Digital Therapeutics (DTx) is a subdivision of digital health, which represents a collection of technologies, products, and services across healthcare and wellness industries. The term “digital therapeutics” was used for the first time in their peer-reviewed publication, and formally defined it as, “evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of healthcare”.
At-home diagnostics are closely related to digital therapeutics. Although they fall into the medical device category, these devices are not necessarily AI-based and are designed specifically to diagnose potential conditions or diseases.
The Digital Therapeutic Alliance (DTA) defines the DTx as “delivering medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders”. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products are held to the same standards of evidence and regulatory oversight as traditional medical treatments and must demonstrate their safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact. These products should be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy and intended use. Digital therapeutics are software-based medical devices.
Future market rise expectations of Digital Therapeutics:
- In a poll conducted among MedTech chiefs, 63% concurred that digital therapeutics will significantly influence the sector in the coming decade.
- The U.S. digital therapeutics market is projected to experience a compound annual growth rate of 29.8% from 2020 to 2025, as per Frost & Sullivan.
Advantages associated with Digital Therapeutics (DTx):
- Personalized Treatment: Digital therapeutics use data from various sources, including wearable devices and health apps, to tailor interventions to individual needs. This personalized approach can improve patient outcomes and adherence to treatment.
- Integration with Traditional Healthcare: DTx are often used in conjunction with traditional treatments. For example, apps designed for managing diabetes might work alongside medication and lifestyle changes.
- Evidence-Based: Much digital therapeutics is backed by clinical research and is gaining regulatory approval. This helps build trust and ensures that they provide real benefits.
- Cost Efficiency: By enabling remote management of conditions, DTx can potentially reduce healthcare costs associated with in-person visits and hospitalizations.
- Behavioral Health: Digital therapeutics have a strong presence in mental health and behavioral conditions, offering interventions for depression, anxiety, and substance abuse.
Advantages associated with home diagnostics:
- Easing strain on healthcare systems as at-home testing and monitoring becomes more affordable, faster, and more accurate, this can ease pressure on HCPs managing heavy workloads – particularly when it comes to routine testing and patient monitoring.
- Improving and increasing telemedicine many medical appointments are now conducted over phone or video chat, and home diagnostics lets HCPs request tests remotely, reducing the need for patients to visit clinics and hospitals.
- Personalizing patient care home diagnostics improves clinicians’ ability to offer faster and better-targeted medical care and gives patients a more accessible and personalized approach to managing their own individual healthcare.
- Improved patient experience in clinical trials home testing can eliminate the need for time-consuming site visits, reducing the burden on patients who may be either too busy to miss work for appointments, or too unwell to leave home for travel.
- Better patient enrollment and retention in clinical trials making the trial process easier on participant’s increases patient enrollment and retention, reducing the commercial impact associated with patients dropping out of trials.
- Cost reduction in clinical trials with fewer and smaller clinical sites required, it becomes easier and less costly for trials to scale up studies for larger regions and bigger patient pools.
Logistical challenges for clinical researchers
The logistics of implementing at-home testing involve a number of key considerations for clinicians and trial service providers alike, including:
- Getting the right kits to the right patients at the right time at-home testing necessitates careful logistics management, particularly for large-scale studies, that clinicians may lack the expertise to undertake. Working with experienced providers capable of managing quick turnarounds and accelerated timelines will help clinicians deal with these emerging logistical challenges.
- Participant coaching patients need to be guided in how to administer tests and study drugs at home. Clinicians may need to provide in-person or video training, and a clear at-home kit and testing design are needed to make the process as simple as possible for trial participants.
- Tracking and tracing of clinical samples to preserve the integrity of clinical materials, trial sample kits must be properly labeled and assembled, with clear instructions for use and automated tracking to mitigate the risk of human error.
- Inventory tracking in order to manage the supply and distribution of testing and drug administration kits, inventory must be carefully monitored. Use of an external system, such as PASSPORT™ from Avantor Clinical Services, can greatly reduce the logistical burden that at-home testing places on clinicians.
- Preservation of sample integrity through the shipping process kits must be properly assembled to make sure samples are securely packaged for their return, including the option of refrigerated shipping to keep samples at optimal temperature during the journey from home to lab.
- Data and privacy concerns to guarantee patient privacy and data security, labeling and indexing must be carefully managed throughout the shipment, collection, and storage of all patient samples and data, to accurately record the source of such samples, where appropriate, or to anonymize or blind samples in other cases.
Conclusion:
While the term Digital Therapeutic may still be unfamiliar to many, these therapies are here to stay. Digital Therapeutics (DTx) is becoming a new category of medicine, poised to address chronic and other hard to treat conditions. While much work remains for digital therapies to be integrated into and across the traditional healthcare ecosystem, Digital Therapeutics will “increasingly influence the way healthcare is delivered and consumed across the world”.
As Digital Therapeutics (DTx) and at-home diagnostics continue to revolutionize patient care, ensuring compliance with evolving regulatory requirements is crucial. Whether you’re developing innovative digital health solutions or navigating the complexities of In Vitro Diagnostic Regulation (IVDR), expert guidance can streamline your journey.
Discover how MakroCare can help you comply with IVDR regulations and accelerate your digital health innovations today!
