Introduction
The digital revolution's impact on health care products and processes is already enormous, from data mining to telemedecine, wearables, remote monitoring, "smart" pills and artificial intelligence (AI). Digital tools are driving an increasingly interconnected health care environment geared to patient-centricity, cost-efficiency and appropriate self-management of diseases. This wave of innovation has brought new hybrid or unique products that leverage digital capabilities to complement or replace more conventional forms of health care intervention.
In the medical device sector, one outgrowth of the digital revolution is software as a medical device (SaMD). These are stand-alone computer programs -- including apps -- using in the prevention, diagnosis, treatment, monitoring or management of disease. They are distinct from software included in, or integral to, medical devices, and from software used in the manufacture or maintenance of devices. Digital therapeutics is one example of SaMD that is attracting a good deal of attention in this space.
For agile, resourceful software develops, as well as mainstream device and pharmaceutical companies, SaMD offers significant opportunities for both commercial gain and health care transformation. It also presents a number of regulatory and market access challenges. These must be carefully negotiated to ensure the competitive velocity and ongoing health of the SaMD industry.
