Medical device contract manufacturing is the outsourced fabrication of a medical device for the medical marketplace. Medical device companies can utilize contract manufacturing partners to perform recurring manufacturing and benefit from costing efficiencies, streamlined supply chain, logistical alignment all of which allow them to deliver commercial products to market while ensuring that all industry requirement are met.

While medical device contract manufacturing definition scope can be broad, a few consistent aspects are:

  • Designing the manufacturing process
  • Device assembly
  • Packaging for shipment

Value-Add Services include:

  • Package testing validation
  • Sterilization validation and recurring processing
  • Process improvement identification

What is the definition of a medical device?

The Food and Drug Administration (FDA) has very specific criteria to define a medical device. This is how they determine if your product is indeed a medical device:1

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
  • Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

Speed to market

Medical device speed to market (commercialization) has evolved thanks in large part to companies who offer multiple critical services under one roof.

A critical component of medical device manufacturing is the speed at which it can be commercialized. Medical device companies may find that outsourcing manufacturing of the Medical Device can be more efficient and effective when they partner with a resource with key in-house capabilities.

Surprisingly, the concept of a one-stop shop for medical device outsourcing was rare twenty years ago. Many medical device companies had to outsource with several companies to deliver their product for market, which resulted in a longer more complex logistics due to the use of multiple locations for Assembly, Packaging and Sterilization.

Companies such as Life Science Outsourcing were created to specifically address that problem. The industry experienced a positive transformation as top-rated manufacturing companies such as LSO, provided all the necessary capabilities under one roof which drastically reduced time to market and the concept of a one-stop-shop became a reality for manufacturers of medical devices.

Regulated services

A key component of medical device contract manufacturing includes offering regulated services which include Quality Management System, ISO Certified Clean Rooms, Sterilization Validation and recurring services, Package Design and Testing.

It is imperative that a medical device company performs due diligence to ensure their contract manufacturing partner offers compliant regulated services.

Learn more about regulated services on the FDA comprehensive regulatory assistance web page.

Lean manufacturing

A review of Lean Manufacturing illustrates how medical device manufacturing can be better for the environment and reduce manufacturing issues. Its core goal is to eliminate waste and achieve improvements to the following:

  • Yield Improvement
  • Increased Efficiency
  • Improved Quality
  • Reduced WIP (Work in Progress)

Companies actively engaged in Lean Manufacturing can enable faster and more efficient turnaround and shorter time to market or end-user.

Quality Assurance

Medical device contract manufacturing requires a mature and well vetted quality assurance process. Adherence to agency regulations is a key component along with other critical items:

  • Maintaining production costs
  • Ensuring quality and patient safety
  • Overseeing operations to meet general and local requirements
  • Verification that internal standards are met

Conclusion

If you are seeking a partner for medical device contract manufacturing, be sure to consider the above points as you explore the best options for your company and product(s). You’ll want to verify they follow best industry practices along with adherence to government regulations, as well as being able to offer reliable service and support when you need it most.


Looking for more on this topic? View an infographic on 3 Ways to Prevent ISO 11607 Package Design Failure

Learn more about Life Science Outsourcing Medical Device Contract Manufacturing

 


References:

  1. Food and Drug Administration. “How to determine if your product is a medical device.” Last modified December 16, 2019. https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.