What Is Medical Device Contract Manufacturing

What Is Medical Device Contract Manufacturing

There’s little doubt that the medical device manufacturing industry is expanding worldwide and contract manufacturing services are a large part of it. The medical device contract manufacturing global market is expected to reach $97.2 billion by 2026 [source IQ41 Research & Consultancy].
The trend is confirmed by an Accenture Life Sciences survey: 91% of medical device contract manufacturers plan to expand their use of CMOs over the next three years.

Both large and small companies regularly work with contract manufacturing organizations and there is a growing pool of CMOs for them to choose from. 

What Is Medical Device Contract Manufacturing?

The term “medical device” covers a broad range of products and according to FDA definition a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body.

Medical device contract manufacturing is a business model in which a medical device company outsources certain or the whole production activities of their whole medical device or certain components of the device to another company with specialized knowledge, technical expertise, and efficient business operations. The services offered by the medical device contract manufacturers (MDCMs) consist of product design and development, Medical device production, Medical device plastic injection molding, Medical device Tooling, Medical Device Mold Making, quality testing services, packaging and sterilization services, supply and delivery to the end customer and regulatory consulting services.

Which Are The Benefits Of Contract Manufacturing For Medical Device Company?

Outsourcing is a powerful tool for medical device companies because it frees-up manufacturer’s time and resources to focus on other activities.

Medical device contract manufacturers often specialize in a certain process or task and can offer expertise from frequent practice of their manufacturing. 

Here the main benefits:

  • Speed to market: Medical device companies may find that outsourcing Medical Device production can be more efficient and effective when they partner with a resource with key in-house capabilities, especially if they take advantage of a one-stop shop for medical device outsourcing, such as Creanova. Providing all the necessary capabilities under one roof, 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 such as Quality Management System, ISO Certifications.

  • 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

  • Cost efficiency: a CMO means there is no need to invest in large amounts of equipment. 

How To Choose The Right Medical Device Contract Manufacturer

When choosing a particular organisation to collaborate with, there are several things to consider. 

It is important to be diligent when choosing a CMO because working with an organisation that lacks the necessary knowledge of the industry can delay your project, put you behind schedule, and lead to costly rework. 

It is good practice to reach out to these organisations at the earliest opportunity, because recruiting one later down the line can mean revisiting and reworking previous elements that are not to their standards, such as particular design features. This means making a considered decision on an important topic early in the process.

When it comes to CMOs, no one size fits all. As well as varying in physical size, these organisations differ in their specialty and range of services. You should always check what type of organisation the CMO is and what its focus is, it is important that you decide whether it has the qualifications and experience needed to take your project on.

Generally, there are two types of CMO to choose from: organisations that are vertically integrated and have a broad focus, and smaller CMOs with a narrow or singular specialism. Choosing the right CMO means knowing their precise focus as well as understanding how the organisation will fit into your wider project.

If you are working on multiple projects at a time, it can make more sense to work with a vertically integrated CMO, a full-service medical device product development company like Creanova, that covers various elements, such as design, engineering, prototyping, tooling, production and assembly. 

Once you have decided to recruit a CMO for your project and you know the type of organisation that you want, the next step is choosing one with the right qualifications. It is important that the CMO has extensive medical industry experience in Medical device production, Medical device plastic injection molding, Medical device Tooling/ Mold Making and also in facilities that are certified for medical-grade device production. The priority is always quality and the organisation meet the required standards for what you need.

While CMOs can operate in other areas of manufacturing without being ISO 13485 certified, this standard demonstrates that their management system meets medical device manufacturing standards. Therefore, when producing scalpels or any other medical device, ISO 13485 is non-negotiable. 

It is important to know that the CMO has a strong grasp on the complexities of medical devices and will be able to deliver your project on time. Do they know what a good device design involves? Will they be able to select the right materials for your application? Questions like these are important for understanding the knowledge of your CMO.

CMOs that lack this knowledge may sometimes offer a low upfront price and then extend the deadline. To avoid this, you should always be clear about your objectives and try to agree on specific targets on delivery. 


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 medical devices. 

As a Medical Device Contract Manufacturer, Creanova provides a full-service for the Med-Tech industry. Creanova is highly experienced in complex and high-quality injection molded enclosures. Through DFM, Mold flow analysis, Polymer definition, Tooling, Product Validation, we anticipate any hiccups and drive your project to the desired end product in the shortest time possible.

We complete our contract manufacturing services with PCB production and programming, Quality Control, Assembly, Cleanroom production & assembly, Product traceability (ISO 13485), Labelling & packaging, Storage & Logistics. 

We also provide industrial design, engineering, prototyping and R&D support which make Creanova a full-service medical device product development company.

Finally, to meet the needs of our clients, Creanova offers assembly facilities in Italy and Serbia – a unique combination of competitive advantage in terms of cost as well as vicinity to Europe – with ISO 13485 certification

These are just a few reasons, medical device companies have looked to Creanova to manufacture their medical devices for about 2 decades. Contact us to learn more.