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Outsourcing a medical device is a serious undertaking for any original equipment manufacturer. For an OEM to entrust a contract manufacturing organization with its research and development, brand, delivery schedule, and ultimately with the safety of the end-users who will be relying on their devices is a matter of significant trust. It can literally be the difference between life and death.
It’s important to know how to choose the right medical device contract manufacturing partner. A large part of that process is interviewing potential CMO partners to ascertain and assess essential information such as their experience, quality assurance, and quality control procedures, production capacity, and other criteria key to a successful manufacturing relationship.
Below, we’ll look at four questions to ask to ensure you’re choosing the right medical device contract manufacturing organization to best meet your needs.
This may be the single most significant factor to determine when considering working with a CMO. Ensuring they have extensive experience not only in the medical device industry but also with your specific segment or market is key to a good working relationship, and can help avoid any unpleasant surprises. An established CMO will stay on top of such things as regulatory standards and required filings, but many other less tangible things come with experience.
Experience matters in medical device contract manufacturing for a wide variety of considerations, from selecting the proper process and materials for specific projects to scaling up production to meet increased demand or further company growth—all while maintaining the highest possible quality standards. When you partner with a CMO, you are putting your reputation in their hands.
It’s essential to correctly ascertain a CMO’s capabilities to accommodate not just your current production needs, but to be able to adjust their processes and systems to account for any foreseeable increase in demand. It’s also essential to determine if they have adequate capacities to handle any future product offerings your organization might make. If necessary, will they be able to dedicate production lines to your needs, either through retooling existing lines or through the creation of new dedicated systems?
You’ll want to know if their manufacturing facility has sufficient space and staffing for such an endeavor and how soon they could bring a customized dedicated line into service. Try to find out if there are any possible bottlenecks—such as quality assurance or control systems that may be shared by other products manufactured by the CMO you’re considering.
The importance of quality management systems can’t be underrated—true of any industry, but especially so when it comes to medical device contract manufacturing. Your business reputation, the safety and efficacy of your products, and the health and safety of the people who will rely on your products are all tied to a candidate CMO’s quality control and assurance methodologies.
Be sure they’re registered with the FDA and ISO 13485:2003 certified. Ask if they’ve ever had any products subjected to approval withholding due to lack of compliance? Have they ever received any warning or violation notices from the FDA or other regulatory bodies? Are their ISO practices certified and up-to-date?
Now more than ever, supply chain expertise is of critical importance in choosing a CMO. Medical device contract manufacturing has unavoidable delays implicit in the process, but these are typically known well in advance and are an integral part of project planning. However, unplanned and unpredictable delays can wreak havoc, not just with end-phase concerns but with every step of the process.
Excellent supply chain control is key to ensuring the agreed-upon delivery schedule and essential in keeping production and shipping costs in line. Supply chain management can, in short, make all the difference in determining the quality of the final product is top tier, and it ultimately impacts the fate of your business.
Many other considerations go into entering an agreement for medical device contract manufacturing, but the questions on this list should be first and foremost in your mind when considering a CMO partnership. It’s of vital importance that you find a CMO that can answer these questions to your satisfaction.
Sanbor Medical has over thirty years of contract manufacturing experience, with an exclusive focus on the medical device industry. Specializing in electronic and electromechanical medical devices of every description, Sanbor Medical has the technical experience and quality procedures you’re looking for.
Contact us, and one of our industry experts will work with you to bring your product to market quickly, efficiently, and affordably.