Designing an innovative medical device can save lives and help treat difficult medical conditions, but it’s only the first step in bringing your product to market. Along with navigating the complexities of the regulatory system, you also need to find a reliable manufacturing partner you can trust to actually create your device. Below are a few things to consider when choosing a medical device manufacturing provider.

How to Choose a Medical Device Manufacturer

1. An Effective Quality Management System

Medical devices have an extremely low margin for error, so you need a manufacturer with effective quality control programs in place. When collecting proposals, ask each manufacturer whether they’re ISO certified, and what accreditation body they are registered with.

A reputable medical device manufacturing company should be proud to walk you through the process and explain how they will create a quality control program for your product. They should also be able to explain how they audit the system to ensure your medical devices ship without defects.

2. Relevant Experience

Manufacturing a medical device requires highly specialized equipment and in-depth knowledge of the regulatory system. When interviewing potential candidates, ask whether they have experience creating similar products in the past.

If so, ask to see samples of their products, and what challenges they encountered in the manufacturing process. Understanding how they resolved past issues will give you insight into how a partner would create your product.

3. Engineering Expertise

Manufacturers often have valuable perspectives on aspects of a design other engineers don’t consider. Their team may be able to recommend other materials or ways to simplify the design and lower costs.

When interviewing potential partners, ask whether they provide sustained engineering services throughout the project. Their advice and services can help steadily improve your product, making it more competitive and effective for the end user.

For over 20 years, Pacific Integrated Manufacturing in Bonita, CA, has been providing trustworthy, reliable medical device manufacturing services for companies around the world. Their 50,000 sq ft plan includes 21 injection molding machines and a highly trained staff capable of producing products to the highest specifications. Visit their website for more on their medical device manufacturing services, or call (619) 921-3464 to discuss your project today.