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When you're looking for a contract manufacturer to produce your medical device, there are several factors to consider. For example, you need to find a company with the experience and expertise to make your device and the capabilities to handle all of the required production processes. Not only that, but the right medical device contract manufacturer will have a solid reputation and be compliant with all relevant regulations. Before you choose your manufacturer, ensure that they meet your expectations and requirements.

Why Use a Medical Device Contract Manufacturer?

Supply chain pressures and a market landscape that values cost-saving measures cause many organizations to outsource their medical device manufacturing efforts. By partnering with a contract manufacturer, you save money, ensure standards are upheld, and free your team so they can focus on business-critical matters.

They help reduce the running costs

Medical device manufacturers reduce the capital venture you would have used to manufacture the devices yourself, especially for small- and medium-sized companies.  A good manufacturer is well-established and can bring down costs that your company would otherwise have invested in research and development.

They take care of quality certifications and standards

A good medical device manufacturer will help you navigate certification requirements and maintain standards.  Your supplier should adhere to the ISO 13485 certification standards for quality management. 

They allow you to focus better on running your company

Because a device manufacturer handles accreditations, ground-level operations, equipment monitoring, and other details, you’re free to focus on your company's presence in the market.

6 Factors To Consider When Choosing a Medical Device Contract Manufacturer

Understanding how the proper medical device manufacturer can benefit you, what do you look out for in making the right choice? Here are the six factors to consider when choosing a partner to manufacture your medical device:

1. Do they have relevant experience in medical device manufacturing ? 

The right manufacturer should be experienced and up-to-date on the latest  advancements in the making of medical devices and components. They should know what it means to manufacture products for the medical industry, and the right partner will be able to provide you with the proper documentation and quality protocols.

2. What are their supply chain management systems?

Your manufacturing partner should be aware of rising issues in the supply chain and offer solutions to ensure that your product is manufactured and delivered to the market on time. In the event of a supply chain disruption, will your device manufacturer communicate delays and discuss solutions to ensure delivery schedules are maintained? 

3. Are they seeking long-term partnerships?

You should look for a manufacturer interested in partnering with you for a long time. They should understand your company’s vision and be willing to help you grow. Usually, such manufacturers are heavily invested in maintaining the business partnership in the long run. Look to see if the medical device contract manufacturer can grow and be flexible with changes in product demand.

4. Do they have quality and standards certifications?

Your manufacturer should practice a culture of maintaining quality standards in their manufacturing processes. ISO 13485-certified companies, for example, adopt the medical device industry’s most widely used international standard for quality management. In the medical industry, it’s imperative that your manufacturer demonstrates a commitment to the safety and quality of medical devices.

5. Do they improve the manufacturing process?

Will your contract manufacturer look for ways to improve efficiencies as demand increases? The right partner will be adaptable and flexible, and will utilize automation and other manufacturing strategies like quick response manufacturing (QRM) to adapt to your production needs.

6. How fast and reliable is their manufacturing process?

An experienced contract manufacturer should have effective ways and means to deliver devices to the market faster and on time. After all, it’s crucial to keep up with innovations to stay on top of your competitors in the health industry, as slight delays in production or delivery can result in a loss of market presence.

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Find a Medical Device Contract Manufacturer Today

Partnering with a device manufacturer has several benefits. If you’re looking to outsource plastic components for your medical devices, Crescent Industries offers quality solutions.

We have experience manufacturing Class I, II, and III plastic molding components and plastic devices using a wide range of medical-grade resin materials. We also provide an integrated, single-source solution for all your plastic medical device injection molding for the medical, pharmaceutical, dental, defense, and OEM/Industrial markets. Contact us today to learn more.

Topics: medical manufacturing, medical device molding