Biodesign: The Process of Innovating Medical Technologies

Everything you ever wanted to know about medical device entrepreneurship and more. Paul, Josh and Stefanos have led an A class team of experienced device company builders to produce a reference document to guide an aspiring device entrepreneur through all the challenges of getting an idea to market. These are tough times. Whether you’™re a physician with an idea, an engineer or a businessman, this is a unique and powerful resource.

Biodesign: The Process of Innovating New Medical Technologies is direct, clear and simultaneously sophisticated yet practical as it unravels the many issues related to successfully navigating the entire biodesign path from concept to final product launch. I highly recommend that anyone seriously interested in developing an entrepreneurial venture in the medical products field read this book. It is likely to spare budding entrepreneurs a lot of trial-and-error and painful on-the-job training.

Biodesign is a handbook for medical device entrepreneurs based upon the key premise that innovation is a process and skill that can be learned. Furthermore, the key to medical device innovation is getting the clinical need in correct focus. This book will walk the student through the innovation process from how to properly define the clinical need all the way through getting the company funded and developing a quality product. Important topics like the FDA regulatory process, patents, ethics, quality and manufacturing are addressed. I don’™t know of any other text that has the wealth of practical and usable information on the entrepreneurial process as Biodesign. This is a much needed ‘˜how-to’™ book written by people who actually have done it many times themselves. No thirty-thousand foot views necessary or appropriate here. Each chapter has a ‘getting started’ section that will help guide the budding entrepreneur through the necessary steps. This book should be required reading for anyone wanting to develop a new medical device or to start a new company in the medical field.