Lyne Charron-Keller

Launching the right product on time and on budget. This is a reasonably straightforward concept that’s vital to end-users and medical device companies alike. After all, realizing this goal can help advance patient care. It also can help a leading medical device company maintain its market position, gain a competitive edge, or propel into a new market segment.

We start out with good intentions. Executive teams identify and allocate the appropriate cross-functional resources to bring an idea to life and commercialize a new medical device successfully. Then why is it that with a willing team of subject matter experts, this proves to be such a challenging undertaking? In order to answer this question, we must better understand the impact the cross-functional team has on effectively achieving this goal.

Design Controls: Compliance Need vs. Effective Implementation
For medical device companies, the concept of working as a cross-functional team is not new. In fact, most companies make a concerted effort to provide cross-functional input during the product development process. This cross-functional focus began several years ago due to a need to comply with new medical device regulations. On Oct. 7, 1996, the U.S. Food and Drug Administration (FDA) revised the current good manufacturing practice regulations for medical devices and incorporated them into a new Quality System Regulation (QSR) 21 CFR Part 820. This new QSR encompassed a design and development sub-system, which included the addition of sub-part C, Design Controls (21 CFR 820.30) for the medical device development process. It states: “The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.”¹ Furthermore, it is clearly stated that Design Reviews: “…shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed…”² Design Control requirements are applicable to all Class II and III medical devices and certain specified Class I devices marketed in the United States.

Along with introducing the concept of cross-functionality as part of product development, the regulation introduced the need for a stage-gate approach for medical device development. During the last 15 years, medical device companies have evolved from providing the minimum requirements to meet regulatory compliance to understanding and embracing the best practice of managing a product development design control process with a cross-functional focus. However, for most companies, the key to effectively implementing and managing a cross-functional team remains elusive.

Cross-Functional Team Output: Cacophony or Symphony?
Consider the desired output goal for a cross-functional team: delivering the right product on time and on budget. This means providing a device to end users that meets or exceeds their needs, while developing it in the most efficient manner with the least amount of scope creep and manufacturing setbacks. To maximize efficiency, the cross-functional team must be synchronized and move in unison, much like the output of an orchestra. To deliver a flawless piece of music /deliver the right product to the end user, having the right conductor/project manager is a key factor; in addition, each member must grasp his unique role and understand and respect the roles of his team members. Like musicians that must play their parts while actively listening to their colleagues to deliver a melody, team players must implement a mutual understanding and respect from the inception of the project.

On the other hand, a lack of understanding or respect can generate turmoil and dissention. As most companies have experienced, a breakdown in communication can disengage team members and slow the product development progress significantly (or in some instances derail the project altogether). To deliver on the desired goal, the team must possess a single focus and, more importantly, a clear understanding of what each party brings to the table.

Key Stakeholder Lens: Timing is Everything
When moving from concept to implementation, there’s a lack of industry consensus on what constitutes a cross-functional team and how soon the various disciplines should collaborate as one on a project, especially when executives must provide the right balance of human resources to maximize efficiency and successfully deliver on multiple concurrent projects. Although some might consider it a cost rather than an investment, it’s preferable for all disciplines to be involved at the concept stage of product development rather than introducing team members gradually into the project as their deliverables come onto the horizon. In an orchestra, it’s expected that all musicians are in attendance and actively listening or participating when a new symphony piece is introduced, regardless of where their active parts occur in the piece. This allows everyone involved to understand the intricacies of the movement and to improve their own delivery when the time comes.

There’s another compelling argument for all members to participate early. In addition to ensuring that design inputs are collected in accordance with regulation, it also allows for a stronger product to emerge at the end of the concept phase by designing it through multiple stakeholder lenses. How often have you heard that sales and marketing aren’t able to discuss the desired product features due to a lack of bench-testing or clinical evidence? Or a new product wasn’t developed for manufacturability? Or that product development delivered their part, but manufacturing encountered issues and setbacks during design transfer? In fact, in a recent study conducted by the FDA, it was found that nearly one-third of recalls are due to design flaws, and almost another quarter are due to issues with manufacturing.³

Having all players at the table early allows everyone to provide insight on key design inputs. For example, it allows supply chain/logistics to ask: “Did we consider this size packaging design, which would optimize palletizing and shipping costs?” It allows an intellectual property expert to discuss how to best protect the early innovation. And it allows manufacturing to discuss material selection with product development to maximize manufacturability prior to design transfer.

However, implementing a cross-functional team at the project onset will present a different set of challenges due to multiple stakeholders, each with their own project lens, collaborating to define the right design inputs. It’s the project leader’s responsibility to facilitate communication and mutual understanding between all team functions, to negotiate and provide flexibility between groups to manage conflicting priorities, and to accomplish the project’s deliverables while maintaining the critical path on schedule. Providing an environment of transparency and trust is imperative to having a successful outcome; sharing as one in the successes and setbacks will promote trust and buy-in from the team members and ultimately will drive them toward success.

Which Orchestra do You Want to Lead?
It’s clear that assembling your cross-functional team as early in the product development process as possible is crucial in optimizing design inputs and overall project efficiency. These key factors have a direct impact on delivering the right product on time and on budget. However, as discussed, the team dynamics and successful implementation of the cross-functional team will produce either cacophony or symphony. Which orchestra do you want to lead?