In Search of a Medical Device Contract Manufacturer? Consider These 4 Tips

Medical Device Contract Manufacturer

Getting the right partnerships for your business is crucial for your success. Your suppliers and other supporting service providers need to deliver quality so that you can do your job right.

When it comes to a medical device contract manufacturer, the same rule of quality applies. As your partners, they support you throughout your product’s life cycle. They help you ensure quality and comply with other critical regulatory procedures in the medical industry.

If you’re in the market for a medical device contract manufacturer, this article will tell you what factors to consider in getting the right one. 

1. Quality Management

When looking for a contract manufacturer, it’s crucial to consider how well their systems are adapted to quality work. The best way to check for quality is to consider the manufacturer’s previous work. As revealed at, the provider needs to have a demonstrated and proven track record of ensuring superior quality in different products. Whether it’s fixation devices, medical adhesives, ostomy components, or diagnostics, their products need to be reputable and compliant with the medical device quality standards such as the FDA regulations. You may also check out other medical assembly companies that offer the highest level of quality and ensure the safety of your products.

Examine their calibration reports to ensure compliance. You can also hire an expert to audit the manufacturer’s quality system before entering into a deal with them. For start-ups that have to rely on the outsourcing manufacturer, the quality standards could make or break their company.

However, the manufacturer should still be able to avoid delays while ensuring quality. Delays will impact customer retention even when you offer a quality product. To avoid delays, you can:

  • Define the scope of the project. At the beginning of the project, clarify what the project details are, how long it will take, and the expected results. Determining this will help you avoid veering off the scope or making changes that can cause delays.
  • Set some timelines with the contract manufacturer. Have someone in your team follow up on this to ensure compliance.
  • Create a communication structure. This system ensures the contract manufacturer has a way of keeping you updated on the progress. They can also let you know in case of anticipated delays.
  • Make approvals as soon as possible. Waiting for approvals can prevent the manufacturer from moving forward on time.

2. Their Scalability

An excellent medical device contract manufacturer should be able to support small companies as well as large manufacturers. This means that if you’re a small company that contracts the service provider, they should have the ability to support you even when you grow.

For a small business, growth is almost inevitable, meaning you have to use your resources wisely. So, having the proper support from a reliable manufacturer becomes essential. The benefit of this kind of scalability is that you don’t have to keep changing manufacturers at different stages of your lifecycle. Constant change might affect the quality standards and result in losses. Still, if a manufacturer is flexible, it helps you meet the changing market demands.


3. Expertise and Size

Often quality goes hand in hand with expertise. The more skilled a manufacturer is, the more likely it will offer the right kind of support. They should provide proper sustaining engineering. Some of the factors to consider when it comes to expertise are:

  • If the manufacturer constantly improves their skills
  • How they handle management design
  • Whether they offer support after launch

Expertise can also be tied to the size of a company. Large contract manufacturers are likely to be able to handle more work expertly without stretching their resources thin.

Additionally, large manufacturers often have access to funding to get the most advanced technology and equipment. However, mid-sized contract manufacturers may be able to offer you the best kind of support. Why? They combine expertise with availability. While large manufacturers may be skilled enough to handle the job, they might not respond quickly to your needs due to their high number of clients. Mid-sized manufacturers can be with you every step of the way.

4. Pricing Model

Although price is an important consideration, it should not be your only factor. Most manufacturers who offer quality products are more likely to use high-end technology, resulting in higher costs. Seasoned contract manufacturers use formula-based pricing methods, working with estimates to determine the final cost. They take into consideration factors like materials, assembly, and labor. 

Before signing up with a contract manufacturer, find out their pricing model so you can estimate what the final cost might be. To get the best deal, contact several manufacturers and compare prices. You can also ask for referrals from people in the industry.

Contracting the ideal medical device manufacturer can make your workflow seamless. To get the proper manufacturer to support you, consider their expertise which determines how well they can handle your project. You also need a manufacturer that can offer quality services without delays. Still, knowing their pricing model in advance will help you prepare.

The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of The World Financial Review.