Usability‑Engineering Projects: What Are the Common Misunderstandings?

At the beginning of this month, Ilkka Juuso and Ilpo Pöyhönen published a book entitled Medical-Device Usability: Human Factors for Medical Device Development, which simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why.

When I spoke with Ilkka this past week, I asked him, "What are the most common misunderstandings developers encounter when starting a usability‑engineering project?" Here is his complete answer:

By far the easiest mistake to make is to think that usability in medical devices is just about an interface that is pleasant to look at and use. That will be a part of it, but far more important is the safety of that interface. An aesthetically appealing user interface is nice, an interface with all the controls in intuitive places is a great start, but what actually matters the most is that it is difficult to use the interface in the wrong way, leading to real harm to patients. That may sound counterintuitive from a general usability perspective – after all, usability typically talks about the ease of all use – but safety and the safe use of a device really is paramount when it comes to health. In an optimal situation, of course, all these rings align so that a safe interface is also intuitive and appealing, and thus hopefully even safer to use. In our book, we approach usability engineering from the viewpoint of safety, but also bring in lessons from the field of general usability engineering, which is useful to a discussion of medical devices.

The second mistake to avoid is keeping usability engineering as an isolated activity, run once and then forgotten about, without much impact on the development or maintenance of the medical device. In the book, we show how usability connects to the overall quality management and risk management activities of the organization, and how usability can actually inform the whole path from an initial product concept to a finished device and beyond. Our message here is that usability engineering is not just something you have to do, it’s something you should want to do because of how it can add to your knowledge of your user, use environment, and the use of your device – and bring benefits to all of these.

For those working in the medical device industry, do you agree with Ilkka's perspective regarding common mistakes? In your organization, does usability connect directly to quality and risk management?

How Should Your Company Pursue and Achieve Innovation?

This past April, Michael Parent published a book entitled The Lean Innovation Cycle: A Multi-Disciplinary Framework for Designing Value with Lean and Human-Centered Design, which addresses what many companies are facing regarding pursuing innovation. His book addresses these concerns by introducing a new multidisciplinary framework for both thinking about and pursuing innovation. By taking key concepts from the quality management practices of Lean and Six Sigma, the framework augments these tools and disciplines by incorporating other problem-solving and design techniques, including Human-Centered Design. The result is a view of innovation that many business leaders will find fits nicely into their existing paradigm of strategy and operational discipline.

When I recently spoke with Michael, I asked him: “How should companies pursue and achieve innovation now?” Here is his complete answer:

Innovation seems to be on the tips of everyone’s tongues. Search social media and you’ll find an ethos of innovation behind every post. But the popularity of innovation and entrepreneurial thinking on social media has done damage to how businesses and industry incumbents should think about and pursue innovation. Especially in a world buffeted by global disruptions – chip shortages, inflation, supply chain issues, pandemics – just to name a few, companies need to have a greater understanding of what role innovation plays in their business and the different ways they adapt to a dynamic organizational landscape.

Regarding innovation, the biggest opportunities for businesses are to pursue an innovative approach styled after the principles of Quality Management. Organizations can mitigate their risks of disruption by holistically evaluating their existing processes, and shoring up gaps that put them in jeopardy. It might not be sexy, but improving supply chain reliability, capability, and in-process quality has enumerable benefits for most businesses, from increasing profit margin, to reducing expenses, to driving towards operational consistency across their entire value chain.

Equally important is how businesses should avoid pursuing innovation. Generally speaking, if you’re anything but a new start-up business, you should stay away from grandiose ideas of disruptive innovation and industry-altering advancements. These promise exceedingly high profits and growth but fail to materialize due to excruciatingly low chances of success, high resource demands, and even internal organizational disruption to the existing business.

A business incumbent has already been successful in their industry. Rather than abandoning the history and tradition of the firm through radical, disruptive innovation, a business ought to re-evaluate its existing value propositions through the lens of a fresh perspective. Amidst global disruptions that have mainly affected business operations (and left the products and marketing themselves untouched) the principles of quality management, Lean, and Six Sigma is an excellent framework to begin this endeavor.

What do you think of Michael’s perspective? What role does innovation play in your company? How is your company pursuing innovation? What have been the pitfalls?