MEDICAL DEVICES
& DIGITAL
THERAPEUTICS
The capacity for digital therapeutics to improve care, use big data sets and artificial intelligence to initiate care in real-time or near real-time and to use predictive algorithms to reduce and attenuate disease is a critical step forward in advancing healthcare and quality of life. Digital therapeutics provide practical benefits in which patients can receive care without the burden of frequent trips to a clinical site, travel, expense, time spent waiting for an appointment, having to take off from work or safety concerns amidst a global COVID-19 pandemic. Digital therapeutics also provide patients an ability to manage and have a more active role in their own care.
While seemingly simple in concept and nature digital therapeutics apps have important distinctions from consumer grade wellness-based apps. Most critical is that digital therapeutics are required to meet regulatory standards for approval and demonstrate a clinically meaningful benefit through the use of a software-enabled intervention. There are standards for security and privacy and validation in the form of pivotal clinical trials is required. Currently, the approval path for digital therapeutics is somewhat similar to that which is used for medical devices.
SPRIM Health has a considerable track record for being a global leader in accelerating a path to market for medical devices and digital therapeutics across a range of devices and apps in diverse therapeutic areas. SPRIM Health provides comprehensive end-to-end solutions for evaluating medical devices and digital therapeutics via human factors usability testing, mapping to the guidelines outlined in the FDA Guidance, “Applying Human Factors and Usability Engineering to Medical Devices”, (2016) and also providing boutique CRO services to efficiently conduct pivotal studies. At SPRIM Health, we routinely support our clients from pre-submission through meetings with the FDA for trial approval through submission for medical device and digital therapeutics approvals.
SPRIM Health, while rooted in traditional clinical trials for over 22 years, has become a global leader in the transformation of trial designs and execution of hybrids and DCT’s. We are particularly adept at applying creative solutions that are uniquely tailored to our client’s needs.
We believe that quality is optimally delivered through the combination of clinical science and technology, understanding our clients pain points and knowing that it is essential to optimize the signal to noise ratio for efficiency and safety outcomes.
We have led and will continue to lead the way for our clients, having successfully delivered medical device and digital therapeutic-based claims using innovations and tech-enabled efficient solutions.
We are scientists who believe that we can make a difference in the way that clinical trials are conducted and that we can effectively help our clients achieve their efficacy and safety endpoints with confidence every step of the way.
