Inside FDA Compliance

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BSI  |  01/25/2005

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Medical Matters

Maintaining the highest possible standards is all part of the process for medical device manufacturers.

More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world. When Lavrovsky needed a new hip replacement in 2004, OTI was more than happy to donate everything that was needed for the operation to be a success. Ian Murray, CEO and chairman of OTI, smiles with pride when he recounts this story. It’s a reflection of the company’s commitment to the high standards in an industry in which perfection isn’t just a goal, it’s a daily requirement.

Mikhail Lavrovsky stated in his recent letter of thanks to the company: “Your great gift means life to me.” For those who require such complex and life-changing procedures, the last thing they want to worry about is the quality of the medical device being used. The implementation and rigorous assessment of internationally accepted standards are essential.

Based in Maryland, OTI designs, develops, manufactures and distributes proprietary orthopedic joint replacements, spinal systems, trauma devices and related instrumentation. It’s a fully integrated design and manufacturing company with an emphasis on product development, and is known for introducing several innovative technologies to the industry, including a modular neck total hip system. OTI has the added challenge of having grown through a series of acquisitions and mergers over the course of more than 12 years, which means quality control has required even more extensive attention than usual.

In 1991, OTI acquired Kirschner Medical Corp.’s manufacturing facility and began to create a full line of orthopedic implants, including total hip, knee and shoulder devices. In 1992, OTI’s product line was extended when it bought Implant Technology. In October 2002, OTI acquired Cage Concepts LLP, and a merger with Advanced Spine Fixation Systems Inc. was completed in 2003.

“I’ve been with the company since its beginning and it’s been a tough road. Mergers and acquisitions aren’t easy,” says Murray. “Quality is something that you must always maintain and when you acquire a company, you don’t sell their products until you’re satisfied that they have reached your levels and standards. Thankfully, most of the management team here has had experience in this process.”

Total control of manufacturing is key. As the OTI corporate Web site points out, “It allows for greater flexibility in the implant design, as well as quick turnaround of products and greater cost efficiencies.” During its history, OTI has achieved ISO 9001/EN 46001 certification, as well as ISO 13485 certification (though BSI) for Canada. OTI also recently began working with BSI in the United States in upgrading its quality management system to meet ISO 13485:2003 for the EU. The company is currently ISO 13485:1996-registered with BSI and holds Annex II Full Quality Assurance to support CE marking.

“The standards are there for a purpose; they are a control,” Murray points out. “For example, I can’t put stainless steel and titanium together, though I wish I could on some applications. It’s not merely a case of standards—it’s also common sense. I think most of the standards in-place are based on common sense.”

Operating within a global marketplace has added to the challenges the company has faced over the years. OTI sells throughout the world—Japan, Korea, Australia, South America, Europe and some parts of the Middle East—and must cope with country-specific regulatory environments as well as maintaining internationally accepted standards.

“We always had a regulatory framework here in the United States,” Murray says. “When we started to go into overseas markets, we had to go through the ISO processes. It was part of the company’s growth.”

However, it isn’t always a two-way street: “Even though we are able to sell a product in Europe, having achieved the CE Mark, for example, and gone through the whole process, that doesn’t necessarily mean we will be allowed to sell that product in the United States,” Murray explains. “In some cases, we have had to go through various costly investigational device exemption (IDE) applications in the United States.”

IDEs permit a device that would otherwise be subject to marketing clearance in the United States to be shipped lawfully for the purpose of conducting a clinical study. This allows studies to be conducted to determine a device’s safety and effectiveness.

“Sometimes, we decide we don’t want to do another IDE because of the cost, and we sell in the European market alone,” Murray says. “Once we’ve gathered enough data, then we’ll decide to sell those products within the United States.”

Such attention to detail when it comes to compliance extends beyond manufacturing and touches on all aspects of the company’s processes, including product design. In an industry where manufacturers are influencing and guiding the standards as much as governments, innovation is about more than just ideas on a page. It’s all about taking a business that’s already operating in a challenging environment to even greater heights.

“We have always tried to be ahead of the market, even beyond what they use in the aerospace market, for example,” Murray says. “Long term, I’m interested in what’s being done with stem cell research, for example, and if we can overcome the social concerns, that’s definitely something we’ll see more of in the future.”

Vanguard thinking
Any company that designs, manufactures or installs medical devices will need to pay close attention to the forthcoming update of BS EN ISO 13485:2003. After July 2006, registration to the current 1996 standard will expire. Increasingly, European customers seek evidence of compliance with recognized QMS standards—even if products are CE-marked. The cost of noncompliance will be reflected in additional time, effort and resources spent convincing notified bodies that these products are meeting acceptable quality standards. The new standard is accepted as a basis for best practice by the 148-member countries of ISO, representing all the world’s major trading blocks including Europe, the United States, Japan, Canada and Australia, although additional regulatory requirements may still exist.

This article originally appeared in the January/February 2005 edition of Business Standards, the global magazine of the BSI Group.

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Founded in 1901 as the Engineering Standards Committee, BSI Group is a leading global independent business services organization providing standard-based solutions in more than 140 countries. BSI develops private, national, and international standards, certifies management systems and products, provides testing and certification of products and services, provides training and information on standards and international trade, and provides performance management and supply chain management software solutions.

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