Bringing a Medical Device to the Market

Bringing a Medical Device to the Market
Author: Gennadi Saiko
Publisher: CRC Press
Total Pages: 274
Release: 2022-09-29
Genre: Medical
ISBN: 1000632180


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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.


Bringing a Medical Device to the Market
Language: en
Pages: 274
Authors: Gennadi Saiko
Categories: Medical
Type: BOOK - Published: 2022-09-29 - Publisher: CRC Press

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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. More
Bringing Medical Devices to Market
Language: en
Pages: 389
Authors: Charlene Cho
Categories: Medical instruments and apparatus
Type: BOOK - Published: 2021 - Publisher:

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"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compli
The Changing Economics of Medical Technology
Language: en
Pages: 225
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 1991-02-01 - Publisher: National Academies Press

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Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. Thi
Medical Devices and the Public's Health
Language: en
Pages: 318
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-10-25 - Publisher: National Academies Press

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In
Public Health Effectiveness of the FDA 510(k) Clearance Process
Language: en
Pages: 141
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2010-10-04 - Publisher: National Academies Press

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse