Reducing product development surprises can help ensure medical device success.

Nothing is more frustrating than developing a plan, then in the heat of the battle having to diverge from the plan when chaos happens. This is not just a military phenomenon; this is also true of the plans we make in our product development processes.

Expect the Unexpected

Initial plans are important and will make you more holistically aligned with the project goals, and therefore more able to easily adapt to change when chaos makes it necessary. Notice that I said “when” chaos happens. It’s being prepared for the surprises along the way—and reducing them as much as humanly possible in the process. I believe this is what General Eisenhower was talking about, and he proved it with his brilliant tactical maneuvers against Hitler in World War II. What does this have to do with medical device design?

In preparing for battle I have always found that plans are useless, but planning is indispensable.

-Dwight D. Eisenhower

Surprise Attack: Hidden Unmet Needs

In medical device design and development, enemies can be hidden needs that lie dormant for months and then pop up in a surprise attack during summative studies, thwarting plans for validation success.

The real tragedy in this scenario is that everything always seems to be going so well up until that point. Budgets are in line, timeframes are in control, and efficacy seems to be strong. When the unmet needs enemy rears its ugly head, we are faced with patients that don’t comply with treatment, healthcare workers that won’t embrace the use of our device (our baby!), and purchasers that can’t be convinced to buy/reimburse it. Ugh.

Counter Attack: Ethnographies

Starting a device design project with a concept is a mistake. Did you ask actual device users—be they doctors, nurses, or home healthcare professionals—what they need to be successful in the situation? We need to start the process with investigation and empathy.

Ethnographies and other observational research are critical to putting yourself in the user’s shoes. These early interventions flush out hidden needs. And, what most people miss is that there are many “little” needs discovered that surround the “big” need our future device will fulfill. It is uncovering these little needs early (and addressing them with design) that can often solve the issues that would otherwise make our device flop in the market.

Reduce Product Development Chaos

Bottom line: Do good research up front.  This will lead to fewer chaotic interruptions to planned schedules, leaving you with more time and resources to adapt and modify plans. The payoff will be a device that has a much higher probability of reaching its goals in the medical device marketplace and to positively affect the lives of as many people as possible. What could be better than that?