Software Development for Medical Device

Software is eating the world. And indeed it is. Medical and healthcare are no exceptions. But software development for medical devices presents an array of challenges that developers used to traditional software development may not be familiar with.

One of the most important aspects of medical software is patient safety. Unlike consumer products, medical devices are subject to rigorous safety regulations, and any software errors could have serious, even life-threatening consequences. As a result, manufacturers must develop and test their software thoroughly before releasing it.

Another consideration is cybersecurity. Medical devices are often connected to hospital networks, making them susceptible to cyberattacks. To protect patients’ data and ensure the safety of their devices, manufacturers must implement strong security measures.

Software in medical device can be either software in a medical device (SiMD) or software as a medical device. Though the two types of software are parts of medical devices, their key functions differ. SiMD solutions ensure the actual medical device’s operation; they can’t provide any medical service on their own. SiMDs are mostly embedded software in the physical medical device. On the other hand, SaMD solutions are fully-fledged medical devices in themselves. Such tools enable continuous monitoring, screening, diagnostics, and even condition management. As for the types of tools, those are remote patient monitoring devices, mHealth, blood sugar monitors, and more.

Whether we develop SiMD or SaMD, we must keep in mind that the product may directly affect people’s health. Hence, the development process should be guided by FDA’s 21 CFR 820.30 or Design Control for US bound products and 2017/745 EU MDR in EU bound products.

The recent adoption of ISO 13485 by FDA, brings EU and US much closer to a common harmonized QMS standard for medical product development. Also the software life cycle processes standard IEC 62304:2006 is already harmonized and adopted by both FDA and EU commision. This paves the way for unified and common methodologies for the development of SiMD or SaMD for both US and EU markets.