Medical technology companies risk creating more problems than they solve if they introduce artificial intelligence into fragmented data and inconsistent processes, according to discussions at this year's Veeva MedTech Summit in Amsterdam.
Across presentations, panel sessions and interviews at the event, a consistent message emerged: successful digital transformation depends less on how quickly organisations adopt AI than on whether the underlying foundations — reliable data, consistent processes, appropriate governance and the people accountable for them — are in place first.
Medtronic's four-year groundwork
Becki Brasher of Medtronic described the company's four-year effort to become ready to implement AI. Rather than starting with the technology, Medtronic focused on harmonising processes, improving data consistency, consolidating systems and establishing governance structures.
"We didn't start with AI. We had to earn AI," Brasher said during her conference session. Her account illustrates why deploying AI in fragmented environments can produce outputs that are difficult to trust, validate or scale.
Brasher also stressed that technology alone cannot deliver transformation. Employees need the knowledge, confidence and oversight to incorporate new tools into their day-to-day responsibilities.
Governance from the outset
Balancing innovation with regulatory compliance was a central theme of the closing keynote featuring Erik Orzechowski and Benjamin Rochette. As adoption accelerates, they argued, MedTech organisations must find ways to move quickly without compromising the quality, safety and regulatory standards expected of the industry.
A key argument was that governance should be built into technology development from the start rather than treated as a final compliance exercise. That requires closer collaboration between IT, Quality and Regulatory teams: IT understands the technology and its implementation, while quality and regulatory professionals assess risks and define the evidence needed to demonstrate compliance.
The speakers also called for proportionate governance. An AI application supporting relatively low-risk administrative work does not necessarily need the same level of control as one influencing patient safety or regulatory decisions. Establishing clear responsibilities, risk assessments and controls early allows a more flexible approach that supports innovation without overlooking obligations.
Human judgement retained
Despite AI's growing capabilities, speakers emphasised retaining human judgement and professional expertise. Brasher said AI should assist human reviewers rather than replace them, and that human judgement will remain essential until organisations build trust that what AI agents deliver is accurate.
AI can analyse large volumes of information, generate documentation and provide recommendations, but its outputs still require scrutiny. A convincing answer is not necessarily a correct one, particularly in a highly regulated environment. Closing keynote speakers compared relying on AI without understanding its underlying subject matter to using a calculator without knowing the mathematics behind it.
The point has implications for the next generation of regulatory and quality professionals: if employees come to rely on AI before developing the necessary underlying knowledge, organisations could find themselves with fewer people able to challenge inaccurate or inappropriate recommendations.
Measuring value through pilots
With a growing number of potential applications available, organisations should resist pursuing every opportunity at once and instead target areas where technology addresses existing operational challenges, with clear measures of success. Metrics cited in the closing keynote included time savings, reduced process cycle times, less rework, improved quality and employee adoption.
Controlled pilot projects can show where AI is most effective, keep appropriate human oversight in place and build confidence before successful applications are expanded. Because the technology and regulatory expectations will keep evolving, governance structures need to adapt alongside new capabilities.
Orzechowski coined the phrase "slow down to speed up" — the summit's conclusion being that getting the foundations right today positions the industry to take up tomorrow's technological opportunities with greater confidence.