IVDR Opportunity Assessment
Clinical Diagnostics
31
7
9
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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Due Diligence
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