Design Viewpoint

Scouting Your Customers and De-Risking Your Medical Technology

Not all new product development needs invention.

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By: Russell M. Singleton

Ph.D., Principal Consultant, Russ Singleton Consulting LLC

By: Aaron Joseph

Principal Consultant, Sunstone Pilot Inc.

In the previous column, we introduced the concept of “Phase Zero on Steroids” and discussed how to frame customer visits to understand “The Customer’s Job.” We started with a description of Concept 1: Understanding the Customer’s Job. Here, we continue, share what happens on customer visits, and introduce Concept 2: De-Risk Technology in Phase Zero.

Understanding ‘The Customer’s Job’ in Action

At one small company in which one of us worked, the team had successfully completed development of a new product line and brought in a new general manager to lead this business (semiconductor manufacturing equipment). Sales weren’t taking off the way they had hoped. To fix this, the general manager did something fairly radical; he pulled four leaders in marketing and engineering, as well as himself, out of their day-to-day responsibilities to focus on this new product’s market requirements.

The main problem was the business hadn’t done a robust job of understanding the customer requirements the first time. There was a desperate need for new marketing insight that would outline exactly what the product needed to be. They picked 10 customer sites to contact for feedback and sent travel scouting teams (composed of at least one engineer and one marketeer) to physically go out and visit these target customers with a kind of “straw man” in the form of a presentation of the proposed next-generation product.

The scouting teams learned the business was heading in the wrong direction. The outcome of the customer visits forced the company to change its whole approach to the market and re-invent the product. The original product was essentially a “Swiss army knife” of various features and capabilities. What the customer needed, however, was a single-function system that performed that task extremely well to enable the customer to accomplish their job. The key was defining a product based on the customer’s job, not a list of features. From there, definition, development, and manufacturing of the next-generation system became a more straightforward effort. When the company introduced the new system, it took the market by storm and fundamentally changed the way the customers performed their jobs. The company grew 10-fold over time and this product market became the largest in the company.

Customer Visits

Among the first matters to resolve are to decide which customers to visit (hospitals, clinics, etc.), identify the roles to include within the customer’s organization, and determine who will visit them. These visits must be vetted by the sales personnel (if in an existing business) who maintains a relationship with the customer.

One mechanism we have used to show customers our thinking is to create a “strawman” PowerPoint model of the product to be developed based on prior input on the unmet need or job to be done. A presentation should be prepared for showcasing the planned product to the customers, and teams comprising two to three individuals should be designated for each customer visit. The duration of a customer visit can vary from an hour to several hours, encompassing site tours and comprehensive explanations from the customer about their role and the challenges they encounter in their work.

During customer visits, one team member should lead the questioning, while another should be the scribe. These roles can be rotated between team members for different customers. Additionally, it is essential to have at least one team member with technical expertise and one with market knowledge.

Following the customer visit, typically on the return journey, the team should convene for a debriefing session to review the questions posed and the responses received from customers. Different customers may provide varying answers and insights. The purpose of multiple visits is to formulate a market model that can anticipate how a specific customer might respond to inquiries. The teams must persist with customer visits until they develop a market model that accurately predicts customer responses.

Sometimes, ranking the importance of specific features can be employed during customer visits, enhancing the information collection process. However, the true advantage of face-to-face customer visits lies in the ability to gauge body language, discern customer reactions, identify points of frustration or enthusiasm, and witness the customer’s job in action. This is more than putting a statistical survey together to be answered by customers, using tools such as conjoint analysis. It requires face-to-face engagement with customers by members of the team.

Depending on the nature of the business, this process can span several weeks to a couple of months and may require significant travel. Ensuring each customer feels appreciated and valued for their time is vital, often accompanied by “thank you” lunches or dinners.

After the customer visits, the team should convene to summarize and agree on the conclusions of the visits. The work here is to convert the understanding of the customers’ “jobs to be done” to outcomes/unmet needs as well as clinical and market needs. It will greatly inform the team whether the proposed product solution envisioned in the strawman hits the mark or needs to be modified or radically changed. This activity also creates a template for informing the team on product requirements/market requirements that would be delineated in the beginning of product development.

Concept 2: De-Risk Technology in Phase Zero

The ability to innovate products involves the invention of new technology to address the gaps in your customer’s job to be done to meet the needs of their customers. Likely, all the technical feasibility of what is needed is not complete. To reduce the risk of significant delays with product development later in the schedule, it is important to first complete the science and engineering of new technologies or areas that are incomplete.

Some teams assume this technical feasibility work can be tackled during the “development” phase. This is a serious mistake. Trying to unravel difficult technical problems during development or even later, such as during transfer to manufacturing, can be very expensive. This can result in huge amounts of time and money wasted in repeating tasks and dead ends. Even more alarming is discovering technical problems after the product has been launched. Multiple design flaws discovered late in development plagued the ill-fated Eagle Project we described in the May column, leading to expensive delays.

Take the Invention Out of Development

The objective is to prove the feasibility of a new technology by developing a breadboard or prototype. It is acceptable if breadboards or prototypes are high-cost and not manufacturable since their purpose is to get the unknowns vetted out. They are just for learning. If an invention is needed to complete the technology, then Phase Zero is the time to do that invention or demonstrate that it cannot be done. If the invention cannot be done, the team needs to determine an alternative to the invention, otherwise the product cannot be developed. This work must be accomplished in Phase Zero and not postponed to the development phase; the failure in development would be much more costly to the company.

Not all new product development needs invention. In one company at which one of us had worked, the VP of engineering led the Phase Zero team of a next-generation medical device through a brainstorming process in which they invited outside vendors to attend. To get the product to market as fast as possible, the team established a technology roadmap in a way that minimized the amount of invention required. It was a multi-day process that resulted in a product roadmap and plan. This eventually led to an extremely successful product launch and growth of market share.

In the next column, we will finish the discussion of Phase Zero with the description of Concept 3, which relates to defining the product strategy.

In case you missed last month’s column: Phase Zero on Steroids in Medical Device 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 earned a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor’s degree in 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.

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