In the previous column, we described how to set up the right organization for new product development of complex medical devices. In this column, we discuss how to empower the team for success.

CONCEPT 5: The Team Truly Understands

Product development is a team sport. The ability to collaborate and function within a team setting is as important as an individual’s skill set or technical expertise. Great products are created when the team works effectively together, but product development can lose significant time and opportunities for better outcomes when the team isn’t aligned.

Earlier, in Phase Zero, there was a focused effort to understand the customer’s job and then use that understanding to develop a product strategy. Following that, in Phase 1 and beyond, ensure the entire product team truly understands the customer’s job and how the product being developed impacts that job. The full product team consists of many more people than the Phase Zero team. In some of the development projects we have worked on, the product team consisted of hundreds of people.

There are many ways to instill this common vision among the members of the product team. Two popular and proven methods are conducting a project kickoff session and taking team members on site visits. 

Kickoff Session

At the outset of product development, a good practice is to have a project kickoff session with a review of the Phase Zero team’s understanding and the focus of the development project. For long-duration projects, it may be useful to record the session so late additions to the product development team can still enjoy the benefits of the information. 

In addition to the focus on the device itself, this kickoff session should include information regarding the clinical application, current market, key technology, proposed regulatory pathway, potential project risk areas, and any other special project characteristics, such as special manufacturing or service requirements. This broad view of the project enables the product team to make informed decisions on the many trade-offs and compromises that will arise during the upcoming design work. 

Clearly, this approach exposes crucial information about the entire plan and should be considered highly confidential to the project team and company. Sometimes, management is reluctant to disclose this information so broadly. This decision is a mistake, because the better the entire team understands the project and its potential challenges, the more likely they will produce a high-quality, timely outcome. The larger the product team and the more distributed its structure (e.g., team members across multiple organizations and locations), the more important it is to have this common vision. This includes any key suppliers that will be doing design work and need to understand this common vision.

Site/Customer Visits During Development

As part of this education/alignment effort, and depending on the complexity of the clinical application, it may be useful to have many of the team members visit clinical sites and watch videos to understand the actual medical procedures. There is no substitute for seeing healthcare professionals perform tasks in the clinical environment. Written descriptions of a workflow often omit critical details. With every development project, many design decisions happen at an individual level without review. As such, the better each engineer understands the target problem to be solved, the more likely they will make optimal design decisions. In addition, key suppliers, contractors, and consultants should be considered as members of the product team, and NDAs and other protections will need to be used for each project. If it is problematic to bring all the team members to a clinical site, have clinicians come to the company to make presentations to the team and answer questions. The key point of these activities is the education of the product team on the customer use cases. The ill-fated Eagle Project from the first column in this series—What Makes Complex Medical Devices Different?—relied on a single retired surgeon for input, who only communicated with a small subset of the product team.

In the experience of one of us, a major project that spanned over 100 engineers and product developers used a conference room reserved for the duration of the project, sometimes referred to as the “war room.” This room was used for small group meetings and featured “live” project information (including key milestones, critical information for the team, and charts with project progress) on the walls and whiteboard. It was an effective mechanism for cross-team communication that kept team members up-to-date.

Role of Culture in New Product Development

An underlying aspect of the product team’s performance is the culture it embraces. Usually, this is inherited from the overarching company culture (see “Organizational Culture and Leadership” by Edgar Schein). A culture that embraces open communication, avoidance of silos, accountability, integrity, and respect for others will be more successful at new product development. This is a complex issue, but an important one to recognize because it can affect all of the concepts and methods we are recommending.

Building trust among the team members and the larger product development organization is crucial to team performance. Multiple mechanisms have been used in companies to foster informal collaboration, such as holding team events like outdoor barbecues, inviting outside facilitators to conduct team-building exercises, and celebrating events for milestones (small and large). In the era of COVID-19 and the popularity of remote work, this can be challenging, but not impossible. There are facilitators who specialize in bringing remote workforces together. This deeply human approach is discussed in “Humble Leadership: The Power of Relationships, Openness, and Trust” by Edgar Schein. Both of us have used offsite meetings to enable this, sometimes working with an outside facilitator.

Following are some examples of a style one of us has used in new product development for many projects.

1. Reach an agreement on the focus and actions to be taken by the core team. Hold them accountable for running the business and delegate with trust. 
2. Determine commitments you expect to meet. Be thoughtful about making commitments. They are your word and should only be made if there is a high level of confidence they can be met. The core team needs to maintain credibility as a unit. All members of the broader product team are impacted when one doesn’t meet their commitments.
3. Mistakes are OK if taking calculated risks, taking action proactively, or still in a learning mode on an issue. Mistakes are not OK if they result from waiting for someone else to accomplish a task, blaming someone else, or not being assertive regarding a business issue. 
4. Integrity is the key to leadership. Be honest, straightforward, candid with other core team members, and willing to face the political impact of doing the right thing.
5. Have respect for others. Treat others as you would want to be treated. Be willing to apologize if you made a mistake and treated someone poorly or were not respectful. 

Summary

Whether you choose to use kickoff sessions, site visits, or other techniques, the most important aspect is to embrace the concept of making the product team truly understand the customer’s job and the goals of the development project. This common vision across a large and distributed product team, combined with a supporting culture of trust, will ensure all of the thousands of decisions and tradeoffs made during development will lead to an optimal design and a successful new product.

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 degree 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.