If you’ve ever wondered what it takes to turn ‘one good idea’ into an app or piece of software that makes a difference to the health and wellbeing of others, it might surprise you to learn that it may be a medical device and so it might need regulatory approval.
Software as a Medical Device (SaMD) is not a new concept, however there’s been a marked increase in software based medical devices in recent years as technological advancements make it easier and more accessible for ideas to come to life in various forms, including via apps and websites.
While this is an important and beneficial development for healthcare and consumers, it’s also created a unique challenge for tech and software Developers who may not realise their idea will fall under the SaMD category.
That’s why Developers should be asking questions and seeking further information sooner rather than later, as it’s important to learn early on in the process whether or not your device will be considered SaMD, and therefore be required to be regulated.
What is SaMD?
If you’re looking to develop software – including an app – that simply provides health or medical information, or will be used to manage a healthy lifestyle, then it won’t be regulated by the Therapeutic Goods Administration (TGA) and won’t be required to be included in the Australian Register of Therapeutic Goods (ARTG). It’s also unlikely to be regulated in other countries.
However, if you’re looking to develop software for the purpose of diagnosing, monitoring, predicting or treating disease, injury or disability; claim it will prevent disease; or for it to be used to control or support conception, then it’s likely to be considered SaMD which means that there will be a compliance requirement.
While our advice to Developers is to consider the customer needs first to ensure good design of a product, a key mistake we see being made – and one of the costliest in terms of money and lost time – is waiting until the end of the development process before checking to see if their product is regulated.
If Not at The End, Then When?
Regulation shouldn’t be difficult, but the process can be complex and lengthy, and it creates new design requirements. This is why compliance work needs to start as soon as you begin to develop your idea.
Significant documentation and information will be required to ensure any medical device product meets stringent criteria, including having proof that it does what it says it does and that you as the developer have properly tested and evaluated it.
Attempting to ensure a medical device is compliant at the very end of the process would be like building a house first and then trying to purchase the land on which it was built and getting the plans retrospectively approved by council.
In the past, SaMD has largely been developed by companies with a medical or scientific background who are looking to find a solution to a specific medical need.
However, improved technology - particularly mobile phone technology – means that outside those ‘traditional medical device manufacturers’, we’re now seeing software medical devices and health apps being created by three broad groups of people;
- Tech-savvy engineers from outside the medical industry
- Business-savvy entrepreneurs
- Patient innovators and entrepreneurs – people with a particular disease or condition who have lived experience with a particular problem and know how it can be solved
This has been great for healthcare as we now have more people solving problems and bringing new ideas to the sector.
However, for many people in these categories, they either don’t realise the regulations exist, or don’t understand how they might apply to their particular idea. And, while the tech experience is important, without expertise in health and medicine it is easy to overlook risk and consequences.
Protection for Consumers, and Developers
While it’s broadly understood that regulation exists to prevent harm to the end user, it also protects Developers.
Medical devices are developed to solve a problem or unmet need, not to intentionally cause harm, but the reality is that there is always a level of risk. Risk is never zero in health and medicine, and even good products are sometimes involved in incidents.
Regulation matters because in the event of harm occurring – be it physical, financial or otherwise – compliance assists in demonstrating that a Developer has acted responsibly and met required standards.
Finally, it also assists in protecting the medical sector more broadly, maintaining a high standard of trust and accountability, and prevents the market from being flooded with low-quality products and devices.
Regulation shouldn’t be difficult, but much like the development of the device itself, it takes time, understanding, planning and the right expertise to navigate it successfully.