Usability has become a hot topic in the healthcare industry as regulatory bodies around the world have enhanced focus on the subject. To better understand packaging’s role in this area, I spoke with human factors engineering (HFE) expert David Grosse-Wentrup, a Sr. Research Manager with Design Science, a usability research firm focused on products in the healthcare space.
Haley Schrauben (HS): Give us a little bit of background on HFE and its connection to packaging.
David Grosse-Wentrup (DGW): From a functional point of view, healthcare packaging is often very similar in that it serves the purpose of protecting a product and often also maintaining a sterile barrier. But the differentiator really is human factors, especially in the healthcare sectors. To create safe and successful products, you have to understand your user - who they are, what are their challenges, what are their needs… If you don’t, you risk creating a product that, at a first glance, seems to function just fine, but at a closer look is absolutely unfit for its intended users or use environments. We are seeing time and again, that the earlier on you consider the user and their needs, the more successful your product is, and the more money you can save during development.
HS: Tell us about your passion for HFE and your perspective on the early involvement of packaging engineers in the process.
DGW: We all know how frustrating it can be when something has poor usability… the newest company software is not doing what you want it to do, you can’t find the button to open the fuel door of a rental car, it is seemingly impossible to open the plastic packaging of something you ordered online, etc. If things like these happen in a clinical environment, it’s not just a frustration; it can be someone’s life. This is why I am so passionate about HFE and usability. As an engineer, you can be detached from the real world – there is potentially so much you haven’t thought about. This is why it is so important to connect packaging engineers to end users, to see what works and doesn’t work in the hospital or clinical setting. When packaging engineers observe usability studies, they always gain new insights and new perspectives on how their products are used.
HS: What are some human factors research methods you use to elicit feedback on packaging designs?
DGW: There are many different tools and methods we can use, depending on where you are in the development process.
Field research: This is often applied early during product development. Here, we go into hospitals and observe actual users, their processes, and their interaction with devices.
Focus groups: For this, we invite a few users from different settings, specialties, and experience levels, and talk through some design concepts with them. Figure out what is important (and what isn’t), let them interact with prototypes or preliminary designs, and get specific feedback on what works, what doesn’t, or what they do/do not care about.
Anthropometric assessments: How does hand size impact functionality of the package opening feature? What forces can users apply to open the package? These are just some of the things we look at in these assessments.
Voice of customer (VOC): At this stage, users are given prototypes to interact with. We observe how they use the packages and assess their preferences regarding various factors such as ease of opening, sustainability, sterility, and others.
Usability testing: Formative usability studies occur earlier in the process, while you are still making changes to the product or package. Validation (Summative) studies come later, using the final product/package, to help meet the requirements of EU MDR (European Union Medical Device Regulation) or ISO 11607.
HS: Can you share any discoveries that you have uncovered while conducting voice of customer research or usability studies for healthcare packaging?
DGW: The general discovery is that there is always an opportunity to better understand your users and how they use your product. As it relates to healthcare packaging, HFE is a relatively new concept. However, there is a shift happening and the importance of packaging, and packaging usability for that matter, is more and more understood. The EU MDR has forced this, but it’s also being driven by other factors such as sustainability (efforts to switch to new materials or use less material) and a better understanding of hospital work environments and workflows. It’s also important to note that the packaging can be the differentiator in a purchase decision. I’ve seen users say, “if the product is the same, I will use the one with the more sustainable packaging”, or “An implant can be very expensive, if the packaging can reduce the chance of it being accidentally dropped, a slightly higher price might still save us money.”
HS: Are there any opportunities related to packaging design that you can share based on your experience?
DGW: There is definitely an opportunity for packaging to be more integrated with the device and overall function of a product. We are quite regularly seeing this, especially for products that are intended to be used in the home. The packaging can help guide the user by forcing them to look at instructions first, can be laid out in such a way that it helps guide the user to do something in a specific order or help understand how specific parts are intended to be used. We conducted a field research study for surgical trays for certain procedures to better understand the order of operations in a real-life hospital setting and used our findings to help redesign a tray to clearly correspond to the surgeon’s workflow.
According to David, the big takeaway here is that the key to product and package design success, especially in the healthcare industry where patient safety is a top priority, is taking the time to understand the needs of the user. To do this, HFE shouldn’t be viewed as a separate activity or function. It needs to be integrated in the development process. There is a growing understanding that the packaging is part of the surgical workflow, so it is important for the packaging engineer to be involved in HFE, understand the users, and thus contribute to developing better and safer products.
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