4.0 KiB
name, description
| name | description |
|---|---|
| method-selection | Selects the appropriate research framework and analytical tools for biomedical, market, investment, CMC/GMP, clinical, R&D, BD, and management consulting topics instead of defaulting to MECE or McKinsey-style framing. |
Method Selection
Use this skill before Phase 0-1 framing and whenever the user changes the report purpose.
Principle
Do not default to McKinsey/MECE. MECE, SCQA, and pyramid writing are useful communication tools, not universal research methods.
Select the method based on:
- report purpose
- audience
- decision to support
- available materials
- evidence type
- regulatory or scientific risk
- output format
Method Router
Market, investment, or commercial strategy
Use when the user asks about market opportunity, competition, investment thesis, BD opportunity, pricing, or commercialization.
Methods and tools:
- market sizing: TAM/SAM/SOM, bottom-up demand model, volume-price bridge
- competitive landscape: segmentation, product differentiation, launch timing, share shifts
- value chain: upstream supply, manufacturing bottlenecks, channel economics
- investment: thesis tree, scenario analysis, sensitivity analysis, risk-adjusted NPV where feasible
- transaction/BD: deal comps, licensing terms, patent cliff, strategic fit
Outputs:
- market map
- competitor table
- assumptions ledger
- upside/base/downside scenarios
Clinical, translational, or evidence review
Use when the topic is efficacy, safety, trial design, disease area, standard of care, biomarker, or clinical development.
Methods and tools:
- PICO or PICOTS framing
- evidence hierarchy
- endpoint and comparator analysis
- trial design critique
- TPP and go/no-go criteria
- benefit-risk assessment
Outputs:
- clinical evidence matrix
- trial landscape
- endpoint comparability table
- evidence gaps and patient-selection risks
CMC, GMP, quality, or manufacturing operations
Use when the topic involves process development, tech transfer, validation, inspection readiness, deviations, CAPA, sterility assurance, supply chain, or manufacturing risk.
Methods and tools:
- ICH / FDA / EMA / NMPA regulatory baseline mapping
- gap assessment
- FMEA or risk matrix
- process validation lifecycle
- control strategy mapping
- deviation/CAPA effectiveness review
- data integrity assessment
Outputs:
- gap register
- risk heatmap
- CAPA prioritization
- control strategy map
- readiness scorecard
R&D feasibility or technology assessment
Use when the topic asks whether a technology, target, modality, platform, assay, or process is feasible.
Methods and tools:
- technology readiness level
- critical path analysis
- mechanism and modality fit
- experiment roadmap
- scale-up risk assessment
- IP and freedom-to-operate screening
Outputs:
- feasibility scorecard
- key experiments
- kill criteria
- technical risk register
Management, organization, or operating model
Use when the topic involves organization, governance, operating cadence, capability building, performance management, or transformation.
Methods and tools:
- issue tree
- operating model design
- RACI / decision rights
- KPI tree
- process maturity assessment
- change management roadmap
Outputs:
- operating model options
- capability gap assessment
- implementation roadmap
- KPI and governance model
Policy, regulation, or access environment
Use when the topic asks about policy, reimbursement, regulatory pathways, pricing access, or regional rules.
Methods and tools:
- policy timeline
- stakeholder map
- regulatory pathway comparison
- access and reimbursement framework
- scenario analysis by jurisdiction
Outputs:
- jurisdiction comparison
- policy impact map
- regulatory milestone table
- access risks
Phase 0-1 Output Requirements
Write a method decision note in phase1/research_brief.md:
- selected method
- why it fits
- methods rejected and why
- evidence types needed
- search routes
- expected output artifacts
If the topic spans multiple scenarios, combine methods explicitly and define which chapters use which method.