The Wonderful World of Biodesign

Biodesign: The Process of Innovating Medical Technologies, 2nd Ed.

By Paul G. Yock, Stefanos Zenios, Josh Makower, Todd J. Brinton, Uday N. Kumar, F.T. Jay Watkins, Lyn Denend, Thomas M. Krummel, and Christine Q. Kurihara, Cambridge University Press, 2015. ISBN 978-1-107- 08734-4, xiii + 840 pages, US$115.

Just as Kermit the Frog once said, “It’s not easy being green.” It is also hard to innovate and profit from inventions relating to biodesign. Biodesign: The Process of Innovating Medical Technologies does a great job of introducing the novice entrepreneur to—and preparing him or her for—the field (this novice generally being an advanced engineering, medical, or business student).

The book begins with a section introducing the prospective entrepreneur to the importance of focusing on the envisioned end product’s value and then offers some insight into the global biodesign market (six markets are detailed). The main text is divided into three parts corresponding to the development phases of a biodesign product: “Identify,” “Invent,” and “Implement.” Each of these is expanded into two substages, which are then further expanded into specific activities related to each stage for a total of 29 design/develop/build/sell/et cetera chapters.

The “Identify” section includes two subsections: “Needs Finding” and “Needs Screening.” “Needs Finding” stresses the requirement for focusing, identifying, and understanding opportunities and— the absolute necessity—finding “a way to address a problem that achieves a given outcome” [emphasis added]. The text notes that a well characterized need is “the DNA of a great invention.” “Needs Screening” involves surveying current needs and solutions (potential and extant), determining who the stakeholders might be, performing initial market analyses (who will pay?), and then winnowing the potential list of needs to be addressed.

The opening subpart of the “Invent” section, “Concept Generation,” surveys generic brainstorming, the potential use of TRIZ (the acronym for a Russian derived methodology that, in English, is often rendered as the “theory of inventive problem solving” or “TIPS”), and the possible need for initial intellectual property (IP) protection; following here is a discussion of initial concept selection processes, such as using concept maps and concept clustering techniques and developing initial acceptance criteria. The next section, “Concept Screening,” is critical and covers IP and regulatory basics [e.g., U.S. Food and Drug Administration (FDA) regulations] and concept exploration, testing, and selection, as well as reimbursement basics and business models (a topic missing from most engineering design textbooks).

At this point, slightly over halfway into the text, the “Implement” phase— ultimately, the high point of the book— is introduced. The first and particularly crucial stage covered in this section is “Strategy Development,” which comprises nine activities: IP protection, research and development, clinical testing (if necessary), regulatory hurdles (including those of the FDA and the European Union), quality management, reimbursement, marketing/ stakeholder considerations, sales and distribution, and overall business strategies. Here, the text makes glaringly obvious why the engineer or medical entrepreneur needs business colleagues, lawyers, fabricators, and area specialists to move ideas to market. This section concludes with a stage labeled “Business Planning,” which covers operating plans and financial models, pitch development, funding approaches, and alternative (funding or buyout) pathways to consider.

Overall, this is an impressive text, both comprehensive and very well written. Over 60 examples are provided to elaborate upon the authors’ essential points (one specific example cited throughout the text follows the development of Acclarent, Inc). Each chapter is well illustrated; tables, in particular, are comprehensive and valuable in terms of design considerations. Chapters are also well referenced with notes. Additional notes and other reference materials as well as excellent supplementary videos may be found at ebiodesign.org, a website developed by the authors in collaboration with other contributors. Overall, this is a very useful text for the biodesign entrepreneur.

In the education sector, I see the best primary use of this text being situations in which a multitalented team (e.g., engineers, medical students, and business students) collaborate on a year-long, fairly involved project to drive items from concept to development prior to going to market. This could involve technology transfer grant work, guided master’s or Ph.D. degree-level design/development theses and dissertations, or contract work (given adequate funding). For the entrepreneur in academia or industry (or in the garage), this text a good guide to read and to follow.