1st Edition
Bringing a Medical Device to the Market A Scientist’s Perspective
Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.
1. Introduction
Part I: Road to Market
2. Regulatory Environment
3. Prerequisites
4. Product Development Process
5. Timelines and Capital
Part II: Important Ingredients
6. Funding
7. IP and Other Moats
8. Business Model
9. Other Considerations
10. Silver Lining
Biography
Gennadi Saiko is the vice president of strategic innovations at Swift Medical Inc., Canada, and an adjunct professor at Ryerson University, Ontario, Canada. He holds an MSc (1990) and PhD (1993) in physics from the Moscow Institute of Physics and Technology, Russia. Prof. Gennadi is an accomplished scientist and entrepreneur whose record spans from world-famous research organizations to Fortune 500 companies to startups. He is an expert in bio-optics, with successful experiences in the intellectual property development and commercialization of medical devices.
