One of the fastest-growing technology areas is Software as a Medical Device (SaMD). With healthcare at the forefront of many people’s minds, creation of wellness solutions is becoming a highly competitive space.

SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, software that serves as a medical product, standalone from any hardware or other equipment. For example, Addison Whitney recently worked with Biogen to create CogEval, an iPad-based assessment designed to evaluate cognitive function in patients with multiple sclerosis (MS). It embodies a Processing Speed Test (PST) that, in two minutes, gauges cognitive function using elements of attention, psychomotor speed, visual processing and working memory. It allows healthcare providers to more easily manage their MS patients in a clinical setting.

Since most SaMD aims to help mitigate, diagnose, or even treat disease, it is important to regulate use to ensure patient safety. Agencies like the U.S. FDA and the E.U. have published broad guidance, but with the speed of innovation, staying abreast of changes can be quite a task.

Smaller technology firms are leading the way with dynamic innovations in medical care. Some partner with larger pharmaceutical companies to bring these exciting advances to broader markets. Large tech companies like Amazon, Alphabet, and Microsoft are branching out into healthcare too. Having worked with many of these companies, Addison Whitney understands both technology and healthcare fields, and is able to navigate the complex regulatory, strategic, and creative needs necessary to create successful medical technology brands.