The differences between SaMD and DTx

With the explosion of the digital health industry, there have been numerous subsets that have grown to meet new and existing market needs. Digital health has now become an umbrella term that encompasses any tech component that is used to support patient health, with digital therapeutics (DTx) taking on the role of supporting patient care directly. As DTx has grown in adoption, so too has Software as a Medical Device (SaMD) with more pharma companies developing these solutions to expand their offering and broaden their value. But what is the difference, and which is better?

What is SaMD?
SaMD is “software as a medical device that is intended to be used for one or more medical purposes without being part of an existing hardware medical device.” An adjacent inclusion of SaMD includes software with the intended purpose of driving a medical device, and those devices that fetch patient data. While those can also fall under SaMD definitions, it remains unclear whether those uses require greater regulations, or stop short of that.

Welldoc is an example of a regulated SaMD. Through their digital health platform, the company offers several products in the diabetes and cardiology space. Vinehealth Cancer Companion is a Class I SaMD. Its mobile application supports patients through their cancer treatment by helping track, manage, and understand their treatment.

What is DTx?
DTx provide software-driven therapeutic interventions in conjunction with treatment, management, or prevention of a disease or disorder. They can be combined with an existing treatment or prescribed as a standalone treatment. However, there is much debate as to their effectiveness as a standalone treatment, and the FDA has given its approval to only a handful of DTx solutions as an approved treatment.

In the more complex treatment instances, some DTx solutions can be classified in the SaMD category because they play a more active role in treatment and management of diseases, and so require clinical evidence to support product claims. Their efficacy and safety claims must also be subject to regulatory approval and oversight.

Examples of DTx and its uses
DTx are one of the more well-defined types of digital health solutions out there, and they offer tangible benefits to pharma. More advanced DTx like Medisafe can place pharma companies at the forefront of innovation in new therapeutic categories, generating new revenue streams and/or business models by extending existing portfolios, or engaging with patients in new digital channels. Capturing valuable patient insights, providing just-in-time-interventions, and clinical engagement is all possible within more advanced digital platforms that help to improve patient adherence and support strong outcomes.

With DTx channels, clinicians can also gain insight and information on patient treatment progress, and support treatment decisions with robust evidence. But it’s impact on patient outcomes can be varied, and hard to measure directly due to limited regulations.

Which is better and why?
The key differences between SaMD and DTx are the stricter regulations to which SaMD solutions are subject. Since SaMD can directly impact patient care and outcomes, any clinical claims associated with the technology solution is required to prove their claims, and the stringency with which the software is regulated.

However, DTx platforms are less strictly regulated as their impact on claims and patient outcomes isn’t as clear. These solutions can still add value when it comes to patient education and onboarding, but SaMD solutions enable pharma organizations to address a much wider range of challenges and differentiate themselves more clearly in the market.

If pharma organizations are stuggling with patient adherence, confusion in dosing, and brand identity, more tech focused DTx platforms may help to achieve their initial goals. However, these aspects may not create as much impact on patient outcomes and care pathways as an SaMD platform that directly connects to medical devices, is part of the treatment, and can be regulated for proven results.

To really maximize benefits for patients, clinicians, and other stakeholders, pharma companies need to determine their primary patient goals. The future of patient health lies in technology solutions, and whether it’s through an advanced digital platform, or a more robust SaMD solution, pharma should embrace digital health to create the future of patient support.

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