Category: Insights
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IVD Industry Monograph No. 4 – Beyond the Data Feed: Diagnostic Contribution in Health Intelligence
Health intelligence is reshaping how diagnostic information is used across healthcare, research and AI-enabled systems. This fourth Persodia IVD Industry Monograph examines how Diagnostics can contribute beyond producing results by enabling information that remains structured, reusable and clinically meaningful across evolving health-information architectures. A structural analysis of an emerging strategic challenge for the Diagnostics industry.…
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IVD Industry Monograph No. 3 – Beyond Market Access – Foundations for Sustaining Europe’s IVD Leadership
Beyond Market Access – Foundations for Sustaining Europe’s IVD Leadership Europe’s diagnostics industry shows visible continuity but declining structural durability. IVD’s share of healthcare expenditure fell from 0.80% in 2009 to 0.60% in 2023. Real growth is weak. Capital duration is stressed. Regulatory and evidence obligations fall disproportionately on smaller suppliers. Five structural gaps—competitiveness, fixed-burden…
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IVD Industry Monograph No. 2 – Earning Position: How Evidence Becomes Authority
Earning Position: How Evidence Becomes Authority Diagnostics fail not analytically but through Evidence Escape: evidence does not automatically become clinical authority. Seven evidence domains govern adoption—analytical, clinical, regulatory, economic, operational. Strength in one domain cannot compensate for weakness elsewhere. The binding-constraint principle identifies the missing domain preventing adoption. Connected laboratories are evidence-generating assets, not merely…
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IVD Industry Monograph No. 1 – Crossing from Analytical to Diagnostics: The Difficulty is the Moat
Crossing from Analytical to Diagnostics: The Difficulty is the Moat Most analytical technologies never reach clinical diagnostics—not due to inadequate performance, but because clinical markets demand structural transformation: from flexibility to constraint, standardization and manufacturer accountability. The crossing requires seven simultaneous conditions across three phases. This structural distance is not a barrier to avoid but…
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The Book – INSIGHT 6 – Health Intelligence Will Not Remove Constraint. It Will Densify It.
The next frontier is not more data. It is the ability to sustain trustworthy meaning across systems. Why does this matter now? Artificial intelligence is accelerating expectations across healthcare. Diagnostics sits close to the centre of that discussion because it already generates structured biological information at scale. The most important question, however, is not whether…
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The Book – INSIGHT 5 – Strategy in Diagnostics Is Selection Under Constraint.
The central question is not which opportunity appears most attractive. It is which exposure the organisation is prepared to inhabit. Why does this matter now? Diagnostics strategy is often presented as a search for opportunity. Which technology should be developed? Which market should be entered? Which partnership should be pursued? Which segment offers the most…
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The Book – INSIGHT 4 – Diagnostic Value Completes Outside the Firm.
The manufacturer creates the product. The system determines whether its value becomes real. Why does this matter now? Diagnostic companies invest in research, development, validation, manufacturing, regulatory compliance and deployment. Yet the value of a diagnostic product is rarely completed inside the firm that created it. It is completed downstream: when information changes care under…
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The Book – INSIGHT 3 – The Same Diagnostic System Can Be Infrastructure in One Market and Strain in Another.
Technology may stabilize globally. Deployment never does. Why does this matter now? Diagnostics companies often speak of global scale as though it were a movement towards uniformity. The technology travels. The product receives regulatory approval. The analytical performance remains consistent. Yet deployment conditions do not converge. The same diagnostic system can function as infrastructure in…
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The Book – INSIGHT 2 – Integration Secured Scale. It Also Reduced Reversibility.
Once laboratories became systems of systems, operational coherence became both a strategic asset and a structural exposure. Why does this matter now? Laboratory integration is usually presented as a straightforward improvement: greater automation, shorter turnaround times, better connectivity and more efficient workflows. All of those benefits are real. But integration carries a second consequence that…
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The Book – INSIGHT 1 – The IVD Industry Did Not Invent Biology. It Stabilized It.
The first industrial achievement of diagnostics was not measurement. It was making trust reproducible. Why does this matter now? Diagnostics innovation is frequently discussed as a sequence of scientific breakthroughs: new biomarkers, greater sensitivity, broader menus and increasingly sophisticated technologies. That description is incomplete. The defining industrial achievement of in-vitro diagnostics was not discovering biology.…