The emerging trend of Digital therapeutics (DTx)

Digital Therapeutics (DTx) is an emerging field of healthcare that utilizes technology, such as software, mobile applications, and wearable devices, to diagnose, treat, manage or prevent various medical conditions. DTx offers innovative solutions to healthcare by leveraging technology to improve patient outcomes, increase access to care, and reduce costs.

DTx products incorporate advanced technology best practices relating to design, clinical evaluation,?usability, and data security. They are certified or cleared by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.

Digital therapeutics empower patients, clinicians, and payors with intelligent and accessible tools?for addressing a wide range of conditions through high-quality, safe, and effective data-driven?interventions.

How Are DTx Products Different From Wellness Apps?

Per industry standards, digital therapeutic products should adhere to these foundational principles:

1. Treat, manage, or prevent a disease or disorder.
2. Produce a medical intervention that is driven by software.
3. Incorporate design, manufacturing, and quality best practices.
4. Engage end users in product development and usability processes.
5. Incorporate patient privacy and security protections.
6. Apply product deployment, management, and maintenance best practices.
7. Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals.
8. Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use.
9. Make claims appropriate to clinical evaluation and regulatory status.
10. Collect, analyze, and apply real-world evidence and/or product performance data.

The clinical trial framework of a DTx follows a similar process as traditional pharmaceutical clinical trials, but with some key differences. DTx clinical trials require a thorough evaluation of the software’s efficacy and safety, including user engagement, usability, and privacy protection. Clinical trials must also demonstrate the software's ability to improve clinical outcomes, such as reducing symptoms, improving quality of life, and reducing healthcare costs.

The main outcomes delivered by DTx that must be evaluated in a clinical trial include:

• User engagement and adoption
• Clinical efficacy, such as symptom improvement or reduction of medication usage
• Usability and safety, including privacy protection
• Health economic outcomes, such as reduction in healthcare costs or improvement in quality of life

The DTx market is expected to grow rapidly in the coming years, driven by increasing demand for digital health solutions and advancements in technology. According to a report by Grand View Research, the global digital therapeutics market size was valued at USD 1.1 billion in 2020 and is expected to reach USD 6.2 billion by 2027, growing at a CAGR of 29.5% during the forecast period.

To scale a digital therapeutic, that depends on doctor prescription and patient trust, the following steps can be taken:

1. Build Clinical Evidence: Conduct large-scale clinical trials to demonstrate the effectiveness and safety of the digital therapeutic and provide evidence for its efficacy.
2. Develop Strong Partnerships: Partner with healthcare providers and institutions to promote the use of the digital therapeutic and educate providers and patients on its benefits.
3. Address Regulatory Challenges: Work with regulatory agencies to ensure that the digital therapeutic is approved and reimbursed in a timely and cost-effective manner.
4. Educate Providers and Patients: Invest in education and outreach programs to increase awareness of the digital therapeutic and its benefits among healthcare providers and patients.
5. Foster Collaboration: Collaborate with other digital health companies and industry organizations to promote the broader adoption of digital therapeutics and build a supportive ecosystem for the field.
6. Address Technical Limitations: Invest in the development of user-friendly software and hardware to ensure that the digital therapeutic is accessible and usable for a broad range of patients.
7. Foster Trust: Ensure that patients' personal and health information is protected through strong privacy and security measures, and be transparent about data collection and usage practices.

By taking these steps, a digital therapeutic can build a strong foundation for scaling and increasing its reach and impact.

One of the key organization helping to define and organise this new trend in healthcare is the Digital Therapeutics Alliance (DTA) is a non-profit organization that aims to advance the field of DTx and promote the responsible development and adoption of digital therapeutics. The DTA aims to establish standards and best practices for DTx, promote collaboration between stakeholders in the healthcare industry, and advocate for the adoption of DTx in healthcare. The organization also provides resources and educational opportunities for healthcare providers, patients, and industry professionals to learn more about DTx and its potential impact on healthcare.

In conclusion, DTx is an emerging field of healthcare that leverages technology to improve patient outcomes and reduce healthcare costs. Clinical trials for DTx must demonstrate the software's ability to improve clinical outcomes, user engagement and adoption, and safety. The DTx market is expected to grow rapidly in the coming years and the average pricing of DTx products varies depending on the type of product, target population, and target indication.

Tech2heal is currently developing a DTx in mental health called Qookka . Designed by Docteur Elisabeth Pakin , Quokka adresses the patients with anxiety and depressive disorders and is a blend intervention based on ACT therapy and Non-pharmacological interventions.