Different medical device companies have diverse needs when it comes to increasing speed -to market. For some, it’s imperative to accelerate a product launch in order to get a leg up on global competition. Others may require expedited upgrades to an existing product to showcase its improved stability and reliability at an upcoming tradeshow.

Whatever the reason, medical device manufacturers that can effectively compress the time it takes for a product to get out the door are the ones that know how to strategically maneuver through increasingly intricate obstacles.

These hurdles run the gamut of keeping up with rapidly changing new technologies, client needs, market demands, and competition (to name just a few), to balancing time efficiencies with the notoriously slow FDA compliance process.

Such complexities leave many scratching their heads as to whether accelerated time to market—that doesn’t compromise quality—is even possible.

What takes speed to market from being a commonly touted industry buzzword to a legitimate differentiator that sets one company apart from another is the processes that are followed from napkin sketch to manufacturing.

Three key processes that foster nimble development and manufacturing operations are discussed here: Concurrent engineering, Scrum, and lean product development.

While not intended to be a one-size-fits-all approach, these processes deserve exploration. Individually, as a combination of two, or aspects of all three can be used to improve operations.

Considering concurrent engineering

Concurrent engineering is more than just an approach to help products arrive to market faster. It’s an organizational and cultural philosophy that permeates a company’s day-to-day business operations.

Concurrent engineering embodies team values of collaboration, cooperation, and collective knowledge. While this reciprocal approach helps an engineering team work more in sync, a key element of concurrent engineering is its emphasis on multidisciplinary teams.

At the very start of a project, concurrent engineering brings together representatives from other departments, embracing their participation throughout the process.

By acting together from the start, cross-functional teams can take the entire life cycle of a product into consideration in the initial design phase and identify issues that might later invalidate the design. Obtaining this input before specifications are finalized reduces the number of major redesigns—especially late-stage redesigns. 

In traditional medical device manufacturing, many of these team members are only involved late in the process. Their perspectives are shared belatedly, often when it’s far more costly or time-consuming to make important changes that create a product that is safer, more reliable, higher quality, and easier to manufacture. Cross-functional teams also work in unity to make informed, agreed-upon decisions related to product, process, cost and quality issues. Differences can be reconciled more easily when trade-offs are made early-on between design features, part manufacturability, assembly requirements, material needs, reliability issues, serviceability requirements, and cost and time constraints.

Since products are designed with shared knowledge, resources, and technologies that are available within the company, this increases the potential that product release times will be condensed.

While concurrent engineering sounds great in theory, it is also backed by successful practice.

When Pro-Dex, Inc evaluated a new battery-powered device for a client, the initial intention was to use a lithium ion battery containing multiple cells. This particular component met the client’s specific power, torque, and design requirements so the engineering team was ready to proceed accordingly.

As a practitioner of concurrent engineering, the design was passed on to the RA/QA team to review transportation and handling requirements while still in the spec stage of design and development. 

RA/QA discovered that the transportation and handling requirements are very limiting for this kind of powered battery. These restrictions would significantly affect how the customer would be able to handle and distribute the product, how they would train with it, and even how they would deliver it.

Because RA/QA was involved early on, this discovery was made within the first month of the process. Pro-Dex was able to inform their client, find a feasible alternative, and offer their client another solution that met the engineering, manufacturing, and distribution requirements of the product.  

A seemingly innocent component could have completely derailed the project. Had the battery issue been found later in the process, when RA/QA is typically involved, the client would have faced tremendous added cost and delayed time to market.

By looking down the line to make early changes and iterations, concurrent engineering bolsters increased accuracy in predicting and meeting project plans, schedules, timelines, and budgets. The result is innovative, defect-free, dependable products that can be released on-budget and in competitive time-frames.