The opportunity and the risk posed by Artificial Intelligence (AI) and Software as a Medical Device (SaMD) need to be finely balanced: misdiagnoses, incorrect dosages or hacked drug delivery systems pose a tangible danger to patient health, but international regulation for AI and SaMDs is divergent and complex. Ruaidhrí Primrose and Jonathan Ripley tackle the challenges and opportunities.
Artificial intelligence has fuelled the global healthcare market with unprecedented growth rates. In 2024, the global AI in healthcare market size was valued at a staggering USD 29.01 billion: it is now projected to grow from USD 39.25 billion in 2025 to USD 504.17 billion by 2034 at a CAGR of 44.0%.1
This ecosystem is as varied as it is large with corporations investing in integrations to existing devices and new start-ups devising every kind of innovation to improve patient outcomes. As clinician shortages, backlogs, and rising costs impede access to care for millions across the globe, automation, remote care and workflow optimisation are not just an exciting development, but an urgent need.
Despite their history or readiness, all digital medical device providers need to make a certain number of considerations to ensure that their device enters and remains on its target market safely. Critically, they need to evaluate how different digital components relate to the device's functionality and how each market regulates Software as a Medical Device (SaMD) and AI-powered medical technology.
Log in or register FREE to read the rest
This story is Premium Content and is only available to registered users. Please log in at the top of the page to view the full text.
If you don't already have an account, please register with us completely free of charge.
