First Burst of Digital Therapeutics

Industry leader, Eddie Martucci has described digital therapeutics as "...something that is digital or software by nature; that engages a patient, and by virtue of the mechanics of the software can by itself and in combination with something else lead to clinical outcomes". Digital therapeutics is still in its infancy, as it jostles for its spot in the sunlight within the medical field. Examples of digital therapeutic solutions can include: digitally enabled drug delivery, software driven behavior modification, and digital products that directly activate physiology with the purpose of achieving outcomes. Pear Therapeutics' Chief Commercial Officer, Alex Waldron, defines his vision of digital therapeutics as being a field that will include randomized controlled trials, Current Good Manufacturing Practices, well implemented quality management systems, and the vouch of approval from a regulatory body. Digital therapeutic solutions should also be defined by their ability to to provide measurable and economic benefits to payers. This is not to say that progress in the field will be solely driven by financial means; but the truth stands that payers will only invest in products that offer them benefits. And more times than not, the sought benefits are financially based.

Barriers that trailblazers of digital therapeutics are facing include: (1)Lack of clear definition of which products can be considered digital, as opposed to some other kind of health technology. (2)Costly and time demanding clinical trials. (3)Public payers are difficult to coax into investing due to the fact that Medicaid and Medicare do not currently offer reimbursement for digital therapeutic solutions.

Digital health solutions companies across the country are involved in the arduous process of validating their solutions and products through approval from the FDA. Companies are seeking validation from the FDA so that their solutions and products will be able to claim equitable effectiveness with more well known treatment options. Thus, opening the doors to gaining consumer trust and improved access to use in clinical care. Jo Masterson, cofounder of 2Morrow, spoke on the precarious situation that many companies and innovators have found themselves in. The situation being, that multi-year trials are not suitable options. With the rapid progression of technology, by the time that data from multi-year are available, the technology that was vetted will be outdated. Technologic breakthrought occur months at a time. Having to delay progress while trials occur does not corrdinate with the time table that the rate at which innovation is occurring. Some innovators have opted to focus on marketing and disseminating their health solutions to as many end users as possible in order to collect data and correspond with future partners. There by, attempting to forgo the process of wading through clinical trials.

Digital therapeutic innovators will be put to the test as they attempt to engage the medical industry. Advertising products/solutions and gaining platform validation amongst multiple digital therapeutic comapanies will be one of the most difficult tasks. Comapnies are also currently devising strategies to develop a myriad of digital solutions that are trusted, accessible, cost effective, and effecacious. If multiple comapnies can succeed in doing this within the next few months, the accomplishment will be one of the largest steps toward shifting digital therapeutics from a compilation of novelty technolgies to a comprehensive sub-field within the field of medicine. Aside from everything else, fffectively engaging the medical industry will nessecitate the ability of the solutions to prove that they can contine to improve through time and application. Payers will need to be assured that such solutions will reduce costs, remove framentation from systems, and improve the experiences of end users.