If you’ve ever been camping – or been to a circus – you know that the longest pole in the tent is what holds everything up. Without it, the tent becomes unstable at best and fails at worst. The concept applies directly to project management, where the longest pole refers to the most important issue or factor that slows, or prevents, progress at any given point in time. Without identifying and addressing that factor early on, the project will languish, or in worst-case scenarios, come to a screeching halt.

In medical device development, it means you must identify the task that is going to take the longest, or that bears the greatest risk, knowing that nothing else matters unless that portion of the project happens. Doing this correctly – and consistently – takes expertise, experience and thinking in a non-linear fashion.

The case for non-linear thinking

In the medical device world, many people approach the development process in a linear fashion. They’ll make their best judgment on a configuration, proceed to build out the product in line with that design, then test it.

As logical as this may be, it doesn’t work well for medical device development – if you’re looking to get a product to market as quickly as possible. A plethora of moving parts, all of which have individual risk factors, requires working on project steps in parallel with each other. That way, an experienced product development team can be continually looking for, and identifying, the longest pole at any given time. They can make necessary adjustments without stopping the entire project and continue along the critical path to market.

Finding the longest pole

As an example, let’s look at biocompatibility testing. Working in a linear process, you might complete all design control documents before moving to biocompatibility testing. But working with the longest-pole approach, you would think ahead to all the steps involved in that testing and identify what the bottlenecks could be. They might range from getting on a third-party vendor’s schedule to making sure a clean room is set up properly for an in-house test. In the meantime, you’d schedule and work on other project tasks.

Or consider a 510(k) submission. Some developers may try to complete all planned tasks before submitting, taking a linear approach. Yet it may be possible to submit with all required testing while you are still working on tests that are suggested (not required). You’ll be ready with those results if and when the FDA requests them, but won’t lose time waiting to complete and submit every possible suggested test.

The point is to identify what could happen to slow things down, and the greatest risk to the project. The longest pole will often shift from one action item to another through the development cycle. It also may shift from one part of the project to another.

Once the project team identifies the longest pole, they can develop a process to reduce (or eliminate) the impact to the project timelines. That might involve completing documentation, tasks or other appropriate activities.

Goldratt Theory of Constraints

The longest-pole concept is analogous to the Theory of Constraints, a process improvement methodology developed by Eliyahu Goldratt, Ph.D. The theory says that there is always at least one constraint in any project, and emphasizes the importance of identifying this constraint, or bottleneck. Then, by leveraging it, companies can achieve their goals while delivering products on schedule.

In medical device development, the bottlenecks could be people, money, supply chain issues, outside testing, technology challenges or other issues. By focusing on and resolving the issues related to the longest pole at every step of the way, you can continue along effectively in the development process. Repeating this process throughout the development cycle is the fastest and most effective way to reach the goal of getting a product to market, to help providers and their patients.