Launchpad for diagnostics
From IVDR certificate to laboratories that order.
For diagnostics and IVD companies up to two years past CE mark or FDA clearance, building repeatable sales in Europe. A Senior Partner leads every engagement.
HealthSeed
Launchpad · Diagnostics
- 6phases, each with a goal
- 1Senior Partner leads
- 35+Expert Community specialists
Where diagnostics launches stall
A certified test still has to be paid for and ordered.
Under the IVDR most tests now need a notified body, and payment for a test is decided country by country.
IVDR class and performance evidence
The risk class sets the route; performance evaluation must stay current after launch.
Chapter 6Notified body and transition dates
Which bodies can assess an IVD, how the agreement works, and the dates that bind.
Chapter 8Payment for a test, country by country
Who applies for reimbursement of a test, who decides, and who pays.
Chapter 13Joint clinical assessment
Which IVDs the EU HTA Regulation selects, and the 100-day dossier that follows.
Chapter 12
The Launchpad route
Six phases, each ending in a goal your board can check.
For a diagnostic, the pilot is usually a laboratory or hospital evaluation that sets the terms for routine orders.
01
Strategy
Goal: first-market decision and a map of who pays
02
Regulatory
Goal: plan in place, an EU authorised representative appointed
03
Market access
Goal: reimbursement route confirmed
04
Customer pilots
Goal: a hospital pilot agreed, with the terms that turn it into a purchase
05
Launch
Goal: first purchase orders
06
Handoff
Goal: your team runs the next country
Read the evidence first
The diagnostics chapters of From CE Mark to Revenue.
Our free reference book sets out the rules each phase rests on, with every source linked.
- Read chapter 1
Qualification, device class, and roles
Whether the product is an IVD, which IVDR class applies, and who answers for it.
- Read chapter 6
Clinical and performance evidence
What performance evidence the IVDR asks for and how follow-up keeps it current.
- Read chapter 12
EU HTA Regulation: joint clinical assessment
Which IVDs fall under joint clinical assessment, and how selection works.
What happens next
- You tell us your product, its approval, and your first market
- A Senior Partner replies with the questions your board will ask
- You receive a written proposal for the phases you need
Next step
Talk to a Senior Partner about your test.
Or answer six questions in Plan your launch and see an indicative route first. A Senior Partner reads every enquiry and replies.
Talk to a Senior Partner