Ball and Joint Becomes Ball and Chain as Requirements Dislocate Joint Implant Market.

Business Editors & Health/Science Writers

SAN JOSE, Calif.--(BW HealthWire)--Sept. 26, 2001

Direct from Medical Newswire: Challenges and restraints in the joint orthopedic implant market could cause delays in new product introduction; the growth in revenues is still expected.

According to new analysis by Frost & Sullivan (www.healthcare.frost.com), U.S. Orthopedic Joint Implant Markets, the total markets for shoulder, knee, and hip joint implants reached $2 billion in 2000 and is projected to grow to $2.8 billion in the forecast period.

"Despite the promise of this field, stringent testing requirements could restrict revenues," says Frost & Sullivan Medical Device Analyst Collin Tam. "The high costs of product development and lengthy clinical testing processes impinges on manufacturers' profitability."

The FDA's requirements delay the time to market for new products. Medical device manufacturers must notify the FDA of their intent to market a product in the U.S. and then demonstrate the implant is as safe and effective as similar prosthetic already in the marketplace.

To provide valid scientific evidence of safety and effectiveness, human clinical trials are required. For many manufacturers, this extensive and costly approval process is a major challenge.

Ensuring the safety of products is also crucial in avoiding product liability claims. A recent lawsuit against a market-dominant manufacturer regarding a hip replacement part led to a product recall. The company offered to pay the unreimbursed medical expenses for patients who undergo revision surgery due to implant failure.

Frost & Sullivan presents the 2001 Marketing Engineering Awards to companies that have worked diligently to make a positive contribution to the orthopedic joint implant industry. These market specific awards are presented to Biomet, DePuy Orthopaedics, Osteoimplant Technology, Inc., Smith & Nephew Orthopaedics, and Zimmer.

Frost & Sullivan is a global leader in international strategic market consulting and training. This ongoing research is part of the Medical Devices Monitor Service, which also includes market analyses on U.S. Orthopedic Fixation Device Markets and U.S. Spinal Implant and Surgical Product Markets. Frost & Sullivan also offers custom consulting to a variety of national and international companies.

U.S. Orthopedic Joint Implant Markets

Study: 7981-58

Medical Newswire: From the Healthcare Information Center in Washington, D.C. Since 1947. To contact Medical Newswire, call 1-800-359-4454 or email [e-mail].