1. Introduction to Biomedical Engineering Design Chapter 1

2. What is Design? Is NOT research or craftsmanship! Involves devices, processes, re-engineering, systems, optimization, regulations, finances, innovation, invention, entrepreneurship, etc.

3. Verb: invent, intend, devise Noun: drawing, arrangement, pattern, plan, art of making designs

4. For What Uses Might Products be Designed?

5. Basic but Essential Questions Who? What? Where? When? Why? How? Your Job Their Job? Well, yes, but also……..

6. Flow Diagram What, Who, Where, When, Why What, Who, Where, When, Why What, Who, Where, When, Why, How How Go/ no-go How No Yes

7. Design: National Academy of Science Product refers to hardware, service, or mission. Process refers to the means by which a product is manufactured and supported Development refers to the refinement of products and processes to correct problems. (Re-engineering, sometimes reverse engineering, …)

8. Design: NAS 1.Mission requirements analysis/Product system strategy - high level engineering analysis - requirements definition

9. Design: NAS 2.Product specification - product strategy - voice of the customer!!! (QFD, etc.) - environment (EPA) & regulatory (FDA!!!) - planned product specification

10. Design: NAS 3. Concept development - target setting (cost, schedule, performance, etc.) - brainstorming on product & process alternatives - development of product and process concepts.

11. Design: NAS 4.Preliminary Product and/or Process design - high level definition of product and process designs - evaluation of same v. targets - high level system trade-offs

12. Design: NAS 5.Refinement & verification of detail product and process designs - development of designs for components, subsystems & manufacturing - Geometry creation - prediction & evaluation of attributes - tracking & trade-offs

13. Design: NAS 6.System Prototype Development - experimental evaluation of attributes that do not meet target values 7.Preparation for production - refine process for manufacture 8.Production, Testing, Certification, Delivery 9.Operation, support, decommissioning, disposal

14. Other Design Concerns Retracing if problem is ill defined Excessive documentation Human patients, animal studies, permissions Design is often iterative Delving into already patented info bases Teamwork, finances, reality Watch – Wed PM