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Fundamentals of design practice for medical devices

Fundamentals of design practice for medical devices. MEGN536 - Fall 2014 Prof. Jered Dean. Overview. ( 1) Customer needs (2) That originating requirements come directly from customer needs (FCR Title 21 requires Validation which proves this for FDA products)

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Fundamentals of design practice for medical devices

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  1. Fundamentals of design practicefor medical devices MEGN536 - Fall 2014Prof. Jered Dean

  2. Overview • (1) Customer needs • (2) That originating requirements come directly from customer needs (FCR Title 21 requires Validation which proves this for FDA products) • (3) Originating requirements include both constraints (physical limitations) and functions (how it works) • (4) All requirements and functions must be verified (per FCR Title 21) • (5) You need to figure out the above (to some level of refinement) before working on form/physical architecture • (6) I'll wrap up with the V-Diagram and how it plays nicely with Title 21 and is one way to stitch 1-5 together logically

  3. Design Process – High Level

  4. Medical Device Regulation • Title 21 • Defines the controls and reviews needed for medical device design • ” for medical device manufacturing • Knee Specific Regulation: • ASTM F2083 - 12 - Standard Specification for Knee Replacement Prosthesis • Misc. ASTM materials standards for implanted devices • Others?

  5. The V-Diagram Lab Research User Analysis Functions and Constraints Validation Concepts and Form Verification Detailed Design

  6. Needs Analysis • Who are your stakeholders? • What are their needs? • Typically you would go out and gather data, for this design project you will have to try to imagine their needs. • Create a list of stake holders and try filling out their SPICE Source: Fraser, H., Design Works, Rotman-UTP Publishing, 2012

  7. To Completely Specify a System… • Ok, so you have some generic needs…you can’t design to those! • Time to turn needs into requirements • You must precisely specify and understand: • Control (Functional Behavior) • Performance (Performance Indexes/Requirements) • Data and Interfaces (Input/Output) • Physical Architecture (System/Component)

  8. The V-Diagram Lab Research User Analysis Functions and Constraints Validation Concepts and Form Verification Detailed Design

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