A Primer on Digital Therapeutics Software Testing

What are Digital Therapeutics Companies?

Digital therapeutics (DTx) companies provide software-backed therapeutic interventions to help prevent, manage, or treat a medical disorder or disease. For example, health tech unicorn Hinge Health partners advanced wearable sensors, mobile applications, and a clinical care team to enable digital physical therapy for elective musculoskeletal (MSK) surgeries, driving lower costs and a reduction in medical claims. 

With increased access and convenience, treating conditions through DTx technology offers an innovative and more accessible patient-centered experience. Digital technology opens up care to more people while reducing non-essential in-person visits.

Many digital therapeutics programs provide an app-driven experience with access to clinicians through telehealth or in-person visits, medicine management, and electronic health records. DTx desktop, tablet, and mobile apps address various conditions and diseases, including diabetes, mental health treatment, heart health, sleep apnea, pain management, smoking, obesity management, and more. In addition, digital therapeutics apps are often localized, and offer therapies in multiple languages.

To compare your health, wellness, fitness, and medical app testing approach to industry leaders, please read Testlio’s State of App Testing 2022: Health & Wellness Industry report.

10 Innovative Digital Therapeutics Apps

1. United Health Group offers members Level2, a digital therapeutics platform focused on improving the health of people living with type 2 diabetes. Level2 equips members with integrated tools that include a wearable continuous glucose monitor (CGM), activity tracker, app-based alerts and coaching to help encourage healthier lifestyle decisions.
2. Abbott’s FreeStyle Libre 2 is a digital therapeutics program that pairs a wearable sensor with a mobile application for continuous glucose monitoring to aid patient and care provider visibility. 
3. Merck offers digital personalized fertility treatments for women. Their platform includes testing interactions between a Bluetooth-enabled SmartCap dosage pen that communicates the amount of medicine remaining to the patient’s My Therapy mobile app. This digital therapeutics platform also includes a physician web interface to manage the patient’s personalized fertility treatment and dosage.
4. Cigna-backed Cricket Health leverages technology and a model of care that includes predictive analytics, virtual access to resources, remote patient monitoring, and targeted in-home care for patients with chronic kidney disease.
5. With partners like Bayer, Pfizer, and Anthem, Sidekick Health offers a multi-chronic digital therapeutics platform that addresses 40 areas such as oncology, diabetes, and rheumatoid arthritis. It’s expanding its video-game-like platform to assist in treating people with multiple chronic conditions while offering a care portal for health care providers to conduct remote patient monitoring.
6. Up to 7% of men and up to 5% of women have sleep apnea. ResMed pairs its myAir™ app with its cloud-connected continuous positive airway pressure (CPAP) sleep apnea medical devices. Their online support program and app onboards therapy, tracks progress with a daily sleep score, and provides encouragement to users. 
7. Lark is an AI-powered digital weight loss coach offering programs for diabetes and hypertension. It includes cellular-connected glucose readings, connected devices, coaching, health content, and personal insights. 
8. Pear Therapeutics offers prescription digital therapeutics (PDTs) for treating substance use disorder, opioid use disorder, and insomnia. 
9. Biofourmis offers an end-to-end technology ecosystem for patients that combines AI-based data analytics, medical-grade wearables with biosensors, and companion apps for continuous, real-time monitoring and patient-specific notifications. 
10. Merck Group’s Growlink division offers a mobile app for families whose children are prescribed Saizen human growth hormone treatment. Doctors use their web portal to track patient treatment and progress, and clinics across different countries use an admin portal.

According to Deloitte, the global digital therapeutics market is projected to grow 118% and hit $13.1 billion by 2026, up from $3.4 billion in 2021. DTx is ripe for growth, but regulations and compliance make testing a top priority.

How Does Digital Therapeutics Software Testing Work?

Conducting DTx software testing requires the right balance of automated and manual testing techniques to identify issues with usability, telehealth live streaming, payments, and other functionality that impacts the patient experience.

DTx testing success criteria and goals typically include improving overall app quality, reducing testing time, and increasing software engineering capacity. Hence, developers have more time to do what they do best – write code and ship new products, features, and updates.

DTx applications often link to medical devices and sensors, offer telehealth video and chat capabilities, and include a self-service educational library of videos, audio, and articles. These unique features require thoughtful testing to prevent escaped issues. In addition, digital therapeutics platforms often support dual audiences. Using two-sided coverage validates the functionality and experience for both patient end-users and medical providers.

Seven common test areas for DTx app and medical device testing: 

1. Sign-in / authentication
2. App updates and functionality 
3. Medical device install instructions
4. Medical device sensor connection
5. Medical device functionality
6. Self-service educational library playlist for video, audio, and text
7. Telehealth streaming video to monitor, test, and validate all app functional and design implementations

What are the Challenges to Digital Therapeutic Software Testing?

According to the DTx Alliance, digital therapeutics are held to the same regulatory oversight as traditional medical treatments and must demonstrate similar levels of product safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact.

In the U.S., the FDA launched a digital health pre-certification program that enables the FDA to approve the development of digital health platforms. While the intention is to streamline innovation, these programs and regulations focused on safety and compliance also require medical applications to follow more rigorous testing processes within their clinical trials and software testing initiatives. 

Another hurdle for healthcare offerings is around software testing capacity. It isn’t easy to hire or secure experienced QA talent in suitable locations with a mix of device types.

According to Testlio’s 2022 Health & Wellness software testing benchmark report, medical device offerings release less often than their App Store and Google Play peers in health, fitness, and wellness genres. Each test run requires more testers and coverage on a more comprehensive volume of devices/OS.

The report found that medical applications often associated with digital therapeutics leverage a tester pool size of 61 testers and test on an average of 118 unique device/operating system combinations. 

An efficient approach to testing must also leverage the efficiency of test automation and quality engineers. Automated testing helps mitigate the tensions between quality, speed, and coverage, yet the quality engineers needed to run those programs are difficult to hire, with 64% of DevOps teams indicating they can’t find enough talent. 

Challenges aside, testing digital therapeutic devices and applications offers many benefits. 

What are the Benefits of Digital Therapeutic Testing?

The number one priority for digital therapeutics testing is patient safety. With digital health care providers and applications focused on chronic disease management, testing could be the difference between life and death. Software testing ensures digital therapeutic platforms, apps, and medical devices work together as intended. Software testing also supports the results from clinical trials.  

Due to compliance and significant regulatory pressure, many medical apps release less often than Health & Wellness applications. Even with fewer releases, digital therapeutics apps with a regulated medical device component can maintain full coverage by assigning more testers with unique devices in multiple locations per run.   

In addition, experienced testers can serve multiple roles to ensure the end-to-end experience is functional for all user groups (think patient or provider, medical admin, insurance). They triage high-priority bugs most likely to impact the end-user experience and provide nuanced insights to enhance user stories and test cases with those sub-groups in mind.

Speaking of user experience, low app store ratings raise user concerns about your ability to deliver on expectations. Moreover, tighter app store quality standards and competition for application discoverability further emphasize the importance of ratings. Solving testing coverage bottlenecks helps to accelerate development, improve technology investments, and provide better experiences. Better experiences equate to higher app store ratings that drive future engagement and revenue.  

An optimized software testing model helps development teams gain efficiencies and release better products more confidently. For example, manual testing with real devices is a low-cost way to test and maintain app vitals like functionality, usability, accessibility, and payments. Adding automated testing to the mix increases speed and overall engineering efficiencies. By fusing manual and automated testing, engineering teams accelerate their ability to build, test and release.

The result? Clean, functional, and usable products released to production offer a better end-to-end experience, impact app store ratings, reduce churn, and enable revenue growth. In addition, software testing supports your compliance efforts and may parallel your use of digital health technology for clinical trials.

What Steps are Involved in Testing Digital Therapeutics Platforms? 

Testing digital therapeutics software takes many shapes. Although simplified, here are ten common steps involved in testing DTx applications: 

1. Identify a testing need.
2. Build an in-house, outsourced or crowdsourced testing team of both QE and QA talent. 
3. To align with HIPAA compliance and other regulatory bodies, identify experienced testers that match your patient or clinical trial subject profiles. 
4. Prepare test cases and upload builds to test run.
5. Integrate software testing tools for both manual and automated testing to work in unison.
6. Ship medical devices/wearables/sensor kit to testers (e.g., a glucose monitoring sensor automati­cally measures and continuously stores glucose readings that feed to a mobile application; a sensor that connects to a patient’s inhaler to track asthma medication use and trigger personalized feedback). 
7. Activate the test run and generate a report based on the completed test cases.
8. Review issue report for clarity, validity, and scope before approving or rejecting issues. 
9. Submit a test end report and solicit feedback and suggestions for improvement.
10. Evaluate test cases, test strategy, and tester performance for continuous improvement. 

Conclusion: Why You Should Start Using DTx Testing Today

Today, the new normal for patients, providers, and payors is a consumer-like “digital front door” that delivers a high standard of care on familiar devices throughout the health care experience. As a result, digital therapeutics companies that combine wearables, web and mobile apps, and in-person care will continue to differentiate and capture market share. 

The use of digital technology reduces costs, increases value-based care, improves patient satisfaction, and serves as a competitive differentiator for providers, payors, and clinicians. However, like the impact on care due to a shortage of nurses, the scarcity of tech talent impedes innovation for traditional health care organizations. 

To learn how to scale your testing and compare your testing approach to your peers, please read Testlio’s Health & Wellness Industry State of App Testing 2022 report.