the model 1830s is shown with a large and intricate tooling nest with several support islands out in the midst of the tray where the packaging engineer would tack the tyvek down in critical areas to keep the product in place.packaging is often one of the last considerations in the development of a new medical device. although the failure of the packaging performance can result in a recall just as quickly as a deficiency in the device itself, the time allotted to the packaging design is often too little or compressed due to other upstream project issues.sometimes considerable efforts are expended in creating detailed timelines that are really patched together from submittals demanded of suppliers. it is not surprising when the sum of the parts exceed the overall time remaining in the project. at that point, two things become obviousthe elements are reduced to artificially project the desired end date.risk is increased proportionally.following are four aspects of package design that need to be considered by medical device developers. suggestions are offered that could save time and money, while also recognizing potential challenges.1. reusedesigners will often reuse an existing package design, as this can reduce risk and the development timeline. one thing that can go unchecked, though, is a change in the volume of the contents, which may increase, causing issues with appropriate fit and even create interference with tray lidding. additionally, there is sometimes an assumption that existing package tooling and capital equipment can accommodate the new project when in fact, the current amount of product requiring that work cell is increasing. if clear communication does not exist between packaging designers working on different projects, this situation may not be realized until it&rsquos a costly problem.2. new materialswhen a previously unused material is selected by the package designer for an aspect of the container, its characteristics may not be as &ldquotroublefree&rdquo as advertised. when working with a new material, time should be allotted for the additional efforts required to optimize its properties in a specific application. for example, if a new lidding material is identified for a project, the requirements to best ensure a complete seal may differ from the designer&rsquos previous experience. if this time is not afforded, the outcome may be a less than ideal package solution, or worstcase scenario, one that fails later in the development cycle. in addition, going through the process of identifying a backup material is a wise investment when working with a new material.3. designpackaging designs, such as a thermoformed tray, look fantastic as a 3d model, but when produced, several unexpected yet somewhat predictable deviations can emerge. asymmetrical features and depth variations will cause tray wall and sealing flange thicknesses to vary. this is common with thermoforming and the sealing operation can be adapted appropriately so long as the variations are consistent. while using the 3d model as a basis upon which to finalize the necessary sealing tools can make up time in the project&rsquos schedule, doing so can also add significant risk to the process. deciding whether or not using the 3d model is sufficient or if a physical prototype is required can be determined by addressing several questions. how much risk is acceptable how complicated is the design what is the target date for completion, and does it require that the risk be taken4. equipment & toolingcapital equipment and tooling are a significant investment. selecting the features and options of this equipment falls on the shoulders of the packaging engineer. requesting equipment quotes for every possible option is a sign that the engineer has little experience and the operation or process has not been examined for improved efficiencies. specific options can ease operator fatigue, reduce range of motion, and preclude errors. inquiring about the correct situation where an option is applied is not something to be skipped. in fact, learning about the evolving range of equipment capabilities is the fun part of the task.these four aspects of packaging development represent several of the most important considerations for the packaging designer. while the list is not exhaustive, it does provide a good starting point and addresses the more common concerns that are encountered
