Medical Device Design and Development
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Follow on Instagram for UpdatesMedical Device Design and Development Syllabus — Unit-wise Content
The official GTU curriculum for Medical Device Design and Development (subject code ME02031071) as prescribed for BE · Semester 2 divides the course into 5 units, covering 77 listed topics. The unit-wise breakdown below is read from the GTU syllabus document for this subject code, so you can check what the course actually covers before deciding which papers to attempt.
Download the official syllabus PDF (ME02031071)Unit 1 PRODUCT DESIGN
- History and Modern Practice – Designs
- Design and Product Life Cycle
- Design Process
- Medical device
- Challenges in medical device
- Understanding the innovation cycle
- Good Design Practice
- analyzing and validating user needs
- Screening Needs
- Technical Requirements
- Concept Generation – Innovation Survey Questionnaire
- Morphological Matrix, QFD, Concept Analysis and validation
- Concept Modelling
- Concept Screening & Validation
Unit 2 PRODUCT DEVELOPMENT AND REGULATORY
- Breakthrough Products
- Platform Products
- Front End of Innovations / Fuzzy Front End, Generic Product Development Process (Concept Development
- System Design
- Detailed Design
- Test & Refinement
- Production Ramp-up)
- Variants of Development Processes (Market Pull
- Technology Push
- High- Risk
- Quick Build
- Complex Systems)
- Good Documentation Practice
- Prototyping Specifications
- Medical Device standards
- Quality management systems
- Medical Device Classification
- Design of Clinical Trials
- Design Control & Regulatory Requirements
- Documentation in Medical Devices
- Regulatory pathways
- Case studies on design and development of medical devices
Unit 3 SCALABLE PRODUCT DEVELOPMENT
- Design for manufacturing
- Design for assembly
- Design for Serviceability
- Design for usability
- Medical Device Verification & Validation
- Product Testing & Regulatory compliance
- Clinical trial & validation
- Device Certification
Unit 4 MANUFACTURING AND BUSINESS STRATEGIES
- Lean Manufacturing – Toyota Production System
- Good Manufacturing Practices
- Framework for Product Strategy – Core Strategic Vision (CSV)
- Characteristics of good CSV, Opportunity Identification Process & Generating Opportunities
- Quality of Opportunities – Real-Win- Worth It (3M RWW)
- Product Planning Process
- Technology S- Curve
- Evaluating and Prioritizing Projects
- Product-Process Change Matrix
- Resource Planning
- Total Available Market (Segmentation
- Targeting & Positioning)
- ServedAvailable Market
- Product Platform Strategy
- Market Platform Plan (Product Platform Management
- Product Line Strategy)
- Program Name: Master of Engineering Level: PG Branch: Biomedical Engineering Course / Subject Code : ME02031071 Course / Subject Name : Medical Device Design and Development
Unit 5 PRODUCT ECONOMICS AND MARKET INFUSIONS
- Economics/Finance in Product Development (Sales Forecasting – ATAR Model/ Bases Model
- Pricing the product
- Cash flow in Product Development
- Categorizing the costs
- Structuring Manufacturing Costs
- Prototyping Costs
- Development Costs
- Cost Volume Profit Analysis
- Breakeven Analysis
- Common Return Metrics – Payback/ NPV/ IRR, Common Comparison Metrics – WACC/ RRR/ MARR)
- Business Model Canvas
- Marketing Channels
- Sales Models
- Post Commercialization Surveillance
- End of Life support
- Case Studies on product economics
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