Medical device packages are expected to successfully accomplish numerous functions in a variety of settings, and expectations are skyrocketing. In the production setting, package designs must be carefully considered so that they are easily filled, handled, shipped and stored. The idea is to maximise production efficiencies (line speeds, cube efficiencies, inventory control, and the like) without imposing unnecessary burden on workers. The package must also facilitate and withstand the sterilisation process, and then maintain the sterile barrier throughout distribution so that the product arrives at the point of use in a safe condition.
End users have their own demands for medical device packages, though many times they do not even understand that their expectation for the product is realised through its package design. End users expect their purchases to be safe, genuine, easy to use and store, and to arrive undamaged with a significant shelf life.
Additionally, they want products that can be readily identified with directions that guide users to the proper use of the device; often this must be accomplished on a single package in multiple languages. Furthermore, with increasing frequency, end users expect customised kits – products that are tailored to a specific procedure, patient or healthcare professional. This frequently comes in the form of a single package that is designed to contain multiple products.
All of these demands must be met in an economic climate that views a reduction in the cost of healthcare as a priority. As a result, the major trend facing medical device packaging is an increasing level of expectation for performance at a reduced level of cost.
The device industry, to its credit, has long been attuned to the needs and wants of its end users. Take the glucose monitor, for instance. It began as a cumbersome device that was difficult to interpret and only administered by healthcare professionals. It has evolved into a compact, intuitive design that can be used conveniently and discreetly by the patients themselves; some even have the potential to link wirelessly to other devices and computers so that patient history can be closely monitored.
Despite the fact that devices have been aggressively evolving to suit the needs and demands of the end user, it has only been in the recent past that device packages have come into their own as a way to add value to the product.
Combination products are a recent example of how packaging adds value to medical products. Products such as insulin injector pens, metered dose inhalers, transdermal patches and prefilled syringes are combination products that add convenience and save the end user time and/or effort. However, this adds complexity to the packaging system. The device itself becomes a package for the drug product, complicating things like shelf life, efficacy, package testing, labelling and regulation.
Device manufacturers that are using the device as drug delivery systems, or a package for the drug, now have to consider issues such as migration, sorption, permeation and drug stability. These are issues that were likely not important to them when they packaged a lone device.
Combination products also include items that are packed together for the convenience of the user. One such example is a kit consisting of multiple surgical instruments packaged with drapes and drugs such as lidocaine. Again, more convenience for the end user but added complexity for the device manufacturer and packager, who must ensure that the kit be efficiently, thoroughly and correctly packed, sterilised and distributed.
Sterilisation, in particular, becomes complicated with these combination products. Not only must the manufacturer be certain that all components within the kit reach a sterile state, all materials must be compatible with the sterilisation process (ethylene oxide, or EtO, gamma irradiation, and the like). In many cases, the package design is expected to facilitate sterilisation. For example, devices that are sterilised using EtO must be contained in packages that incorporate a porous membrane. This membrane allows the EtO gas to penetrate (and evacuate) the package during the sterilisation process.
Packaging design must also be carefully considered if the device manufacturer employs gamma irradiation to sterilise their products. When utilising irradiation for sterilisation, both product and packaging materials must be accounted for so that they are not adversely impacted by the sterilisation process; an inappropriate material may become brittle or discoloured after sterilisation. For both gamma irradiation and EtO, designers must also consider the package geometry and size so that sterilisation cycle times are optimised.
Despite the added complexity to the system, the number of combination products is growing, due to the advantages that these products provide the end user, including better outcomes and easier and more intuitive therapies. According to the Online Ambulance website, "Combination drug delivery products are growing at an annual rate of 14% across all technology segments, and will total $38bn in 2008." The fastest growth is predicted from "products that add value and provide greater efficiency", according to a report published by The Freedonia Group, Inc (Cleveland, USA).
Adding value and providing greater efficiency is not only important to those in institutional settings. End users in home markets are equally as demanding. Products that are easier to use can equate to higher rates of compliance, which translates to better outcomes. This is becoming increasingly important as the population ages.
The ageing of the population has contributed significantly to the trend of value-added packaging. As the age structure of world population continues to shift, with older age groups making up an increasingly large proportion, home consumers of medical devices and their healthcare providers will continue to demand convenience and ease of use. However, these users can be challenging to design for, as people tend to become increasingly disabled as they age.
The shift in demographics to an older population has coincided with a rise in home-based health alternatives. Acute care facilities, faced with the contradictory goals of increasing the quality of care and decreasing cost, have developed new approaches to healthcare such as ambulatory care, hospice programmes and other home-based therapies. These solutions minimise the amount of time that patients spend in an acute care setting, and shift much of the care into the patient’s residence.
As a result, many devices that were previously administered by healthcare professionals in an acute care setting are now being used by patients themselves in their homes.
Consequently, packaging designers must carefully consider the patient, their abilities and condition as the package is designed. This includes the infirmities associated with ageing.
Ageing consumers frequently have changes in cognition, perception and dexterity. These changes impact their ability to decode information on the packaging as well as their ability to open and use it. Labelling must be noticeable, decipherable and readily understandable by users that have a variety of abilities; this is something that is important for all products, but is imperative for medical products, given the criticality of the information required for their safe and effective use. Pull tabs, opening features and the like must accommodate those with limited strength or use of their hands. Directions must be simple and clear, guiding the consumer to the correct and appropriate use of the package’s contents.
All of these efforts – combination products, clearly designed directions and packages that are easy to use – are intended to benefit the end user. Packaging works to deliver devices safely and effectively so that they reach their therapeutic potential. However, package designers must now also consider the possibility of sinister forces that lurk in the supply chain. High dollar products, such as medical devices, present opportunities for profit to those with unwholesome intentions. Counterfeiting is yet another trend that adds complexity to package design.
Long-recognised as a problem in the drug industry, counterfeiting is beginning to attract the attention of those working with medical devices. Transdermal contraceptive patches, condoms and implants are among the medical devices that have been identified as counterfeit in the recent past. The ramifications of unsafe and/or ineffective knock-offs is of the utmost concern to the industry at present.
Package design is one way that counterfeiting can be deterred and/or detected. Like the drug industry, medical device manufacturers are turning to technologies such as radio frequency identification (RFID) to provide an ‘electronic pedigree’, or a complete history of a product’s location as it traverses the supply chain. This tracking technology is frequently layered with other technologies that deter counterfeiters because they are difficult to reproduce and technologies that help the manufacturer to determine whether or not a product is genuine. The layered features can be covert or overt in nature and include holograms, latent image technology, tagents, and colour-changing inks.
The use of technology and thoughtful design for packaging is accelerating in an attempt to accomplish the myriad of user expectations related to medical devices for both institutional and home users. Expectations must be met or exceeded in an economic climate that views the rising cost of healthcare as reaching a crisis state. Package designers in the medical device field are likely to be expected to accomplish more with fewer resources for years to come.