IVD Go-To-Market StrategyFrom Clearance to Repeatable Adoption

Start with the ordering decision

Every IVD sale ultimately depends on a clinician choosing to order the test and a lab or health system choosing to run or send it. Map who makes each decision, what they are measured on, and what would make them switch from current practice.

Choose beachhead segments deliberately

• • Prioritize settings where clinical need is acute and the test changes a management decision.
• • Favor accounts where coverage is already favorable or a clear path exists.
• • Identify early clinical champions who can generate real-world experience and peer credibility.

Pick a channel model that fits the product

• • Direct sales for complex, high-value tests requiring clinical education.
• • Distribution partners for broad instrument or reagent reach.
• • Lab partnerships or LDT pathways when centralized testing is the realistic route.
• • Hybrid models that start direct and expand through partners once demand is proven.

Sequence launch around evidence and coverage

Launching sales ahead of reimbursement often produces trial usage that never converts. Align commercial ramp with coding, coverage milestones, and the clinical utility evidence payers and guideline bodies will ask for.

Common go-to-market gaps

• • A value story written for regulators rather than clinicians and payers.
• • No defined workflow integration (ordering, sample logistics, result delivery, EHR).
• • Sales targets set before reimbursement is secured.
• • Lack of post-launch metrics beyond revenue, such as reorder rate and account penetration.