Medical devices are incredibly diverse – from the lowliest disposable hypodermic needle to the most sophisticated imaging equipment – but they all have one thing in common. They are all physical things. However, back in December, the IMDRF published a set of definitions that include software as a medical device in its own right.
Of course, many medical devices include software as an integral part of their operation. However, the document from the International Medical Device Regulators Forum aims to expand definitions to include the SaMD (software as a medical device) to assist regulators in creating co-ordinated legislation.
The definition excludes software necessary for a physical medical device to operate. However, the SaMD could interface or be used in conjunction with other medical devices (including other SaMDs). It must be possible to run it on a general computing platform – and this can even include mobile apps.
But including mobile apps opens a whole can of worms. The recent Consumer Electronics Show included products that have pushed the function of smartphones towards the medical scanners of science fiction. There is even a company with a product that can turn your mobile phone into a form of electric stun gun.
One of the strengths of the app marketplace (at least for Android apps) is its open source, unregulated nature. Sure, an app may not be massively polished but it’s probably free and if you don’t like it, there will be dozens of similar ones to choose from.
Do we really want to see medical device technology going down the path of Angry Birds or Minecraft – with dozens of me-too products that don’t offer the same quality as the original?
Of course, I’m not suggesting we stop progress – even if that were possible – but it will be interesting to see how things develop over the coming years.
I’m glad I’m not a regulator. Now… where’s my phone?
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