Outsourcing the manufacture of a new medical product has become somewhat essential in the last years due to lack of funding necessary for equipment and logistics, and contract manufacturing organizations (CMO) are able to help by offering kitting and packaging services for their clients to best fit their needs. Still, even if a CMO is great in manufacturing your product(s), this doesn't mean they have the skills and equipment required for kitting, labeling and packaging a product in order to grow your sales. There are a few aspects you need to remember before choosing a company, and you should consider these points when conducting your search:
As well as in the manufacturing of medical products, kitting requires a cleanroom as well, to avoid any exterior factors that could damage the kit's components. Packaging has to be done in an aseptic environment, with HEPA ventilation systems and with good communication systems that enable the workers to talk with other team members outside the room without having to enter and exit frequently, disturbing the sterile environment.
A good CMO that also specializes in kitting should be able to offer you a great variety of products and materials in order for you to choose which of them best fit the kits, and be cost-effective at the same time. Medical Poly Bags, Chevron Design Pouches, Tubing and high Barrier Foil Lidding, Header Bags, Linear Tear Packaging and Heat Sealable and Sterilizable Pouches are only a few of the kitting systems you should be able to choose from.
Most commonly used materials are polypropylene, polyethylene, polystyrene, polycarbonate, PVC, HDPE, PETG and Aclar, but choosing the material depends in part on the sterilization method chosen for a particular kit and how it reacts with the material, but also on what special requirements some of the products in the kit may have. Some need extra protection from heat or cold; and special coating can be added by using materials such as coated paper, foil lid stock or coated Tyvek.
Kitting and packaging can be done through various methods such as custom foam molding, custom plastic molding, plastic pressure and vacuum forming and custom plastic fabrication. Beside these, all kits should have clamshell-type packaging to reliably maintain sterility of the pouch/kit.
No matter what CMO you choose to outsource your kitting production, you should be aware they have to abide by FDA regulations and make sure they are ISO 90001:2008 certified, in order for your product to maintain their sterile properties over time.