長庚大學 Chang Gung University
BIODESIGNBiomedical Design & Innovation
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[115-1 CGU STB Biodesign] Healthcare Innovation Bootcamp

115-1 / CGU STB BIODESIGN

Six days from a clinical pain point
to a testable medical device.

Six full days across three phases, starting at the Linkou CGMH bedside. Free to attend — for clinicians, engineers, designers, and students.

  • Free
  • Lunch included
  • Certificate
  • Clinical fieldwork
6teaching days
36hours
7hospital branches
0registration fee
SCHEDULE AT A GLANCE

Know exactly which days to show up

ALL SIX ON WEEKENDS

Six full days, 09:00–17:00 — work-friendly.

Day 1Identify
1411/
六

Needs Finding

09:00–17:00
Day 2Identify
2911/
日

Needs Characterization

09:00–17:00
Day 3Invent
1212/
六

Concept Generation

09:00–17:00
Day 4Invent
2012/
日

Rapid Prototyping

09:00–17:00
Day 5Implement
1001/
日2027

IP & Clinical Strategy

09:00–17:00
Day 6Implement
1601/
六2027

From Insight to Impact

09:00–17:00
Nov 16 – Nov 27Clinical immersion (dates TBC)

A flexible two-week window for bedside observation and interviews, guided by clinical mentors.

  • Identify2 days
  • Invent2 days
  • Implement2 days
DAY-BY-DAY SYLLABUS

Open a day for the full detail

Methodology in the morning, hands-on work in the afternoon, with concrete deliverables each day.

0111/14六Needs Finding
Morning09:00–12:00
Biodesign Introduction & Needs Finding

Prof. Ting-Ting Yeh (Center Director)

  • 1. Biodesign Identify - Invent - Implement Framework
  • 2. Needs-driven innovation methodology & clinical case studies
  • 3. Principles of clinical needs finding
  • 4. Anatomy and criteria of a well-defined Need Statement
Afternoon14:00–17:00
Clinical Observation & Interview Skills

Prof. Shih-Ying Chien (Industrial Design)

  • 1. Clinical observation methodologies in hospital environments
  • 2. Interview techniques, stakeholder communication & research ethics
  • 3. Workflow and patient journey mapping
  • 4. Observation worksheet hands-on practice
  • 5. Pre-immersion preparation and observational assignment briefing
You leave with
  • Observation Plan
  • Interview Guide
  • Need Statement Exercise
0211/29日Needs Characterization
Morning09:00–12:00
Needs Characterization

Mr. Alvin Chua (Singapore Biodesign)

  • 1. Clinical immersion debrief & experience synthesis
  • 2. Structuring and consolidating needs candidates
  • 3. Formulating Need Statements: Population - Problem - Outcome
  • 4. Disease state fundamentals & patient care pathways
  • 5. Stakeholder mapping & alignment analysis
Afternoon14:00–17:00
Needs Screening & Validation

Mr. Jing Ming Chew (Singapore Biodesign)

  • 1. Existing solutions, gold standards & competing approaches
  • 2. Quantifying clinical impact and measurable outcomes
  • 3. Market sizing & competitive landscape assessment
  • 4. Defining rigorous Need Screening Criteria
  • 5. Team scoring matrix & Gate Review stage-gate decisions
You leave with
  • Top 3 Prioritized Needs (down from 10+)
  • Need Screening Matrix
0312/12六Concept Generation
Morning09:00–12:00
Concept Generation

Prof. Tsung-Hsun Hsieh (Physical Therapy)

  • 1. Translating needs into design requirements
  • 2. How Might We (HMW) reframing prompts
  • 3. Structured brainstorming techniques & mental models
  • 4. Divergent ideation across Device, Digital, AI & Service models
  • 5. Strategies to avoid premature solution lock-in
Afternoon14:00–17:00
Concept Screening & Selection

Prof. Tsung-Hsun Hsieh (Physical Therapy)

  • 1. Defining Concept Screening Criteria
  • 2. Hands-on scoring with Pugh Decision Matrix
  • 3. Clinical usability & ergonomic feasibility assessment
  • 4. Technical feasibility & prototyping considerations
  • 5. Integrating preliminary IP, regulatory & commercial factors
You leave with
  • Lead Concept + Backup Concept (selected from 10+ generated ideas)
0412/20日Rapid Prototyping
Morning09:00–12:00
Rapid Prototyping

Dr. Chien-Li Ma (Medical Prototyping)

  • 1. Purpose, tiers & validation milestones of prototypes
  • 2. Identifying & ranking critical design assumptions
  • 3. Low-fidelity rapid prototyping techniques
  • 4. MVP (Minimum Viable Product) & Proof of Concept models
  • 5. Build - Test - Learn rapid iterative sprint philosophy
Afternoon14:00–17:00
Test, Feedback & Iteration

Dr. Chien-Li Ma (Medical Prototyping)

  • 1. Simulation test design & benchtop setup
  • 2. Usability testing protocols & behavioral observation
  • 3. Analyzing clinical feedback & qualitative user insights
  • 4. Core distinction: Verification vs. Validation in medical devices
  • 5. Prototyping iteration & performance refinement
You leave with
  • Physical Prototype v1/v2
  • Testing & Validation Plan
  • User Feedback Record
0501/10日IP & Clinical Strategy
Morning09:00–12:00
IP, Regulatory & Clinical Strategy

Prof. Shao-Hsuan Chang (Biomedical Engineering)

  • 1. IP landscape, patent novelty search & drafting strategy
  • 2. Freedom-to-Operate (FTO) principles & risk mitigation
  • 3. TFDA & US FDA device classification and clearance pathways
  • 4. Clinical evidence generation & trial strategy
  • 5. Regulatory considerations for Medical AI & SaMD
Afternoon14:00–17:00
Market Access & Business Strategy

Mr. Chun-Jen Liao (Medtech Commercialization)

  • 1. Who uses / buys / pays? Healthcare buyer persona analysis
  • 2. Reimbursement, NHI coding & private insurance landscapes
  • 3. Market sizing calculations (TAM, SAM, SOM)
  • 4. Business Model Canvas for healthcare ventures
  • 5. Pricing models & Go-to-Market channel strategy
  • 6. Early-stage funding, venture capital & grant navigation
You leave with
  • Translation Roadmap
  • Validated Business Model Canvas
  • Market Access Strategy
0601/16六From Insight to Impact
Morning09:00–12:00
From Innovation to Impact

Dr. Chien-Hung Liao (Physician Innovator)

  • 1. Commercialization roadmap & regulatory milestones
  • 2. Strategic choices: Startup spin-off vs. Patent licensing
  • 3. Translational development timeline & resource allocation
  • 4. Financial projections & break-even forecasting
  • 5. Early-stage pitch deck anatomy & storytelling strategies
  • 6. Effective delivery for investors, physicians, and executives
Afternoon14:00–17:00
CGU Biodesign Demo Day & Final Pitch

Dean Ching-Shiun Chen, Dir. Chih-Hao Chen, Dr. Chien-Hung Liao & International Judges

  • 1. Hands-on physical prototype demonstrations
  • 2. Final Pitch presentations by student & professional teams
  • 3. Multi-stakeholder evaluation: Clinicians, Industry executives, OTDIL & VCs
  • 4. In-depth panel feedback and strategic critique
  • 5. Go / Pivot / Stop determinations & incubation transition planning
You leave with
  • Final Validated Prototype
  • Investor Pitch Deck
  • 12–18 Month Post-Bootcamp Action Plan
CHANG GUNG UNIVERSITY

Where medicine, engineering, and management meet — the foundation of CGU Biodesign.

Guided by the motto “Diligence and Simplicity,” CGU combines a pragmatic industrial ethos with the clinical capacity of the Chang Gung healthcare system.

3University alliance
7Hospital branches
8Principal investigators
36Hours of bootcamp