Implantable Medical Devices and Biocompatible Materials Industry Review

BCC Research
June 1, 2000
231 Pages - SKU: WA810
License type:
Table of Contents Related Reports
Countries covered: United States

Implantable Medical Devices and Biocompatible Materials Industry Review

 
Surgeons use implantable medical devices to save patients' lives or to improve their quality of life. This report focuses on a wide variety of implantable devices available today for treating diseases, deformities and trauma. Materials used to make implantable devices and accessories are explored at length, along with biocompatibility testing methods, standards and regulations. For each device category, competitive climates are described and key manufacturers are profiled. Current market positions for U.S. and foreign competitors are explored and forecasts to 2003 are included.



Additional Information

STUDY GOALS AND OBJECTIVES

This report examines the competitive climate of the U.S. medical implant industry in the international marketplace. It is an analytical business tool whose primary purpose is to systematically reveal the challenges and opportunities provided by the industry at this point in time. The information contained in this report will provide a look at one of the fastest growing industries in the world.

REASONS FOR DOING THE STUDY

In the medical implant industry, acquisitions, mergers and alliances frequently occur. This means that the corporate landscape is always shifting and changing the competitive positioning of manufacturers. Moreover, implant devices are among the more advanced medical technologies available today and are becoming more so with every new innovation in the industry. Consequently, the state of the industry must be updated more frequently than most other businesses.

CONTRIBUTIONS OF THE STUDY

For an industry that can literally change overnight, up-to-the-minute information is imperative. Proprietary information is difficult to come by in an industry driven by innovation and intellectual property. In this report, new technology is presented in the context of current implant products on the market today in the U.S. and internationally, and in light of competitive research and development when known.

This report also provides information for manufacturers, distributors, exporters, suppliers of raw materials, researchers, regulatory specialists, investors, or anyone else interested in an industry analysis.

AUDIENCE FOR THE STUDY

This study is targeted at manufacturers, distributors and suppliers of medical implant devices for the domestic and international market. This report also is relevant for researchers and product developers who need to know what is available on the market today and what research is being done to bring new products to market.

SCOPE AND FORMAT

Today, there are many artificial implant devices available that have been designed to replace a number of body parts. These include a battery-powered artificial larynx; synthetic ears, noses and throats; penile implant and testicular prostheses, temporomandibular joint (TMJ) prosthesis, esophageal and tracheal prostheses; and fallopian tube prosthesis, to name a few. New implantable devices are continuously being developed, and most recently, there have been brain stimulators to control tremors and bladder pacemakers designed to restore urinary control.

This report, however, explores the primary implant devices having to do with the heart, skeletal structure, eyes, ears and breasts. These implant devices are used to treat life-threatening medical conditions or to improve the quality of life for patients who otherwise would suffer pain and immobility.

In general, there are two types of implant strategies, depending on the length of time ("indwelling time") the implant is intended to remain in the body:

  • Short-term implants that typically, are used for emergency purposes, e.g., shunts or tubes that extend both inside and outside of the body.

  • Long-term implants which are mechanical or fixation devices intended for more or less permanent indwelling or until they have served their purpose. These devices are surgically implanted entirely within the body, although they may be partially controlled or programmed from outside of the body. Some of these devices are composed of degradable materials so they eventually will be absorbed and eliminated from the body according to a predetermined time frame.

This study focuses entirely on long-term, permanent implants such as pacemakers, defibrillators, heart valves, joint replacements, fixation devices, bone cement, ocular implants and cochlear and breast implants.

METHODOLOGY

The material presented and the data interpretations are based on information gathered from personal contacts with industry sources. This has been combined with a thorough review of the business climate, competitive factors, commercially available technology, and current research and development efforts. Where data are unavailable, estimates have been made based on recent trends, economic influences both within and outside the industry, along with the expectations from company sources and trade associations.

INFORMATION SOURCES

Information for this report was gathered from technical papers; Federal Drug Administration (FDA), Department of Commerce (DOC), National Library of Medicine (NLM) databases; other governmental databases; statistical reports; annual reports; and company literature. Final analyses and projections are based on a combination of a consensus among primary contacts. This has been combined with our understanding of the trends from a historical perspective.

Additional data were obtained from extensive reviews of secondary sources such as trade publications, fact sheets issued by trade associations, press releases and company studies. This was done to supplement our understanding of applications, markets and trends in the medical implant industry.

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