Multiple factors are impacting the closing, but critical, processes associated with the end of product manufacturing.
Packaging and sterilization are critical stages of medical device manufacturing—lives are on the line if sterilization is compromised through packaging or sterilization failures. Both sterilization and packaging markets remain mature, relying on standard, accepted materials and methods. The most prevalent materials are legacy materials such as Tyvek and nylon. Large-scale sterilization depends on the well-established ethylene oxide (EO) and gamma radiation processes. FDA and ISO standards continue to become more stringent, especially regarding quality. OEMs focus on how to abide by these standards, which can seem open to interpretation. Everyone is pressured to reduce costs.