Chapter category: BioMaterials
Product Development in a Small Company Environment
Biomaterials in the Design and Reliability of Medical Devices
Edited by: Michael N. HelmusISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «
Chapter authors:
Roger W. Snyder
A small company, particularly a start-up operation, is an exciting, and often stressful, environment. If the company has a limited number of products, all under development, there is always pressure to get those products to market as soon as possible to generate sales and income. If the new device is also a new concept, the excitement of developing the product adds to the feeling of urgency. In this environment of excitement and pressure, it is easy to concentrate on the day-to-day problems and difficult to look ahead. However, decisions made in the early phases of product development can have major impact on the success of product commercialization. Neglecting to initiate certain tasks early in the development process can significantly increase the time (and the cost) of getting your device to market. We discuss a number of case histories in this article that illustrate this point. These examples are real, but are not intended to be all-inclusive. They are used to illustrate pitfalls that small companies have encountered. Much of the data required for patent filings and FDA applications are completed during the early phases of product development. Some of this same data is also useful for specification development, process validation, and possibly in future lawsuits. One of the most important and most overlooked aspects of product development in a small company environment is good record keeping. In the rush to fabricate samples of a new product and to develop the necessary processes, it is tempting to skip the recording of experiments and proposed design specifications. This missing information may be important at a later date. The risk of losing valuable information is high. The time required to get a product to market can actually be lengthened. since experiments will have to be repeated if pertinent information is missing.
Additional chapters from this book:
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Tissue Engineering Constructs and Commercialization
Kelvin G.M. Brockbank
Tissue engineering is an interdisciplinary field that applies the principles of engineering (materials science and biomedical engineering) and the life sciences (biochemistry, genetics, cell and mol...
Product Development in a Small Company Environment
Roger W. Snyder
A small company, particularly a start-up operation, is an exciting, and often stressful, environment. If the company has a limited number of products, all under development, there is always pressure...
Failure Analysis: Learning for the Future from the Past
Michael N. Helmus
One of the most important tasks a medical device manufacturer can make is to have a detailed methodology in place for explant analysis. The ability to examine the device for both adverse biological ...
Nonclinical Medical Device Testing
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument...
Regulation of Medical Devices
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufactur...
Standards and Guidelines for Biocompatibility of Medical Devices
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirement...
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be ...
