O'Connor

More device companies, including large manufacturers, are moving towards a concept of virtual manufacturing, and as a result, they rely on the supply chain and contract manufacturers. “When you’re bringing a finished product to the market, managing a supply chain is a lot different than [when your company is] bringing in raw materials,” says James O’Connor, vice president of worldwide regulatory, quality, and clinical affairs and surgeon ethics and compliance at Small Bone Innovations Inc. (Morrisville, PA). The main responsibility of compliance is in the hands of the company whose supply chain is made up of the contract manufacturers.

Orthopaedics companies must be even more diligent about compliance, especially considering the negative attention focused on the industry during the past few years. “The orthopaedics industry has been singled out with healthcare laws–the antikickback statute, HIPPA, and to a lesser extent, the Starks law and False Claims Act,” says O’Connor. “HHS is interested in [these laws] because they can affect healthcare costs.” The spotlight was placed on the industry during the Department of Justice’s investigation of the big five orthopaedic device companies regarding physician consulting payments. Despite this attention, product regulatory compliance in the orthopaedics industry is no different from other segments of the device industry, says O’Connor, who is chairing a conference session about compliance at OrthoTec 2011.

“When I think of compliance, it’s a more worldly discussion that involves other areas of law,” says O’Connor. “It’s important to understand the entire picture of compliance–the supply chain is just a piece of that picture.”

When managing a contract manufacturer’s supply chain, it’s important to have a team approach in purchasing, quality, engineering, and manufacturing. During the conference session, “Quality in Orthopaedics: Developing and Maintaining a Compliant Program,” the speakers will delve into these areas, along with discussing risk management and recalls, and will help attendees understand their responsibilities in maintaining compliance.

Although there haven’t been changes regarding requirements in this area, O’Connor is seeing increased awareness among regulatory agencies as they place more weight on premarket approval (PMA), prePMA, and postapproval inspections, and contractors and subcontractors. “I’m seeing agencies reach into the second tier of vendors,” says O’Connor. “In many cases, such as Japan, we have to defend that we control these vendors throughout the quality system.” In Europe, O’Connor says quality agreements and the terms and responsibility between a vendor and legal manufacturer are now the subject of scrutiny for inspections.

With certain regulations, compliance is black and white. “I think many manufacturers can get away without a complete assessment of what risks are associated with a process because there might be a lot of people who watch every step,” says O’Connor. “As we move forward, risk assessment is becoming more important—not just in risk and failure analysis [related to] design, but also in risk and failure of the clinical application of a device. In order to assure the utmost patient safety and keep up with compliance in the world today, manufacturers have to focus a lot more energy on risk assessment of the design, manufacturing process, and the clinical use of the device.”

The conference session on compliance takes place Tuesday, May 24 at OrthoTec 2011.