|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.
Packaging 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.”