting a platform provider, DTx innovators need confidence that this scalability exists. This scalability comes down to more than simply translating a product into a given language: Tech-wise, documentation-wise, and process-wise, it requires the possibility of catering to market-specific requirements.

At smartpatient, we have used MyTherapy to deploy partner products to over 25 markets, gaining the experience required to work with players who operate on a truly global scale.

4. How does the platform integrate with physicians’ workflows?

In our discussions with physicians, it is apparent that the last thing they need is to have to log into an entirely new system to access information and data collected from digital therapeutics.

The majority of healthcare professionals appreciate the theoretical benefits of digital health solutions - and COVID-19 has for sure had a role in this - but insist that for them to be truly effective they must integrate with existing workflows rather than being disruptive.

If a digital solution contains a chatbot, for example, that patients use to describe how they are feeling and any side effects they are experiencing, the data they enter can trigger several actions. One might simply be the automated delivery of self-care contents. Other inputs, though, might trigger the need for a physician’s involvement. How easily and quickly can the physician access the information that triggered this escalation? Is it available in the patient’s electronic health record? How does this work across different EMR vendors? And how does it work for doctors who cannot or do not want to have this digitally?

The nature of the integration might depend on the scope and functionality of individual digital therapeutics, but it is a question that needs asking. A lack of integration with physicians’ workflows will undoubtedly reduce adoption rates, regardless of how well the digital therapeutic performs in other aspects.

5. Are we strategically aligned and do we own our strategic control points?

Should a platform provider satisfy the aforementioned questions and a partnership with pharma is on the table, details regarding strategic control will need to be addressed for an agreement to be reached.

In recent years, several such partnerships have broken up or been restructured as time passes and differences or conflicts of interest emerge. Although creative partnership models are helping address the issue of longevity, as we discussed in our roundup of eyeforpharma 2020, pharma must ensure it can retain ownership of strategic control points should there be a need to part ways.

In our experience, there are three main control points to consider:

Intellectual Property (IP): Unlike traditional therapeutics, a DTx cannot typically be protected through patents. For pharma, that makes ownership of IP and agreements relating to trade secrets particularly important.

Portability: Relying too heavily on a platform provider can cause headaches for pharma down the line, should the need arise to change partners, or partner with another firm to release a DTx in a particular market. If you are relying on the host platform’s medical device certification, for example, it can mean needing to gather clinical evidence from scratch to be able to re-register a medical device on a new platform, which can take years.

Customer access: Who should be in control of delivering a DTx to physicians? Some platform providers aim to take charge of customer relations, claiming the approach will help improve adoption and drive distribution. That may be true, but it puts an awful lot of control into the hands of platform providers, who can pick and choose which DTx to promote to physicians the most heavily.

We discussed the importance of pharma maintaining ownership of strategic control points in more detail in a previous blog post, which you can read here: Partnering in Digital Therapeutics: 3 Control Points You Should Own

A Platform Trusted by the World's Leading Pharma Companies

At smartpatient, we leverage MyTherapy, the world's fastest-growing medication and disease management app. We combine MyTherapy's outstanding user engagement and or ISO 13485-certified processes into an 'Operating System for Digital Therapeutics'. We use this operating system to offerings for leading pharmaceutical companies such as Novartis or Merck. Our partners benefit from exceptional usability, engagement, and patient adoption whilst cutting time-to-market and bringing all necessary capabilities. If you want more information about how we can do the same for your company, please don’t hesitate to reach out.