Tag: monograph
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IVD Industry Monograph No. 3
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 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 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…