For decades, orthopedic device companies in the United States have been using companies in other countries to complete their manufacturing needs. Historically, India and Pakistan have been the countries where the largest percentage of manufacturing is outsourced, but the UK and the EU, as well as South Korea, also have several manufacturing companies.
However, many companies fail to realize the expertise and capacity of orthopedic implant manufacturers located within the United States. These American companies have the capability and capacity to manufacture simple orthopedic devices such as pins and screws to more complex hip implants and even orthopedic instruments. With healthy markets here in the US there is also a constant competition to use the cutting edge of technology and equipment, something that may not be a factor with the established international manufacturing companies.
There are several important reasons to look to the American orthopedic implant manufacturers. Not only are these companies producing exceptional quality implants and devices but they also offer some features that cannot be found with manufacturers located overseas.
FDA Qualified and Compliant
While many of the international manufacturers will be ISO registered companies, they may not understand the specifics of FDA (Food and Drug Administration) standards. With the American company that has the required ISO certifications, including ISO 9001 and ISO 13485, you can be assured they will also be FDA compliant if they are currently producing medical and orthopedic devices and implants.
Logistics Simplified
International shipment of parts and components can become a challenge, particularly from some companies, where changing political and economic issues make it uncertain for companies in the US.
Working with one of the top US orthopedic implant manufacturers eliminates this concern while also simplifying supply chain logistics. This can not only save time on production, but it can also help to save costs and allow the product to get to market much faster once it is moved from prototype and approval into full-scale production.
