Medical packaging is at a crossroads. The western world's ageing population means that demand is at an all-time high: recent analysis by Frost & Sullivan of the North American medical device packaging market suggested that earned revenues of $569m in 2006 would rise to reach $918.8m in 2013. Innovation, however, has arguably not kept up with demand: the next few years could prove to be very interesting indeed.
Dr Laura Bix, assistant professor at Michigan State University's School of Packaging, is well placed to comment. Bix, who specialises in healthcare packaging, believes that manufacturers will have to be smarter in order to deal with the challenges of this new era.
"We are going to see an increasing level of complexity [in the healthcare packaging market]," she says. "We're seeing escalating demand for our products – we're expecting to do more and more things, not only in maintaining efficacy and safety but also in being a convenient delivery mechanism for an increasingly ageing population.
"We're seeing increasing demand but at least in the US, and I suspect throughout the world, we're also seeing a tightening of budgets. The overall trend to me is 'do more and more with less and less'. I don't see that ending any time soon.
"Packaging manufacturers have to be cleverer. An interdisciplinary approach is going to be one way we slay that dragon. People need to sit down with others that they maybe haven't sat down across the table with before and brainstorm from the beginning – 'how do we meet these challenges in this increasingly competitive world?'."
The ageing population will be a key problem for the medical packaging sector, according to Frost & Sullivan research analyst Urmila Kishore. "The medical device packaging industry is directly dependent on the medical device industry," she says. "According to a recent study, the medical device market is expected to grow by approximately 11% from 2005 to 2011 due to a growing ageing population and increased awareness of diseases."
Bix believes a fresh approach could be the key to dealing with the challenge of an ageing population. "It creates a lot of problems," she says. "We've done some work with children and older adults and we find that there aren't a lot of ways to segregate the two. For most measures of strength we've found no statistically significant difference comparing a group of young children to a group of people with disabilities. When you compare their dexterity, there's no clear statistical difference.
"The one clear difference we were able to find was hand size, and yet that's not something that we traditionally leverage in terms of keeping children out of child-resistant (CR) packaging and letting adults into it. It's not one of the paradigms that we've frequently used, at least here in the US, for our CR packaging."
Bix believes this is a problem that needs to be addressed as soon as possible "I think we're going to have to be clever in terms of our approaches," she explains. "Older consumers are more likely to have severe levels of disability: 53.5% of the 80+ population has a severe level of disability and 70% has some level.
"If you combine that with the fact that in the US one in 20, or 5% of the US population, is supposed to be over the age of 85 by the year 2050, that is something that we should be paying attention to."
A change in the way older patients are treated also creates new problems, Bix adds. "We have people being moved with increasing frequency from acute care facilities to ambulatory care or home-based programmes.
"Where in the past many package designers have considered their audience to be providers, now it may be a patient's elderly spouse that is going to be a large part of their care. That changes the paradigm for device and drug design.
"From where I sit, the ageing population is something I don't think we're paying enough attention to. The move from acute care to ambulatory care is a trend that is on a collision course with the ageing population.
"And then there's the escalating cost, which is on a collision course with the increasing pressure to reduce costs. All of these things are coming together and making it very challenging and driving the need for these combination products that are easy to use and yet we are going to have to deliver those types of things in a very cost-effective fashion."
Combination products, as Bix points out, are in increasing demand but they bring with them their own challenges. "It means increased complexity," she says. "You used to have traditional silos for pharmaceuticals – the pharma guys would worry about things like moisture-vapour transmission, light and chemical damage to the product and the medical device guys would worry more on the physical side and sterility maintenance. Now, with these combination products you have the challenges of
"You have to understand the science of physically maintaining sterility and also the chemical issues with water-vapour transmission and oxygen, light and things like that.
"Making sure your device is able to administer a consistent, uniform dose from beginning of shelf-life to end also has its scientific challenges."
Ensuring these challenges are met will require greater knowledge, Bix says. "I think education becomes increasingly important. Many of the people who have traditionally worked in the drug industry are reaching out to continue their education in short courses or in some cases, higher education degrees, to understand the other side as well.
"Also, you see a lot more interdisciplinary teams of researchers and scientists coming together – so you have a chemist sitting down maybe with the logistics guys, with the dynamics people. You are seeing a lot of cross-pollination across the sciences."
REGULATORY AND ENVIRONMENTAL PRESSURES
There are other issues to be dealt with, some of which have already begun to have an impact on the medical packaging world. "[At the moment] we need to do more with less and serve multiple masters," says Bix.
"Increasingly we're seeing people wanting to look at the environmental impact and the footprint. The medical sector has been slow to get there as opposed to other sectors of the packaging industry. We are hearing people start to mumble and murmur about it and source reduction. From both a cost perspective and environmental perspective reducing that impact is going to be increasingly important."
The environmental impact of medical packaging is an issue that has been taken more seriously away from the US, according to Bix. "I would say Europe is probably ahead of us on many fronts. In the accessibility for older consumers, Europe is ahead of us as well," she admits.
"Japan has led the world in terms of accessibility. I think the US is very slow to respond. We are significantly behind many parts of the world in reading and responding to the trends.
"I don't know why it is: I don't know if it's the issue of cost, because our medicine is not socialised. It may be the heavy regulation and legislation that we have and once you have a system in place that works and that has been tested, it is very complicated to change that system so the medical system here is very hesitant to go away from something that has been working."
Those that sell medical devices in the US will likely be dealing with more requirements in the near future because of the recent mandate for unique device identification (UDI)."UDI is a mandate from Congress to US FDA to more effectively track and trace devices through the system. We have a very complicated supply chain and I don't think this is unique, it happens in Europe too.
"We have wholesalers and secondary wholesalers and research has shown that there are as many as 18 different changes of hand between the manufacturer and the hospital. Right now we don't have a very good system for tracking where those things come from and that's a problem, particularly when you start to talk about counterfeiting, the illicit ways that things get worked into the supply chain and recall."
While the pressures on medical packaging are many, Bix hopes an internal change within the industry can have as great an impact. She argues that it is time for the medical packaging world to concentrate more on the patient. "What I hope to see is more of a change towards patient outcome," she says. "For a long time we have been very product focused and I am slowly seeing a switch to a patient-oriented approach; patient outcomes will begin to drive what our products and packaging look like.
"We need to think in terms of understanding in a deep and meaningful way, 'how are they using these products, what impact does it have on their lives and are they using them in the correct form?' Are we making this as easy as we can?
"But the regulations are about providing science that proves safety and efficacy so it's very much about the product – and that needs to be in place – but everything we do is based on the product, not the patient. Can we put some science about the interaction between the person and the package, to understand what information do they need? Are they looking at that information? Are they using it effectively? How do we make a package that makes them compliant, that delivers the best therapy to them?"
A focus on patients, taking into account age and ability, is how the packaging sector must proceed. Innovation needs to occur in order to keep up with demand, particularly in the US where the medical packaging industry seems to be falling behind.