Countless industries are turning to contract manufacturing, including medical device companies. A medical device contract manufacturer can make the entire medical product or a component of the medical device through injection molding. This may include life sciences products, medical circuit board assembly, and items used in medical research. 

A medical device manufacturer has a unique set of development and manufacturing capabilities conducted in a specialized facility, as the FDA regulates all medical devices that are sold in the United States. 

Whether you are interviewing medical component manufacturers or device contract manufacturers, you need to ask the right questions. You want to ensure they can provide the manufacturing services you need and meet all of your requirements, from consultation to design to product development. Bottom line, you need to find a reputable medical device contract manufacturer you can trust because your business and reputation depends on it.   

To help you do this we have compiled a list of the top seven interview questions to ask a medical device contract manufacturer. 

1. Are you FDA registered? Do you meet ISO standards?

A robust quality management system is important. Even the slightest deviation from medical device regulations set by the FDA would have dire consequences for your business. The medical device manufacturing process is highly regulated, and you need to trust that your medical device contract manufacturer can assure quality and follow processes. 

This is the first question in this list for a reason. Even after a positive response, do your due diligence. Look to see if the medical device contract manufacturer previously received any violation letters from the FDA or if the FDA has ever withheld products because the manufacturer didn’t comply. Having your production lot discarded because it didn’t meet standards is costly and must be avoided. A medical device contract manufacturer should also meet other regulatory standards such as ISO 13485 for the quality management of medical devices. 


You need your medical device contract manufacturer to meet your business needs. 

Many contract manufacturers maintain line utilization at a high level. Generally, this is done by balancing current operational demands with new business expectations, and while they are looking after their business, you need to look after yours and make sure you are both aligned. Ask if they have the human resources and space for a new line, and if so, when will a new line be produced (time to market). And in the event that you need more volume than initially forecasted, can they increase production quickly?

3. Do you have supply chain experience?

Effective supply chain management will ensure everything from production to delivery is completed on time. Does this medical device contract manufacturer have experience in planning, forecasting, assembly, quality assurance, storage, and shipping? Let’s say you use different vendors and suppliers for your raw materials. Are they experienced and equipped to change the vendor without disruption? How would they handle long lead items so that production wouldn’t be stopped? Do they visit suppliers, use quality materials and stand behind them? It is best to get the answers out on the table early and use a written contract to clearly outline who is responsible for any failure. 

4. Are you experienced in your market?

If you were interviewing a person for a role in your company, you would ask for their previous employment experience. The same idea applies when interviewing a contract manufacturer. Ask if they have experience working with products of components in your market. An experienced contract manufacturer will better understand required filings, regulatory standards, and raw materials. Further, they will be better equipped to handle growth and a high volume. Ask for examples of products similar to your product, and ensure those whom you are working with are the same individuals who have the experience. 

5. How will you manage our production plan?

During the interview/consultation stage, the medical device contract manufacturer will come up with a plan that will outline how they will meet your production needs. This plan should lay out exactly how they will meet your timeline and expectations. At this time, you will also finalize scheduling which will be included in the contract. In this contract, ensure dates are outlined for installation, inspection, and production. 


This isn’t necessarily a question you can ask outright and expect to receive the most transparent answer to. If finances are rocky, they aren’t likely to tell you. Instead, you’ll need to do a little digging. Ask about their suppliers and then follow up with them. Do they pay suppliers on time? You’ll also need to do some credit checks of your own. This is critical. If the medical device contract manufacturer failed to pay a supplier for an essential raw material or piece of equipment, it could cause costly delays or entirely shut down the production line. 

7. Will your facilities meet our needs?

The facility where medical devices are produced must meet regulations, deliver a quality product and meet demand. Ask for the specifics of the exact location and the layout of the facility your device will be manufactured. Ask for verification that the facility has the necessary classification (e.g., ISO Class 7, ISO Class 8), is environmentally controlled, and has state-of-the-art technology. Additionally, ensure the storage facilities meet standards as well. 

You must also inquire about their contingency plans. For example, if a large storm took out power lines, could they continue production? Do they have emergency power generators? If operations needed to be performed at another facility, would they take the same precautions and abide by the same standards? You will get a solid understanding of their ability to deal with unprecedented events by asking if they have dealt with any unexpected issues in the past and how they handled them. 

The medical device contract manufacturer you use will ultimately determine the quality of your product. You must do your research and ask the right questions before signing a contract. In addition to these questions here, ask for documentation like training logs or references. By doing your due diligence in the beginning, you can establish a solid relationship that will allow you to grow your business.

Applied Engineering