Tracking Implants is a Problem; One Company Might Have a Solution
Reporting by ProPublica this week took aim at FDA's lack of a tracking system for medical device implants, such as artificial hips. The journalism nonprofit drew attention to the fact that the agency has no way to keep tabs on how many devices are implanted each year and pointed out that the process for reporting device malfunctions and failures is severely flawed. While progress has been made...
An Exclusive Chat with Michael Son, VP of Corentec America
Earlier this year, Korea-based Corentec Co. Ltd. announced the creation of a U.S.-based wholly owned subsidiary, Corentec America Inc. Orthotec recently had the opportunity to speak with vice president of the subsidiary, Michael Y. Son. Previously, Son has worked at a number of global healthcare companies specializing in hip- and knee-replacement joints as well as spinal...
Orthopaedics Largest Segment of U.S. Implant Market, to Hit $29.4 Billion
    With an anticipated 8.8% annual growth rate, the orthopaedic implant market is expected to reach $29.4 billion in 2015, according to a recent report from The Freedonia Group Inc. (Cleveland). Growth for this segment is attributed to improvements that affect safety and durability. However, the study notes that this largest segment of the U.S. implant market will also be challenged by...
Zimmer President and CEO Dvorak Named AdvaMed Chairman
AdvaMed has said goodbye to chairman Jim Mazzo (Abbott Medical Optics) and today named Zimmer's president and CEO, David Dvorak, as its new Chairman of the AdvaMed Board of Directors. Dvorak will serve for two years and already has several items on his agenda, according to an AdvaMed press release, including strengthening the association's advocacy in China, India, and Brazil; working with FDA on...
Using Crowdsourcing to Reform the FDA
Kevin Stone, MD, an orthopedic surgeon and chairman of the Stone Research Foundation in San Francisco, has an interesting idea for reforming the FDA: In Dr. Stone’s view, FDA should continue to require Phase I clinical trials to ensure safety, but the additional phases of clinical trials, which can be lengthy and end up bankrupting many companies, would be done away with. In this plan, if a...
AAOS 2012: Medicine Eats Up Federal Budget
  The U.S. government is headed straight toward bankruptcy, according to Pulitzer prize-winning commentator George Will, who spoke at the AAOS annual meeting this month in San Francisco.   As reported by OrthoTec’s editor-at-large Brian Buntz: The government is larger than most people understand it to be. One fifth of American personal income is derived from the government....
AAOS 2012: Stryker's President and CEO MacMillan Resigns
ON MACMILLAN'S RESIGNATION: MacMillan cited family reasons for his departure. Despite this unexpected announcement, analysts don't expect the company's stock to take a beating. Analysts from Canaccord Genuity expect the company to remain strong due to its solid senior leadership. CFO Curt Hartman has been named interim CEO and William Parfet is taking over the chairman role....
AAOS 2012: South Korean Ortho Company Launches Corentec America
The Bencox stem provides wide range of motion, enhanced neck shape, and a trapezoidal neck design that allows wide angulations, and protects impingement and dislocation.       A Seoul-based orthopaedic company is setting up shop in the United States. Corentec America will be based in Irvine, CA and will market the company’s hip and knee joint replacements, spine...
AAOS 2012: DePuy Orthopaedics
DePuy has launched products for shoulder reconstruction, hip revision surgery, and joint replacement. As always, the company’s goal is to expand its product line while reducing healthcare cost.   AOX Polyethylene contains a blend of polyethylene resin and Covernox (an antioxidant), which creates a material that traps free radicals and scavenging oxygen. It is approved for use...
Manufacturing and Inspection Technology Are Way Behind in Orthopaedics. Do You Agree?
  It’s no secret that the medical device industry in general is far behind industries such as electronics in terms of speed-to-market and the ability to get breakthrough technologies to patients. In most cases, products fall victim to the hurdles presented by FDA. But what about technologies that are used to inspect orthopaedic devices? Should they, too, be so far behind?  ...