---
name: method-selection
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.
---

# 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.
