Technology
Accelerating AI in medical device development
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. While on the one hand compute capability
and cloud infrastructure have matured vastly over the last decade, enabling the creation of AI tools with demonstrable clinical value (such as faster radiology reads, more reliable decision- support processes, personalised treatment insights, and continuous patient monitoring), on the other, the regulatory framework to provide guardrails for this breakneck development is still in its early stages. Although international regulators put patient safety at the top of the agenda, the framework to assess risk is still evolving making for a very complex and shifting regulatory environment.
The opportunity and the risk posed by AI and 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.
Is this a wellbeing app or an SaMD? The first step to ensuring that a digital-native device or integration is compliant is determining whether its software or AI features actually make it an SaMD or not. To help provide some clarity, the UK Medicines and Healthcare products Regulatory Agency (MHRA) which regulates medicines, medical devices and blood components for transfusion in the UK, has provided a new critical piece of guidance on the topic. Although designed for the UK market, its clear examples and definitions offer a starting point for devices entering any geography. The MHRA considers intended purpose and
level of functionality: if the software explicitly states that it diagnoses, treats, prevents, or monitors a medical condition, it is more likely to fall under medical device regulations. Despite this, a digital device may have a medical purpose but still be excluded from regulation if its functional impact is low. This ensures that only those tools providing a clinical effect or influencing patient care decisions require additional scrutiny.
Building the dream team From managing data quality and privacy to preventing cybersecurity issues, through to understanding which geographies require which ISO certifications and assessments, the dream team for SaMD development is certainly diverse. The team requires a range of development and regulatory roles in addition to clinical expertise which makes for teams that stand at the cross-roads between software development
June 2026 I
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