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