Today, the smartphone is less a communication tool and more a computerized personal assistant, helping us manage everything from scheduling to navigation and banking. It should come as no surprise, then, that many are now looking to bring the power and convenience of these devices into the healthcare field, seeking new ways to bring high-quality care to patients no matter where they may be.
Digital Therapeutics, often known more simply as DTx, refers to a class of therapies filling the gaps between traditional healthcare and the modern, personalized lifestyle management we already employ each day, focusing on the use of digital solutions to collect diagnostics, administer treatments, and provide health management assistance. Propelled forward by intensely amplified demands for at-home healthcare following the outbreak of COVID-19, this field is an already sizable and rapidly expanding segment of the medical technology market and the site of some of its most cutting-edge offerings.
Yet, as exciting as the future of digital healthcare may be, it remains a relatively new area of interest and, as such, comes with many unique, unfamiliar challenges to be encountered when developing within it, including concerns over the collection of data, the definition of usage models, and presentation of health claims, among many others. To further complicate matters, the waters of digital healthcare have been muddied by a consumer healthcare market left untouched by regulatory bodies for too long, meaning developers in DTx must be particularly attentive while designing, testing, and commercializing their solutions.
Fortunately, with nearly three decades' experience bringing medical technologies to life across a wide range of specialties, MIDI is well equipped to guide emerging DTx technologies' development through the turbulent waters of this pioneering field. In the newest MIDI Innovation Vault series, we will explore this new world of personalized treatment entirely, tracing its evolution from primitive remote monitoring technologies to the new world of customized treatment we know today, diving deep into the challenges uniquely tied to it and the new business opportunities created by it.
First, it is essential to establish that, although one may be tempted to think of the Fitbit and other such devices when discussing digital therapeutics, proper DTx solutions are entirely distinct from consumer healthcare products. Where the latter takes a role in improving the overall status of health from a general standpoint, digital therapeutics are directly tied to clinical treatment and specifically claim to drive clinical outcomes. Still, it is a simple misconception; those digital therapeutics include an extensive selection of devices and platforms, including apps and wearables, so it can often be difficult for consumers to tell the difference. For this reason, developers of DTx technologies must be cautious in establishing the exact clinical claim they intend to present. Within DTx, these claims can fall under one of three categories.
- Digital Services: Digital therapies that serve to modify patient behavior while claiming no specific therapeutic benefit.
- Adjunctive Digital Therapeutics: Therapies used alongside traditional techniques to improve clinical outcomes, such as an adjunct to medication.
- Digital Drug Replacements: Digital therapeutics are intended to replace traditional therapies that provide clinical benefits due to the application of technology.
With hundreds of thousands of digital health applications and products already available on the market with no evidence to back their claims nor body to hold them accountable, developers must be aware of potential consumer skepticism and carefully avoid being lost in the lurch of a crowded market boom. At the same time, they must also consider the novel challenges that emerge at the intersection of personal healthcare, regulatory oversight, and commercial service. As such, this series will propose strategic questions to organizations looking to develop and launch DTx solutions designed to assist them in realizing the actual potential value of their products and effectively communicating that value to stakeholders, as well as creating an ecosystem-based approach to accelerate go-to-market strategies.
As we look into the future of medical technology, it increasingly promises to be one in which personal smart devices, used in conjunction with next-generation medical devices and guided by the expertise of healthcare professionals, are as much a part of providing care as the common cannula or hypodermic needle, providing access to world-class information and treatment on a scale never before seen. As part of our effort to make this future a reality, we intend this series to serve as a primer to digital therapeutics as well as a guide to prospective developers bringing new DTx solutions to market.
Join us in the MIDI Innovation Vault™ to learn more today!