Medical Device Link.

Outsourcing Guide

Image courtesy of Sterigenics

One important piece of the puzzle when manufacturing a medical device is the package that contains it. And, of course, a finished medical device isn’t much good to an end user if it’s not sterile. So, how can a med-tech OEM be confident that the packaging being used is sound and that the products are adequately sterilised? For some firms, it makes sense to invest in the necessary packaging and sterilisation equipment and employ an expert staff to oversee these operations. “I fully understand the concept of vertical integration to optimise and cut costs,” says Leonardo Maghetti, Managing Director of S.I.F.RA. Est SpA (Trieste, Italy; www.sifraest.com). “But when the strategy to keep everything in house ends up involving activities that are not the company’s core business, it is usually preferable to outsource.”

Although there are often financial benefits for OEMs that outsource their packaging and sterilisation operations, many firms decide to work with contract firms because of the logistical advantages and time savings that can result from such relationships. In addition, packaging and sterilisation outsourcers often are able to help device companies stay compliant with evolving regulatory standards. Many medical device firms don’t have the resources to constantly monitor revisions to sterilisation and packaging standards. Conversely, contract packaging and sterilisation firms that have a medical focus carefully follow regulatory agencies and their evolving standards, often enabling them to anticipate changes to the regulatory climate years before they take effect.

Outsourcing firms also can help device firms avoid mistakes that can lead to expensive product recalls. “The key factor is to be certain you don’t wait until you’ve gotten your product complete to seek the advice of a contract firm,” says Ron Peacock, Marketing Director at Sterigenics (Somercotes, UK; www.sterigenics.com). “If both sides inform the other of any problems or complaints early on, they can work together to resolve them before they become critical.”

There are two approaches one can take when deciding on the appropriate packaging to use, Peacock says. “You can either decide which sterilisation method you are going to use early on and design the product accordingly, or seek out the help of a knowledgeable contract sterilisation firm when your product is close to completion, letting them decide which packaging and sterilisation method is best for your product,” he says. “It’s really a nightmare when a company has decided on using a sterilisation method for a particular product and selected packaging for it, and the chosen sterilisation method ultimately isn’t suitable,” Peacock explains.

What to look for

In the end, the success you have with outsourcing depends on the capabilities of the firm you choose. But what kind of criteria should a device firm consider when shopping for a contractor? “Quality, reliability and price. In that exact order,” Maghetti says. “Poor packaging can transform the best, safest and most-economical medical device into an inferior, unsafe and expensive product,” he explains.

It may sound like common-sense advice, but make sure you only choose contractors that are thoroughly experienced working with medical devices. Occasionally, a company that specialises in technical or food-grade packaging will develop a sense of adventure and try to enter the medical packaging segement, explains Maghetti. “They think ‘it must not be that difficult,’ but, in the end, they usually dramatically fail to comply with regulatory standards.

“Ultimately, it is the responsibility of the OEM to perform effective audits to determine if the contract company has the appropriate quality systems in place, GMP licenses and basic capability to perform the activities,” says Howard Gray, Operations Manager at SCM Pharma (Northumberland, UK; www.scm-pharma.com). An OEM also should look to work with an outsourcer that can act like an extension of its project team, he advises. “It’s really important to find a contract partner that’s a good match and then build up a good working relationship.”

Another consideration is location. When outsourcing sterilisation, seek out a local sterilisation contractor, if possible, Peacock stresses. “At the end of the day, if you start shipping things all over the place, the logistics will cost you more than the contract services.”

After you have compiled a list of companies offering the services you need, narrow it down to a few firms and go and visit their facilities in person, Gray recommends.

When looking for a contract steriliser, be sure that they offer multiple sterilisation technologies, so they can provide you with the best option for your product, Peacock advises. There’s no “one size fits all” method when it comes to sterilisation. So, it’s important that they offer a variety of services and that they provide you with expert advice. “A good steriliser can help you address problems such as shadows in E-beam sterilisation and optimise your device for gamma or EtO sterilisation,” Peacock says. “When dealing with EtO, for example, valves should be open to allow a sufficient pathway for gas.”

Getting the contract right

After you have decided on a contract firm, the first step of action to take is to draft a project initiation document, Gray stresses. “This document should clearly define what is expected from a project. Avoid making assumptions when pulling it together,” he says. “It should not be ambiguous—everything should be spelled out in black and white,” he recommends. “Your company should be confident that the contract contains all of the correct procedures needed to manage the entire project successfully.”