We have spent much time over the years defining the core skill sets necessary to develop an optimal medical device: project management – ideally someone with a mechanical engineering background, engineering; regulatory; marketing; and manufacturing.

A good core team can shepherd a device across the major transitions of the medical device development process, ensuring that the knowledge base and intent remain intact. However, next comes the challenge of managing the many other activities for success and regulatory approval.

I have long argued that in development programs, particularly long and complex ones, there is value in having continuity with a wider array of skill sets. For now, I’ll focus on human factors industrial design (HFID) or usability expertise.

To my mind, these two skill sets live between the user and the device on a multitude of levels that are sometimes subtle, but often critical to ultimate success. They are translator roles that ensure devices will not only be safe, but will be satisfactory to use, and properly exalt properties of the brand. An integrated HFID activity provides valuable dialogue between marketing and engineering, advocating for the user, and ultimately resulting in more defined products and outcomes.

For example, consider that:

• Thirty percent of surgeons are now over 50 and 30 percent are females. What does that mean in terms of their use of a medical device? While older physicians may wear glasses and in some cases, hearing aids, they may also be the most experienced. In human factors observations and usability testing, is there a difference in the way male and female surgeons handle a device? Addressing these specific tactile challenges in the design can make all the difference.
• If a device will be used overseas, what unusual circumstances exist? We’ve developed products for inoculation in Africa where you can’t go in with a lot of assumptions. You can’t assume, for instance, that there will be power and water. The working environment, the cost structure, the number of times the product will be used, the different cultures that will interface with it—these are all factors.
• Any guided/software user interface, should be worked in from concept, along with all of the other elements of industrial design and usability.

Considering these human factors in medical device design provides opportunities to develop products that will not only safely accomplish what they’re intended to do, but do so with pleasure.

There are multiple tools and methodologies developed in technology and consumer fields that are only now being used in the medical arena. Highly competitive, time critical, and targeted on a focused understanding of the user, these tools can help define new markets, differentiate product strategies, and hone the next generation of products and devices.

The challenge for management is, rather than involve HFID as a series of unique outsourced activities, to involve it as an adjacent concurrent activity over the duration of a project. All the while, it should ramp up and down as needed, working between marketing and engineering disciplines, while empathizing with the needs of the user.