Medical Device Design
Innovation from concept to market
- Peter Ogrodnik, Professor of Engineering Design at Staffordshire University (UK) and co-founder of Intelligent Orthopaedics Ltd.
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their productsâ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through to commercialization and FDA/regulatory approval.