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ISO 13485 Contract Manufacturer

Medical Device OEMs are increasingly finding the value in utilizing ISO 13485 Contract Manufacturers in their business for tasks ranging from engineering to final product assembly. While operating in as strictly a regulated industry as Medical Devices, leveraging the capabilities of an experienced and vertically integrated CM can be advantageous in mitigating risks, reducing costs and increasing the efficiency of the overall product cycle. The need for a dedicated full service manufacturer becomes ever more important and beneficial with the mandated high levels of control by the USFDA, which differ between Class I, Class II and Class III devices. Here are three key advantages to consider from using an ISO 13485 Contract Manufacturer.

1. Less Complex Project Management

The relationship between an OEM and a full-service CM drives a shortened duration of time between development, assembly and market. This process becomes very simple when the CM puts a Program Manager onto the project with a dedicated team to help enable the handoff between both companies.  Allowing the contract manufacturer to handle the day-to-day project management duties and directly oversee the machining, sheet metal fabrication, assembly and other areas enables the OEM to efficiently allocate manufacturing and engineering resources.  By keeping the processes tightened in this manner, great CMs will be able to handle the toughest projects while still maintaining the documentation, traceability and discipline it takes to manufacture at the ISO 13485 level.

2. Positive Cost Implications of Higher Efficiency

The standards outlined by ISO 13485 create a culture dedicated to quality and efficiency within an organization. Through the improved efficiency of a certified full service Medical Device Contract Manufacturer, cost savings can be achieved through the identification of product or service deficiencies and the formulation of improvements. The end result is less waste or rejected work, fewer complaints, and more consistently met and on time orders. By partnering, this efficiency and cost saving gets passed on from the Contract Manufacturer to the OEM, creating more opportunities in the marketplace.

3. Manage Demand Uncertainty

Today’s Medical Device OEMs face a highly competitive market that is often times susceptible to fluctuations in demand caused by the global economic or political climate. Accurately predicting these shifts in the market and the resulting effect on demand can be difficult if not impossible and any interruptions in the process flow can negatively affect profitability. One method more Medical OEMs are using is partnering with an ISO 13485 certified Contract Manufacturer to better manage these interruptions and mitigate any ill effects of swings in demand.

CONCLUSION:

Today’s Medical Device OEMs face a highly competitive market that is often times susceptible to fluctuations in demand caused by the global economic or political climate.  Accurately predicting these shifts in the market and the resulting effect on demand can difficult if not impossible and any interruptions in the process flow can negatively affect profitability. One method more Medical OEMs are using is partnering with an ISO 13485 Contract Manufacturer to better manage these interruptions and mitigate any ill effects of swings in demand.  For more information on PEKO Precision Products medical contract manufacturing, click below or contact me direct at sbaxter@pekoprecision.com

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