Digital therapeutics revealed: evidence-based healthcare solutions

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By 2030, it is estimated there will be a global shortage of 15 million healthcare workers. Alongside a rapidly aging population, disease and outbreak prevention, and other issues, healthcare is in dire need of innovation. 

Digital therapeutics (DTx) takes aim at these massive challenges. By creating new care pathways and approaches to medicine, it will not only alleviate workers shortages but also deliver personalized and effective care to entirely new populations.

These technologies (DTx) may sound futuristic, but they build on technologies that have been around for decades with features like video chatting, remote patient monitoring, and wearable tech, that we’ve all experienced at some point. 

So what are DTx? How will they transform our relationship to medicine? How do DTx providers create effective products? Here’s everything you need to know.

Your DTx questions answered

While digital therapeutics components have been around for some time now, several new factors have created the condition necessary for it to expand rapidly. 

First, the technology behind many DTx solutions has matured enough to where they are more affordable, capable, and patient-centric. With smartphones in everybody’s pocket, delivering DTx is easier than ever. But that’s just the beginning. Artificial intelligence (AI), machine learning (ML), natural language processing (NLP) have also reached the crucial milestones necessary to create digital therapeutics solutions at scale. 

Further, similar to telehealth, digital therapeutics is also capitalizing on skyrocketing demand for contactless care. People are now ready to accelerate the proliferation and adoption of digital therapeutics solutions in ways they weren’t in the past.

What are Digital Therapeutics?

The Digital Therapeutics Alliance defines DTx as the delivery of therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioural, mental, and physical diseases and disorders. 

As a subset of digital health, DTx solutions are often powered by high-quality software, artificial intelligence, machine learning, natural language processing and other health innovations to prevent, manage, and treat medical disorders. 

The specific DTx categorization is nonetheless vital. While many apps and devices claim to deliver improved health outcomes, DTx products, on the other hand, are actually backed by evidence, strive for key KPIs, and have frequently undergone FDA or other forms of regulatory scrutiny.

What is the difference between DTx, digital health and telehealth?

All of these terms are overlapping but don’t necessarily point to the same therapeutic products and interventions. DTx is one category of digital health, which also includes a broad swathe of new digital products and services designed to address a broader set of stakeholder needs across a healthcare ecosystem that includes payers, providers, Pharma, Medtech and distributors.

Telehealth is the means by which you communicate with healthcare professionals. Think of it as the channel that connects patients to providers. DTx also uses many telehealth technologies, including video consultation, messaging, remote patient monitoring, and so on.

How will DTx reshape the lives of patients and the pharamecutical industry?

Since DTx is by-design patient-centric, digital therapy adoption is immensely beneficial for patients. Above all, increased adherence rates are among the most promising advantages DTx provides for patients. 

Healthcare providers know how big a problem this is. In an Annals of Internal Medicine review, researchers found that 20-30% of all medication prescriptions are never filled. In addition, 50% of medications for chronic diseases are not taken as prescribed. This results in an estimated 125,000 premature annual deaths in the US alone. Simultaneously, 33-69% of medication-related hospital admissions are due to poor adherence.

Digital therapeutics adoption delivers two immediate advantages over traditional healthcare to solve these challenges.  First, many of the treatments it promotes are “beyond the pill.” These interventions do not require medication but tap into other areas including health tracking to drive better health outcomes.

Further, DTx can be used to drive adherence through virtual assistants, apps, treatment plans, and more accessible information to facilitate greater patient adherence to medication regimens. 

Digital therapeutics solutions are not only improving patients’ lives, but they are also reshaping the pharmaceutical industry. Bertie Odendaal, Head of Therapeutic Area Transformation and Business Innovation at Boehringer Ingelheim, described how DTx will “provide patients and consumers with broader access to convenient, accessible, evidence-based and personalized therapies largely independent from physical location and help maximize the benefit of conventional drug-based therapies.”  

Through these interventions, Odendall notes digital therapeutics will become an “integral part of future treatment algorithms, clinical pathways and set a new standard in providing individually tailored treatment,” driving improved patient adherence rates. 

At the same time, digital therapeutics create numerous interactions between patients and pharmaceutical companies that previously were impossible. In addition to directly engaging patients, pharmaceutical firms will be able to gather critical data about their products and how they are being used to inform new therapies. This will trigger a wide array of positive health outcomes and innovations, further fueling wide-scale pharmaceutical industry transformation.

Does DTx adoption have any parallels to other industries?

Digital transformation has impacted every industry, but the most parallel example is fintech. App-based banking experiences have almost entirely replaced physical interactions. The experience has been so well designed that interacting with the app is not just more convenient but often easier than similar in-person encounters. 

The result is that people have much more control over their finances. The Newly minted unicorn, WealthSimple, is one such case. Disruptors like these have made it possible for the average person to invest with little to no fees and take advantage of resources that only brokers had access to in the past.  

DTx delivers similar results for healthcare. While they will provide an opportunity for established players to revamp and create new service offerings, it also opens up space for a large number of new entrants and innovations. 

In fintech, many banks were resistant to change and afraid digital transformation would damage their business model. The winners were those who took the risk to adapt. Big pharma, healthcare providers, and other life science players similarly should seize this moment and embrace the opportunities DTx provides.

Which areas in healthcare are most ready for digital therapeutics adoption?

Nearly every healthcare sector is ripe for DTx innovation. However, there has already been significant traction in diabetes, mental health, addiction, MSK, behavioral health, asthma, IDS, and obesity prevention. Many of these play into the core strengths of DTx, which is managing chronic and long term conditions through coaching and enhanced provider-patient interaction. 

DTx also integrates well into existing treatment modalities. It is filling end-to-end cancer care needs by offering a broad breadth of new services, including digital triage, remote patient monitoring, and post-clinical follow-up and evaluation. This role of DTx in cancer treatments demonstrates its flexibility as both a new care modality and supplement to traditional interventions. 

What are some of the most exciting breakthroughs in digital therapeutics?

Most people don’t realize that digital therapeutics have arrived. Some of the most exciting breakthrough people can start using right now include: 

• Virtual Coaches: We all have experienced AI chatbots when seeking help or information about products and services online. Virtual coaches unlock the technology’s full potential by guiding patients through specific programs.
  There are already companies that have integrated voice and avatars into their DTx offerings that are building stronger connections and fuel high levels of interactions with patients. Pay attention to players like Kaia Health, whose products can demonstrate exercises and combine computer vision to give corrective feedback to patients suffering from MSK conditions.

• Chronic condition management: DTx applications for managing chronic conditions, including diabetes and asthma, have made it beyond clinical trials and have been available to patients for a few years. Propeller’s digital platform has improved medication adherence by up to 58%, reducing rescue inhaler use by up to 78%, and asthma- and COPD-related visits and hospitalizations by up to 57% and 35%, respectively.
• Care companions: these apps and devices play a variety of roles throughout the care journey. Cognitive AI technology transforms how people interact with machines to build personalized relationships built on trust. Care companions include digital solutions like Pilo, a care companion with an emotional UI that combines computer vision and voice AI to administer daily medical dosages according to their personal treatment plan.

What healthcare industry obstacles does DTx have to overcome?

The original paper and pencil CBT tools were created decades ago and don’t fit neatly into 21st century life. Having an app which keeps all the CBT effectiveness of the tools but allows for easy in-app use makes a patient much more likely to use them, not lose them, and make progress at a quicker pace.

Chris Mosunic,
PhD, Chief Clinical Officer,  Vida Health

While digital therapeutics will provide undeniable benefits for patients, providers, and payers, it has to navigate serious challenges on the road to universal adoption, such as: 

• Lack of awareness about digital health programs. DTx is in its infancy. While demand is growing, most consumers don’t know that these types of treatment options even exist. Education is essential for spreading the word and showcasing why patients should embrace DTx solutions.
• Data privacy issues. DTx is data-driven. This data is highly personalized, and there is an immense amount of it. With the future of digital therapeutics contingent upon even more data collection, providers need to build solid foundations for ensuring privacy and security now. 
• Regulatory approval.  DTx challenges many of the underlying assumptions about healthcare. While medication follows the USP protocol, there is no global standard for DTx. Even more challenging, since DTx products are so diverse, creating a universal framework for regulatory bodies to evaluate them and administer approval more quickly is likely years away.

How do providers successfully integrate digital therapeutics into the overall patient experience?

Providers must take a patient-centric approach to the design process. Fintech has seen major wins because companies have created intuitive and personalized that fit seamlessly into users’ lives. 

These same lessons are even more vital in DTx products. An attractive design isn’t just for impressing patients. It helps them forget a product is clinical, encouraging them to use it as a health companion rather than a reminder of their condition. 

Concurrently, fueling emotional gains and creating valubale metrics are similarly vital. Measuring and quantifying progress and changes helps create a better understanding of health for users. Digital therapeutics from Big Health like Daylight and Sleepio are particularly successful because these scores are not arbitrary but based on the NHS’s sleep efficiency measures. 

Focus on patient pain points, educate patients on how a product will solve specific needs, and enable them to self quantify. This will ensure products thrive in the long term. 

What are the main principles of building a powerful digital health engagement strategy that drives adoption?

The best summation of principles for building an effective digital health engagement strategy is found in the DTx alliance framework:

Engagement is essential for creating effective DTx products. Jessica Shull, European Lead at Digital Therapeutics Alliance, advised companies “to plan and study your specific patient population, see how they think, listen to them, and involve them. Then a successful patient engagement strategy will evolve.” 

For a global engagement strategy, DTx team should likewise communicate with local and national stakeholders to ensure they are meeting requirements such as interoperability standards, data protection standards while generating trust in the healthcare system.

How can DTx companies create products that fit into provider workflows?

Physician buy-in is integral for any DTx or digital health solution. They are the de facto marketing team for any medical product. While DTx is patient-centric, companies should also focus on the critical physician pain points that their products solve while working toward regulatory approval. 

The voice transcriber tool, Suki, is an excellent example of this. Suki is a machine learning virtual assistant that can help physicians complete notes 76% faster than traditional transcribing with 100% accuracy. This solves a serious challenge for physicians who are time-poor, automatically logging conversations and translating human language into medical language synced to EHRs. This not only gives physicians more time to engage with patients, but also is an excellent foot in the door for DTx companies. 

Simultaneously, for patient-centric DTx products to thrive, payer support is crucial. What do payers want? Payers want the effectiveness of treatment to be demonstrated before the sign-off on any reimbursements. Everything is connected. If DTx companies pursue FDA regulation and consistently demonstrate their product’s ability to deliver positive health outcomes and efficiency gains, they’ll win over physicians who will then recommend them to their patients.

What barriers are standing in the way of large scale DTx adoption?

Put simply, the more data available, the more developers can refine existing products while building better and more encompassing solutions over time. 

The success of DTx largely hinges upon this data. Right now, however, collection is dependent on the user’s willingness to manually log data. Without this, data doesn’t have the integrity it needs it to be useful to DTx providers. 

For DTx to further evolve, users need to be able to log data effortlessly and automatically. This means passive tracking with minimal requirement to manually input data. While it is easy enough for an Apple Watch or Fitbit to count how many steps you take, it’s another story to track blood sugar levels — though products like BlueStar and One Drop are headed in that direction.  

Fortunately, DTx providers are already finding ways to integrate voice to enhance the data collection process. It will soon be possible to interact with virtual assistants like Siri and Alexa to record health information directly. While this won’t be as effective as passive tracking, it does lower some of the current data collection barriers while DTx companies build new data collection tools.

What is the right business model for digital therapeutics?

The biggest question that DTx companies face is whether or not to aim for FDA approval, the path to acquiring it can be complicated, lengthy, and expensive. Many OTC products, like those that treat sleep disorders, don’t necessarily even need approval. Happify has done precisely this and already has tens of thousands of downloads. 

The best long term route to market, nonetheless, is through securing FDA approval. Even Happify, which has been successful, is now seeking clearance through the FDA. This is essential for moving a DTx product from the fringe into the mainstream since it is an integral part of physician buy-in and getting players on board. Without it, a product likely won’t be able to break out of niche ecosystems. 

Rather than seeing it as an either/or question, DTx companies need to understand the regulatory environment from the start and get their products headed down that pipeline as possible. Happify and other DTx companies can serve as an excellent model. Start with an OTC product, continue building and iterating the product, and earn revenue while working towards approval.

How will DTx evolve over the next decade?

Propeller’s sensors attach to a patient’s existing medications and transmit data on medication use to the patient’s smartphone and to the Provider Portal, which can then be used to inform treatment decisions. With this objective data, providers no longer have to rely on patient recall to understand their disease progression. 

David Van Sickle,
CEO and co-founder, Propeller Health

Further voice integration into DTx products will be transformative for building user engagement, and rapport with devices. DTx will not be as tied to screens as it is now as more varied physical devices are released. 

Care companions will continue evolving from virtual assistants into standalone devices capable of serving a range of different needs. Caregiving robots have already made their debut in a range of settings, including in senior assisted living facilities their ability to provide companionship and alert staff of residents in distress will hopefully alleviate some of the daunting medical worker shortage. 

Population health management is another arena in which DTx will be truly revolutionary. With vast amounts of patient data, healthcare professionals will be able to make more informed decisions through improved care coordination and patient engagement supported by new care models. 

There is growing excitement for digital twins. Major players like IBM and Siemens, along with new entrants, will make it possible to create digital replicas of physical options and services. Providers will have digital twins of patients to pull data and use analytics to make predictions about people’s health and the best course of treatment.

These insights can be applied to entire populations to do everything from preventing the next pandemic to modeling giant-scale testing of new medications. 

Countless other applications of DTx will also emerge. Those most finely attuned to patient needs and the challenges providers and players face will define a new era in medical technologies.

Building successful digital therapeutics solutions

Healthcare is changing rapidly. Digital health, telehealth and digital therapeutics create new paradigms and solve some of the industry’s most pressing needs. 

By developing patient-centric, evidence-based and FDA-approved digital therapeutics, healthcare companies will build personalized, adherence-driving medical innovations and establish themselves as market leaders. 

At Star, our strategists, designers, and product managers have deep expertise in digital health and a uniquely cross-market and global perspective that helps our clients build holistic, forward-thinking strategies and products needed to outpace digital disruption.

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