Clinical Needs Spec Template Stakeholder Interview Rubric Worksheet 2.1: Pathology Mapping Worksheet 2.2: Stakeholder Protocol Worksheet 2.3: Target Specifications Worksheet 3.1: Precedent Benchmarking Worksheet 4.1: Biophysical Modeling ← Syllabus Week 3
Phase 1 Master Deliverable Template · Due Week 3

Clinical Needs Specification Master Template

The official course template for compiling the Phase 1 Deliverable: Target Disease & Clinical Needs Specification Dossier. Integrates disease neuropathology, primary stakeholder interview evidence, and quantitative diagnostic performance criteria.

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Dossier Requirements: This template provides the standard section framework for your Phase 1 submission (due Week 3, Sep 11). It forms the baseline documentation that panel reviewers will grade during your Midterm Preliminary Design Review (PDR, Week 7). Complete each section rigorously with primary stakeholder citations and quantitative engineering metrics.
1 Project Identification & Team Metadata
2 Formal Clinical Need Statement
Articulate the core clinical need using the classic Stanford Biodesign formula. Do NOT prescribe your engineering mechanism yet; strictly define the problem, population, outcome, and constraint.
Formula: "A way to [PROBLEM] in [POPULATION] that [QUANTIFIABLE OUTCOME] without [CRITICAL CONSTRAINT]."
3 Neuropathology & Epidemiological Impact
4 Current Diagnostic Pathway & Unmet Need
5 Stakeholder Value Propositions (Voice of Customer)
Summarize primary insights and value propositions synthesized from your stakeholder interview protocol (Worksheet 2.2).
6 Target Product Profile (TPP) & Technical Envelope
7 Preliminary Regulatory & Risk Assessment