In the previous two columns, we described the importance of regulatory strategy and market validation in your overall product strategy. In this column, we introduce concepts for setting up the right organization for new product development of complex medical devices. The concepts are intended to maximize success, especially for the cross-functional and multi-disciplinary nature of these types of development projects.

When product development goes wrong, there’s a tendency to blame individuals. Surely, if we had the “right” team members, the development would have gone perfectly…right? However, even the “right” individuals do not lead to successful development when they are used to form the “wrong” team structure. Ultimately, it is the product development team as a whole that will determine success.

Product development is a team sport. The challenges are fundamentally a human problem, where leadership and good management are key. An essential aspect is the formation of the team.

CONCEPT 4: Building the Right Product Team

There isn’t one “right” team that will propel an organization to project completion, but there are certain criteria the product development team should meet. Broadly speaking, the team should have core-team leadership, cross-functional members, and a determined amount of autonomy based on product needs. In this article, we describe a product development structure that has been successful for many companies developing complex products.

Successful development of highly complex, innovative products is the result of the integration of many contributions from different functions within a company. The group of individuals associated with the project that materially contributes to its development will be referred to as the product team. This group includes the entire engineering project team, as well as members from marketing, manufacturing engineering, purchasing, regulatory, quality, and service.

Core Team

The leaders of the product team are known as the core team. This group consists of three to four leaders from engineering, marketing, clinical, and operations. Their main qualifications include the abilities to lead and keep the team accountable.

One individual is designated the core team leader (typically from engineering or marketing). In some organizations, this leader may be a program/project leader—independent of the functions—who reports to a program office. The core team leader (program manager or individual from any functional area) is responsible for leading the core team and product team meetings, ensuring all issues are attended to (Figure 1). 

This approach emulates the leadership of a new business venture. That leadership would be empowered to make decisions quickly and to directly implement those decisions. Think of a company structure; the CEO is not making major company-wide decisions independently. Rather, that CEO relies on input and contributions from other members of the senior team.

It is key the core team leader not only has the technical competence to oversee the project, but the leadership skills to guide the team in decision-making along the way throughout the development process. Complex medical device development projects are rarely short, and in some cases, may span years (especially with large capital equipment such as surgical robotics). With very large projects, there may be subordinate program managers overseeing key subareas. The point here is the process and organizational structure are important, but the right leadership is key.

In one notable case involving a large medical device company, we saw upwards of hundreds of people on the product team. The team was led by a very strong program manager, as well as strong cross-functional leaders with different deliverables for the product development. The cross-functional leaders were from engineering, marketing, operations and supply chain, clinical and field support, and regulatory and quality. The program’s objective was to develop a next-generation, complex medical product to improve reliability and quality over previous generations. The new product received recognition for high quality and created a large backlog of sales at launch time.

Cross-Functional Development in Engineering

Highly complex, innovative products are often the result of integrating many engineering disciplines. For example, automation/robotic systems will need to integrate mechanical, electrical, optical, machine vision, and software engineering. It is important to consider cross-functionality at both the technical and business levels.

At one medical device company with which we worked, the engineering team was organized so there were no discipline managers (e.g., mechanical or electrical engineering managers). Rather, those leaders took on the roles of subsystem or market category leaders within engineering. The small teams that solved problems were from different disciplines, which enabled problem solving and creativity insights that would not have happened within a single discipline or silo structure. Over several years, this company released more than 20 systems and software products, growing revenue five-fold and leading to an IPO.

Types of Engineers and Developers

When selecting team members, one should recognize there are different types of developers, which we will call “Starters,” “Implementers,” and “Finishers.” Typically, Starters do well with the Phase Zero invention work and during the early stages of product development. Implementers shine during the middle stages through to the completion of product development, as well as during the transfer to manufacturing. Finishers excel during the transfer to manufacturing and product launch. While an engineer may resemble one type of “profile” more than the other two, he or she can adapt to the other stages as well. For best results (and to encourage “constructive confrontation”), combine different types of engineers within each phase. For example, a Starter may come up with innovative new designs that can then be refined through input from an Implementer. Identification of project risks and mitigations in Phase Zero can greatly benefit from insight from Implementers and Finishers.

Systems Thinking

In development of complex medical devices, the mix of the types of engineers in a project are varied and many. Design and testing of the new product may require mechanical, electrical, software, optical, materials, and biomedical engineers. Integrating and optimizing their work requires yet another type of engineer: a systems engineer, who may come from electrical, mechanical, software, or other discipline. Systems engineers should have the ability to think about the whole system and the interrelationship of the subsystems. The architect of the system should have this ability, as well as the technical core team leader. Clearly, this was a problem on the ill-fated Eagle Project described in the May 2024 MPO column “What Makes Complex Medical Devices Different,” where the project leader was experienced, but had no systems experience or insight. 

Product Team Summary

The right product development team is much greater than the sum of its individual team members. Forming teams for complex product development involves effective leadership, cross-functional contributions, and optimized team structure for the project. Our experience dictates well-designed teams will produce innovative products in a timely manner that, over years, will create great value for the company.

In the next column, we will describe additional concepts to keep the product team focused and productive throughout development.

MORE FROM THESE AUTHORS: Market Validation of a Complex Medical Device—Will Anyone Buy What We Are Developing?

Russ Singleton, principal consultant with Russ Singleton Consulting LLC, is based in California. He has extensive experience in VP R&D, general management, and C-suite roles in the semiconductor equipment and medtech sectors. He holds a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor of engineering from the Pratt Institute.

Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. With over 20 years of experience across a broad range of medical devices from surgical robotics to medical imaging to IOT and SaMD products, he helps clients efficiently tackle risk management and design controls for new product development.