Stéphane Donzé is the Founder and CEO of AODocs, with more than 20 years of experience in the enterprise content management industry.
Amid the rapid proliferation of artificial intelligence (AI) across industries, medtech companies face a critical choice that may determine their competitive position for years to come.
According to an industry analysis, 24% of companies across all sectors have created measurable value from generative AI, while only 10% of medtech companies have achieved similar results, with 90% seeing limited or no measurable impact. Even within healthcare, biopharma companies are leveraging AI to streamline document creation across R&D, manufacturing and commercial operations, demonstrating a clear path forward that medtech can follow.
Successful AI implementation in highly regulated industries requires more than technology adoption. Companies need organized document management systems that can support AI tools effectively. Medtech companies that delay addressing document management challenges may find it harder to fully leverage emerging AI capabilities, creating disadvantages as competitors streamline their operations.
Document-Intensive Processes Create AI Opportunities And Risks
Regulatory and quality processes represent major operational bottlenecks for medtech companies. They require the creation and continuous refinement of complex documents, making them natural applications for AI tools that excel at analyzing, generating and reviewing text-based content. Procurement operations present similar opportunities, involving extensive documentation around supplier evaluation, contract analysis and compliance verification.
Organizations that have implemented AI solutions in these areas report significant performance improvements. Biopharma companies using AI for regulatory document generation have achieved 60%-70% reductions in initial drafting time and weeks of improvement in overall review cycles. Similar gains are possible in procurement, where AI can evaluate supplier proposals by simultaneously analyzing pricing structures, delivery timelines and compliance requirements across hundreds of submissions while detecting subtle changes in contract terms between versions.
However, these benefits materialize only when companies have established proper document management infrastructure. AI tools require clean, structured and current data to function effectively. When critical documents exist across fragmented systems—email chains, shared drives and manual processes—AI implementation creates additional complexity rather than operational improvement.
Implementation Risks Amplify Existing Document Management Problems
The consequences of deploying AI on disorganized document systems are particularly severe in medtech, where regulatory and procurement decisions carry significant financial and compliance implications. When procurement teams make sourcing decisions based on AI analysis of outdated supplier contract terms, budget overruns and compliance failures follow. Similarly, when AI systems cannot properly access or categorize supporting documentation, supplier selection proceeds on incomplete information, creating downstream operational and regulatory risks.
In regulatory affairs, these problems compound. AI systems processing incorrect versions of technical files may generate compliance documentation that conflicts with current product specifications. Quality management systems analyzing outdated deviation reports miss emerging patterns that indicate systemic process issues requiring immediate attention.
The pattern repeats across functions. When AI operates on incorrect documents—outdated versions, incomplete files or improperly categorized information—it amplifies existing document management deficiencies rather than solving operational problems. In medtech, where procurement decisions involve millions of dollars and regulatory submissions determine market access, document accuracy becomes mission-critical for AI success.
Human Oversight And Governance Requirements
Successful AI implementations in medtech maintain rigorous human oversight throughout all processes. AI generates initial drafts of regulatory documents, but regulatory professionals conduct comprehensive reviews and provide final approval. AI identifies potential issues in supplier contracts, but procurement teams retain decision-making authority. This ensures regulatory compliance while capturing significant efficiency gains.
The most effective implementations position AI as a capability enhancement rather than a human replacement. Regulatory teams can focus on complex compliance issues while AI manages routine documentation tasks. Procurement teams can evaluate larger supplier pools more thoroughly because AI handles initial screening and analysis, enabling human experts to concentrate on strategic decision-making.
Strategic Implementation Considerations
Companies considering AI applications should begin by conducting comprehensive assessments of their current document management capabilities. Critical questions include whether teams can rapidly locate the current version of any document, whether workflows are standardized and automated across departments, and whether audit trails comprehensively track changes and approvals. These capabilities directly determine whether AI implementation stands to generate value or create additional operational problems.
Procurement operations illustrate these requirements clearly. AI can transform supplier evaluation when it accesses complete, current contract information with proper categorization of supporting documents. Without these elements, identical AI tools produce costly mistakes based on incomplete or outdated information, undermining rather than enhancing operational performance.
Medtech companies do not face a choice between document management and AI adoption. They require document management to enable successful AI implementation. Organizations that recognize this relationship are better positioned to build operational capabilities that will serve them as AI tools continue advancing. Treating document organization as an administrative function poses risks as AI becomes standard across healthcare.
Biopharma companies are already demonstrating the competitive advantages possible when AI and document management function together effectively, establishing a clear precedent that medtech companies can follow—provided they address the underlying document management requirements that determine AI implementation success.
Forbes Technology Council is an invitation-only community for world-class CIOs, CTOs and technology executives. Do I qualify?
