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Unique Challenges in Instrument Manufacturing

What challenges are unique to the manufacture of orthopaedic instruments? BONEZONE asked Dean Poulos, Sales & Marketing Manager for Gauthier Biomedical, for some perspective on this specific market segment.

BONEZONE: What are OEMs seeking from supplier partners in the manufacture of instruments, lately?

Dean Poulos: We’ve noticed an increase in requests to provide product design files for instrumentation, or to assist customers with product design. While Gauthier Biomedical has always offered this service, it’s becoming increasingly apparent that OEMs seek to outsource more and more of their product development. We have 11 engineers on staff and a substantial quality team. We offer off-the-shelf instrumentation and contract manufacturing, and provide the assurance that our products are safe and effective.

The customer wants to know that our product is suitable for their application, therefore it’s imperative that design controls are in place. Relying on the supplier for this type of design validation enables the customer to launch quickly, safely and cost effectively.

BONEZONE: What is one significant challenge that instrument manufacturers are facing, of which OEMs should be aware?

Poulos: Cost-effectiveness measures. OEMs face many financial pressures today, so finding cost-effective ways to go to market is a concern. However, it’s important that orthopaedic OEMs don’t compromise price for quality when they outsource product design and development. Look for suppliers that maintain the highest quality with a track record for reliability. Seek a partner whose manufacturing process is backed by robust engineering processes and a quality management system. Knowing that the product went through proper design development stages and has been tested and validated means that the OEM’s risk has been properly assessed, and the likelihood is very low for issues further down the road. That means the OEM customer can plan on years of reliability and consistency as they go to market with quality instrumentation.

Gauthier Biomedical, Inc. manufactures instruments for spine, trauma, hip, shoulder, knee, ankle and small bone surgical applications.

Gauthier Biomedical, Inc.