It can be incredibly convenient to have an EMS provider who will package, seal, and ship your product in addition to manufacturing it. However, not many EMS providers in the market have direct ship capability for medical products.
Part of this shortage is the necessity of a clean room for many packaging applications. “The clean room is crucial for packaging a variety of applications,” explained Craumer, “For example, we are building a Class 2 orthopedic device right now inside of a clean room. As soon as we are done with the manufacturing, we can seal it in a medical bag in that same room.” Suntron maintains clean rooms in all of its facilities for this reason. By keeping the process to one room, they can be confident in the product integrity and ensure ease of manufacturing for the medical device company. “We also manage the sterilization and biohazard screening of these devices,” continued Craumer, “Once they are released from quarantine, we package and box the product in our customer’s packaging. At that point, we ship to our customer, or to our customer’s customer in the market.”
This is not to say that all medical devices need to be built in a clean room. “We have several devices that we build, package, and ship with the paperwork and everything, and they never touch the clean room,” said Winters, “However, many of our customers appreciate having the clean room capabilities. They see it as an indication of our commitment to quality and meeting specific customer and regulatory requirements.”
Unfortunately, a company’s manufacturing responsibilities do not always end once the product is out the door and in the market. Devices can stop functioning. They can require upgrades. They may need to be recalibrated, retested, or reinspected.
“When an EMS provider can handle refurbishment and depot repair,” said Craumer, “that can be a big help to medical device OEMs who don’t have the staff to manage that sort of work. Having that ability and then being able to provide sterilization and packaging services is a truly valuable asset.”
At first glance, this can seem like the least important of an EMS provider’s qualifications. While it’s always more pleasant to work with a company that understands and appreciates your vision, many OEMs would place more emphasis on the practical points made above than on culture compatibility. However, a CM’s culture can arguably have the most long-term effect on your company.
Understand that the company you chose needs to have a culture that complements and expands your current values as well as where you like to be in the future. “As an extension of your company, your partner should be committed to being there in difficult times. This is important to your long-term success— after all, this is manufacturing, so difficult times do happen. The CM’s commitment to continuous improvement should make both companies better the longer the relationship,” said Winters.
Craumer concurred, “Before choosing a CM, it’s important that you visit the company and take a tour of their manufacturing area. Engage them in discussions about their quality systems. Ask about their engineering expertise. Understand the manufacturing and test processes that are in place. Your manufacturer should be extremely knowledgeable, and that knowledge should shine through in their answers. If they have that expertise, they’ll most likely be ready to adapt to your changing needs with unique, outside-the-box solutions.”
Total Cost of Ownership
The most important question at hand, however, may be “How will this EMS provider or CM affect my total cost of ownership?” When you outsource manufacturing, you want to be sure you are getting the cost benefits you expect. Your EMS provider should be a resource for you in every way: engineering, inspections, quality, and cost. Otherwise, they aren’t worth hiring. Remember, total cost of ownership is not purchase order price. In the end, this is real value.
This article was supplied by Suntron Corporation, Phoenix, AZ. For more information, visit http://info.hotims.com/45603-160.