The medical device industry is a fast-paced and ever-changing field. As medical device companies work to bring new medical technologies to the market, they face many challenges. One of these challenges is that medical device companies often have limited in-house manufacturing capacity. In this situation, medical device contract manufacturing can provide a solution that helps medical device manufacturers gain access to medical devices without adding significant overhead or taking up valuable resources.

The medical device industry has many misconceptions about medical device contract manufacturing, and it is important for companies to know the truth behind these myths in order to make an educated decision when choosing a partner.

Misconception #1: The Costs Involved in Switching Production to a Contract Manufacturer are Prohibitive

It’s true that there are costs involved in switching medical device production to a contract manufacturer, but the benefits of outsourcing far outweigh the costs. Capital expenditure associated with the purchase and maintenance of the necessary machinery and skilled staff to facilitate in-house production is significant. When you choose to outsource, the costs are drastically reduced and medical devices can be made more efficiently and quickly. Contract manufacturers are adept at reducing cost and maximizing efficiency, providing medical technologies that meet the highest quality standards at a cost that is typically lower than many expect.


With in-house production, you have full control over every aspect of the production process and while this may sound like the most sensible plan, if you choose the right contract manufacturing partner, any concerns around losing control over your product can be laid to rest.

Naturally, with the outsourcing of any product, you may lose a measure of control around the processes. However, this should not dissuade you from exploring contract manufacturing options. When working with an experienced medical device contract manufacturer, you will normally be assigned a dedicated project manager providing full transparency in the production process, and enabling you to be fully involved at every stage if desired.

Misconception #3: Outsourcing Will Decrease Quality of the Product

While medical device manufacturing is a complex process, when working with an experienced medical device contract manufacturer that you are confident in, outsourcing can actually help to improve quality control processes. Quality control and regulatory compliance is a critical part of medical device manufacturing and your chosen medical device contract manufacturer should be well-versed in all current regulations. Always check that they have departments or staff dedicated to quality assurance!

Working with an experienced medical device contract manufacturer can help to ensure that your product meets quality standards while also saving you time, money, and resources on any additional compliance work needed for regulatory agencies.

Misconception #4: It Takes Too Long to Train People on Specific Processes When Outsourcing

When it comes to training, not all medical device contract manufacturers are created equal. When you opt to outsource your medical device manufacturing, make sure your chosen partner is experienced in the medical device industry and has a good track record of producing medical devices to high standards. 

Hiring and training in-house employees can be extremely time-consuming, however by working with an experienced medical device contract manufacturer, there will likely be skilled workers who are already fully trained and equipped to operate the necessary equipment and carry out industry-specific processes.

Misconception #5: Medical Device Contract Manufacturing is Only for Small Companies

Outsourcing medical device manufacturing is not just beneficial to small companies. Many medical technology companies and medical device manufacturers find great value in outsourcing their medical device production or assembly and rely on experienced medical device contract manufacturers who can meet the needs of large-scale projects while still maintaining high-quality control standards that will meet the medical device regulatory requirements. By outsourcing medical device manufacturing, large companies can still work flexibly, maintain a lean workforce and keep costs low.

As you can see, there are lots of misconceptions about medical device contract manufacturing, from how it works, what people should expect when they work with an outsourced manufacturer to produce their product, and the time and costs associated with doing so. Now that we’ve outlined the main misconceptions and addressed common concerns, we hope you better understand the process and are able to make a more informed decision when it comes to contracting out medical device production for your company.

What misconceptions have you heard about medical device contract manufacturing?

There are many benefits of outsourcing medical device manufacturing, but medical device contract manufacturers should be chosen carefully. Do your research, ask the right questions, and find a medical device contract manufacturer that is experienced, highly skilled, and provides the resources required to meet all of your medical device needs from start to finish.

If you're looking for a dedicated medical device manufacturing partner feel free to contact us! We provide medical device contract manufacturing for a variety of medical devices and we look forward to discussing the possibility of partnering with you on your next project. Please contact sales at

Applied Engineering