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Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

March 2008

2008 Surgical Instruments Guide

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What to look for in a surgical equipment manufacturer

by Erdogan Okatan, director of business development, Business Development Center, Olympus Surgical America

Length of establishment – A longer history of surgical instrument manufacturing can indicate a level of commitment to the industry and an accumulation of expertise in the use, design and manufacturing processes of these highly innovative instruments.

Quality controls for manufacturing, packing, storage, and installation should be in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulations. Surgical OEMs are required to meet these standards. Look for OEMs that go one step further with ISO 9001 certification, which underlines their commitment to quality control and continuous improvement.

Customer satisfaction – What systems does the OEM have in place for handling faulty or otherwise unsatisfactory products? Have they established a formal customer care unit? What sort of product support do they have in place? What is their policy on product returns, and how do they handle that process?

Extended warranties – Help protect your asset for a longer period. If an OEM offers an extended warranty, it also demonstrates a level of confidence in their product and its useful life.

Quality control for supplied parts – What percentage of the parts used in manufacturing the instrument are provided by outside suppliers? What system does the OEM have in place for quality control on these supplied parts and finished goods?

Original manufacturer’s parts and protocols should be used by service/repair vendors in the repair process. To protect the integrity of your equipment, make sure that broken and worn parts are replaced or repaired immediately using only factory-certified parts and processes.

Ongoing training – An organization’s investment in ongoing training for their employees demonstrates its commitment to quality. Formal training programs for employees can contribute greatly to the product’s overall superiority.

Waste handling – Environmental protection standards and policies help to reduce consumption and control hazardous chemical substances used in the product’s manufacturing process. They also promote efficiency and recycling, resulting in better cost management.
 

• Make instruments last

• Throwing out good instruments?

• Selecting a supplier

• What to look for in a manufacturer

• Buyers Guide Charts

• Controlling maintenance costs