Good Design Practice For Medical Devices And Equipment

Due to the direct health and safety effects they have on users, medical devices are subject to many regulations and must undergo extensive validation procedures before they are allowed on the market. Requirements formulation is one of the most important aspects of the design process because it lays the foundation for the rest of the design.

The objective of this workbook is to help people design medical devices and equipment that are easier and more economical to validate. The book has been developed to satisfy an industry need for guidance to support concurrent design development and validation.

Case histories show that the effects of releasing a device that is unfit for purpose to market can be catastrophic - for those who use the device and the manufacturer. Medical devices must be proven to be fit for purpose before they are marketed. Part of this proof is given by documenting evidence of design verification activities, which show that device design requirements have been met. This workbook - the third in the series - presents an approach for identifying and selecting verification methods, determining when verification should occur in the design process and ensuring that it is carried out within a commercially viable framework. engineers and project managers in the healthcare manufacturing industry. Readers will benefit from having had some previous experience of medical device design.

vi The process is important! I learned this lesson the hard way during my previous existence working as a design engineer with PA Consulting Group's Cambridge Technology Centre. One of my earliest assignments involved the development of a piece of labo- tory automation equipment for a major European pharmaceutical manufacturer.Two things stick in my mind from those early days – first, that the equipment was always to be ready for delivery in three weeks and,second,that being able to write well structured Pascal was not sufficient to deliver reliable software performance. Delivery was ultimately six months late,the project ran some sixty percent over budget and I gained my first promotion to Senior Engineer. At the time it puzzled me that I had been unable to predict the John Clarkson real effort required to complete the automation project – I had Reader in Engineering Design, genuinely believed that the project would be finished in three Director, Cambridge Engineering weeks.It was some years later that I discovered Kenneth Cooper's Design Centre papers describing the Rework Cycle and realised that I had been the victim of “undiscovered rework”.I quickly learned that project plans were not just inaccurate,as most project managers would attest,but often grossly misleading,bearing little resemblance to actual development practice.

The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

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 products’ 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. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance