Design of Biomedical Devices and Systems

Citation

King, P. H., Fries, R. C., & Johnson, A. T. (2019). Design of Biomedical Devices and Systems (4th ed.). CRC Press.

Chapter Summary

The fourth edition runs to about 540 pages with some two dozen chapters and four appendices (a chi-squared table, percent rank tables, the 40 inventive principles with engineering parameters and conflict matrix, and a glossary). The publisher says it is a substantial revision of an established text, intended for senior design capstone courses in biomedical engineering, bioengineering, biological engineering and medical engineering, and that every chapter was updated. The contents follow a design project from first idea to product and then into the regulatory, legal and business setting. The publisher's list runs the title of the second chapter together with periods, so that title is quoted below as it appears to read.

Introduction to Biomedical Engineering Design; Fundamental Idea Generation Techniques, Process Analysis Tools, and Evaluation Methods; Design Team Management, Reporting, and Documentation

The book opens with an introduction to design, then methods for generating and evaluating ideas and for analysing a process, and then the management and documentation of a design team. These chapters supply the working methods a capstone team needs before it starts. The publisher adds that this edition has new material on the discovery of projects "worth pursuing" and on design for health care in low-resource environments.

Product Definition; Product Documentation; Product Development

Three chapters take the project from definition through documentation to development. The public contents give no detail beyond the three titles.

Hardware Development Methods and Tools; Software Development Methods and Tools

Separate chapters treat hardware and software development methods and tools.

Human Factors; Industrial Design; Biomaterials and Material Testing

These chapters cover the user and the physical form of the device, and the materials from which it is made and how they are tested.

Risk Analysis—Devices and Processes; Testing; Analysis of Test Data; Product Liability and Accident Investigations

This group covers hazard and risk analysis, testing, the analysis of test data (the chi-squared and percent rank tables in the appendices point to a statistical treatment), and the legal side of product liability and accident investigation. The publisher says the book addresses multiple safety and ethical concerns in the design of medical devices and processes.

The FDA and Devices; FDA History and Relevant Non-Device Regulations; International Regulations and Standards

Three chapters cover regulation: the Food and Drug Administration's rules for devices, its history and the regulations outside the device area that matter to designers, and international regulations and standards. The publisher says relevant FDA regulations and their effect on the designer's work were updated for this edition.

Biological Engineering Designs

A chapter on the design of biological systems, which sits alongside the publisher's note that this edition adds new material on bioengineering design and CRISPR.

Intellectual Property; Manufacturing and Quality Control; Miscellaneous Issues; Professional Issues; Concept to Product?

The closing chapters cover patents, copyrights, trade secrets and licensing, manufacturing and quality control, a chapter of miscellaneous issues, professional issues, and a final chapter whose title asks how a concept becomes a product. The publisher lists multiple case examples of entrepreneurship in the field among the features, and new material on entrepreneurship and clinical trials.

Key Concepts

Design process and teamwork

• Idea generation and evaluation methods: techniques for generating and judging ideas, with process analysis tools.
• Product definition, documentation and development: the chapters that carry a project through its stages.
• Inventive principles and conflict matrix: the appendix on the 40 inventive principles, engineering parameters and conflict matrix, a tool for resolving design conflicts.

Safety, testing and regulation

• Risk analysis for devices and processes: its own chapter.
• Analysis of test data: statistical treatment of test results, supported by the chi-squared and percent rank tables.
• FDA regulation and international standards: separate chapters on the FDA and devices, FDA history and international regulations and standards.

Business and professional context

• Intellectual property: patents, copyrights, trade secrets and licensing.
• Manufacturing and quality control, and product liability.

Critical Analysis

Strengths

• Written for the capstone course. The publisher states the intended use, senior design capstone courses, and the contents follow the course's arc from idea generation and teamwork through development, testing and regulation to manufacture and professional practice.
• Regulation, liability and intellectual property are all covered. Chapters on the FDA, international standards, product liability and accident investigation, and intellectual property bring together topics that a design team meets late in a project.
• Authors with industry and teaching experience. The author biographies describe Paul King as an emeritus professor at Vanderbilt with some thirty-five years as an instructor and practitioner in the medical device industry, Richard Fries as a medical device designer since 1978 holding over twenty patents, and Arthur Johnson as an emeritus professor at the University of Maryland who has taught medical device and human factors courses.
• Current additions. For this edition the publisher lists new material on entrepreneurship, bioengineering design, clinical trials and CRISPR, more examples including 3D printing, and updated FDA regulations, with case examples of entrepreneurship.

Limitations

• Breadth over depth. About two dozen chapters on topics from human factors to patents mean that each is introductory; teams that need to follow design controls or risk management in detail will want dedicated texts.
• Some chapters read as collections. Titles such as Miscellaneous Issues and Professional Issues suggest a collection of topics rather than a single thread.
• United States regulatory emphasis. Two FDA chapters sit beside one on international regulations and standards, so the regulatory material leans toward the United States.
• Little public detail below chapter level. The public contents are chapter titles only; how deep the statistical, risk and regulatory chapters go is not shown.

Where It Fits in the Course

King, Fries and Johnson is the engineering-design and regulation reference for a capstone course. Yock and colleagues' Biodesign is the process-and-venture companion: it organises a project into needs, concepts and implementation stages and ends in business planning and funding, whereas King and colleagues give more attention to the engineering and regulatory chapters. Tranquillo, Goldberg and Allen's Biomedical Engineering Design is a student textbook that walks a team through the whole process from finding a clinical need to preparing for market, and Ogrodnik's Medical Device Design combines design method with classification rules, quality-management standards and regulatory requirements in Europe and the United States.

Two specialised books go deeper than any single chapter here: Teixeira's Design Controls for the Medical Device Industry explains the design control requirements of the FDA Quality System Regulation and ISO 13485, and Elahi's Safety Risk Management for Medical Devices is organised around ISO 14971.

How to Use This Book

The book is for senior students in biomedical engineering, bioengineering, biological engineering and medical engineering taking a capstone design course, and for engineers entering the medical device industry. The publisher states no prerequisites; a general engineering background, and basic statistics for the testing and data-analysis chapters, are sensible preparation.

In a capstone course, read the opening three chapters (introduction, idea generation and evaluation, team management and documentation) at the start of the project and use the product definition, documentation and development chapters as the project advances. Human factors, risk analysis, testing and the data-analysis chapter belong in the middle of the project, and the FDA, international regulation, intellectual property and manufacturing chapters before the design review. Treat the final chapters as reading for professional practice, and use the appendix tables and the glossary as reference while working.