CLIENT RESULT

IVDR Opportunity Assessment

Client INDUSTRY
Clinical Diagnostics
Interviews
31
Technologies Assessed
7
Countries
9
Project Details
capability
Voice-of-Customer Research

Objective

A top-10 diagnostics company wanted to gauge preparedness and reactions to implementation of IVDR, and how that would impact a potential new product

Our Approach

Primary Research

  • Conducted 31 in-depth interviews with stakeholders across biopharma, academia, clinical labs, and commercial reference labs to understand perspectives on IVDR

Outcome

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
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