Today’s medical device OEMs live in an age of abundance: both abundant options and abundant regulatory requirements. With so many options and so many restrictions, it can be very difficult to select the right contract manufacturer (CM) or electronics manufacturing services (EMS) provider. So many factors come into play. What are their testing services? Do they have clean room capabilities? How do our corporate cultures mix? Will this be a long-lasting or one-time relationship? Could they help me with miniaturization?
Below are some of the most important qualities to consider when choosing an EMS provider. This article will take you through the questions you need to ask before you choose the perfect manufacturing partner for your device.
Extensively Proven Quality Systems
One of the first qualities that a medical device company should evaluate prior to beginning a partnership with a CM is its quality system. “In my mind,” said Tim Craumer, Regional Sales Manager at Suntron Corporation, Phoenix, AZ, “there are two primary aspects to consider in a contract manufacturer’s quality system. The first is the overall quality system that drives the entire company.” At its most basic, this umbrella system involves having both the correct qualifications (FDA registration, ISO13485 certification, and cGMP) and the proper controls in place to monitor the quality system. But there are also other important questions to ask. What is the documentation like? How are they tracking your product on its path through the manufacturing floor? These processes should be clearly outlined when you are selecting a CM partner. If the information is not available in the company literature or on the corporate website, be sure to ask them specifically.
“The second component is focused more on the manufacturing and test process requirements specific to your project,” said Craumer. “Are these processes developed to the point that the outcome is predictable, repeatable, and results in good quality?” A trusted medical device EMS provider will have the ability to evaluate, document, and retain the data resulting from these processes. They should be able to reference this data whenever necessary and satisfy FDA or other regulatory requirements. “The outcome should be predictable,” agreed Jen Winters, Marketing Manager at Suntron, “and you should feel secure that if your EMS provider simply follows the structure they’ve created, the product will come out the same every time.”
High Level of Engineering Support
Another consideration is the EMS provider’s strength of engineering. Of course, the term “engineering” takes on a variety of different meanings and constitutes a lot of different activities, depending on the industry. “When we talk about engineering in the context of the design, development, and manufacture of a medical device,” said Craumer, “what is critical at the EMS level is their expertise and experience. Not only should the EMS provider be able to generate the repeatable processes mentioned above, they should also be willing to invest the time and effort of understanding the functionality of the device and to perform an analysis regarding the manufacturability of the device.” When they perform that analysis, OEMs gain access to an in-depth knowledge about their device before the manufacturer has even started building the first part.
Why would you want that knowledge? After all, in a typical customer-manufacturer agreement, it is understood that the customer has designed the product to meet contractual quality standards, while the manufacturer has implemented process controls to ensure high quality and on-time delivery. However, even when both parties fulfill these promises, unexpected defects and field failures can occur. A Design for Manufacturability process review provides an additional, objective engineering resource for the customer engineering design team to mitigate or avoid these unforeseen issues. It allows customers to ship a better product to market more quickly— and isn’t that why you hired a CM in the first place?
This may seem like the most basic of the CM requirements, but it presents a surprisingly complex question. Does the EMS provider have the capabilities to manufacture the device you need? This is probably most relevant for OEMs of Class 2 and Class 3 devices, where miniaturization is a growing priority. Winters explained: “Miniaturization is not simply about shrinking the size of the device, but also decreasing the weight, extending the battery life, and reducing power consumption. It is essential that a contract manufacturer have the ability to place and test small package components on circuit boards. For example, here at Suntron, we have the ability to place and test a small 01005-size surface mount technology (SMT) component.” While your device may not be that small yet, if you are looking for a CM with whom to have a lasting relationship, it is important that they can evolve alongside your company. (See Figure 1)
Another aspect of the manufacturing process which can prove important for medical devices is a clean room manufacturing environment. As with miniaturization, this is a concern that is especially relevant for Class 2 and Class 3 devices. Since these devices may be implanted or used inside the body, contamination could prove fatal. A clean room environment is also essential if you want a CM who can build a complete device and ship it directly to market (or through the OEM). (See Figure 2)
Manufacturing and Test
It is important that a contract manufacturer not only have the ability to test devices, but that they can offer different levels of testing. From basic flying probe tests to more complex in-circuit board assembly tests and full functional tests, a qualified EMS provider will have several options to meet the OEM’s requirements. “If you are building to final device level,” said Craumer, “your EMS partner should definitely provide a functional test. This is a key verification step that ensures your device is working correctly and built to standard.”
Above, it was mentioned that CMs should be able to place small form factors, but once they are placed, the CM should also be able to test them. “Some companies do not want to make an investment in the new equipment and training necessary to inspect and test such tiny, tiny devices,” explained Winters, “It introduces all kinds of new issues with processes that may have already been in place. You have to modify them because the items are now so small.” Craumer added: “Make sure you choose a company that has made this investment. Rework is costly; device recall is exponentially more costly. It is better that the OEM have a partner who will identify any issues during the device manufacturing process versus finding it after the device is already in the field.”
Packaging, Sealing, and Direct Shipping
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, Click Here .