Quick Tip: Clearly define electronic interfaces of interoperable devices
Identifying and managing risks across electronic interfaces is critical.
Medical devices are becoming more interconnected and smart! Internet of Medical Things (IoMT) is more than an industry buzzword; it is now a growing reality. Flow of data and information through interconnected medical devices is an important aspect of their functionality in the current model of patient-centered delivery of healthcare.
Interoperability basically means the ability of two or more devices to connect and share information. This connection can be hard-wired or wireless. When you use your phone to make a payment, you are using interoperability of the card reader at the kiosk. You can think of many other examples in your daily life.
In this operating model, you have to think about different electronic interfaces for your medical device. Each interface presents an opportunity for error in data transmission which may lead to a hazardous situation. Security and cybersecurity of information also becomes critical in this environment.
Simply focusing on device functionality is not sufficient. The first step is to clearly define all electronic interfaces and users. As the number of interfaces and anticipated users increases, the number of potential hazardous situations also goes up. Therefore, a very comprehensive risk analysis is needed to support the design process by identifying all relevant design inputs.
