In the previous two columns, we discussed the ill-fated Eagle Project, which encountered significant delays after a multi-year development project. In this column, we introduce several concepts for the crucial pre-development work that needs to be accomplished in Phase Zero before beginning commercial development. This pre-development work needs to be completed successfully before deciding to start commercial development of the medical device.

The traditional approach of marching head-first into development—with Gantt charts, project planning software, and sophisticated CAD models—does not work for complex medical devices. For teams developing complex products, there needs to be a market definition, invention, and learning phase before actual development—a period of time before proceeding with “Phase 1” in the company product development process. Driving off into the sunset becomes much harder when you don’t know where the sun sets.

Phase Zero is your compass, a crucial front end to new product development that ensures the company is heading in the right direction. While the concept of Phase Zero has existed for decades and many companies include some form of it in their “Phase-Gate” processes, it is often not executed effectively or at all. Fundamentally, Phase Zero is a safe space for focused exploration and failure (where upper management is not hovering over the team’s every move). “Phase Zero on Steroids” refers to investing the time and resources to fully leverage this crucial project stage.

The primary focus is to determine whether or not there is a product that can be developed to match the customer’s problem to be solved. It is also an evaluation of the product opportunity and its alignment with the company’s business strategy. It enables the organization to make decisions about whether the product concept has merit and should be funded. The nature of Phase Zero is dependent on the complexity of the problem to be solved and the maturity level of the technology or market understanding. It is particularly important for new technologies or new market opportunities.

Phase Zero is typically led by the product champion and a very small team; it can also be augmented by consulting experts within the company who facilitate the evaluation. For example, a team may consist of a market leader, a clinical leader, engineers who can complete the invention, and a regulatory professional to resolve the clearance or approval pathway. This is a cross-functional effort consisting of different disciplines from within engineering, as well as key personnel from other segments of the company.

An organization should complete the invention part (science, research, etc.) in Phase Zero before starting commercial development. Intensive activity in Phase Zero should not be misinterpreted as a way to avoid design controls (an unfortunate habit in some medical device companies). Phase Zero is a way to efficiently proceed through subsequent design controls by first focusing on fully understanding the customer’s job to be accomplished and by project risk reduction before product development starts.

During Phase Zero, the team focuses on three main areas to set the stage for development: the customer’s job, taking the invention out of development, and the product strategy. These form the first three concepts, out of a total of seven concepts, that are fundamental to managing the development of complex new medical devices. We will start with a description of Concept 1: Understanding the Customer’s Job and describe the remaining concepts in subsequent columns.

Understanding the Customer’s Job

At the start of a project, when it’s just a concept in someone’s mind or “a napkin sketch,” the first priority is understanding what the customer’s job to be done is and how the new product will fit into their use cases (and what knowledge, science, technology, and logistics are needed to fulfill those expectations). At this point, it is critical to get a sound definition of the customer’s problem to be solved. (The concept of “The Customer’s Job” was described in “Competing Against Luck” by Clayton Christensen.) A key problem in the aforementioned, ill-fated Eagle Project from the previous two columns was the team launched directly into development without much or any customer insight.

Understanding the customer’s job to be accomplished is not about getting a list of features and benefits. It is getting true insight into it. Further, it is to identify where the gaps are in your customer’s ability to meet the needs of their customers. This is not about defining the UX (user experience) in detail; That work is to be done at the beginning of product development. Here, we are trying to understand whether our customer’s user experience needs to change—and how—for them to do their job.

Understanding the customer’s job truly necessitates visiting the customer’s place of work or facility where they do their job, stepping into their environment, and engaging in meaningful conversations with potential users. Effectively conversing with these prospects demands the presence of a proficient scouting team capable of asking pertinent questions and comprehending the customer’s perspective.

The Role of a Scouting Team

A competent scouting team typically consists of at least two individuals: a technologist or engineering leader and a clinical marketing leader well-versed in the specific domain of the customer. One of these team members should assume the “product champion” role—the one who possesses a deep understanding of the proposed product and serves as its primary advocate within the company. The engineering and marketing leaders should grasp each other’s domains, meaning the engineering leader should possess some understanding of the market and the marketing leader should have some understanding of the proposed product technology.

When engaging with customers, the primary objective is for the leaders of the proposed development to understand customers’ challenges and envision an effective solution. By “solution,” we mean a product concept strawman, not a fully designed solution (that will happen much later). This entails a profound understanding of the customer’s unique use case. For example, in surgery, it necessitates comprehending the key issues surgeons face for a particular procedure, identifying tools to enhance their efficiency, and illustrating how your product could seamlessly integrate to address these concerns. This might even entail constructing mockups for demonstration purposes.

Brainstorming Customer Questions

To ensure productive customer visits, meticulous planning is paramount. In our experience, this is best achieved through a series of brainstorming sessions involving the scouting team. The outcome of the brainstorming sessions is a detailed list of questions to be addressed and a list of customers to be visited. The purpose of these customer visits is to understand the customer’s job, any unmet or under-met user needs, and how a proposed product could help the customer in their job.

The way to accomplish this is to put together the elements of a business plan. Keep in mind, this is a new venture, and the product being developed is creating a new market or augmenting an existing one. There are a set of questions that need to be asked and answered in this process. Some of these will be addressed during the customer visits, and some can be answered by the team after the visits. They will, of course, include what the product is and the technology involved. But as importantly, they will identify and describe the business model, the cost structure, the product buyer, the financial premise, etc.

Brainstorming aims to flesh out the details of the questions to be answered by a small team. These meetings should include whomever else in the organization could contribute to asking the right questions, including members of sales, finance, and other technology members not part of this development. The outcome of the brainstorming sessions is a detailed list of questions to be addressed and a list of customers to be visited. This may sound like the team is forming a model to be tested. That is correct; the customer visits are not a fishing expedition but a validation of the product concept or to disprove it.

In the next column, we will finish the explanation of the Customer’s Job and introduce Concept 2 for de-risking development. 

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.