The packaging system is a crucial component to getting a medical device to market on time. Time constraints with new projects can affect the packaging system and may prohibit a proper design. The earlier a manufacturer starts thinking about the packaging of the medical device or system, the better things will turn out in the long run.

UFP Technologies designed and engineered custom case and foam insert systems for a line of endoscopes for a medical device manufacturer. Packaging specialists advise manufacturers to be aware that timing may be an important factor in determining what materials and fabrication methods can be used for their packaging systems.
Most device manufacturers have a certified packaging engineer on staff or on retainer to assist during the design of a new device. Ideally, the packaging engineer can inform the medical device manufacturer of limitations and help mitigate any unrealistic expectations about packaging that can hold up the launch date of a new device.

Device manufacturers without their own packaging engineers would benefit from consulting a medical device packaging specialist who is able to alert them to protocols that could be crucial to gaining FDA approval down the line. Overlooking these considerations may affect a product’s expected launch date and result in lost revenue.

Accelerated Aging Tests

Companies conduct accelerated aging tests to determine how long the packaging system will last on the shelf. These tests can be a major factor in meeting timelines, schedules, and product launch dates. In some cases, it is important to have the tests done concurrently to test the materials that will be used. The complete system must be tested, including materials or components such as foam, blisters, and/or lids for sealing. The test mimics the temperature and seasonal changes that will occur during the life cycle of these devices.

Accelerated aging tests can take many months, and the FDA will not approve a device before an accelerated aging test is completed. Companies must submit their test results to the FDA and confirm that the packaging will support their claim of how long it will last.

Packaging Materials

Time is also a crucial factor in selecting a manufacturing process and material. Shorter lead times may dictate which materials and fabrication methods can and cannot be used for the packaging system.

Medical device manufacturers are sometimes forced to use a process or material based on their lead times. For example, compression molding a packaging solution may not work due to the time needed to create custom tooling, so a die-cut part may have to be used. Selecting materials upfront could help reduce overall lead time.

The following is a brief overview of some types of materials used in medical device packaging applications.

Cross-Linked Polyethylene: Cross-linked polyethylene foam is a closed-cell foam characterized by a compact feel and resistance to water that enables the material to be compression molded or thermoformed. It has many of the same properties as polyethylene foam but also has the ability to protect class “A” surfaces and is used extensively for packaging medical products and equipment.

Applications include: case inserts protecting endoscopes and fragile medical devices, orthopedic implant packaging (i.e. hip, knee, joint replacements), and surgical instruments.

PETG: A tough, thermoplastic material that is easy to thermoform. It is ideal for medical applications because it stands up to radiation and chemical sterilization techniques without changing color. Applications include: orthopedic implant packaging, surgical instruments, and medical electronics.

TPU: Thermoplastic polyurethane is a class of materials used for medical device packaging and components due to its great abrasion and puncture resistance. Most TPU resins meet USP Class VI standards. Packaging applications include: surgical screws and rods, orthopedic implants, and head trauma implants.

Combination of Foams & Plastics: A packaging partner like UFP Technolo gies (Georgetown, MA) has the ability to fabricate almost any foam or plastic material. The combination of foams and rigid plastics allows for the transformation of simple thermoformed trays and packages into highly protective cushioned packaging — providing a unique solution for shock and vibration protection throughout the distribution chain, while permitting sterilization for medical devices.

Packaging Project Examples

UFP Technologies has worked with many customers to create packaging solutions for devices, ranging from endoscopes to surgical systems. One customer required an all-in-one packaging solution for a complete specialty surgical procedure kit. UFP Technologies designed, engineered, and manufactured a compression molded foam clamshell that included a thermoformed plastic window, living-hinge, and magnetic closure system. The kit is used by surgeons in operating rooms and can be disposed of after use. It was designed to be a first-of-its-kind, all-in-one solution, providing nurses and doctors with all of their necessary tools in one portable and sterile package.

UFP Technologies also designed, engineered, and fabricated custom case and foam insert systems for a line of endoscopes for a medical device manufacturer. Another project involved contract manufacturing and packaging a surgical hand immobilizer, made with a pliable aluminum interior for easy hand positioning, and laminated to a foam exterior for patient comfort. The product was then sterile wrapped, sealed in a polyethylene and paper pouch, and shipped for gamma sterilization.


Working with a medical device packaging specialist could shorten the time it takes to get a device to market. Packaging design can be done concurrently with the rest of the product’s development; if a sample of the device is complete, the company can get started on packaging design as well. For best results, packaging design and production should be programmed into the release schedule of a device.

This article was written by Thomas Fitzgerald, Marketing Coordinator for UFP Technologies, Georgetown, MA – HQ and 11 other locations. For more information, Click Here .