Combating Chaos With Product Organization

Nothing is more frustrating than developing a plan and 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.

Product development chaos rarely comes from a single big mistake.  In many cases, changes in the development timeline are the result of a missing product development structure: No clear design control plan, no defined change control workflow, and no early research to catch problems before they become expensive ones. Chaos in medical device development is manageable, and it starts with better product organization from day one through trusted and reliable processes that were built specifically to account for this type of chaos.

What Is a Design Control Plan, and Why Does It Matter?

A design control plan is the framework that ties user research, requirements, and testing together throughout a device’s development. If it’s done well, it will be able to satisfy FDA design control requirements while also giving your team the product organization necessary to make informed decisions when chaos hits.

Paired with a solid change control workflow, a documented process for reviewing, approving, and teaching changes made to a device’s design, a design control plan lets teams document and evaluate design changes without losing sight of the original user needs that shaped the project. That combination, structure plus flexibility, is what allows teams to recover from chaos without getting derailed by it.

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 about being prepared for the surprises along the way—and reducing them as much as humanly possible in the process. 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

Preparing For Battle Amid Risk

Planning amid risk doesn’t mean predicting every possible failure. It means building enough product organization into your process that when something goes wrong, your team has a structure to fall back on instead of starting over. That structure typically includes:

• A documented design control plan that maps requirements, verification, and validation activities from the start
• A change control workflow that captures design changes without derailing your timeline or losing regulatory traceability
• Early, ongoing user research that resurfaces problems before they reach summative testing

The teams that handle chaos well aren’t the ones with the fewest surprises. They’re the ones with the product development structure to absorb surprises without losing momentum.

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.

This is usually a symptom of a design control plan that existed on paper but wasn’t built around real user input. A design control plan is only as strong as the research behind it.

Counterattack: 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 flesh 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 positively affecting the lives of as many people as possible. What could be better than that?

A strong product development structure, backed by a real design control plan and a working change control workflow, can turn chaos from a threat into a manageable part of the process. 

Not sure if your current plan can handle the unexpected? Let’s talk about how we can help.