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When deciding to entrust your medical device to a contract packaging company, you want to know they have the expertise required to deliver. Evaluate whether they have successfully managed a situation similar to the one you now face. Make sure they have expertise in navigating complex FDA requirements for sterilized medical devices.
- Ask about solutions they’ve provided for customers in similar situations
Quality is always paramount and never more so than in the medical device industry where patient’s lives are at stake. Your consideration list should include contract packaging companies that are ISO 13485 certified. They have quality processes in place to protect the integrity of your product and the safety of your patients.
- Ask to see their ISO 13485 certificate
- Visit their facility and ask about cleanroom certifications
For new product launches in particular, you can’t always predict all the obstacles you’ll face. As a result, make sure that your packaging partner isn’t overly rigid and won’t force you to conform to their needs. Adjusting to unforeseen changes is a critical capability of a seasoned contract partner.
- Ask for examples where they have demonstrated their flexibility and have adapted to changing conditions
- Check out their breadth of services as an indication that they are used to a variety of situations
Ideally, you want to find a partner who cares about the success of your business. It’s difficult to evaluate, but find senior leaders who are highly customer-focused and preach that to their team. Evaluate who will be working on your business day-to-day and whether they will have a team dedicated to your business.
- Ask about a time when they’ve gone the extra mile
- Meet several layers of people at the company to see whether commitment is instilled at all levels
A good relationship is a partnership; even when it’s a vendor-customer relationship. To prosper, you have to develop trust and collaboration so that everyone contributes to your common goals. Partnerships also evolve. Be sure that the contract partner you choose has to capability to grow as you grow.
- Visit the facility to see how their people work together.