The 5 Misconceptions of Switching Medical Device Contract Manufacturers

Why Switch Medical Device Contract Manufacturers?

The need to switch medical device contract manufacturing suppliers often arises from a variety of shared objectives. Medical product quality improvement is often a major driver, which may involve refining yield or cycle time to optimize pricing. Another objective is to alleviate frustrations and communication issues surrounding customer service by partnering with a more attentive supplier.

Many OEMs choose to consolidate contract manufacturing services (such as injection molding and assembly services) into a single local (i.e., U.S.-based) entity to simplify communication and centralize accountability. This consolidation has the added benefit of simplifying coordination and problem-solving as well as reducing overall costs. It also eliminates the tendency of suppliers to pass the blame when a problem arises.

Switching to a local manufacturer simplifies logistics and international trade risk while reducing shipping fees. Other reasons to switch manufacturers may include the need to upgrade legacy tools used for prototyping to more durable, high-volume production molds or the need to move away from the supplier acquired by a competitor.

When Should You Add Secondary Medical Device Manufacturers?

The decision to switch medical device contract manufacturers often stems from the necessity to augment production volume beyond the capability of the current supplier. In many cases, adding secondary suppliers helps an OEM cover efficiency or capacity gaps. Another key motivation is the quest for better business continuity, which includes more robust contingency plans, better pricing structures, and improved supply stability. Despite these clear advantages, many companies hesitate to take this step due to prevalent myths and misconceptions in the industry.

The 5 Misconceptions of Switching Medical Device Contract Manufacturers

Misconception 1: “Transferring tooling and production is a long and arduous task that disrupts product supply.”

Transferring production does not need to be a long and arduous process. Appropriate planning, communication, and follow-through are key in the production transfer process, helping to eliminate or limit any disruptions to production. OEMs should ensure that the proper preparations are carried out upfront. Doing so can avoid common issues associated with poor planning, such as discovering problems with the mold after transfer or encountering extended training times for assembly equipment operation. These challenges can prolong the transition and delay the production of quality goods. However, with sufficient time devoted to preparing for a successful production transfer, the process can smoothly transition to production without disruptions.

Follow the guidance below to avoid product shortage disruptions:

  1. Prioritize Product Transfer Expertise

Work with a medical device contract manufacturer with expertise in transferring production. Ensure the supplier knows what thorough preparation steps are needed for a safe and secure transfer. Enplas is experienced in product transfers and has the knowledge, customer communication, and full manufacturing capability to support your transfer. Refer to Enplas’s mold transfer guide for more information.

  1. Start Research and Preparation as Soon as Possible

As soon as you consider transferring production, you should begin preparations and research what options are available for the specific transition you are considering. Dedicating more time during the preparation phase will significantly reduce the chance of potential issues, costs, and time spent during the transition phase. Better yet, it will reduce stress and give you peace of mind during a smooth transfer. If you’re considering a potential product transfer and need guidance or advice, talk with an Enplas representative before planning, even with preliminary questions you want to address. We are always open to discussion.

  1. Be Aware of the Estimated Timeline and Required Processes to Start the Production Line

Stay informed on process requirements and ensure that the new supplier provides a realistic, accurate timeline of how long it takes to start producing your products. Prepare enough safety stock to cover the transfer period. Consider speaking to Enplas about establishing a new production line. We will work with you and your existing partner to establish a realistic timeline and provide regular updates.

  1. Be Transparent and Provide All the Necessary Information Upfront

When engaging a new manufacturing partner, it’s essential to be upfront with existing processes and all related information. View the Mold Transfer Guide to see specifics on what kind of information needs to be prepared. Many clients feel a little uncertain about handling information about manufacturing processes that they may not necessarily be closely familiar with. Work with a communicative manufacturing partner willing to take a direct and holistic approach during the transfer. This might entail contacting your current provider directly as necessary to exchange manufacturing details. Enplas has guided many clients to a successful move to our production facility. We stay in regular communication and collaborate on complex production issues. For a more involved approach, Enplas will oversee all your production transfer needs and keep you in the loop at every stage.

Mold Transfer Guide

Gain in-depth insights into the mold transfer process.

Misconception 2: “When transferring mold tooling, there is a risk of loss or damage to the mold, disrupting production.”

This only applies if proper precautions are not taken before the transfer. In such cases, the mold can be subject to damage or rust. If the new supplier does not have the appropriate tool room capabilities, any such damage may delay the tooling from being ready for production. To avoid these issues, enact a thorough prevention program to ensure the mold preparation is sufficiently documented and protected.

Follow the guidance below to avoid potential issues with the mold transfer: 

  1. Use a Trusted Partner to Inspect and Prepare the Mold for Transfer

Employ a trusted manufacturing partner to inspect the mold on-site before the transfer. This may include taking photos of the condition of the mold before transfer. When the mold is being prepared for transfer, ensure that rust preventatives are properly applied. Ask for photos of the condition of the mold to be taken at the receiving end too. Enplas assesses existing mold conditions and visits the current production site, as necessary.

  1. Take Out Appropriate Insurance

Ensure you back up all shipping and transportation processes with tracking features and appropriate insurance. This will give you peace of mind that your equipment is protected during shipping.

  1. Work with a Medical Device Contract Manufacturer Who Also Provides In-House Engineering and Tooling

Although rare, issues can happen during shipping despite proper preparation. A supplier with tooling knowledge and expertise can start inspecting and assessing the mold immediately and, if necessary, provide any repair work required. An engineering group with expertise in mold design can support any other significant requirements and ensure that all aspects of the mold design are considered. Enplas has the full in-house tooling capability to include tool design engineering and inveterate toolmakers to provide such services as mold making, repair, and preventative maintenance. Enplas’s knowledge of assessing molds and the capability to work on them makes us the ideal partner for medical device product transfers.

Misconception 3: “When transferring production due to quality issues, you can’t be sure if a new supplier can achieve the required quality until the transition is complete.”

With proper root cause analysis and testing, there should be clarity regarding whether the new production partner can troubleshoot and achieve the required quality. Misunderstandings could occur if the previous provider misidentified the root cause (e.g., blaming the product design when the true cause was an issue with processing).

Follow the guidance below to establish an effective manufacturing partnership:

  1. Work with a Supplier with a Good Engineering and Quality Department

A dedicated quality department will conduct appropriate performance tests, make relevant and accurate measurements, and analyze data to identify the true cause of any production issue. An experienced engineering team will take these data to recommend a solution for the issue. Working with a manufacturer with good engineering and quality management will ensure that the true cause of potential production issues can be identified. When switching suppliers, OEMs should stay transparent and provide all relevant information and sample products that the new supplier can use to analyze and confirm the root cause. Enplas works with customers to analyze the root cause of product issues and suggests measures to achieve the quality you need at the volume you desire. For example, one of the common product issues medical device OEMs face is leaks. Enplas has successfully analyzed the causes of leaks and executed several solutions. See our case study on preventing leaks when using thermoplastic elastomer (TPE) fluid seals.


  1. Choose a Manufacturer That Can Achieve the Right Quality, Precision, and Scalability

Your ideal medical device contract manufacturers should be able to ensure quality and precision manufacturing at large scales. Even if the current batches are relatively small, considering future demand and how that may augment current manufacturing capabilities is key to success.

Enplas manufactures high-quality, high-precision custom plastic products for medical devices. Enplas ensures quality through DFM support, in-house precision tool making, cleanroom injection molding, cleanroom assembly, and quality assurance that includes process validation. Our specialty product, microfluidics, achieves channel depth tolerance as small as ±1µm with millions of productions annually. Quality, precision, and scalability are at the core of what Enplas does.

Misconception 4: “Consolidating multiple suppliers into one is a big task that takes a lot of time and money, which cancels out the cost and time benefits.”

Consolidating multiple suppliers could mean bringing multiple injection molded parts prototyped/manufactured at different sites to one injection molding supplier. It could also mean vertically consolidating several production steps conducted at different sites into a single one (e.g., consolidating injection molding and assembly steps, including lyophilizing and onboarding reagents). Transferring multiple components or manufacturing elements can take more coordination and resources for the new supplier to assess, execute, and validate each manufacturing process. However, an experienced provider should lead and navigate the process in a way that minimizes the time taken by the client.

Follow the guidance below to avoid problems with supplier consolidation:

  1. Work with a Manufacturer Experienced at Moving Multiple Productions

Each part and production process needs scrutiny as if it was the project’s sole focus. A manufacturer needs to be holistic and consider all relevant steps and parts to avoid other potential issues (such as those previously outlined in this blog). Enplas pays close attention to the details while sustaining a comprehensive, bird’s eye view of the entire project. Enplas incorporates not only plastics injection molding and assembly processes but also lyophilizing and preloading of reagents. Our one-stop process significantly reduces your coordination and logistic costs compared to other manufacturers.

  1. Work with a Supplier That Provides Flexible Assembly/Manufacturing Options

Some manufacturers require an upfront investment to set up equipment and production in anticipation of larger volume production in the future. This may not always be economically feasible for medical device OEMs. It’s better to work with a supplier that provides flexible assembly and manufacturing options that fit your current demand but can also be scaled up in the future. Enplas provides a flexible platform to suit any production size. From manual to semi- and full-automated assembly, Enplas only requires the appropriate investment at the right time to ramp up production.

Misconception 5: “Adding a secondary supplier introduces more complexity and increases cost over just managing one.”

This may sound contrary to the above misconception, but adding a secondary supplier to increase manufacturing capacity or ensure business continuity is a valid strategy in certain circumstances. If the secondary supplier only supplements the same products that the primary supplier is providing, there is no need for additional coordination or shipping costs between the two sites. In fact, OEMs may be able to negotiate a better price with the first provider, as adding a secondary supplier is an opportunity to review efficiencies. The obvious problem to avoid is a quality fluctuation between the two sites. This can be avoided by carefully selecting the right secondary supplier of your choice, depending on your goals.

Follow the guidance below to establish an effective manufacturing partnership:

  1. Pick a Secondary Supplier with Good Communication and Flexibility

When selecting the secondary supplier, pay attention not only to their production capabilities or qualifications (e.g., ISO 13485) but also to their culture of communication. This is a key indicator of the potential for cooperation and collaboration. Enplas stays in regular communication with all customers across a range of comprehensive manufacturing projects. We highly value the exchange of information and requirements from OEMs to medical device contract manufacturers.


With appropriate and thorough communication and planning, the switch to a capable medical contract device manufacturer and moving production to a different or secondary supplier can achieve vital supply chain goals.

If you’re considering finding a new place to bring your existing production, Enplas offers the best services and support for a successful transition and continuation of reliable supply.

Enplas provides:

  • Expertise in successfully transferring production, which includes the transfer of injection molds and assembly processes.
  • Over 60 years of injection molding experience.
  • Dedicated guidance to customers with open communication throughout the transfer process (and after).
  • Over 100 engineers available to provide engineering analysis and problem-solving.
  • A global network of local and global molding facilities.
  • Ramp-up plans from prototyping to high commercial volumes with incremental investment.
  • Excellent quality manufacturing maintained at high volumes.
  • Comprehensive medical device contract manufacturing services: DFM and engineering, in-house tooling, ISO class 6 and 7 injection molding, assembly, and reagent lyophilization and preloading.

Whether you’re considering reshoring production to the U.S., consolidating multiple production processes for efficiency, or adding a secondary supplier for expansion or risk mitigation, start your planning now by contacting an Enplas engineer.

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