Outsourcing Guide

Cleanroom assembly has long been a vital part of the production process of many medical devices. In recent years, it has become even more important to the industry. A number of factors are responsible for this trend including the growing market for disposable devices and combination products and the expanding role of electronics in medical devices, which must be manufactured to rigorous sterility controls. In addition, regulatory agencies such as US FDA have contributed to the growth in cleanroom use by instituting stricter cleanliness controls and increasing scrutiny of validation requirements.

Nevertheless, for many medtech OEMs, the costs associated with constructing and maintaining in-house cleanrooms can be prohibitive. “To build a 20 × 40 ft Class 6 or Class 8 cleanroom, for instance, can cost approximately US$250 000, depending on how it is constructed,” says Jeffrey Zajac, Global Technical Director of Jabil (St. Petersburg, FL, www.jabil.com). “And then you have the cost associated with getting it set up and validated,” he adds. Another consideration is that employees who work in cleanrooms must be trained to follow strict guidelines and procedures, which, of course, entails further cost, says Rick T. Smethers, President of Inteprod (Eagleville, PA, USA; www.inteprod.com). And on top of all that is the cost of cleanroom supplies and maintenance. The bottom line is, if a company does not already have cleanroom or controlled-environment manufacturing capabilities, outsourcing is typically less costly and faster than investing in new infrastructure, Smethers stresses.

“The financial angle has become even more critical to many OEMs choosing to outsource cleanroom assembly in the past year or so because of the state of the global economy,” Zajac says. “But even OEMs that have very strong balance sheets are looking to work with contract manufacturers to further enhance their financial positions.”

Though the cost argument for outsourcing cleanroom assembly may be compelling, there are a number of strategic reasons that ultimately sway many OEMs to partner with a contractor, says Stefanie Selck, Manager of Contract Manufacturing and Product Transfers at Creganna-Tactx Medical (Galway, Ireland; www. cregannatactx.com). Typical reasons that OEMs cite when deciding to turn over assembly to a specialist include improved time to market for their products and a streamlined supply chain. Outsourcing assembly also can help OEMs fill in a gap in production or enable them to devote more resources to new product development.

As with any outsourcing venture, though, the benefits your company can gain from outsourcing cleanroom assembly largely depend on your firm’s choice of a contractor. “No matter the reason for outsourcing, central to the success of the outsourcing relationship is choosing a trusted contract manufacturing partner with well-established quality systems and a strong team to deliver on core competencies,” Selck says.

Starting out

Before taking the plunge and beginning your search for a cleanroom assembly specialist, OEMs would do well to sit down and really think through their business activities from a strategic perspective, says Richard S. Crane, Vice President of Manufacturing Operations for J-Pac (Somersworth, NH, USA; www.j-pac.com). “The key is to think in terms of the big picture,” he says. This analysis will help you pick a firm that matches your firm’s specific needs. “You want to make sure the company you ultimately choose to work with provides the best possible match of services for your firm,” he says. “If the OEM is farming out a single job, that is very different from pursuing outsourcing as a strategic initiative,” Crane explains. “OEMs should look below the level of the product or the service to really understand what the company’s competencies are,” Crane says.

One successful strategy that many OEMs use when sourcing a provider of assembly services is to send assessment teams to the prospective contractors’ facilities, according to Crane. “The teams take a look at the technical competencies, quality systems and market presence and develop an overview of the outsourcer’s business viability,” he explains. “OEMs like these really reap the benefits of outsourcing, being as detail-oriented as they are.”

What to look for

Once you know what you are looking for in an outsourcer, you should draw up a checklist of criteria, Smethers recommends. “The first thing to consider is whether the contractor specialises in serving the needs of the medical industry,” he says. The next thing to check is the contractor’s commitment to quality control and compliance with the regulatory requirements. “Do they have a quality department, and is this department an independent entity with full and final authority over all quality issues? Check to make sure all of the required systems and procedures are in place,” he says. “The company should maintain inspection protocols and provide complete documentation for identification and traceability,” Smethers advises. In addition, the company should use individual production cells to ensure quality control of each project. The importance of the ISO 13485 certification shouldn’t be underestimated, according to Crane. “It’s really the standard for this sector.”

Next, make sure the firm at least offers the certification to the minimum cleanroom class you require for your products. In general, OEMs should choose outsourcing partners that operate cleanroom facilities rated to at least Class 10 000. Some cleanrooms have environmental controls that monitor humidity levels, which can be helpful for certain types of products, Crane explains. For instance, a low-humidity cleanroom offers further protection against bacteria and other biological contaminants.

“You also should be completely confident that the contractor has the space and resources to complete your project in your time frame,” says Smethers. “Check to see how much of the cleanroom’s space is currently allocated to other projects,” Smethers says. “Is there enough space available to manufacture your product on the proper scale?” The company should operate facilities that are big enough to meet your firm’s short- and long-term needs. Also make sure that the company has the staff and capabilities to provide purchasing and planning, inventory control, supply chain management and post-production support, Smethers says. The staff should be continually trained in quality procedures. “Does the contractor have an experienced engineering team in-house and is there enough trained staff in place to handle your project?” he says.

Zajac recommends that OEMs ask prospective outsourcers what kind of cleanroom protocols they use. “Things to inquire about include how they keep their facility clean, how they operate from a cleanliness perspective, how often they change their cleaning chemicals,” he says. “Other things to check on is their ability to add more space, their footprint and ability to transfer products from one facility to another,” he says. “You might want to start a product in a location near the OEM and eventually transfer it to a low-cost facility located far away,” he explains. “Also evaluate the historical results of bioburden testing to make sure that it has consistently met cleanroom requirements.”

Another consideration is the value-added services offered by the firm. “Feedback from OEMs indicates that they are looking for turnkey manufacturing capabilities that include cleanroom assembly, full packaging and sterilisation services,” Selck says. “OEMs are choosing outsourcers that can perform a range of services under a single roof, including metalworking, injection moulding and assembly.”

“A successful contract manufacturer needs to be able to partner with the OEM on all relevant levels and demonstrate capability to manage the total product lifecycle, if required,” Selck says. “An OEM should expect an enhanced level of commitment from the contract manufacturer, the more complex the assembly becomes. For example, for a complex cleanroom assembly project, the contract manufacturer needs to be willing to consider a more open-book approach with comprehensive CAPA systems and accessible product traceability records,” says Selck.

K.K. Tsang, Marketing Director of MediConcepts Ltd (Hong Kong; www.mediconcepts.com.hk) stresses the importance of partnering with an outsourcer with a sound financial background. “This is especially important because the typical life cycle for a medical device is significantly longer than other commercial products,” he says. “The outsourcer also should have proper procedures for risk management in place,” he adds.

Keeping open the lines of communication

It may sound a bit like cliché advice, but OEMs should seek to develop a sense of partnership with their outsourcers. “In the end, both the OEM and the outsourcer are really looking for a partnership,” Crane says. Perhaps the most important element in this is good communication. “The key thing for us is to get involved in their product-development programmes early. We like to work with customers who treat us as team members on their project. When we can do this, the relationship we have with them tends to be very successful,” Crane adds. “On the other hand, companies that pursue a strictly business relationship, which proceeds from purchase order to purchase order, tend to be less successful.”

Scheduling regular business reviews can help facilitate the relationship,” Crane says. “We have ongoing set of meetings with our customers. We alternate locations—either at their facilities or ours. We go through a broad range of topics discussing not only our business but theirs too. We discuss new initiatives, personnel changes and so on,” Crane says. “This allows us to get to know the people we are doing business with so they are not just voices on the phone.”

Zajac recommends using a resource checklist. “Right at the very beginning of a project, we start using a checklist that clearly explains the roles and responsibilities of the staff at both companies,” he says. “Doing this makes sure the expectations are understood by all parties.” A project manager at each company oversees the process to “make sure there are no surprises.” Zajac also stresses the importance of aligning resources between the two organisations. “For instance, you want quality engineers at one firm speaking directly to the quality engineers at the other firm,” he says. “Any project is completed by teams—not one or two individuals.”