Bringing a Medical device to the market:
a scientist's perspective
by Gennadi Saiko
from the author
Many of us in science have this “Aha!” moment when a mental puzzle is put together and we get a clear picture of a product that will change the world. Moreover, we have a clear understanding of how it can be a commercial success. So, we decide to start a new company, a startup, and have a clear path to success. However, soon we come face to face with reality, where things are much more complicated. Only a minute fraction of startups survive and become successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this one is specifically about startups on medical devices, which are very different from the others. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.
Dr. Sohaib Siddiqui
BSc, MB, BCh, BAO, LRCPI, LRCSI
Managing Partner, Kettlebeck Ventures
"We have seen a tremendous rise of the healthcare innovation economy, which was certainly accelerated by the pandemic. Despite this 'gold rush' of new ideas and innovation, the sector remains as daunting and competitive as ever. This book is a clear structured guide for anyone who plans on building a med device company or any healthcare company. This is the type of 101 boot camp that I would recommend to any one of my future portfolio companies. "
George A. Perdrizet, ME, PhD, FACS
"Dr. Gennnadi Saiko has assembled, in a single volume, a very detailed and practical treatise on the steps required to bring a medical device from initial concept to final marketplaceDr. Saiko possesses a powerful combination of practical experience and formal training which enables him to write this useful and valuable resource.This document has a sharp focus on medical devices that will immediately enhance the readers’ future success at medical device commercialization. It outlines, step-by-step, the complex processes involved in bringing a medical device to market. Included is clear information on the FDA-regulatory environment and its navigation. The chapters on funding sources and stages, as well as onbusiness models provide added practical guidance and benefit.Overall this document will efficiently educate and inform those venturing to take their “first jump” into bringing a medical device to market. Review of this document will be time well invested and permit the reader to jump start the process in an efficient manner.Highly recommended."
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