Bringing a Medical Device to the Market
Title | Bringing a Medical Device to the Market PDF eBook |
Author | Gennadi Saiko |
Publisher | CRC Press |
Pages | 274 |
Release | 2022-09-29 |
Genre | Medical |
ISBN | 1000632180 |
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 Medical Devices to Market
Title | Bringing Medical Devices to Market PDF eBook |
Author | Charlene Cho |
Publisher | |
Pages | 389 |
Release | 2021 |
Genre | Medical instruments and apparatus |
ISBN | 9781641059718 |
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
The Changing Economics of Medical Technology
Title | The Changing Economics of Medical Technology PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 225 |
Release | 1991-02-01 |
Genre | Medical |
ISBN | 030904491X |
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Medical Devices and the Public's Health
Title | Medical Devices and the Public's Health PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 318 |
Release | 2011-10-25 |
Genre | Medical |
ISBN | 0309212456 |
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 recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Bringing Medical Devices to Market
Title | Bringing Medical Devices to Market PDF eBook |
Author | AMERICAN BAR ASSOCIATION. |
Publisher | |
Pages | 420 |
Release | 2022-05-02 |
Genre | Cooking |
ISBN | 9781641059701 |
This book guides readers through the process of bringing a new medical device from proof-of-concept to the market.
Medical Device Design
Title | Medical Device Design PDF eBook |
Author | |
Publisher | Academic Press |
Pages | 369 |
Release | 2012-12-17 |
Genre | Technology & Engineering |
ISBN | 0123919436 |
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Medical Device Regulation
Title | Medical Device Regulation PDF eBook |
Author | Elijah Wreh |
Publisher | Elsevier |
Pages | 680 |
Release | 2023-02-22 |
Genre | Technology & Engineering |
ISBN | 0323953530 |
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations