Venky Gopalaswamy

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field. Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner. Specifically, this text explores the process from start to finish, establishing a workable design and development plan complete with relevant definitions. It reviews FDA and other regulatory expectations and covers resource requirements, manufacturing pitfalls, post-launch compliance requirements, and agency audits and challenges. Drawing on the experience and expertise of two leaders in their respective fields, Combination Products boasts the credentials of Dr. Smita Gopalaswamy, a 20 year veteran of technical consulting responsibilities in medical device, biologics, and pharmaceutical industries as well as combination products, along with the support of Dr. Venky Gopalaswamy, an expert in business improvement methodologies such as six sigma, lean, and change management, to provide a comprehensive assessment of the field and an efficient and effective approach to the creation and implementation of combination products.