The term “medical device” is one that can be used to describe a variety of different items, from things as simple as a BAND-AID to as complex as an MRI machine.
The World Health Organization (WHO) defines a medical device as “an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.”
Experts estimate that there are over 2 million different kinds of medical devices on the market, which could be categorized into more than 7,000 groups. Fortunately, this discussion doesn’t need to get quite so granular. At Synopsys, we like to say that medical devices fall into three broad categories:
- Medical equipment that can be found in labs and hospitals. This covers devices like ultrasounds and CT scanners that can only be operated by medical professionals.
- Internet of things (IoT) medical devices that can be used by anyone in the home. Devices like blood pressure monitors, glucose monitors, and health-tracking wearable devices fall under this category.
- Implantable devices that are attached to the body in some way, most of the time through surgery. Examples for this final category include pacemakers, left ventricular assist devices (LVAD), certain types of hearing aids such as cochlear implants, etc.
While each of these categories has its own specific requirements and considerations that designers need to examine, all three of them require careful analysis of power (specifically low power), reliability (especially for devices that are expected to last for 10 years or more), and security (in terms of both protecting private medical data and preventing breaches).
We’ll dive into each of these medical device design considerations with more detail in the coming sections.