persodia research
ivd industry, structured

persodia.org – Repository of IVD Industry Structural Documents

Persodia Research produces structured analytical work on the organisation, constraints, and strategic dynamics of the in vitro diagnostics industry. This repository collects that work in full — monographs, field intelligence, tools, notes, and datasets — without editorial selection or promotion. Items are listed as published. The archive grows as the work advances.

4 items

Monograph Published New

Earning Position: How Evidence Becomes Authority

Most diagnostics that fail to reach sustained clinical use do not fail analytically. The evidence exists. The performance is demonstrated. What is missing is alignment — across the domains that govern adoption, the actors that grant authority, and the timelines that determine whether evidence built before market entry reaches the practice it was designed to change. This monograph examines that structural condition, and what it takes for evidence to become position.

Evidence·April 2026
Monograph Published New

Crossing from Analytical to Diagnostics

Most analytical technologies never reach clinical diagnostics — not because they lack performance, but because they are not built for the structural conditions clinical markets impose. This monograph examines what those conditions are, why they defeat most crossings, and what a complete crossing actually requires.

Infrastructure·March 2026
Tool Published New

Crossing from Analytical to Diagnostics (tool)

The Crossing Assessment Tool evaluates how a product aligns with the structural conditions required for clinical diagnostics deployment. It makes visible what is already in place, what is being built with committed resources, and what remains absent — turning an otherwise opaque transition into a structured, comparable assessment.

Infrastructure·March 2026
Book Published

Inside Clinical Diagnostics Industry

The diagnostics industry is governed by enduring structural constraints that determine how technologies are developed, deployed, and adopted at scale — more strongly than managerial choice or product quality alone. This book maps those constraints across four structural layers and argues that understanding them is a prerequisite for understanding how the industry actually operates.

Access·February 2026

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