The Complete Package: Five Things To Look For In A Medical Packaging Vendor
How does a company create a package that's a perfect 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 packaging company that can handle the entire life cycle of a medical package "in-house". This includes services from 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 quality of the package.
A packaging company should have a wide range of materials at its fingertips. Seek out a company that works with a diverse selection of materials – including plastics, foams, and fibers and other materials, and has 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 that the option of working with either PETG (common for all medical packagers because of its ability to withstand gamma radiation), PVC or polycarbonate plastics is a huge plus. Some packaging manufacturers are working with polyurethane films, which are rugged and durable, but also flexible enough to accommodate sleek designs and customized trays. Niche-specific packaging vendors may also offer a variety of foam densities and types, including cross-linked polyethylene and polypropylene.
Picking the optimum packaging solution requires that a medical product device company finds a manufacturer that offers some specific and precise 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 varying packaging needs, so certain conversions are more suitable for certain products. By using CNC routing, a company can make customized trays or case inserts for protection and organization of surgical instruments. Packaging companies that possess the ability to create laminates can offer products with the combined medical market benefits of cushioning and breathe-ability. The packaging company should also demonstrate a range of processes that include skiving, slitting, die-cutting, and heat-sealing.
UFP Technologies, Inc., with corporate headquarters in Georgetown, MA and eleven manufacturing facilities throughout the US, 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 by creating a package for a delicate orthopedic implant. UFP manufactured a thermoformed plastic blister for outer protection and then custom designed and fabricated a compression-molded foam top and bottom cushioning insert that precisely fit inside of the blister pack, thus, securing the implant within the package and preventing particulate from forming during transport. The entire package was created at UFP's on-site clean room facilities, enabling the medical device manufacturer to sterilize the entire product without compromise.
2. Partnership. Choose a company that is willing to work with you as a partner in every step of the way and one that can offer you expertise and efficiencies that manage costs.
Choose a company with extensive medical packaging experience that has a history of producing positive results for medical device companies. It's not always essential to work with a large company, but it can have its advantages. A larger company may be able to "flex its muscles" and attain preferred pricing on materials. Also, a company with a national footprint can more likely produce large volumes and ship more quickly and efficiently.
A packaging company can't design a product without input from the customer. When it comes to the product that needs packaging, the medical device manufacturer is the expert, and the packaging company must have the systems in place that allow for fluid communication that enables engineers and marketing teams to share input regarding everything from selection of materials to establishing design criteria. Some vendors encourage collaborative design by utilizing software like SolidWorks, allowing the companies to work together online.
It is important to make sure the packaging company has a track record of problem-solving successes, as well as a clear understanding of the requirements of the device being packaged and transported. Single-use sterile medical devices require a sterile package that protects the device from anything that could compromise it. Many titanium-based implants (like hip implants) need the additional cushioning of compression-molded foam to keep the package's thermoformed tray from cracking and protect the product from damage during shipment. Also, any packaging for medical devices used in clean rooms is bound by the additional requirement that it be manufactured in a clean room environment, ensuring sterile and non-pyrogenic quality.
Some projects may require a certain degree of confidentiality. Make sure the vendor is willing to sign a confidentiality / non disclosure agreement before the project gets rolling.
3. Standards. Make sure the packaging company has a solid set of guidelines in places that are aligned with the specifications of the medical device.
Don't just take the packaging company's word regarding quality. The FDA establishes Good Manufacturing Practices (GMP) that dictates requirements to medical device manufacturers, which interpret the guidelines specific to the product. The packaging company should be familiar with a customer's regulations and comply with those necessary to support its customer's business, to ensure things such as material traceability. Any licensed device manufacturer should be able to get information regarding GMP from the FDA and check to ensure that the packaging company follows these rules. Another indication of a company with high standards is ISO 9000 certification, which is a standard of quality for manufacturers and shares many guidelines with the GMP. In addition, the packaging company should be willing to comply with any special standards that its customer requests.
Companies that manufacture medical packaging should have clean room facilities at their disposal to create packaging in a controlled environment. The best packaging companies can offer a wide selection of processes in their clean room facilities, including compression-molding, vacuum-forming, die cutting, 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 important, driven by 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 its customer in the desired time frame.
In the medical device market, quality is paramount in any job. But in today's market, timing and cost are 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 efficiencies. If necessary, some companies, like UFP, will even sub-contract components of the tooling to expedite the process.
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. We then do a "proof-of-concept" design that requires a couple of days to a week. The customer reviews this for a day or so and then the final changes are made. Manufacturing drawings are completed over the course of about a week. We then move to tool prototyping, which takes 2-3 weeks, including validation samples. Once the customer approves the samples, UFP has the green light to go into production tooling – about a 3-4 week process. Once the tooling is set, all that's left to do is production scheduling."
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 the sake of sales and a company's 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 must also allow easy product access for an operator.
Clearly the selection of the right medical device packaging manufacturer can be a key factor in increasing efficiency, and reducing costs. By following these guidelines listed above, a company is more likely to get a quality package that meets both the unique needs of the device and the boundaries of its budget – a package that's just what the doctor ordered.