For a smaller or larger North American company that has an idea for a new orthopedic implant, or for another company that may be unhappy with their current manufacturer, there are several considerations and practical issues that come into play.
By evaluating what orthopedic implant manufacturers can bring to the table and how they can help your business, it is possible to find ways to save money, speed up manufacturing times and ensure continual, on-time delivery of parts or end devices. Often companies work with manufacturers for years without being satisfied in some aspect of the service or the product, but with the options available there is no need to continue these unproductive arrangements.
Look for Local
While many of the biggest orthopedic implant manufacturers are global companies that do most of their manufacturing in China or India, these are not the best match for many US-based companies.
This is particularly true for first-time device developers or for small to mid-sized companies with specialized niche products. The reality is that these big companies often require large orders and, if they do work with smaller companies, they are not given priority.
Looking for local or regionally based orthopedic implant manufacturers here in the United States will allow you to find more personalized service, fewer complications and more flexibility with orders and production volume requirements.
Consider Quality
Quality is going to be a priority in all orthopedic devices. The best companies in the United States will be certified ISO 13485 companies, which ensures they utilize recognized quality control methods for the production of all medical devices they manufacturer.
It is always a concern when using a cheap manufacturing company outside of the US to ensure quality in products. While the ISO 13485 is a recognized international standard, not all companies producing parts in other countries follow these standards, or they may subcontract out some elements of the manufacturing to non-certified businesses.