Foundations and Strategies for Medical Device Design PDF

CATS Abstract:

Cutting-edge medical device design techniques, strategies, and insights.

A complete curriculum, this practical book provides the novice design engineer of devices with a rounded exposure to unique medical device design practices. The text contains key medical device design strategies and offers real-world insights, analysis, and rationale. Foundations and Strategies for Medical Device Design contains special and specific design approaches and clear discussions on why each method works—or doesn't work—in various applications.

The book includes a common vocabulary for communicating and understanding the scientific, regulatory, and business aspects of medical device design. Detailed case studies along with enlightening anecdotes demonstrate how proper oversight can avoid missed opportunities and catastrophic failures.

Coverage includes:

• Key regulations and practices

• Thalidomide and the Dalkon Shield

• Understanding today's FDA

• Preparing a regulatory strategy

• Clinical and preclinical research

• Clinical study planning

• Kyphon and reimbursement

• Navigating codes for reimbursement

• Device-associated infections

• Designing for postmarket safety

• Designing for biocompatibility

• Designing for the use case

• The 21st-century design landscape

Author: Vikki Hazelwood, Ph.D., FNAI