Why Contract Manufacturing?

Medical device contract manufacturing, assembly, and packaging is a cost-effective option for many start-ups, early stage, and well-established Original Equipment Manufacturers (OEM’s) to get their product produced and in the market. Why is outsourcing to a Contract Manufacturer right for you?

As the owner of a medical device portfolio, your desire is to focus on selling the product(s) to the market and off-load the “heavy lifting” to a contract manufacturer (CM). This allows you to focus on expanding your presence in the market, and leverage the expertise of a manufacturing firm that specializes in sourcing, manufacturing, assembly, packaging, and sterilization management.


  • Focus. By utilizing a CM, you can focus on growing your business. You can offload the heavy lifting such as; sourcing, assembly, packaging, and sterilization management. This allows you to free up resources and grow your product sales effectively.
  • Savings. CM’s often have extensive in-house capabilities and optimized processes that allow you to realize a cost-effective solution for getting your product manufactured. CM’s also utilize their infrastructure to serve many programs therefore various operating costs can be spread across multiple platforms.
  • Scalability. Scalability, flexibility, and efficiency in production processes allow for CM’s to help you grow. One of the many advantages in utilizing a CM is their ability to scale with your program. CM’s often have extensive in-house resources that can meet the demand of your program as it grows.
  • Responsiveness. Given their focus on delivering product, and their extensive in-house infrastructure, CM’s are well positioned to respond quickly to your needs as your program evolves.
  • Turn-Key. At times, CM’s (like Keystone), offer a holistic approach with their service offerings to assist you through the entire development and launch process and to provide you with a complete, salable product ready to ship. We call this from Dream to Distribution. This approach provides an efficient, effective, one-stop solution for all of your product development and production needs.

Keys to Success

There are Keys to Success when selecting and partnering with a CM. A few of these Keys are provided below:

  • Culture. Culture is often overlooked in the initial engagement and quoting processes, however, it is just as or more important than all other aspects of the relationship. However you define and drive your culture, the chances of success improve significantly when you ensure the CM’s culture aligns with yours.
  • Competency. The medical device field is diverse so it is key to find a CM that has expertise, infrastructure, and capabilities in your specific area. With the diversity that exists in the medical device arena, the corresponding manufacturing processes, regulatory requirements, facility and equipment requirements are also very diverse, making it difficult for one CM to be an ideal fit for all product types. Align with a CM that knows your product space. The right CM for the program has extensive tribal knowledge in your specific space to produce a high quality product in a cost-effective, timely fashion.
  • Capacity. The ideal CM has the capacity in place to produce your current demand and beyond. Capacity goes beyond in-house production and extends to all aspects of working with a medical device program including; sourcing network, quality resources, equipment, engineering, workforce scalability, and others.
  • Communication. Pressure test your CM’s focus on communication as part of your due diligence. From the initial data exchange to ongoing project meetings, continual, open, transparent communication is key to ensuring the expectations of all parties are met.
  • Compliance. Reputable CM’s ensure compliance with quality and regulatory standards and provide rigorous quality control during the manufacture of your product. Your CM will ensure that Good Manufacturing Processes (GMP) are also followed.


Offloading your manufacturing needs to a CM has many advantages. The right CM can provide you with a cost-effective, compliant, and scalable solution that allows you to focus on and grow your core business.

The selection process is key, and it is critical to find the right fit in terms of Culture, Competency, Capacity, Communication, and Compliance. When you find a CM that aligns on all of these points, you have found a partner that can help you take your initiative to the next level.

If you are currently searching for such a partner, please contact Keystone today. We look forward to exploring how we can collaborate with you to grow your business.

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