Choosing a contract manufacturer (CM) is a critical path on your road map to success. Choosing the wrong CM may run the risk of losing time and money. However, if you find an expert within your device specialty, you will foster a professional relationship and partnership that will be sustain the lifetime of your company.
Here are 4 recommendations when choosing a contract manufacturer:
Engineering and Development Teams
Knowing that your CM has engineers and product developers on-hand saves time and money since they will be able to resolve issues that arise throughout stages of prototyping and ensure the best materials are being used when manufacturing the product. To save extra money, look for a CM that won’t charge you for every small change in the product since these prices will add up quickly. Plus, if you want to design, develop or manufacture another product down the road, you already have a relationship built with not just the company, but also their engineers.
Track Record of Success
Track record of success is comprised on 3 main areas: case studies, testimonials and customer service. When reading case studies, be mindful of whether the piece is more a creative writing piece or an actual case study. Always check for accuracy in case studies. If a CM is not being fully truthful about something as important as a case study, what else are they doing to make themselves look better than they really are? Furthermore, testimonials are a great place for a company to demonstrate their expertise and relationship with their customers. If a company does not have testimonials, search for reviews online or talk to previous or current customers about their experiences with the CM. Finally, acknowledgement of customer service is vital in the CM you select. Unfortunately, in today’s day and age, there is a real lack of customer service. Lack of customer service is a blaring warning sign that the CM does not value their customers and just want your money. Even though customer service is on the decline, you still deserve it!
Make sure the CM’s manufacturing capabilities matches your volume requirements, otherwise this will lead to problems and a hassle of switching CMs. If you are in the beginning stages and are only manufacturing 300 devices per month, often times the larger contract manufacturing companies won’t even look at your product. This is not a black and white rule to follow though; some companies may be able to manufacture smaller quantities while simultaneously handling larger orders. The best way to alleviate this issue is to speak with the CM to ensure they have the experience and capabilities to meet your needs before you sign the contract.
A great way to check the CM’s validity is to check if they are ISO certified. ISO certified companies are required to meet certain quality management standards in their people, training, facilities, services and equipment. A common ISO certification is ISO 9001:13485 which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer regulatory requirements applicable to medical devices and related services.
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