Choosing a medical injection molding manufacturer is an essential element of your medical device’s production strategy. It is undoubtedly a delicate process as it touches the healthcare sector – a sector known for its stricter regulations and guidelines. This is why your future partner should already have mastered the regulations and guidelines associated with medical devices.

Here are four questions you should ask any manufacturing partners to ensure that they meet the minimum manufacturing standard for your plastic molded medical devices.

ISO 13485 Certification: Is Your Medical Injection Molding Manufacturer Qualified? 

Quality assurance is the cornerstone of medical device manufacturing. Medical devices can come in contact with bodily fluids or work to support functions inside our bodies. Therefore, their utilization requires the highest level of quality to avoid contamination and infections. For this reason, you want to select a manufacturing partner with a robust quality assurance process. And a certification is undoubtedly the fastest way for you to evaluate their quality insurance’s credentials. So, to start, check if the manufacturer has a current ISO 13485 certification and FDA registration. 

Clean Room Facilities: Does Your Medical Injection Molding Partner Have the Right Environment? 

In most cases, the assembly of medical devices happens in a clean room. Manufacturers build clean rooms to limit product contamination by airborne particulates, contaminants, and pollutants. Therefore, clean rooms are climate-controlled to reduce the amount of dust and other particles entering the space. Additionally, equipment inside the clean room creates minimal air contamination. Depending on the clean room’s class, personnel could be required to wear garments that cover their hair or their entire body. You should ensure that your medical injection molding manufacturer of choice has a clean room and not just an area separated by a plastic curtain. If you are doubtful or unsure, ask for a form of proof such as clean room certification. 

Experience in Medical Device Injection Molding: Does Your Manufacturer Have a Proven Track Record?

You want to choose a plastic injection molder with prior experience in medical device manufacturing. Preferably, you will select a manufacturer that has successfully produced devices similar to yours in the past. Thus, look for an experienced medical device manufacturer that already has the equipment, facilities, personnel, vendor relationships, design knowledge, and other specialized skills necessary. 

Design Support: Can Your Partner Help You Optimize Your Device?

Your medical injection manufacturer’s design support team should help you add value and functionality to your device. The materials used for production and the techniques used to develop the part must align with the unit’s intended use. For example, specific methods will produce a component that is resistant to heat, while others will provide a part that resists microbes. The wrong choices of raw materials could lead to a disastrous breakdown of the manufacturing process. Medical injection molded device design requires many layers of consideration that will be difficult for an inexperienced supplier to navigate. 

In conclusion, when choosing a medical injection molding manufacturer, prioritize those equipped with the necessary tools, certifications, and experience to produce your device to the highest standards.

Start by getting the initial questions answered in this guide, then consider additional factors important to your business, such as production lead time, price, and services. The right medical injection molding partner can make all the difference in your medical device’s success.

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