Outsourcing medical device manufacturing allows even small developers to quickly scale up to meet demand without the expense of building a production line from the ground up. However, your company’s reputation and future depend on the quality of your products, so it’s essential to choose a manufacturer carefully. Asking the questions below when interviewing contractors will help you find a partner to meet your needs.

4 Questions to Ask Before Hiring a Medical Device Manufacturer

Have you produced similar devices in the past?

Successfully producing medical devices requires an in-depth understanding of industry standards and government regulations, which apply to different classes of products. Medical implants, for instance, are subject to higher scrutiny than bandages or test tubes. When comparing medical device manufacturing facilities, ask whether they have worked with similar products in the past and what results they achieved.

What is your quality management system like?

There’s no overstating the importance of quality control, especially when manufacturing medical devices. Even minor deviations from industry standards can trigger closer regulatory scrutiny, cause hospitals to discard lots, and endanger patients’ lives. Any reputable commercial manufacturing specialist should be happy to walk you through the process they use to ensure every piece is produced with the highest standards.

Where will my items be produced?

Hiring a third party means trusting them with the reputation of your entire company, so you’ll want to know where your items will be manufactured. If the facility you’re interviewing outsources products to another provider, find out how they enforce quality standards with the other party.

Do you offer improvements and ongoing support?

While your product design may function perfectly, easily overlooked factors like the placement of a screw can make large-scale manufacturing more difficult and expensive. The best medical manufacturers review the process and will recommend changes that can streamline production without compromising quality. Rotating a part or using a lighter material on one component can eliminate many steps, potentially saving thousands of dollars.

For over 15 years, Pacific Integrated Manufacturing has produced high-quality medical devices for companies across the world. Their 50,000-square-foot facility in Bonita, CA, features state-of-the-art equipment and a team of professionals dedicated to manufacturing reliable products efficiently. Visit their website for more information on their medical device manufacturing services, or call (619) 921-3464 to discuss your project today.