Seán Egan, Nelipak Healthcare Packaging, examines the evolving role of thermoforming suppliers in medical packaging design.
Thermoforming
The sterile medical packaging market continues to grow, with research published by MarketsandMarkets projecting sales could increase by a Compound Annual Growth Rate of 5.72% over the next several years, bringing it to a $35.07 billion industry by 2020. Thermoforming represents one of the main manufacturing processes used in medical packaging production.
Today’s medical device OEMs are looking to their thermoforming supplier to be more than just a manufacturer. Thermoformers become an extension of the customers’ packaging development team, taking on expanded roles in design, development and testing. Furthermore, OEMs expect thermoformers to not merely design around the product, but to fully understand how both the product and pack are to be used within the clinical environment. This increasingly results in device packaging not simply being a transport vehicle to get the device to the OR - but in many cases the pouch or tray may be used as part of the procedure.
Design for manufacturing is another important consideration for the thermoformer in the package design process; having a pack that ticks all the boxes for the customer is no use if the product is difficult to manufacture. Prediction tools allow designers and tool makers to understand how a part will behave during manufacturing and amend accordingly to maximise production runs. On the OEM side, automation is increasingly being introduced into the manufacturing setting; the design team needs to take account of the requirements of the process balanced with the needs of the end user.
Thermoformers also need to understand how packaging influences the customers’ packing operations and supply chain. In addition to reducing the overall amount of plastic used, well-designed products have the ability to reduce labor and handling costs such as transportation, sterilisation and storage through the supply chain. Reduction in overall footprint of the end pack should also lead to less plastic finding its way into the waste stream in situations where recycling is not practical, such as hospital waste with risk of contamination.
Thermoformers and OEMs also need to work together to determine which materials should be used for packaging. The decision behind material selection is based on the product which is being packed, the sterilisation method and material costs. Pricing can affect material choice if one or more materials can meet the same need for the pack, but where there is no alternative customers expect that package design will minimise the amount of material required to lower unit cost.
In regards to packaging materials, healthcare device and pharma companies tend to be more conservative about change than other sectors of the market, largely due to the regulatory scrutiny they face. Healthcare rigid packaging predominately uses PETG, APET, HIPs and Barex materials. OEMs will generally favour these packaging formats and materials already proven in the market, which can limit their ability to innovate for evolving market needs. But new packaging formats or material combinations require validation and preparation of documentation for submission, which is both time consuming and costly to carry out. New materials need to address a critical market need in order to get quick acceptance, otherwise penetration of the market can be slow. Choosing a thermoformer who is experienced in navigating these challenges can open the door to expanded possibilities for next generation packaging.
A thermoformer also must have an intricate understanding of the factors which impact seal integrity, which is critical to the product efficacy of healthcare packaging, as the seal maintains necessary sterile barriers. Seals must always remain intact under the strains of shipping and handling, yet peel open quickly and easily for the end-user in a surgical environment.
Understanding and applying best practices during the heat sealing process and using custom built cleanroom sealing machines designed to the specifications of a medical device, pharmaceutical thermoformed blisters, or trays can result in better quality products that consistently have the necessary seal strengths and properties.
Over the next few years, new medical device technology will emerge where packaging will play an even bigger part in the functionality and use of the device and have a larger role in educating home users in the device’s proper use. Choosing a thermoforming partner with the expertise, technical capabilities and industry knowledge to add value at the design and development stages will be critical for OEMs looking to keep up with the needs of their end users and capitalise on the opportunities of the growing healthcare packaging market.