At the Veeva MedTech Summit in Amsterdam, the central message was that medical technology companies face a readiness problem before they face an adoption problem. AI is already being used to streamline regulatory work, improve access to information and support more efficient operations, but speakers said fragmented data and inconsistent processes can make those efforts harder to trust, validate and scale.
Medtronic's Becki Brasher described a four-year effort to prepare for AI rather than starting with the technology itself. The company harmonised processes, improved data consistency, consolidated systems and established governance structures. Brasher's summary of the approach was that Medtronic did not begin with AI; it had to earn it. The implication was that AI introduced into a fragmented environment can create more problems than it solves.
The workforce is part of that foundation. Brasher's session also stressed that technology alone cannot deliver transformation. Employees need the knowledge, confidence and oversight to use new tools in their daily responsibilities, and human reviewers should remain involved rather than being replaced by AI.
In the closing keynote, Erik Orzechowski and Benjamin Rochette focused on the tension between faster AI adoption and the quality, safety and regulatory standards expected in MedTech. They argued that governance should be built into technology development from the start, not treated as a final compliance exercise. That requires closer collaboration between IT teams, which understand implementation, and Quality and Regulatory teams, which assess risk and define the evidence needed to demonstrate compliance.
The speakers also called for proportionate governance. An AI application supporting low-risk administrative work does not need the same controls as one that influences patient safety or regulatory decisions. Clear responsibilities, early risk assessments and appropriate controls can give organisations a more flexible route to innovation without losing sight of their obligations. In that view, compliance and innovation are not opposing priorities.
Human judgement remained a recurring theme. Brasher said AI should assist human reviewers, not replace them. In an interview at the summit, she said human judgement would remain essential until organisations build trust that what agents deliver is accurate. AI can analyse large volumes of information, generate documentation and make recommendations, but its outputs still require scrutiny. A convincing answer, the discussion suggested, is not necessarily a correct one, especially in a highly regulated environment.
The closing keynote used a calculator analogy: relying on AI without understanding the underlying subject matter is like using a calculator without knowing the mathematics behind it. The concern is particularly acute for the next generation of regulatory and quality professionals. If employees rely on AI before developing the necessary knowledge, organisations could end up with fewer people able to challenge inaccurate or inappropriate recommendations.
On business value, the summit's message was to resist pursuing every potential application at once. Organisations should identify where AI can address existing operational challenges and set clear measures of success. The closing keynote cited time savings, reduced process cycle times, less rework, improved quality and employee adoption as ways to assess value. Controlled pilots can show where AI is most effective, preserve human oversight and build confidence before wider deployment.
The broader conclusion was that digital transformation is a collective challenge. Technology, regulatory compliance, data management and organisational culture cannot be addressed in isolation. Progress will depend on collaboration within companies and between manufacturers, technology providers, regulators and other stakeholders. Orzechowski's phrase for the approach was to "slow down to speed up": getting the foundations right now, the summit argued, will leave the industry better prepared for later technological opportunities.