Artificial intelligence is spreading through medical technology for regulatory work, information access and operational efficiency, but speakers at the Veeva MedTech Summit in Amsterdam argued that the decisive constraint is not how fast companies adopt the technology. It is whether reliable data, consistent processes, governance and accountable people are in place to support it.
Medtronic's experience was presented as the clearest illustration. Becki Brasher described a four-year programme that began with organisational groundwork rather than algorithms: processes were harmonised, data consistency improved, systems consolidated and governance structures established. Her summary of the effort was that the company did not start with AI; it had to earn it. The implication is that inserting AI into fragmented or inconsistent environments can create more problems than it solves, because outputs become difficult to trust, validate or scale.
People and oversight
Preparation also extends to staff. Technology alone cannot deliver transformation, according to the summit discussion; employees need the knowledge and confidence to use new tools within their everyday responsibilities, together with appropriate oversight of how those tools are applied.
Balancing innovation with regulatory compliance dominated the closing keynote from Erik Orzechowski and Benjamin Rochette. As adoption accelerates, companies must move quickly without compromising the quality, safety and regulatory standards expected of the sector. Their argument was that governance should be built into technology development from the outset rather than treated as a final compliance exercise.
That requires closer collaboration between IT, Quality and Regulatory teams: IT understands implementation, while Quality and Regulatory specialists assess risk and define the evidence needed to demonstrate compliance. The speakers also called for proportionate governance, noting that an AI application supporting low-risk administrative work does not need the same controls as one influencing patient safety or regulatory decisions. Clear responsibilities, early risk assessments and suitable controls allow a more flexible approach.
Human judgement retained
Speakers also stressed that human judgement remains essential. Brasher said AI should assist human reviewers rather than replace them, and that such judgement will stay in place until organisations build trust that what agents deliver is accurate. AI can analyse large volumes of information, generate documentation and make recommendations, but the outputs still require scrutiny; in a highly regulated environment, a convincing answer is not necessarily a correct one.
The closing keynote compared relying on AI without understanding the subject matter to using a calculator without knowing the mathematics behind it. That raises a workforce question: if employees lean on AI before developing the underlying knowledge, companies may end up with fewer people able to challenge inaccurate recommendations. The consensus was not to avoid AI but to make it complement expertise, with accountable individuals retaining responsibility for important decisions.
Measuring value
With many potential applications available, organisations were urged to resist pursuing every opportunity at once. Instead they should target existing operational problems and define success measures. The keynote cited time savings, shorter process cycle times, less rework, improved quality and employee adoption as ways to judge value, and recommended controlled pilots to establish where AI is most effective, maintain human oversight and build confidence before scaling.
Because the technology and regulatory expectations continue to change, governance structures need to adapt alongside new capabilities. Success will depend less on the number of initiatives launched than on the ability to turn promising applications into reliable, scalable capabilities.
The summit's overall message was that digital transformation is a collective challenge: technology, compliance, data management and culture cannot be handled separately, and progress requires collaboration inside companies and between manufacturers, technology providers, regulators and other stakeholders. The mood was optimistic but pragmatic — as the closing keynote put it, organisations sometimes need to slow down in order to speed up.