Client Result

IVDR Diagnostics Strategy

Project Overview

A top-10 diagnostics company wanted to gauge laboratory preparedness and reactions to the impending implementation of IVDR, and how that would impact portfolio strategy

DeciBio Approach

Primary Research

  • Conducted 31 in-depth interviews with stakeholders across biopharma, academia, clinical labs, and commercial reference labs to understand perspectives on IVDR
  • Assessed trends with respect to current and expected use of NGS testing of various types and panel sizes thoguhout Europe, and how IVDR would impact that

At a glance
Technologies Assessed

A deliverable presented to the client team dived into:

  • Quantified perspectives on IVDR rollout (e.g., familiarity and expectations)
  • Stakeholder technology utilization by type
  • Stakeholder expectations for vendor engagement
  • Key pain points and unmet needs
  • Notified body concentration by geography
  • Expected pathway for IVDR rollout and adoption behavior

The client leveraged these findings to inform which new diagnostic assays to develop for the European market and ancillary capabilities to invest in to service the transitioning European market


5 weeks

Geographic Scope



Clinical Diagnostics


Voice-Of-Customer Research

Biomarker and Diagnostic Strategy

Related Client Results

Precision Medicine is evolving at a rapid pace

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