Designing and manufacturing medical devices are complicated tasks and should be the main focus for the companies doing it. Therefore, when forming a team upon which to rely for ancillary components—such as the device packaging—they need to ensure they partner with a reliable company. This article offers five guidelines for selecting the right packaging solutions provider.

By Dan Shaw
Medical device manufacturers need product packaging that serves an array of functions from product protection to enhancement of a product’s visibility and the company’s corporate image. The choices made on the best material, or combination of materials, for a specific application can span across a diverse selection of plastics, foams, and other materials. The packaging might also be required to meet unique application-specific needs depending on where and how customers will use the medical device. These needs might include sterile transport or damage protection.

This chart outlines some differences and benefits of a cross-section of packaging materials. (Click here to enlarge)
It is critical to create a package that meets the specific needs of a medical device, as well as meeting time and budget constraints. Following are five criteria that can assist device manufacturers in finding the right company to partner with to fulfill their medical device packaging needs.

1. Choose a packaging company with numerous materials and capabilities under one roof.
A packaging company should have a wide range of material options at its fingertips. It should work with a diverse selection of plastics, foams, and other materials, and have the expertise to help a manufacturer choose the best material, or combination of materials, for a product. The company should recognize that different rigid plastics work better than others depending on the specific application. The option to work with PETG (common for all medical packaging because of its ability to withstand gamma radiation), PVC, or polycarbonate plastics is a significant benefit. Some medical packaging manufacturers can work with polyurethane films, which are rugged and durable while flexible enough to accommodate sleek designs and pouches. Suppliers should also offer a variety of foam types, including closed cell cross-linked polyethylene and polypropylene. Packaging companies can create laminates or combinations of materials that offer custom solutions to meet the functional and aesthetic requirements of a specific device.

Finding the optimum packaging solution can require a specific or combination of manufacturing processes; manufacturers should seek a company that demonstrates a broad range of flexible conversion capabilities, including vacuum forming, compression molding, and cleanroom manufacturing. Different medical devices have different packaging needs, so certain conversion processes may be more suitable for a given product. By using CNC routing, a packaging company can make customized trays or foam case inserts for protection and organization of surgical instruments. Packaging companies that can create laminates offer products that combine benefits in the medical market, such as cushioning with breatheability. The medical packaging supplier should also demonstrate expertise in a range of processes including foam skiving, foam slitting, foam and plastic die-cutting, plastic and foam thermoforming, foam compression molding, and heat-sealing.

Figure 1: This package for delicate orthopedic implants features a thermoformed plastic blister as outer protection and a precisely compression molded foam insert to help secure the implant within the package and prevent cracking of the tray during transport. The entire package was manufactured in an on-site cleanroom manufacturing facility, enabling the medical device manufacturer to sterilize the entire product.
The packaging required by a medical device such as an orthopedic implant offers an example of the need for a packaging supplier to understand the strengths of multiple materials and manufacturing processes. First, the packaging should be manufactured in a Class 10,000 cleanroom, so that it can be sterilized and is suitable for use in a sterile environment. The package could be a combination of materials (plastic and foam) and forming processes (thermoforming and compression molding). Combining thermoformed sheet plastics with foams (Figure 1) transforms a thermoformed tray into a highly protective cushion package. This solution provides shock and vibration protection throughout the distribution chain, while permitting sterilization of the medical device.

The use of clear, thermoformed plastics creates a protective shell and allows for item identification and easy retrieval. Engineered compression-molded foam retainers enable a standardized base tray and modified foam inserts to accommodate different products, saving time and money, reducing tooling costs, and lessening the burden of maintaining multiple packaging components in inventory. Additionally, a variety of foam colors can add a bold, distinctive look to a package, enhancing brand recognition.

2. Choose a packaging company willing to “partner” for every step of the process.
Best results can be achieved when working with a medical device packaging company that can handle the entire development cycle of a medical package in-house. This includes product definition, initial solid-model design, prototyping, and production tooling for short- or long-run manufacturing. Keeping all aspects of the process in-house allows for maximum control of both the design and package quality (Figure 2).

Figure 2: This custom designed medical endoscope case with foam inserts features a durable, scratch resistant ABS plastic housing that protects instruments from damage when stored and transported. An integrated product design team of customer and packaging suppler engineers designed it using 3D solid and 2D CAD systems. This process fast tracked case development through design and prototyping to reviews for manufacturability and finally to manufacturing where the inserts are CNC-machined, which makes them easily revised without tooling. Inserts feature one-piece construction for durability, and multiple cavity depths provide a custom fit for each item.
Device manufacturers should seek a company with extensive medical packaging experience and a track record of producing positive results for medical devices similar to those of the device manufacturer. In addition, it is advantageous to work with a company with enough buying power that it can secure better pricing on materials. Also, a company with multiple geographic locations can help scale a product, ensuring a timely, uninterrupted introduction to the market.

The packaging company selected cannot design a product without the customer’s input, as the medical device manufacturer is the expert with regard to the device. Therefore, the packaging company should have a system in place that allows for fluid communication, enabling engineers and marketing teams to provide input regarding everything from selecting materials to design criteria. Encouraging collaborative design using software like SolidWorks allows both companies the ability to work together online.

The chosen packaging company should have a track record of problem-solving success, as well as an understanding of the type of device the manufacturer is looking to protect and transport. For example, “single-use” sterile medical devices require a sterile package that protects the device from being compromised. Many titanium-based devices (like implants) need the additional cushioning characteristics of compression-molded foam to keep the package’s thermoformed tray from cracking and to protect the product from damage during shipment. Devices used in cleanrooms need a cleanroom manufacturing process that ensures sterile and non-pyrogenic quality.

3. Choose a medical packaging company with a solid set of guidelines in place.
The FDA establishes Good Manufacturing Practices (GMP) that dictate requirements specifically for medical device products. The medical packaging supplier should comply with these regulations and ensure certain critical elements, such as material traceability. Another indication of a packaging company with high standards is ISO 9001:2000 certification. This is a quality standard for manufacturers and it shares many guidelines with the GMP.

Companies that manufacture medical packaging should have cleanroom facilities at their disposal to create packaging in a controlled environment. The best medical packaging companies offer a variety of processes in their cleanroom facilities, including vacuum forming, die cutting, compression molding, laminating, and bag and pouch sealing. In addition, the staff should be knowledgeable about the process as the people who make the product are critical to successful quality control.

4. Choose a packaging company that can meet the desired time frame.
In the medical arena, quality is the most important aspect of any job. However, having a device reach the marketplace in a timely fashion is critical as well. It is difficult to predict time to market, but an experienced packaging company should be able to outline its packaging development timetable, including approvals and anticipated obstacles. A typical schedule for a packaging company that starts a package from conception and brings it to production would include:
  • Initial meeting followed by a “proof-of-concept” design — two days to a week
  • Customer review of the design — one to two days
  • Completion of manufacturing drawings (after agreement on final modifications is reached) — approximately one week
  • Prototyping — two to three weeks (including validation of samples)

  • Once the samples are approved, the packaging supplier can move forward with production tooling and set a production schedule.

    5. Choose a packaging company that demonstrates a strong sense of form and function in its designs.
    While the packaging’s protective function is of paramount importance, visual appeal is also significant. The chosen packaging company should develop a design that compliments the product. Review the company’s portfolio. Look for a range of products in different colors, textures, and densities. Find examples of packaging that is user-friendly (easy to open and access), but also aesthetically pleasing—enhancing visibility and promoting easy identification. The product deserves packaging that stands out with a distinctive and attractive design.

    Over time, a company’s medical device packaging needs may range from functional inserts to sales kits. Finding a packaging supplier with which it can partner to develop consistently superior packaging that provides functionality and distinctive looks can set that company apart in the marketplace. Further, as the company builds a history with its packaging partner, it will also find that the closer relationship is a key factor in increasing efficiency, purchasing power, and reducing costs.


    Following these five key guidelines when selecting a packaging solutions provider will enable a company to achieve a competitive advantage over other similar companies in the marketplace—one of the primary goals of every medical device manufacturers. The device manufacturer need not settle for less than what is outlined in these specific steps.
    For additional information on the technologies and products discussed in this article, see the following websites:

  • Dan Shaw is the vice president of product development for UFP Technologies Inc. He has years of experience with materials, processes, and applications in the medical device packaging arena. Shaw can be reached at 978-352-2200 or