What is interoperability?

In medical devices, “interoperable medical devices refer to the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device. Interoperable medical devices can be involved in simple unidirectional data transmission to another device or product or in more complex interactions, such as exerting command and control over one or more medical devices. Interoperable medical devices can also be part of a complex system containing multiple medical devices.” [The US FDA, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Device, issued on September 6, 2017]. For example, a blood glucose meter that can send data to a smartphone app, an x-ray that can communicate with a picture archiving and communication system, or a ventilator that can adjust its settings based on the patient’s vital signs are all examples of interoperable medical devices.

A common query from entrepreneurs establishing a software as a medical device company is, “When should we start to implement a QMS system, especially design control?” In response, it’s suggested to initiate this process when you’re prepared to construct your Minimum Viable Product (MVP) (p.7).

It has been more and more often that equipment and software companies providing their products to clinics and hospitals are, actively or passively, due to requests from the regulatory authorities, documenting/filing their products as medical devices. Such changes in the status of a product particularly often occur on software. This is [thankfully] due to the huge progress in the use of software in improving physical and mental health. Common scenarios that a company needs to consider converting an existing software product to a medical device or bringing a legacy software item into part of a Software as Medical Device (SaMD) include: