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?

The Six Fears that Impede Corporate Innovation

New business innovation isn’t working in most large corporations. This is true even though we have made great progress over the past two decades in understanding the mechanics and dynamics of radical innovation. We have got the methodologies for creating the businesses right, but our organizations still seem to snatch defeat from the jaws of victory.

Why is this? New business creation is thriving in the startup sector, often disrupting incumbents, so the problem is not a lack of opportunity. What is going on? 

I recently spoke with James Euchner, whose recently published book -- Lean Startup in Large Organizations: Overcoming Resistance to Innovation -- addresses such questions. During our conversation, I asked him about the sources of resistance and their connection to Lean Startup. Here is his complete answer:

Any new venture confronts uncertainty: uncertainty in customer demand, uncertainty in the timing of the market, uncertainty about new channels or new business models or emerging technologies. Corporations have gotten better and better at managing these types of risk. The Lean Startup movement has done much to help with this.

It is ironic, but the very methods that have led to success in creating product/market fit have interfered with venture/corporate fit. There are, in fact, six fears that Lean Startup awakens inside the corporation that impede innovation.

The first is the fear of chaos: the concern that the iterative and experimental approaches of the Lean Startup will lead to an unmanaged innovation process. An Innovation Stage-Gate helps to contain the chaos. 

The second is the fear that the innovation process will lead to disruption of ongoing operations. Every corporation has established norms that define “how we do things around here.” New business innovation naturally challenges some of these norms. This disruption needs to be acknowledged and explicitly managed for a new venture to succeed.

The third fear is the fear that the lean innovation process will lead the company into opportunities that the company just can’t exploit. Worse, the new directions may even undermine the identity of the firm. A company needs to innovate within clearly defined opportunity spaces to counter this fear.

The fourth fear is that the new business will succeed by cannibalizing the core: the new business will appear to drive revenue and profit, but only at the expense of the financials of the ongoing business. To counter this fear, companies need to explicitly model not only the economics of the business but the impact of the new company on the core business. Sometimes, cannibalization is necessary to the ultimate growth of the firm.

I believe that the fifth fear is the cause of the failure of more new ventures in corporate settings than any other. This is the fear that the investment in the new business will drain resources from the core. It causes the core business to react in ways that smother the new business. Countering this fear often requires separating the new company from the mother ship, at least during incubation. 

Finally, executives often fear making a career-limiting blunder when investing in a new venture. After all, the new venture, by definition, moves into spaces that are less well-understood by executives in the company. To counter this fear, companies need to develop ambidextrous leaders – those who can both execute and innovate. A key requirement is for the executives to spend time in the new ecosystems. 

What has your experience been with new business innovation? What are your thoughts on Jim Euchner’s suggestions for inoculating companies against these corporate antibodies?