There’s no question that interest in human factors is increasing. But are pharmaceutical and medical device designers actually putting such principles to use? PMP News asked Pharmapack Europe speaker Craig Scott, director of Greensand, a few questions about human factors as they apply to drug-delivery devices and packaging. On February 2, Scott and Martin Schlaeppi, also director for Greensand, will present "Why Better Human Understanding Is the Only Future."

Scott tells us that Greensand works across the medical device spectrum from early innovation and concept assessment with users through to pre- and post-launch and has a particular expertise in understanding the functional and emotional needs of medical device users.   

PMP News: Why should pharmaceutical and medical device manufacturers consider human factors?

Scott: Firstly, because it’s a regulatory requirement for some classes of medical device. However, it’s such a great opportunity to engage with users—be they physicians, nurses, or patients. The primary focus of human factors research is risk reduction by ensuring users can interact with medical devices safely and effectively. This, clearly, is no bad thing, but why wouldn’t you take the opportunity, whilst you have these users available to you, to talk to them more holistically? You will undoubtedly learn about how they interact with a device functionally but people engage with their lives, their health conditions, and other people emotionally. By understanding and acting on this knowledge, offering both functional and emotional benefits, you put yourself in a position to better connect with users and achieve greater desirability and, therefore, competitive advantage.

PMP News: Are companies increasing their use of human factors studies? Is there still a need for educating companies on the need to do so?

Scott: Yes, they are, as the regulatory need is understood and met. You can see more companies setting up to meet the increased need. There is still a lot of education about human factors that is needed, but Greensand also thinks that there is a need for educating the medical device industry about best practices from other industries. There’s fantastic learnings to be had from, say, the consumer industry, who have long been masters at understanding their customers. There’s absolutely no reason why the medical device industry can’t adopt and benefit from the powerful techniques and approaches that are commonplace elsewhere. There seems to be a lot of talk about being ‘patient-centric’ but we don’t think people necessarily know how to go about this.

PMP News: Could human factors studies help companies design products that minimize human errors?

Scott: Undoubtedly. That’s the prime reason for doing them. We’ve personally seen patients and nurses pick up autoinjectors the wrong way and attempt an injection. We’ve also seen patients and nurses misunderstand how to use a device because they’ve not read the instructions for use (IFU) or the IFU is not clear enough about the steps to follow. It should be appreciated that human factors studies do aim to minimize human errors, but they can’t remove the risk of error entirely as user error is out of your control, and it is amazing how creatively wrong users can be—in ways you could not dream of. But, that is the curse of knowledge—you can’t unknow what you know. What is so obvious to you could be completely lost on a user interacting with a device for the first time. That’s why engaging with device users at every stage of device development is critical—from the very earliest stages of ideation through early- and late-stage prototyping to the final summative test of a production-ready device.

PMP News: Are there any common errors that could be addressed?

Scott: It depends on the device. Given that medical devices cover such a vast spectrum with each one addressing very different needs, the type of error that is common tends to be common only to that type of device. Holding an autoinjector the wrong way being a classic—for autoinjectors. What should be common is, where possible, to get users to simulate or use the device in as realistic a way as possible. That may mean, for example, re-creating the environment a device is used in. A classic error for a monitoring device being used in an ER setting is that the alarm is too quiet to be heard. You can hear it perfectly in the peace of a test lab but not in a noisy emergency situation. There is a component within the human factors process that addresses known use-related problems via a number of databases and also via heuristic analysis whereby a device’s user interface is evaluated against user interface design principles, rules or “heuristic” guidelines.

PMP News: What types of products should be developed with human factors in mind?

Scott: Primarily any product that could pose a risk to a user from incorrect use; this inevitably covers many types of devices but not all. The principles of human factors and usability engineering are still valid even in less risk-prone devices, because anything that people interact with that is easier to use, well designed, comfortable to use, and so on will tend to be preferred over less-well-designed offerings. The risk of not engaging with users is that you develop something nobody cares about.

PMP News: Should products used by both professionals and patients be subjected to human factors studies?

Scott: Yes, absolutely. The critical consideration is the “user.” This may be wider than it seems at first. It may be obvious that a physician, nurse, or patient might be a user, but what about technicians, pharmacists, physiotherapists, occupational health, social workers, caregivers, teachers, and so on? Part of the initial definition process for human factors research is to consider and evaluate all potential users of a medical device.

PMP News: How will human factors change drug-delivery devices?  Packaging design? The future of healthcare?

Scott: For those who assess devices as we think it should be done (understanding the user holistically) then drug-delivery devices should evolve to become better and more desirable, offering relevant solutions to user’s needs. What is often overlooked is that drug-delivery devices exist in a competitive set. Some being better than others. The best is the one that will be selected or recommended most often, being more desirable to the user. A good example is a GPS-enabled inhaler (similar to the ‘find my iPhone’ function). Not only is it a practical system for assessing areas where the device is used frequently—perhaps highlighting areas of high allergenicity (a clinical benefit) —but it could also help the user locate a lost inhaler (a functional benefit). Also, importantly, this system can address the well-known heightened anxiety asthmatics feel when they cannot locate their medication (providing an emotional benefit). Needless to say, cost is a perennial factor, but mass production always quickly reduces cost, and a highly-valued function will be traded-off against price in many instances.

The same goes for packaging design—changes that address users’ needs can offer real functional benefits that will deliver competitive advantage for the manufacturer. Beyond purely functional benefit, packaging also has a role in developing the “brand,” and it is that which users engage with at an emotional level and results in “desirability” —not a tangible asset but an asset nonetheless.

For the future of healthcare, bringing users into the mix to evaluate how they interact with devices can only be a good thing. It remains, however, a huge missed opportunity if all you’re doing is satisfying legislation and not taking the chance to learn as much about users whilst you’re there. We foresee a day where human factors is the final sign-off of a developmental journey that has had user input and feedback from beginning to end.

PMP News: What will pharmaceutical and medical learn during your presentation at Pharmapack?

Scott: That better human understanding is the only way forward. That human factors, ironically, lacks humanity. That an industry founded on data and rational thought only can lead you to think too much and feel too little. That we can learn from others and apply that learning to compete harder, to raise our game and to benefit users everywhere. That, for drug delivery, your device could be the point of competitive advantage—not the medication. That he who understand his users the best, and actions that understanding, wins. 

PMP News: What do you hope they do differently after attending your presentation?

Scott: That they understand, from the real examples we’ll share, how appreciating users’ holistic needs, both functional and emotional, could give them an advantage in the competitive market place. That this knowledge, combined with raised awareness and interest, is enough to be willing to try methods and techniques that may be new to them but are very common in other industry sectors.

For more details, visit www.greensandconsulting.com or contact Scott at [email protected] and + 44 (0)1483-461809.