Nmblr Proof Step 1: Evidence Needs
What you’re trying to achieve
Turn each outcome opportunity (tagged as Clinical differentiation / Regulatory / Value story / Positioning) into a small set of decision-critical questions the team must answer.
How to approach it (facilitator guidance)
Set the frame for each outcome opportunity
Remind the group: “We’re not designing studies yet. First, we agree the questions we must be able to answer.”
Brainstorm KBQs by category
Invite the team to generate questions that match the value category tags for the outcome opportunity:
- Clinical differentiation: What would clinicians need to see to believe we’re meaningfully better?
- Regulatory: What questions must be answered to support approval/label/claims and de-risk review?
- Value story: What must payers/HTA believe to reimburse and recommend?
- Positioning: What must be true to clarify where we win, for whom, and why?
Force KBQs into question form (decision-ready)
Use prompts that keep the questions sharp:
- “In which patients does X improve vs. standard of care, and by how much?”
- “Compared to what, on what endpoints, over what timeframe?”
- “What would change a decision if we knew the answer?”
Have decision-makers finalize the KBQs
This is the “commitment moment.” Get the team to agree the few KBQs that truly matter:
- “If we could answer only 2–4 questions for this outcome, which would they be?”
- “Which unanswered question would most delay or weaken our next decision?”
Keep KBQs living, not frozen
Make it explicit that KBQs can be:
- Added when strategy or stakeholder needs shift
- Archived when no longer relevant
Output
A summary of the finalized list of decision-critical KBQs, each tagged to the category (or categories) it serves.