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Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition, by Elaine Whitmore
Free PDF Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition, by Elaine Whitmore
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Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem.
The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development.
The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences.
Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates.
- Sales Rank: #1581165 in eBooks
- Published on: 2012-03-20
- Released on: 2012-03-20
- Format: Kindle eBook
Most helpful customer reviews
1 of 1 people found the following review helpful.
A Must Read for any Healthcare Professional
By Tyler
The updated version of this book provides new insight into the development of medical products in changing times, where regulation now takes longer to pass through than development. This is really a beginners overview of the process, so if you work in the industry some of the chapters may seem a bit simple and lacking in content. Overall it is a great read for anyone (especially healthcare providers) that want to know more about how medical devices are regulated.
5 of 5 people found the following review helpful.
Finally, Someone gets it right!
By Joseph P. Sener
I have been working in medical device design and design assurance for over 10 years. I have been having the fight and argument with management that "of course it is harder to do it right than not but your current approach has really not worked so well!!!
Elaine Whitmore really gets this right. The one paragraph that really got me ranting is on page 80: "A significant challenge for anyone working in product development in the healthcare field, especially with medical devices where stringent controls and requirements are a relatively new issue, is overcoming a bad attitude." "...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations."
I am going to have to buy several copies of this for my clients!
3 of 3 people found the following review helpful.
Essential guide for medical product management, investors, scientists and engineers
By David M. Wiseman
Dr. Whitmore exposes a raw nerve too long protected by the bubble that has been the biotech boom of the last 20 or so years. In her opening salvo she observes "there is no lack of innovation or shortage of important scientific discoveries in this country, but our ability to transform scientific advances into new and effective medical products has been disappointing."
In attempting to pinpoint the reason for the gap between expectations and actual productivity, Dr. Whitmore rounds up the usual suspects of outdated clinical trial models, and an inefficient system of regulation, but reserves the focus of her scrutiny on the way in which investment money is spent and in the product development process itself.
The days when Big Pharma or Big Device companies funded their own internal R&D have dwindled, the mammoths now choosing for the most part to outsource their innovation and early stage product development to a larger, more diverse pool of start-ups whose investors assume much of the risk. Although this system provides the opportunity for more innovation in small companies unconstrained by Big Pharma bureaucracy, the focus of risk imposes pressures on the start-up either to cut corners or to abandon prematurely perfectly good avenues of innovation.
There has to be a better way.
Invoking the term "Translational Research", i.e. the methods used to accelerate the path of a scientific discovery from the bench to the patient, Dr. Whitmore dissects the entire process, charting the path needed to ensure success and, more importantly needed to avoid the "Valley of Death", that graveyard of innovations that have failed to implant, gestate or deliver.
Dr. Whitmore's subtext is that there are no shortcuts, but there are smarter ways to navigate the path to success. Her guidebook not only provides beacons for the scientist, engineer or innovator, but a guidebook for investors and management who can better understand the challenges and more appropriately balance their risks and expectations.
The style is clear and concise and achieves its goal of helping to "provide a shared foundation from which cross-functional participants...can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products."
Should be required reading for anyone in the industry.
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