Medical device packaging cost varies depending on design, materials, assembly, structure, and other factors unique to a product. The packaging design might need to maintain device sterility, maximize shelf life, or be visually appealing for the end user. Well-designed medical device packaging is worth the money as it can ensure product integrity and better serve doctors and patients.
The Purpose of Packaging
Without proper packaging, a product may be damaged when shipped through the supply chain. Packaging may protect the product from bacteria, heat, cold, moisture, and other environmental conditions and can also serve more than one function in commerce:
- Branding: Represents the company.
- Transactability: Can include bar codes.
- Versatility: Should be designed for easy inventory and dispensing.
- Usability: Informs the user on product contents and uses. The FDA requires that all medical packaging include a physician Instructions for Use (IFU) inside the packaging.
Types of Packaging
Most medical devices are packaged in a pouch or tray, but packaging could be made from a variety of materials, including foil, plastic, cellophane, cardboard, and aluminum. Some standard packaging designs include poly bags, clamshell packaging, shrink wrap, chipboard boxes, paperboard cartons, and corrugated cardboard. Manufacturers use three categories to identify layers of packaging:
- Primary – Primary packaging is in direct contact with the product. If primary packaging is defective or damaged, it often compromises the integrity of a medical device.
- Secondary – Secondary packaging is used to contain the primary packaging during shipping and distribution as well as to collate individual units during storage.
- Tertiary – Tertiary packaging protects bulk products during transportation and is often never seen by the end user. Examples include corrugated cardboard boxes or warehouse pallets.
When designing medical device packaging, manufacturers must consider the fragility and volume of the product as well as what role the packaging will have in the supply chain. Other determining factors that affect packaging design include:
- Labor – how long it takes to assemble packaging and
package the product.
- Packaging must take into consideration
- Cost – how intricate does the packaging need to be? Packaging can add considerable cost to the project—lowering margins or even eliminating profit.
- Packaging must take into consideration sterilization needs.
- Warehousing – how the product will be stored and shipped.
- Logistics – ease of handling.
- Inventory – how distributors will keep track of the product.
- Vendors and purchasing functions – how the product will be sold.
- Waste – how much of the packaging will be recycled.
Packaging Cost, Time, and Requirements
The cost to outfit a product with packaging depends on time, labor, testing, and additional features such as graphic design or extra bags, tape, void fill, stretch wrap, or other assembly materials. Medical device manufacturers must accommodate for lead time during package testing procedures. FDA standards outlined in ISO 11607 specify seal strength, material integrity, distribution, and shelf life requirements that must be met before a product can be marketed.
At Via Biomedical, we take the whole project cost into consideration, from prototyping to packaging. Throughout our process, we communicate with our clients to ensure all requirements are met and expectations are exceeded. Our engineers have more than 17 years of experience brainstorming packaging solutions for clients. We offer packaging services, including design, labeling, instructions for use, palletization, and more. Contact us today.