FUNDAMENTALS OF DESIGN PRACTICE FOR MEDICAL DEVICES MEGN536 - Fall 2015 Courtesy of Prof. Jered Dean.

FUNDAMENTALS OF DESIGN PRACTICEFOR MEDICAL DEVICES

MEGN536 - Fall 2015Courtesy of 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)

‣ (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

Design Process – High Level

User Needs

Function Definition

Form Definition

Detailed Design

Implement

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?

The V-Diagram

Lab ResearchUser Analysis

Functions and Constraints

Concepts and Form

Verification

Validation

Detailed Design

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

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)

The V-Diagram

Lab ResearchUser Analysis

Functions and Constraints

Concepts and Form

Verification

Validation

Detailed Design