You need the expertise of a medical device contract manufacturer to bring your devices to the market. But how do you choose a partner you can trust?
Your manufacturer needs to excel at managing complex processes and keeping records to ensure compliance with some of the strictest standards in the world. Failure to find a manufacturer who can uphold rigorous safety and cleanliness standards can result in medical devices that can’t be sold or cause user issues.
Before you choose a company for contract manufacturing in this demanding field, make sure that they’ll meet all of your expectations with these tips and tricks.
Complexities in Medical Device Manufacturing
Among the many industries requiring specialty manufacturing, few are as demanding and exacting as the medical device industry. Meeting the highest quality standards is a matter of life and death in some cases. You simply can’t cut corners or miss out on essential details when planning a contract to manufacture medical device parts. ISO 13485 is a common standard of certification used for the medical industry, but some facilities carry even more certifications.
Today’s medical devices often integrate wireless controls, long-term monitoring equipment, and features that must be integrated from the earliest manufacturing stages. Choosing a medical device contract manufacturing partner that can help with the design, testing, and material selection stages further streamlines the development of a new medical device or product.
Factors To Consider When Choosing a Medical Device Contract Manufacturer
Once you decide that outsourcing your medical device manufacturing needs makes sense for your team, it’s time to find the right partner. Here’s what to look for when choosing a manufacturer in this sphere.
Experience & Expertise
Does the company have a history of working in the medical device industry, or is it more of a general manufacturer? Companies with experience and expertise in this specialty niche can make all the difference to the success of your device. Without sufficient experience, it’s too easy to make small mistakes that delay the release of the finished medical device.
Certifications
Your products can’t compete in the medical device market, not to mention pass necessary inspections, if they’re produced in a facility without the necessary certifications. For example, the Food and Drug Administration requires IQ, QQ, and PQ protocols to verify that all manufacturing equipment used through the process meets standards for consistency.
Production Capacity & Scalability
When starting out, working with a medical device manufacturer with limited production capacity may seem acceptable. That doesn’t bode well for scalability if demand suddenly grows for a successful medical device product. Switching production teams just to scale up is a major undertaking that can interrupt sales. Start with a team that can grow with you as your manufacturing needs expand over time.
Quality Control & Regulatory Compliance
Quality control for medical devices requires more than seeking a manufacturer with numerous certifications. You need to verify the processes used for manufacturing to meet all of the relevant FDA regulations and other requirements for medical use. Lot traceability plays a significant role in this. You need proof of how each device was handled during every stage of manufacturing, especially if there were any cleanroom requirements along the way.
Supply Chain Management
Your manufacturing partner needs to stay on top of trends and challenges in the supply chain and keep you updated as well. If there’s a delay or disruption in the delivery of the medical resin needed for your devices, they can guide you to an available alternative or locate a new source.
Practical Tips for Choosing the Right Manufacturer
Do you have a partner in mind to sign a contract manufacturing medical devices? Use these tips to ensure you’re making the right choice.
Research the Manufacturer’s Past Projects
It’s not enough to determine what regulatory standards they’re comfortable with during manufacturing. You need evidence of the medical industry projects they’ve handled in the past, including challenges and how the manufacturer handled them.
Request Client Testimonials & References
Don’t just take the company’s word for their level of expertise and quality standards. Request specific references for the manufacturing processes you’re interested in using. Seeing the results of real projects that required specialty curing processes or fine-tolerance molding will convince you that you’re choosing the right partner.
Visit the Facility
If it’s at all possible, visit the facility in person to verify the quality standards. It shouldn’t be a problem to tour the accessible parts of the manufacturing equipment. Even virtual tours go a long way in reassuring you that the facility will live up to your demands for a successful partnership.
Check Communication & Responsiveness
Medical device manufacturers committed to going further will use quality management systems with communication opportunities built right in. Checking up on the progress of your project should lead to a timely response. You don’t want to wait days or weeks just to find out when to expect completion or delivery.
Partner with Crescent Industries To Ensure Precision
If you’re sure that a medical device contract manufacturer is the partner you need to bring your product to life, look no further than Crescent Industries. We want to be your contract manufacturing partner for injection molding in the medical device industry. Outsource your Class I, II, and III plastic molding needs to a single-source solution with our help. Contact us today to learn more about what we can do for you.