Over the course of last year, MDX had the privilege of working on a potentially groundbreaking digital therapeutic product. We decided to distil what we learned and observed in the process, with the hope of continuing the discourse on an ethical, impactful, and human-centric future for digital healthcare. If anything in this article resonates with you, surprises you, or sets off alarm bells then please—get in touch. We'd love to hear from you.
The potential is huge
At the risk of beginning with the obvious, the impact of digital therapeutics might be greater than it seems. Beyond availability and overburdened staff, no small issue in its own right, digital therapeutics offer two key opportunities for impact: access to care and repeatability. The ubiquity of the smartphone is far greater than that of high-standard healthcare, particularly in disadvantaged or remote communities, to name just two instances. Digital therapeutics bring the care to the patient, and by their nature offer an identical standard of treatment to every user. But the level of responsibility this places on those creating the products is as high as it sounds—the development of a digital therapeutic is not to be taken lightly, as our next insight discusses.
Digital therapeutics are not your average 'wellness app'
It is important to note that we are referring specifically to a product in the regulated medical space, to be prescribed by a healthcare professional, and not something that a user can simply download from the app store on a whim. Such apps are practically unregulated and with only a very loose scientific basis drawn from a single, non-peer reviewed source, often orchestrated by the app creators themselves.
In one study, out of nearly 1000 apps reviewed for the key word depression, only three included full citations to a published scientific study as a basis for their content. In addition, a large number of apps becoming unavailable even inside of the study period, raising critical questions about reliability and legitimacy of such environments as a general app store for serious healthcare endeavours. This presents a huge challenge in a booming 'wellness' scene with potentially disastrous consequences.
The alternative can of course be daunting: not only long, complex regulatory processes, but a need for robustness even in the MVP that stands up to clinical scrutiny and delivers a medically viable impact on the targeted conditions of the patient. In terms of founding teams, it is not for the faint of heart. It requires a strong nerve, perseverance and laser focus on the outcomes, as well as the ability to masterfully identify what is and isn't needed for your MVP to succeed. Nevertheless, we found that some of the wherewithal to ride the storm in this process comes from the very field itself, as we discuss below.;
Clinical mindset drives product vision
Who are we helping with exactly what symptoms, and what is the specific impact of our product? These questions need to be answered in order for any medically regulated digital therapeutic (in fact, for any therapeutic full stop) to end up in circulation; it is an inherent and essential part of the clinical trial and regulatory process.
To those working in the digital product space, these questions might sound familiar. They overlap rather perfectly with something that many start-ups and innovators struggle with today: setting a clear product vision. Knowing who to cater to and what to build first is an age-old struggle, but a clinical environment—defined by its rigour and precision—can be a great platform and catalyst for getting a product off the ground. What may feel like a constraint or a barrier might instead be a blessing for digital therapeutics, requiring clear focus and intention in product creation from the very start.
Patient-centric = human-centric in digital therapeutics
Let us pick back up on a point from earlier in the article. "Digital therapeutics bring the care to the patient". From a medical perspective, this ultimately means we are changing the clinical environment. Whilst the digital environment itself can be meticulously crafted, the context in which it is used cannot. Is the patient using their digital therapeutic app between breakfast time and taking the kids to school? Do they have to fit their session in between two shifts at different jobs? How stressed or concentrated are they? How can we offer enough flexibility to fit into their schedule without adversely affecting the efficacy of the treatment itself?
This is as much about expectation management and engagement as it is about the therapeutic protocol. How can I strike a balance between a delightful product experience, but still make it clear that this is something to be taken seriously, and completed with regularity and attention? And perhaps most importantly: what is it not? What should I not expect from my digital therapeutic and how should I think about whether or not I am doing 'well', whether or not it is 'working'?
In an age of doomscrolling and dark patterns, it is of extreme ethical importance to employ our expert knowledge of digital products in a way that serves the patient, not the product. Even something as simple as showing data on a patient's progress is not to be taken lightly. What data is genuinely valuable to their progress? What data could start to negatively shape behaviour, influence outcomes, or create false expectations of the role of the therapeutic itself? Defining what the product is and what it is not, and ensuring that this is clearly embodied within every design decision, is paramount as we enter a new paradigm of healthcare…
They will not replace your doctor
As the digital healthcare space continues to grow rapidly, whether that be telehealth (remote consultations) or digital therapeutics delivering the treatment themselves, we must view the developments in the context of the wider healthcare system. The goal is not to replace all healthcare treatment with a digital therapeutic—that would most certainly not succeed. But the potential for knock-on impact on the healthcare system—cost, time, strain—is gigantic, even with the more limited, diligently selected and rigorously examined use cases that are being brought into being today.
For the front-runners and trailblazers, navigating that change will be an additional part of their challenge. There will no doubt be missteps and readjustments based on the realities of healthcare on the ground vs. in theory, but the potential payoff for those first movers is an attractive prospect.
Data ethics and trust must be in your DNA
It is in this sort of 'gold rush' era, however, that mistakes can be made which take the industry as a whole a significant amount of time to recover from. Privacy and trust around the collection and use health-related data will only intensify an already ever-present discussion. Distrust and suspicion has grown amongst the general public regarding the handling of their personal data by technology firms, ultimately shaping behaviour around product loyalty and usage patterns.
The dystopian vision painted—with good reason—by many with regards to a fully digitised healthcare service is not to be ignored. Those companies at the forefront of digital healthcare should be as concerned with setting an example for ethical, accountable and extremely robust handling of personal healthcare data as they are with building a great product. This means participation in and contribution to the establishment of legally binding frameworks and technical standards for the generation, handling and storage of healthcare data. As is the case with many other technology ethics conversations, the question is not only if we can, but if we should.
Let's build it
We are delighted to have taken part in the developments in this space, and greatly encouraged by the wide number of brilliant, driven, diverse and dedicated people we encountered along the way. We think the future for digital healthcare can be bright indeed—but it's on all of us to make it happen!