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Exploring the essence of design in biomedical engineering, covering key topics such as product development, system optimization, regulations, and innovation. Learn the fundamentals and importance of design processes in this comprehensive guide.
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What is Design? • Is NOT research or craftsmanship! • Involves devices, processes, re-engineering, systems, optimization, regulations, finances, innovation, invention, entrepreneurship, etc.
Design • Verb: invent, intend, devise • Noun: drawing, arrangement, pattern, plan, art of making designs
Basic but Essential Questions • Who? • What? • Where? • When? • Why? • How? Their Job? Well, yes, but also…….. Your Job
Flow Diagram What, Who, Where, When, Why What, Who, Where, When, Why What, Who, Where, When, Why, How How No No Go/ no-go Yes How
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, …)
Design: NAS • Mission requirements analysis/Product system strategy - high level engineering analysis - requirements definition
Design: NAS • Product specification - product strategy - voice of the customer!!! (QFD, etc.) - environment (EPA) & regulatory (FDA!!!) - planned product specification
Design: NAS • Concept development - target setting (cost, schedule, performance, etc.) - brainstorming on product & process alternatives - development of product and process concepts.
Design: NAS • Preliminary Product and/or Process design - high level definition of product and process designs - evaluation of same v. targets - high level system trade-offs
Design: NAS • Refinement & verification of detail product and process designs - development of designs for components, subsystems & manufacturing - Geometry creation - prediction & evaluation of attributes - tracking & trade-offs
Design: NAS • System Prototype Development - experimental evaluation of attributes that do not meet target values • Preparation for production - refine process for manufacture • Production, Testing, Certification, Delivery • Operation, support, decommissioning, disposal
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