The world of medical electronics has changed considerably in the last decade. With the proliferation of the smart phone as a human-machine interface (HMI), growth of Internet of Things (IoT) services and low-power microcontrollers coupled with high-density energy sources, applications and approaches that were previously considered not to be impractical or unfeasible in the past are being reconsidered.

An increased interest in the monitoring of one’s health has seen many wearable devices come onto the market, capable of measuring a limited collection of vital signs and monitoring how much physical exercise we undertake. Systems developed around ultra-low power microcontrollers, low-power sensors with novel approaches to vital sign measurement, together with lithium-based batteries or even supercapacitors as an energy source, have helped to raise awareness around what can be measured and how to measure it. However, serious medical equipment development, leveraging the latest generation of sensing and microcontroller technologies, still requires strict adherance to the standards of functional safety as defined by, amongst others, IEC 60601, IEC 62304 and the Food and Drug Administration (FDA). Strict approval processes demand that requirements coverage and software coverage are sufficiently demonstrated, activities that are challenging to fulfil without appropriate support or consultants if this is being undertaken for the first time. Increasingly, such devices are being developed by teams that have little prior experience in the development of medical devices.

iSYSTEM’s hardware and software solutions support the embedded developer by enabling the measurement of, for example, code coverage during the execution of unit tests, or even during black box testing. By selecting the appropriate microcontroller architecture, with suitable debug and trace interfaces, hardware-in-the-loop testing can be undertaken, allowing the injection of both hardware failures and software faults to prove the ability of software and hardware to detect failures during operation. The scripting capability of iSYSTEM’s ecosystem also allows regular automated testing to take place. By coupling this feature with Continuous Integration (CI) platforms, such a Jenkins, potential faults, software errors and functionality failures can be detected early in the development cycle. Finally, complex hardware-in-the-loop (HIL) systems can be controlled synchronously via our BlueBox™ On-Chip Analyzer technology, making it possible to support testing of wireless, vital sign measurement applications.

If you are looking to deliver safe electronic medical equipment more efficiently, why not draw upon our team's extensive experience in this field to get you ahead of the competition – you'll be glad you did.