DTx also create a great opportunity for healthcare decision-makers, policy makers, and payers to improve clinical care by integrating DTx into clinical settings. For these reasons, the popularity of DTx products is increasing.
The rapid growth of DTx then raises questions: “How should a healthcare decision-maker or payer decide to use or invest in a new DTx product?”; “How can we evaluate a DTx product to make sure it is safe and effective before integrating it into a clinical setting or recommending it to patients?”
In response, the Digital Therapeutics Alliance (DTA) has taken the responsibility for creating a reliable framework to assess DTx products. The framework is called DTx Value Assessment & Integration Guide.
The DTA guide provides healthcare decision-makers and DTx manufacturers with a common language and set of evaluations to assess DTx products. It also enables clinicians, policymakers, and payers to evaluate DTx products more consistently and confidently across national and local settings.
The guideline is a comprehensive document. In this Sidebar article, we review the DTx Product Evaluation Considerations of the guideline, which covers 18 considerations to evaluate a DTx product. To make it more digestible, we have grouped those into ten sections.
Covering all aspects of the DTA guideline in this short article is not possible. To solve this, we have created a list of questions divided by sections complementing this article, which you can download here. This article and the question list will make it possible for you to evaluate a DTx product more thoroughly and confidently.
DTx Product Evaluation Considerations
1. Product Basics
Digital therapeutics provide patients and clinicians with validated, evidence-based, and targeted interventions to treat, manage, or prevent a broad range of disorders. Evaluating a DTx product begins with a baseline framework that includes the following considerations.
- Name, target health condition, and patient population.
- Product use specifics such as approved indication, therapy duration and frequency, risks, and side effects.
- Product’s function in monitoring, managing, or preventing a disorder.
- Intended environments for starting the therapy and ongoing care.
- Product’s current stage of development, commercialization, and reimbursement.
2. Clinical Impact
Digital therapeutics affect patient care by delivering software-driven therapies directly to patients. They can provide new therapeutic options or support the existing ones for various health conditions. How they fit in the care pathway is then an area for assessment.
The guidelines suggest the following considerations to evaluate the clinical impact of a DTx product:
- Product’s ability to address patients’ needs.
- Product’s relationship with other therapies for a specific disease.
- Product’s position in the current standard of care and its alignment with current guidelines.
- Type of clinical measures used by the product and impact of product-generated data on patients’ treatment progress.
3. Technical Considerations
Digital therapeutics are generally considered medical devices. Therefore, they are subject to a variety of standards and regulations. Understanding the technical aspects of a DTx product will help healthcare decision-makers and product teams optimize a digital therapy for easier and more efficient use.
The guideline divides the technical aspects of a DTx product into product-specific and patient-related. Potential considerations to evaluate the product-specific technical elements include:
- Product’s ability to function as a standalone or part of a multi-product platform.
- Product’s core system to generate the intervention (i.e., static algorithms, artificial intelligence, or machine learning functionalities).
- Built-in processes to prevent bias and manage malfunctions.
- Product’s data infrastructure (i.e., data hosting and access, frequency of system updates, and cybersecurity improvements).
- Entities responsible for and hosting location of data storage.
Considerations to assess patient-related technical aspects include:
- Systems (hardware or software components) required by the DTx product to run the therapeutic intervention.
- Network connection required for the product to function.
- Product software compatibility with mobile operating systems.
- Types of technical support and customer service available to patients and clinicians.
4. Product Usability
Patients may not benefit from the full therapeutic values of a DTx product unless the product is user-friendly and appropriate for their needs. Following usability criteria will help healthcare decision-makers to identify patient populations that may benefit the most from a specific DTx product.
Identifying the appropriate end-user and ensuring they can use the DTx product correctly may improve clinical outcomes, prevent patients’ confusion, and reduce costs. Evaluating product usability includes reviewing:
- End-user characteristics needed for successful use of the product (i.e., language, age, literacy level, disability, and cultural aspects).
- Patient-centric usability aspects of the product (i.e., user-centric design and instruction, usability testing).
- Patient information security and data protection.
- End-user support (i.e., reliable product performance, methods of technical support).
- Type and quality of research done for testing the product design for human use.