Five questions before you trust your launch advice.

Useful launch advice should identify the local assumptions behind a recommendation, explain what could challenge them and show which management decision would change. A convincing presentation is only the starting point.

Before entering a new European life sciences market, executives need to distinguish informed local judgement from a strategy that could have been written for almost any country. These five questions provide a practical way to challenge the advice without having to become the local expert yourself.

1. Which local assumption is most likely to fail first?

“Payers may challenge the price” is too broad to guide a decision. Ask which assumption is vulnerable: comparator choice, endpoint relevance, budget impact, treatment pathway, procurement process or intended place in therapy.

A useful answer identifies the specific issue, explains the evidence behind the concern and describes what should be tested next. It also distinguishes a documented requirement from an experienced adviser’s interpretation.

2. Who can influence adoption before formal access?

A list headed “KOLs and payers” is not a stakeholder strategy. Ask which clinical groups, hospital stakeholders, pharmacists, patient organisations and budget holders can influence how the product’s role is understood.

The answer should explain their role in the care pathway and the questions they are likely to raise. It should also show where the team needs genuine input, rather than assuming that stakeholder engagement means delivering a message that has already been finalised.

3. What evidence may be challenged locally?

Good advice examines the limitations as well as the strengths of a data package. Which endpoints, comparators, subgroups, real-world evidence gaps or economic assumptions may attract questions in the intended market?

Ask what additional work could resolve the uncertainty and whether it can still affect development or launch decisions. An adviser should be comfortable saying where the available information does not yet support a firm conclusion.

4. Is country sequencing based on access readiness or market size?

A large potential market is not automatically the best first market. Compare the opportunity with evidence fit, the access route, operational requirements, stakeholder understanding and the resources required to execute.

Ask why the proposed sequence is preferable to a realistic alternative. A useful recommendation makes the trade-offs explicit and identifies the conditions under which the sequence should change.

5. What are competitors already shaping?

A competitor table should go beyond products that are approved, priced or reimbursed. Ask how competitors may affect guidelines, treatment habits, procurement expectations, price references and the evolving standard of care.

The answer should separate observable developments from speculation. It should also consider the environment at the expected launch date, rather than assuming that today’s market will remain unchanged.

Turn the answers into a quality test

For each recommendation, ask: what would make it wrong? Who locally might disagree? Which assumption should be tested first? What management decision changes if the advice is correct?

In the Benelux, apply those questions to the specific country and care setting. Regional experience is valuable, but an answer should still explain the relevant local differences. The strongest advisers connect practical experience with evidence and are clear about the limits of both.

Health Devotion uses focused feasibility work to help leadership teams test launch assumptions. Explore our Market Exploration & Validation services or discuss the questions behind your launch plan.

About the author: Ivo Vink, Health Devotion. This article presents a practical framework for assessing launch advice.