Selecting A Medical Electronics Contract Manufacturer?

Quality assurance in the medical electronics industry requires close cooperation with the contract manufacturer (CM).

This is due to the growing share of intelligent electronic systems, increasing miniaturization, the presence of multiple sensors and electronic control systems in such devices, and the increasing usage of 3D technology for remote patient monitoring.

All of that means that medical OEMs need professional contract assembly services. However, how can you correctly select a contract manufacturer of medical electronics? Thankfully, we have the answer!

In this article, we have indicated five of the most important aspects that should be considered during the selection of a contract manufacturer of medical electronics. As you may have guessed, this is not an exhaustive list. Finally, we would like to draw your attention to one more issue – trust.

Most Important Aspects In Selection Process 

Compliance with ISO certificates

There is no room for errors in electronics production, especially when it comes to the production of medical devices. If the CM you are going to work with is ISO certified for medical electronics manufacturing, this means that they understand the need for exceptional build quality. In particular, your CM should have:

ISO 9001 

The standard proves a high level of quality management in the course of organizational processes, documentary compliance and more, including production or testing. It is focused on understanding and meeting customer requirements, i.e., specific needs for products of a given organization.

ISO 13485 

Guarantees that the CM supplier who has this standard meet medical device production requirements. The standard ensures that CM will provide products of the highest quality, in accordance with legal requirements and client’s expectations.

Professional supply chain management

Supply chain management is much more than just purchasing, assembling, packing, and shipping. An optimal supply chain combines flexibility, responsiveness, and security. Thus, it ensures cost minimization, material risk reduction, and continuity of supplies.

The contract manufacturer that you cooperate with should have built solid relationships with component suppliers to ensure an uninterrupted supply of high-quality parts and materials for medical electronics production.

Box making services

Working with CM, which can make both high-quality PCBA and box build for you, can maximally speed up the time needed to assemble a completely new device. If the same manufacturer provides new product introduction with boxbuild there is no need to coordinate the collaboration between multiple vendors. As a result, the risk of error is minimized.

Professional tests

Testing is another critical aspect that should be considered when selecting a CM. The company you are working with should offer to run tests to ensure the reliability of each product.

Only advanced inspection and control technologies can make medical electronics fully functional. And this is extremely important in the case of devices on which human life or health depends.

Experienced engineering staff

Cooperation with CM, whose engineering staff has specialist knowledge, ensures that your project is verified for potential productivity problems before production begins. CM will present all possible issues with recommendations for corrections.

Moreover, it is good to cooperate with CM at the design stage. Thanks to this, experienced engineering staff will be at your disposal for consultation purposes before the project goes to the company for manufacturing. Such activities ensure that the project is fully prepared for construction.

You should trust the CM you work with to support you at every stage of production, whether the subject of your cooperation is the creation and management of supply chains for hundreds of product versions, maintaining efficiency in the event of complex changes, or implementing high-value, advanced technologically assembled circuit boards.

Contract Manufacture Vs. In House 

Very high-quality requirements characterize medical devices. Therefore, it usually does not pay off for OEMs to invest in advanced technologies necessary to produce electronics at the desired level.

This makes medical equipment manufacturers turn to contract manufacturers that already have the machinery park and the necessary competencies and knowledge to ensure the required quality of services.

It is also important to support engineers, both at the stage of designing electronic systems and production. When deciding to choose a contract manufacturer of medical electronics, it is worth paying attention to a few crucial questions.

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