Overlooked Questions When Evaluating Medical Device Contract Manufacturing

New companies working with medical device contract manufacturers typically focus their selection criteria on a few basic factors. These include the price per unit of production, understanding of the requirements for production with regards to medical devices, as well as the contract manufacturer’s ability to deliver to the schedule.

While these are all essential factors to know when hiring a company for medical device contract manufacturing, there are some other important questions that should be asked and answered before making a final decision. Reviewing the contract manufacturer and ensuring there are no issues in the background, such as defect products and components or recalls, is always a central concern.


Most US-based medical device contract manufacturing include very specific language around confidentiality and protection of the innovative aspects of both the device as well as any specific parts, components, and processes designed to produce the product.

The same is not true of many international medical device contract manufacturers. This should be a significant concern for any OEM as it opens the door to the contract manufacturer sharing the technology or even producing the parts and components on their own for other OEMs.


While this may seem obvious, but an experienced medical device contract manufacturing service has added value as compared to a relatively new manufacturer in the market.

Asking how long a contract manufacturing business has been in the market, and specifically in the medical device manufacturing industry, should be a top priority question.

In addition to just having the experience, does the medical device contract manufacturing company have the equipment, the production capacity and the advanced technical support needed for your specific project? Ideally, working with a company with all of these features already in place is beneficial in speeding up time to market and in ensuring future production capacity is never in question.

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