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THE COMPLETE PACKAGE:
FIVE THINGS TO LOOK FOR IN A MEDICAL PACKAGING VENDOR
Medical device manufacturers need a packaging for their products. This packaging must serve an array of functions from delivering product protection to enhancing both the product's visibility and a company’s corporate image. The packaging may also have to meet some unique application-specific needs, depending on where and how the device will be used, such as sterile transport and damage protection. The packaging must also be available in a timely fashion and fit the constraints of a finite budget.

How does a company create a package that’s a great fit for its medical device? It comes down to selecting the ideal medical packaging partner. The following five points can guide medical device manufacturers towards the packaging company that’s right for them.

1. One-stop shopping. Choose a packaging company with numerous materials and capabilities under one roof.

The best results can be gained from working with a medical device packaging company that can handle the entire life cycle of a medical package in-house. This includes product definition, initial solid-model design, prototyping to tooling and short-run or long run manufacturing. Keeping all aspects of the process in-house allows for maximum control of both the design and package quality.

A packaging company should have a wide range of materials at its fingertips, working with a diverse selection of plastics, foams, fibers and other materials and have the expertise to choose the best material, or combination of materials, for a product. The company should recognize that all rigid plastics are not the same and the option to work with either PETG (common for all medical packagering because of its ability to withstand gamma radiation), PVC or polycarbonate plastics is a huge plus. Some medical packaging manufacturers are working with polyurethane films, which are rugged and durable and also flexible enough to accommodate sleek designs and pouches. Niche-specific packaging vendors may also offer a variety of foam types, including closed cell cross linked polyethylene and polypropylene.

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

UFP Technologies, Inc., of Georgetown, MA, is an example of a custom converter that works with an array of materials and processes. Producing packaging solutions for the medical community for more than 20 years, the company recently demonstrated its skill in creating a package for delicate orthopedic implants. UFP used a thermoformed plastic blister as outer protection and then fit a piece of compression molded foam inside to help secure the implant within the package and prevent cracking of the tray during transport. The entire package was manufactured at UFP’s on-site clean room manufacturing facilities, enabling the medical device manufacturer to sterilize the entire product without compromise.

2. Partnership. Choose a company willing to work as a team every step of the way and one that can offer expertise and efficiencies.

Choose a company with extensive medical packaging experience that has a history of producing results for medical device companies similar in size and with projects that are similar in scope. It’s not always essential to work with a large company, but it can have its advantages. A larger company may be able to secure superior pricing on materials. Also, a company with a wide range of geographic locations can help produce large volumes and ship quickly.

The medical packaging company cannot design a product without input from its customer. When it comes to the device, the medical device manufacturer is the expert and the packaging company should have a system in place that allows fluid communication enabling engineers and marketing teams to provide input regarding everything from selecting materials to criteria for design. Some vendors encourage collaborative design using software like SolidWorks, allowing both companies the ability to work together on line.

Make sure the packaging company has a track record of problem-solving success, as well as a clear understanding of the device that needs packaging and transport. Single-use sterile medical devices require a sterile package that protects the device from being compromised. Many titanium-based devices (like hip implants) need the additional cushioning of compression molded foam to keep the package’s thermoformed tray from cracking and to protect the product from damage during shipment. Also, devices used in clean rooms need a clean room manufacturing process that ensures sterile and non-pyrogenic quality.


3. Standards. Make sure the medical packaging company has a solid set of guidelines in place that comply with the needs of the medical device.

Don’t just take the packaging company’s word for its quality. The FDA establishes Good Manufacturing Practices (GMP) that dictate requirements to medical device manufacturers, which are interpreted specifically for its products. The medical packaging company should be familiar with a customer’s regulations and comply with those that are necessary to support its customer’s business and ensure things such as material trace-ability. Another indication of a company with high standards is ISO 9000 certification, which is the standard of quality for manufacturers and shares many guidelines with the GMP.

Companies that manufacture medical packaging should have clean room facilities at their disposal to create packaging in a controlled environment. The best medical packaging companies offer a wide variety of processes in their clean room facilities, including vacuum-forming, die cutting, compression-molding, bag/pouch sealing, and laminating.

In addition, make sure the staff is knowledgeable about the process. “We put people through training programs to make sure they know how to make products and understand the specifications. Quality control is driven by the people who make the product,” said Rich LeSavoy, vice president of manufacturing at UFP.

4. Time to market. A packaging company should be able to bring the project to their customer in the desired time frame.

In the medical arena, quality is of number one importance in any job. But in today’s market, timing and cost can be a close second and third. It’s hard to predict time to market, as every project is different and there are always obstacles encountered. But by having multiple plant locations, a company can maximize production. If necessary, some companies, like UFP, will even sub-contract components of the tooling to speed things up.

Dan Shaw, vice president of product development for UFP, discusses a typical schedule when his company is making a package from scratch. “The initial meeting with the customer takes a day; then we do a proof-of-concept design which takes from a two days to a week. The customer reviews this for a day or so and then final changes are made. Manufacturing drawings are completed over the course of about a week. We then go to prototype a tool, which takes 2-3 weeks, including validation samples. Once the customer approves the samples, UFP has the green light to go into production tooling, which takes 3-4 weeks. Once the tooling is set, all that’s left to do is schedule production.”

5. Aesthetics. Make sure the packaging company can develop a design that also compliments the product.

While function is of foremost importance, there are other things to consider. For both sales and company image, the product deserves packaging that stands out with a bold, distinctive and attractive design. Check out the packaging company’s portfolio. It should demonstrate a wide range of products in different colors, textures and densities. Look for packaging that is aesthetically pleasing, enhances visibility and promotes easy identification, but is also user-friendly. A package also has to be easy for the user to open and access the product.

Clearly the selection of the right packaging vendor can be a key factor in increasing efficiency and purchasing power and reducing costs. By following these guidelines, a company is more likely to get a quality package that meets both the unique needs of the device and the restraints of its budget – a package that’s just what the doctor ordered.
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