The medical device industry puts enormous effort into developing devices that improve the lives of patients, but there can often be a disconnect between the product and the packaging. End-users’ first contact with a device is through the packaging, which can help or hinder them in using it. Medical Device Developments spoke to Dr Laura Bix, associate professor at Michigan State University, about why user-centric packaging should be at the top of the agenda.
In October 2012, in a state-of-the-art healthcare simulation facility at Michigan State University (MSU), healthcare practitioners and medical device packaging professionals came together to share the experience of using medical packaging in a real-world environment. Leaving aside the devices, they got to grips with how they encounter medical products in a clinical situation. It was no surprise to Dr Laura Bix, associate professor at MSU’s School of Packaging, that the shortcomings of the packaging soon came to the fore.
Bix has a passion for improving healthcare through packaging and, along with others at MSU, has worked on the interface between packaging and end-users to improve utility, prevent medication errors and better understand microbial penetration of medical packaging in order to ensure products remain sterile. It has long been her desire to see the industry put as much thought into packaging as it does into the products and medications it develops.
"I have been an advocate of a more user-centric approach to packaging for a long time and I think it is becoming more urgent, not only because the population is getting older, but also because there is a lot of stress in the healthcare system," says Bix. "Cost pressure is a big factor and, as a result, there are even more demands being made of people who are already working in stressful environments."
The event organised by Bix and her team was the healthcare packaging immersion experience (HcPIE). Taking place at MSU, which is the only university in the world that brings together the Colleges of Human Medicine, Nursing, Osteopathic Medicine and Veterinary Medicine on one campus, HcPIE is a collaboration between the university’s Learning and Assessment Center (LAC), its world-renowned School of Packaging, and a distinguished panel of experts from across the medical packaging industry.
Each year, attendees can witness a surgery simulation, including preparation of an operating room and medical device; an emergency department trauma event; and an obstetrics event that takes place in the back of an ambulance. After these simulations, there are round-table discussions between senior-level packaging professionals, doctors, nurses and paramedics to analyse the performance of packaging in these contrasting environments.
"We have developed a blueprint for collaboration between industry and academia," says Bix. "The industry comes to see the research that is being done here, and the money they pay for the event goes towards funding future research projects. Also, students get to meet people from the packaging industry and get input that helps them to hone their research and move it in the right direction."
"What was encouraging about this year’s event was that the user-centric approach I have, which was once seen as being altruistic, is now understood. Now, people get it, although there has not yet been much change in packaging design. We are on the cusp of that change. The industry is starting to look beyond the needs of the product to include the needs of the end-user in packaging design. I am no longer seen as this hippy fringe figure because people understand that the ideas I have make good business sense," she adds.
Turning the tide
There are many drivers of this change in attitude, the greatest of which is necessity, as the problems caused by shortcomings in packaging become more visible. Technical changes are also altering the equation, including the introduction of the unique device identifier (UDI) system in the US (see ‘Unique device identifier’ box, opposite). One of the consequences of the UDI is that it is possible to track individual products through the supply chain, right up to the point of use and, importantly, to the impact of the treatment on patients, which means that there is scope for more in-depth analysis of different aspects of each product.
"Before, decisions about medical devices were piecemeal and tended to be made on the basis of keeping costs down," explains Bix. "Now, products and packaging can be tied to patient outcomes, so there is a more holistic and integrated approach. For instance, we can now see that if you spend a little more money on a device, it may result in one less day in hospital for the patient. That makes that choice more cost-efficient.
"We are moving towards a time when people are not working in silos, but are working together for positive outcomes," she continues. "Many of the ideas we have about improving packaging come up again and again, and while they are not new, they are getting more traction."
Among the most important issues that arise consistently are asepsis – keeping medical products free of pathogenic microorganisms before use – and clear labelling. Both of these issues can be addressed by a user-centric approach to packaging.
"It is clear that asepsis and labelling are often problems for OR nurses and surgical technologists," remarks Bix. "Important information like the name of the product, the latex status, sterility status and the expiration date is often randomly scattered throughout the labelling. Non-critical information often gets in the way, and small font sizes can be a problem, too."
"Some packaging is startling in terms of how bad it is; often the flaws are quite obvious. So, research is under way to improve labelling and develop a solution that can be used across the industry and that has been objectively tested."
Bix cites research projects at MSU such as that undertaken by DoChan Seo, whose dissertation is titled ‘Assessing the critical information on existing commercial labelling of indwelling, urinary catheters to develop new designs for enhanced attention capture and comprehension’. By using urinary catheters, which come in sterile and non-sterile forms, and in latex and non-latex forms, Seo will use eye-tracking software and other techniques to monitor improvements in packaging that enable end-users to find important information faster and increase the rate of correct product selection.
"Information is one of the areas in which the medical device industry makes mistakes," observes Bix. "Too frequently, we focus on applying science to product packaging, looking at issues like maintaining sterilisation and making sure gamma doesn’t penetrate the packaging. But we do not worry enough about what happens in the home or in the hospital. That is why the industry has been too productcentric."
"End-users work in stressful situations, with doctors barking orders at them while they are busy assessing patients," Bix continues. "So, if product packaging is not easily useable then it becomes another obstacle to their doing their job well. Another factor is that, in the US at least, there is an increase in home healthcare, so you may find an elderly spouse has to change an IV or remove a catheter, so the packaging of these products must not make the job harder."
The crest of the wave
Bix senses a change in the way the healthcare sector is approaching packaging, and hopes that the industry will be able to build on its successes in creating devices with user-centric principles in mind.
"The medical device industry has had some great successes by embracing user-centric principles," she says. "Glucose meters for people with diabetes, for example, are now portable and have large numbers that are easy to read. But beyond the product, I often find that packaging is an afterthought. A recent study looking at emergency crash-cart drugs show that even with simple designs, there can be major problems."
It appears that often the cartons on crash trolleys that contain drugs are opened incorrectly. They open from the bottom, which Bix believes is counterintuitive, and if opened from the top then the dividers inside are torn out. In some cases, this leads to glass vials dropping and breaking. There are instances where this problem is recognised and the box is simply shredded, meaning the drugs are stored on the cart without the packaging, which may make it harder to find the right drug in an emergency situation.
"We did a study where we flipped the box so that it opens from the top, and we put the instruction ‘tear’ in the appropriate place," she says. "We saw significant improvement in its use and, importantly, greater time savings and fewer mistakes. The directions were not shredded any more. This is a simple solution, but in this industry even a small change has to be validated, so any change can be costly.
"The question is how to incentivise the industry to make changes, but the first barrier to overcome is that fact that the end-user is not making the purchasing decisions in a hospital," Bix continues. "Usually, purchasing is done on behalf of the hospital by a third party, which means the focus is usually on cost. So, if we can tie the items to the cost of care then we could see a change of perspective."
Change can be a slow process in the healthcare sector, not least because the industry is so heavily regulated, but Bix is positive about the direction that change is likely to take in the future.
"There is more excitement now about user-centric packaging than I have ever seen, and I have been talking about it for at least ten years," she says. "There are regulatory hoops to jump through, but the discussion has begun and more people are making noise about it.
"The problems with medical packaging are prevalent; they are increasingly visible and will become more so as the population ages and fewer people are available to care for older people in their homes."