Medical device packaging is an important part of delivering your device to market safely and securely, yet there is no doubt that navigating the process can be a bit confusing and complex for device manufacturers. With decades of experience in assisting device manufacturers with their packaging design solutions, we offer the following three tips for a successful packaging design as a way of avoiding costly and time-consuming mistakes.
Avoid These Mistakes When Working with a Packaging Supplier
The most common mistake medical device manufacturers tend to make is providing the packaging supplier the final device too late in the packaging design process. Designing off a frozen device at the 11th hour could result in design changes that end up being costly and time consuming. Early in the design process, it is wise to consider using a 3D-printed prototype of the device, a previous-generation product, or something very close to the actual device. However, before finalizing and placing an order, it is imperative that the packaging designer is provided with the actual device with enough time to make any necessary adjustments. The weight, dimension, and material textures of a device are paramount to deciding packaging elements, so it is important to realize that any change to the device may affect the packaging design altogether. For example, the actual device may vary in weight considerably compared to that of a model, which could change the effectiveness of the retention elements. If the first generation of a device has a tacky surface, yet the final product has a smooth surface, this too could affect previously designed elements and their ability to retain the device. If there are dimensional changes, again, retention elements are affected, which may change the primary package, which in turn can lead to changes in your secondary package.
Medical device packaging should be designed around your device to provide the most efficient, safe, and protective packaging. Providing the packaging supplier with the final device could save you time, money, and the hassle of potentially redesigning your entire packaging project.
Take an “Inside-Out” Design Approach
As I explained in the Packaging Digest article, “3 steps for designing the ideal medical device packaging system,” loss of sterile integrity could result from improperly sized packaging elements in relation to the device. For instance, a backer card or tray that is too large for a pouch will place constant pressure on pouch seals, and a backer card or tray that is too small could move around and possibly abrade the pouch. The results are stress and fatigue that could lead to pinholes, seal failures, or some other compromise of your sterile barrier system.
To avoid ineffective packaging and possibly risking the sterility of your device, consider taking an “inside-out” design approach.
This means designing your “primary packaging” first, whether it be a backer card or tray. Using the dimensions of the primary packaging, begin designing a properly sized pouch or lid, followed by shelf cartons and master shipping cartons – all based on the dimensions of the previous component. Adjustments can be made every step of the way for the most efficient and protective packaging.
The inside-out design approach optimizes the size of each element for a smaller package footprint. Smaller packages mean reduced material costs, less weight, less shipping cost, and less shelf space. A smaller footprint also means more units can fit into a tote, reducing sterilization costs per unit.
A system that is designed from “off-the-shelf” components or an “outside-in” approach introduces risk and uncertainty that can be avoided. For example, beginning a package design with an off-the-shelf box or pouch may result in packaging that is unnecessarily large or weighs more than needed. More importantly, components that don’t fit properly or utilize excess material will result in unnecessary movement or force that may lead to a failed transportation validation.
Consider All Stakeholders in the Packaging Design Process
It is important to consider each stakeholder in the package design process. Stakeholders include any individual who will interact with the package of your device. The key stakeholders, of course, are those who touch the actual finished device, specifically the pack-out technicians along with the doctors, nurses, and other healthcare professionals who utilize the device.
Other less obvious stakeholders may include, for example, seal operators, labelers, sterilization technicians, warehouse personnel, and other factory employees. If distribution centers are utilized, then shippers, receivers, stockers or pickers, and inventory managers are also considered stakeholders. The same is true at treatment facilities where receiving clerks, material managers, and circulating nurses, among others, are all interacting with your packaged device and therefore are stakeholders in the finished package.
Each of these stakeholders will have different needs when it comes to how they handle and interact with the packaged product. The objective is to understand and consider each stakeholder’s needs and to incorporate this into the packaging design. Doing so will help improve their experience with the product and establish its acceptance in the marketplace.
In conclusion, while it’s acceptable to begin packaging design off a 3D model, it is imperative to provide your frozen device as early as possible in the package design process. Avoid the hassle, cost, and delays of a potential package redesign by utilizing a device-specific “inside-out” approach vs. an outside-in approach with off-the-shelf packaging components. And lastly, consider and understand the needs of all stakeholders who will interact with your device and incorporate those needs into the design process. This will help ensure that you have designed a safe, effective, and complete packaging solution for your device.