At this moment, advances in modern technology are contributing to paradigm shifts in almost every major industry category in the world. However, not all of these revolutions are given the same press and publicity.
One of today’s most significant emerging categories is digital therapeutics (DTx), yet most people who aren’t involved in the healthcare field most likely have never heard of it. Regardless, the lack of notoriety does not diminish the category’s impact and the promise it holds for the future of medical care.
In this blog, we’ll discuss the background of DTx, the current state of the category, and how Freespira is taking a unique approach to DTx that offers some significant advantages.
Digital Therapeutics Defined
A significant trend in the healthcare field is the emergence of DTx, a category poised to revolutionize healthcare as a whole. According to the Digital Therapeutics Alliance, a leading trade association in the DTx category, DTx is best defined as “evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a disease or disorder.” A DTx solution often works by having a patient adhere to a specific protocol, which is a proven and sometimes individualized plan of attack for treating a disease or disorder.
In most cases, DTx is made possible through software applications, such as smartphone apps or websites, that enable users to receive real-time clinical treatments without the need for immediate access to a professional. Recipients of DTx follow protocols on their own and are expected to adhere to schedules without assistance from medical professionals. From here, data about a patient’s adherence to the protocol and other relevant information are shared to the cloud, where service providers and medical professionals can monitor a patient’s progress and intervene as necessary. Thus, the goal of DTx is to optimize patient care and health outcomes in a way that is more accessible, democratic, and effective than traditional treatments.
Currently, DTx solutions treat a vast array of diseases and disorders, but behavioral health conditions—such as anxiety, depression, posttraumatic stress disorder (PTSD), and attention-deficit/hyperactivity disorder (ADHD)—have gained the most traction. There are two types of DTx products: One is a smartphone application that provides treatment programs that are unlocked on an individual’s own phone or tablet. The second is a software/hardware combination system that is shipped directly to the patient and has software embedded in the smartphone or tablet. An example of a software app includes a video game that helps teach ADHD patients techniques for maintaining focus through a series of treatments that guide the patient. An example of the software/hardware combination would be guided breathing exercises that train the patient on developing new breathing habits to help mitigate the effects of anxiety is one example of a DTx solution..
For these types of conditions, DTx treatments are used independently or in conjunction with medications and/or other therapies. Many DTx are recognized as medical devices; therefore, they are highly regulated, peer-reviewed, and only received through prescriptions from medical professionals.
Industry Standards and Shortcomings
Today, several different approaches to DTx exist, but most companies and cases take the same form. Usually, the relevant DTx company develops its custom app and treatment protocol for a given disorder/disease. When the DTx solution is prescribed to the patient, the patient visits the DTx company website, finds the instructions, and downloads the related software to their own device (smartphone or tablet). From there, the patient is expected to follow the schedule and protocol as defined by the company until completing the treatment.
There are several apparent shortcomings to this approach.
- First, the relationship between the DTx provider and the patient is not cohesive. The patient is expected to take full responsibility for the treatment, completing the time-consuming and often confusing steps of installing the necessary software and following protocols. A particularly concerning aspect of this scheme is that it assumes that patients will have access to smartphones, computers, or reliable internet connectivity, which is not always the case. In a way, these schemes, which are meant to make healthcare treatments more accessible, neglect people without access to technology.
- Another challenge with this scheme is that no foolproof way exists to ensure that the patient performs the exercises as prescribed. Current DTx software tracks user adherence (i.e., tracking if the app is opened daily and for how long) but cannot accurately track how well the user follows instructions. While these data offer some value, it is simply not enough to ensure maximum benefit to the patient.
All in all, truly unlocking the potential of DTx requires a means of having more direct insight into a user’s experience.
Freespira’s Unique Approach to Digital Therapeutics
Whereas most DTx companies simply provide patients with software, as described above, Freespira takes an alternative approach.
Freespira directly provides patients with all the hardware and software necessary for their treatments. When a patient is prescribed treatment, Freespira ships that patient an off-the-shelf tablet, which comes preloaded with Freespira’s app and all other necessary software for Freespira’s protocol. This tablet is configured through an MDM solution to be “locked-down” and is only able to be used for the Freespira treatment.
Additionally, Freespira is unique in its use of custom hardware to monitor patients’ DTx exercises. Along with the tablet that Freespira ships patients, Freespira sends its custom-made exhaled carbon dioxide (CO2) monitoring sensor for use in treating PTSD and panic attacks.
The patient keeps the hardware for the duration of the treatment and sends it back once the treatment concludes. Freespira receives the equipment from the patient, cleans and disinfects it, updates the software or the firmware as needed, refurbishes/repairs the device as needed and prepares it for the next patient.
The sensor samples the user’s breathing through a small cannula, measures exhaled CO2 and respiration rate, and then transmits this data by Bluetooth® wireless technology directly to the tablet running Freespira’s app. On the app, users see a real-time display of their own physiological parameters. The protocol, which is built into the app via voice and written prompts, guides patients based on these data, ensuring that they breathe synchronously with rising and falling audio tones and that they are inspiring the correct volume of air to keep their CO2 levels in a normal range. Patients are also assigned a dedicated health coach who works with them over the course of the four-week treatment. Coaches can view the patient’s treatment sessions, which enables them to provide specific, informed guidance and leads to protocol adherence typically greater than 70 percent.
By taking this approach of directly supplying the patients with the necessary infrastructure for their treatments, Freespira is able to simplify the patients’ experiences significantly, which undoubtedly leads to greater adherence, greater ease of adoption, and better results overall.
Patients can learn exactly how to perform their exercises in such a way that, when the treatment concludes, they can continue to replicate the exercises successfully on their own. In fact, Freespira’s data have shown that the positive impact of Freespira’s protocol remains tangible for more than a year after treatment ends, mostly owing to the efficacy of Freespira’s hardware-based approach.
To further bolster this claim, a recent U.K. study of Freespira’s protocol considered whether it was possible to improve patients’ symptoms by having them follow the exercises without the CO2 feedback. The study showed that the treatment was not nearly as successful, proving the value of custom hardware, physiological sensors, coaching, and patient engagement in DTx solutions.
DTx is one of the most important emerging industries in the healthcare field. Yet, as the category gains more traction, many challenges remain to be addressed before it can reach its full potential.
Today, concerns about access to technology, patient oversight, and the lack of physiological feedback are all outstanding issues for many solutions in the category. Freespira aims to reduce those barriers by developing and deploying custom hardware solutions and directly providing patients with all of the technology they’ll need to have success with Freespira’s protocol.
By solving these challenges, Freespira’s hopes to enable a future where DTx is an instrumental part of medicine.
Simon Thomas is President of Freespira. He is a proven leader with experience developing and bringing to market powerful new medical devices and treatments. Simon joined at Freespira’s founding and in the years since has led product development, clinical studies, quality, biostatistics, finance, operations, and regulatory approvals, including the company’s two Food and Drug Administration clearances. Before Freespira, he led engineering, research and development, QA/RA and operations for a number of successful medical technology companies.