Standard, Sterile and Small: Packaging Trends Focus on Savings and Speed to Market

Hooker WEB Lucenti WEB Nielsen WEB Tyler WEB
Robin Hooker Kelly Lucenti Mike Nielsen Alison Tyler
UPS Millstone Medical Outsourcing Barger Beacon Converters


Changes to orthopaedic device packaging are shaped by the need to reduce costs and maintain functional designs that meet increasingly complex regulatory requirements and harsher supply chain environments. The package must be intuitive and simple to open, yet undergo— and pass—stringent quality standards. These complexities have manufacturers seeking expertise from outside consultants and suppliers in order to uncover process efficiencies and allow internal resources to focus on new product development and manufacturing support.

“Regulatory requirements are a significant area of concern,” says Alison Tyler, Technical Director at Beacon Converters. “There is a deep level of expertise that is required to successfully navigate packaging requirements and comply. Some companies simply don’t have the staff to complete these tasks without outside help. Sometimes it isn’t until FDA is at your facility that you realize that you don’t have the right people on board. Many customers rely on us to help navigate testing, regulatory questions and problem solving.”

Product safety, effectiveness and efficiency will always be the end goal. In assisting OEMs in designing and manufacturing safe and efficient packaging, suppliers recognize three trends in packaging—an increase in standard designs, sterile packaging and smaller packaging for shipping—and offer efficiencies for speeding to market.

Packaging3Packaging is intimately linked to the device R&D process and therefore not immune to shrinking budgets.

“We’re seeing a continuing and strengthening trend in the demand for universal packaging designs from our customers,” says Mike Nielsen, National Sales Manager, Barger. “As price pressures increase and packaging development budgets tighten, customers are becoming more open to a one-size-fitsmost packaging concept.”

Barger and Millstone Medical Outsourcing co-developed a package that fits about 80 percent of spine and extremities implants, that can be sterilized by gamma irradiation, EtO or e-beam, says Kelly Lucenti, Millstone’s president. A one-sizefits- most package for devices cuts validation costs, as well as the timeline to move sterile packaged products to market.

A second trend that Lucenti notes is a movement toward more sterile packaging, driven largely by increased infection rates at hospitals, European sales and subsequent regulatory requirements, regulatory implications surrounding cleaning and a focus on disposable, single-use instruments.

The move toward sterilization is not without challenges, though. It adds steps and time, neither of which OEMs always leave room for when planning a product launch.

“It’s interesting how differently customers approach the entire packaging and sterilization validation process,” Nielsen says. “Risk avoidance and tolerance seems to be a constantly moving target, which can create confusion in OEM packaging development groups. We approach the packaging process from a more conservative side of risk tolerance, aiming to work with OEMs to understand the steps in the process that are absolutes versus the ‘nice to haves.’ We never design a package and then just send it off, wishing our customers luck with validations.”

Previously, some orthopaedic manufacturers considered sterile barrier testing to be supplemental to visual inspection on sterile barrier package test samples. However, sterile barrier testing is a standard requirement for design and process validations. FDA and Notified Bodies have been active in auditing and highlighting gaps in orthopaedic manufacturers’ packaging in recent years, which has forced manufacturers to get smarter and comply with all elements within standards like ISO 11607— packaging and terminally sterilized medical devices.

Still, greater understanding of the sterile packaging process is demanded of OEMs that desire a smoother product launch. The one question Lucenti says he wishes customers would ask is, How long does each sterile packaging validation take to complete? “Many of our customers do not plan for adequate time to conduct all of the sterile packaging validations required—sealing validation, ultrasonic cleaning validation, sterilization validation, ship testing validation, label system validation, accelerated and real-time aging validation,” he says. “As a result, everyone is under tremendous pressure to meet product launch timelines. We often have to expedite the validations at every step.”

As more tests are required and packages are shipped longer distances, high barrier materials and designs are needed to pass processing and maintain integrity through transit.

Tyler says she has seen an increase in interest in specialized packages that protect from moisture loss and gas penetration.

“High barrier materials that can withstand deep freeze temperatures are in high demand,” she adds. “Many companies that deal with tissue based products need to package in materials that will protect the product from moisture loss and deterioration, and also be able to take the product in its package down to low temperatures. This is tricky from a packaging standpoint, so specialized materials are needed.”

Orthopaedic device manufacturers have also asked for packages to take up a smaller space.

“We have had several projects with a primary goal of taking a relatively large footprint package and making it much smaller. Some of these require moving out of a thermoformed tray into alternative packaging designs,” Tyler says.

The request to decrease size has extended to secondary and tertiary packaging, as well. Manufacturers face increased pressures to optimize their product and shipping cartons to minimize unused space and design precise packaging configurations, says Robin Hooker, Healthcare Marketing Director, UPS.

“Empty spaces in and between articles can drive cube size and transportation cost inefficiency,” he says. “The effect can be particularly acute in shipping pallets and parcel containers. Manufacturers that do not continually review, evaluate and update packaging best practices leave themselves open to product damage and gaps in cost efficiencies.”

As packaging engineers consider best practices to getting product into customers’ hands faster, outside influences should be considered. Regulatory agencies continue to evaluate manufacturing environmental guidelines, as well as the logistics environment.

“Manufacturers are being asked to align manufacturing and distribution practices in a manner that supports the product from an end-to-end perspective,” Hooker says. “This means proper identification and conditions of manufacturing storage and distribution will be more stringent in the future; the days of trunk stock implantable device inventory as ‘regulatory compliant’ healthcare space is a thing of the past. More robustpackaging may offer a degree of protection as a stop gap.”

Added to packaging engineers’ list of changes and challenges is UDI implementation and DuPont Tyvek transition, as well as business interruptions like mergers and acquisitions, supplier process changes and demands on global sourcing. Suppliers’ primary advice to manufacturers is to seek expertise before a regulatory body shows up and informs that you don’t have the right people or resources.


Carolyn LaWell is Content Manager at ORTHOWORLD. She can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

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Ms. Tyler will present “Lessons from FDA Recalls: Design and
Develop the Best Package for Your Device
” at OMTEC 2015.


In preparation for the session, we asked what can be learned from recent packaging recalls.

“Some more common failures that we see that are realized in validations and commonly in ship testing include insufficient protective packaging and undersized secondary packaging. People often fold the sterile barrier to accommodate a shelf-carton size that is dictated by marketing or other requirements. This is a universally bad idea. Folding sterile barrier packaging will often lead to delamination of the Tyvek® or film—sometimes these internal delamination events visually appear as breaches in sterility. I have seen more than one occasion where a complex fold in a sterile barrier pouch has created a hole in the pouch through the action of abrasion at the points of multiple folds.”

Learn more about here session and and register for OMTEC at OMTECexpo.com.

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 Photos courtesy of Millstone Medical Outsourcing.