Biodesign: The Process of Innovating Medical Technologies

Citation

Yock, P. G., Zenios, S., Makower, J., Brinton, T. J., Kumar, U. N., Watkins, F. T. J., Denend, L., Krummel, T. M., & Kurihara, C. Q. (Eds.). (2015). Biodesign: The Process of Innovating Medical Technologies (2nd ed.). Cambridge University Press.

Chapter Summary

The book is organised around a process rather than around subject areas. Its three parts, Identify, Invent and Implement, contain six numbered stages, and each stage is divided into short numbered sections (1.1, 1.2 and so on) and closes with a case study. The Library of Congress contents note also lists three preface themes for this edition: focus on value, global perspectives and process insights. The publisher says the edition was rewritten to reflect industry globalisation and value-conscious healthcare, and that it is the work of a team of medical, engineering and business experts. The printed book is long (839 pages in the Library of Congress record; the publisher's data gives 952).

Part I, Identify: Stage 1, Needs Finding

Stage 1 has three sections: Strategic focus, Needs exploration and Need statement development. Together they move from picking a strategic focus, through exploring needs, to writing a need statement, followed by a case study.

Part I, Identify: Stage 2, Needs Screening

Stage 2 narrows the list of needs. Its sections are Disease state fundamentals, Existing solutions, Stakeholder analysis, Market analysis and Needs selection, again closing with a case study. The titles show that a need is judged against the clinical condition, current alternatives, the people affected and the market before one is chosen.

Part II, Invent: Stage 3, Concept Generation

Stage 3 contains Ideation and Initial concept selection, with a case study. It has the fewest sections of any stage.

Part II, Invent: Stage 4, Concept Screening

Stage 4 tests concepts against practical constraints before one is chosen. The sections are Intellectual property basics, Regulatory basics, Reimbursement basics, Business models, Concept exploration and testing, and Final concept selection, followed by a case study.

Part III, Implement: Stage 5, Strategy Development

Stage 5 is the largest, with nine sections: IP strategy, R&D strategy, Clinical strategy, Regulatory strategy, Quality management, Reimbursement strategy, Marketing and stakeholder strategy, Sales and distribution strategy, and Competitive advantage and business strategy. A case study follows. The section titles repeat the topics of Stage 4 (intellectual property, regulation, reimbursement), now as strategies to carry out rather than as screening tests.

Part III, Implement: Stage 6, Business Planning

The last stage has Operating plan and financial model, Strategy integration and communication, Funding approaches and Alternate pathways, with a case study. The book closes with an author-team note, image credits, a glossary and an index.

Key Concepts

Part I: Identify (Stages 1–2)

• Need statement: the written formulation of a clinical need that Stage 1 builds toward.
• Needs screening: judging candidate needs against disease state, existing solutions, stakeholders and the market.

Part II: Invent (Stages 3–4)

• Concept screening: testing concepts against intellectual property, regulatory and reimbursement basics and business models before choosing one.

Part III: Implement (Stages 5–6)

• Strategy development: IP, R&D, clinical, regulatory, quality, reimbursement, marketing, sales and competitive strategies.
• Business planning: an operating plan and financial model, funding approaches and alternate pathways.

Critical Analysis

Strengths

• A usable sequence. The contents give an explicit order from need to concept to business plan, so a team can see where it is and what comes next. The "Getting Started" sections at the end of chapters, described by the publisher, are meant to turn each lesson into action on the reader's own project.
• Breadth across disciplines. The publisher stresses authorship by medical, engineering and business experts, and the section titles span clinical need, intellectual property, regulation, reimbursement, quality, marketing, sales and financing.
• Case studies at the end of every stage. The contents list a case study for each of the six stages, and the publisher says the cases cover products from around the world, including successes and failures.
• Supporting material. The publisher lists nearly one hundred videos created for this edition, links to external sites, supplementary appendices and a companion website, accessible from within the ebook.

Limitations

• A process book, not an engineering text. The contents show no section devoted to engineering design methods or technical analysis, and the descriptions emphasise identification, screening and strategy. Readers who need engineering design methods will have to add another book.
• Orientation toward start-ups and the commercial route. The stages end in business planning, funding and alternate pathways, so the book is most useful to teams aiming to bring a product to market; a student project with no commercial ambition will use only part of it.
• Length. At more than eight hundred pages and with a full set of online resources, selecting the sections that match the project is part of the work.

Where It Fits in the Course

Biodesign is the process-and-venture book among the device-design titles. Tranquillo, Goldberg and Allen's Biomedical Engineering Design also walks a team through finding a clinical need and preparing for market, written as a student textbook, and is the closer choice for a first design course that wants engineering methods alongside the process. Ogrodnik's Medical Device Design adds classification rules, quality-management standards and regulatory requirements for Europe and the United States, while Biodesign presents regulatory and reimbursement material at the level of basics and strategy.

When a project reaches the stage of formal quality documentation, Teixeira's Design Controls for the Medical Device Industry (FDA Quality System Regulation and ISO 13485) and Elahi's Safety Risk Management for Medical Devices (ISO 14971) are focused treatments of topics that Biodesign handles as sections of Stage 5 (regulatory strategy, quality management). King, Fries and Johnson's Design of Biomedical Devices and Systems is the engineering-design and regulation reference to pair with it.

How to Use This Book

Biodesign is meant for teams: graduate and fellowship programmes, capstone design courses, clinicians and engineers at start-ups, and entrepreneurs. The site lists no technical prerequisites; some exposure to clinical settings and to either engineering or business helps.

Read it alongside an actual project, one stage at a time. Stages 1–2 (needs) are the core for any reader, because the choice of need drives everything else, and a student team should finish them before inventing anything. Stages 3–4 move from ideas to a chosen concept. Stage 5 is a reference to consult by topic, so a team can read the IP, regulatory or reimbursement sections as the questions arise, and Stage 6 is for teams producing a business plan. Read the case studies after each stage to compare your own decisions with real ones, and use the "Getting Started" sections and the companion website materials as the working checklist.