The development of artificial intelligence in medical technology is usually discussed as a technical challenge – better algorithms, larger datasets, more computing power and closer integration with clinical practice. For companies attempting to bring AI-enabled medical devices to market, however, another constraint is becoming increasingly important. Ivor Campbell (pictured), Chief Executive of Snedden Campbell, a specialist recruitment consultant for the global medical technology industry. provides a brief introduction to the problem.
There is a need for people who can translate technical innovation into clinical evidence, quality systems and a regulatory strategy that will withstand scrutiny throughout the product’s lifecycle, and that combination of expertise is difficult to find. In executive search, we have traditionally been asked to identify either technical specialists or experienced business leaders.
AI-enabled medical technology is creating demand for something more unusual: professionals who understand medical-device regulation but can also engage credibly with machine learning, software development, data quality, algorithmic performance and post-market monitoring.
The shortage is not simply a lack of regulatory-affairs professionals but rather global lack of people who can work effectively across disciplines that have historically developed separately.
In a recent report Life Sciences 2035: Developing the Skills for Future Growth, a group of UK life-sciences organisations – including the Association of British HealthTech Industries – estimated that the sector could require 70,000 additional jobs by 2035, as well as 75,000 people to replace those leaving the workforce.
Those figures cover the broader life-sciences industry rather than AI regulation specifically, but they provide important context. Companies are trying to recruit highly specialised AI regulatory professionals from a labour market that is already under pressure.
The challenge is intensified by differences between regulatory systems. In the European Union, for example, AI-based software intended for medical purposes can fall within the high-risk provisions of the AI Act while also being subject to the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation. The European Commission identifies risk management, data quality, information for users and human oversight among the requirements that apply to high-risk healthcare AI.
The AI Act also requires providers and deployers of AI systems to take measures to ensure an appropriate level of AI literacy among relevant staff. That obligation has applied since 2 February 2025, ahead of the later phases of the Act’s implementation.
Compliance therefore involves more than appointing a single expert. Organisations must develop a wider understanding of AI among the people responsible for designing, evaluating, deploying and overseeing these systems.
The UK is following a different route. Rather than introducing one comprehensive cross-sector AI law, it has generally asked existing regulators to apply common principles within their own areas of responsibility.
For medical technology, the Medicines and Healthcare products Regulatory Agency is developing its Software and AI as a Medical Device Change Programme to clarify requirements and protect patients.
The MHRA has also used its AI Airlock regulatory sandbox to examine some of the distinctive difficulties associated with AI medical devices. Its pilot work underlines the need for regulators, developers and healthcare professionals to learn together as the technology evolves.
The competitive question is therefore not which market has the least regulation. It is which companies can understand and navigate the applicable requirements most effectively.