How to Choose a Medical Device Contract Manufacturer

You know that choosing the right medical device contract manufacturer is one of the most important, and challenging, aspects of successfully bringing a medical product to market.

Lean manufacturing should be in your medical device contract manufacturer's toolbox.
Lean manufacturing methods should be included in your medical device contract manufacturer's toolbox.
Consider these important factors, and find a medical contract manufacturer that addresses each, to make the best choice.

What to consider when choosing a medical device contract manufacturer:

  • Cost of Goods Sold (COGS): Look for a manufacturer that can keep costs down while maintaining quality. They should tout cost-saving methods such as lean manufacturing and Design for Manufacturability and Assembly (DFMA) practices.
  • Quality: Your medical device manufacturer should follow strict quality assurance standards, such as ISO 13485 compliance, as well as meet and exceed your own quality requirements. Ask if the company has it's own quality system in place and to explain it to you.
  • On-Time Delivery (OTD) Performance: Find a manufacturer that offers rapid product development through people, processes and technology to stay on time and on budget throughout the manufacturing process.
  • Supply Chain Management: Ask your potential medical device contract manufacturers what it takes to become one of their suppliers, if it's not laid out on their website. There should be a stringent supplier process in place to ensure quality and regulatory, such as RoHS, compliance. To streamline the process, seek manufacturers that can leverage a large corporate supply chain.

Now that we've covered the basic essentials for choosing a medical device contract manufacturer, watch for more criteria in selecting a medical product outsourcing partner in next week's blog

Do you have other medical device manufacturing questions or concerns? Contact us or leave a comment below! 


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Topics: medical device manufacturer, medical device contract manufacturer, medical device contract manufacturing