Medical Device Contract Manufacturing: Frequently Asked Questions

Working with a medical device partner can bring you project flexibility, vertical integration, unique expertise, and reduced time to market. We answered the top questions organizations have when considering a Medical Device Contract Manufacturer.

What Are the Key Benefits of Using a Medical Device Contract Manufacturer?

Using a medical device contract manufacturer offers several key benefits, including cost efficiency, access to specialized expertise, and faster time-to-market. Contract manufacturers, like Nextern, provide the necessary infrastructure and regulatory compliance, reducing the need for in-house investments. We also bring extensive experience in medical device production, ensuring high-quality products that meet stringent industry standards. Partnering with a contract manufacturer allows companies to focus on core business activities while leveraging the manufacturing partner’s expertise in scaling production.

How Do I Choose the Right Contract Manufacturing Partner?

Choosing the right contract manufacturing partner for your medical device involves evaluating several critical factors. Look for a partner with expertise in your specific device category. Consider production capabilities, quality control processes, and ability to scale as demand grows. It’s also important to assess how communication practices and culture fit would integrate with your organization. A thorough due diligence process will help ensure that your chosen partner aligns with your long-term goals and can deliver reliable, high-quality manufacturing services.

What Regulatory Standards Do Medical Device Contract Manufacturers Need to Comply With?

Medical device contract manufacturers must comply with a range of regulatory standards to ensure product safety and efficacy. Key standards include ISO 13485, which sets global requirements for quality management systems in the medical device industry, and FDA 21 CFR Part 820, which applies specifically to the U.S. market. Compliance with these regulations ensures that the manufacturing processes meet the required quality and safety benchmarks. Contract manufacturers must maintain up-to-date certifications and undergo regular audits to ensure ongoing compliance.

What Is the Typical Timeline and Cost Structure for a Medical Device Contract Manufacturing Project?

The timeline and cost structure for medical device contract manufacturing can vary depending on several factors, including the complexity of the device, the stages of development necessary, and the volume of production. 

Typically, the process involves several phases: design and development, prototyping, validation, and full-scale production.  Each phase has its own timeline, with the entire process taking anywhere from several months to several years, and Nextern partners with companies in each of these phases. Take a look at Nextern’s process below: