In earlier columns, we discussed the critical importance of Phase Zero activities in maximizing the chances of success when developing complex medical devices. In this column, we turn our attention to market validation—specifically addressing the question: “Will anyone want to buy the amazing new product we’re developing?”

For companies working on complex medical devices, obtaining customer input early in the development cycle is essential. By collaborating with customers during the market validation process, companies can ensure they are heading in the right direction before committing significant resources. The primary goal of market validation is to determine whether there is a genuine market need for the product, helping to guide development efforts and minimize risks.

Assembling the Market Validation Team

The first step in the market validation process is assembling a cross-functional team. This team should include marketing, application, and technology experts who will work together to develop a strategy for market validation and define the key questions to ask customers. The team’s role is to gather and document market feedback continuously and ensure insights are integrated into the product development process.

It is critical to include a customer representative on the team, such as a practicing physician or clinical expert, to ensure the feedback is relevant and actionable. In addition to customer representatives, the team should include an application expert who is familiar with the product’s intended use and a technical expert who understands the product’s implementation and the trade-offs associated with its key performance attributes.

Identifying Key Questions

A critical component of market validation is asking the right questions. Rather than attempting to ask every possible question, companies should focus on a small set of three to five key inquiries for each customer interaction, typically no more than 10 questions in total. These questions should center around specific use cases and encourage customers to talk about their current processes and how the new device could improve outcomes. It is important to emphasize measurable benefits and quantitative insights rather than qualitative opinions.

The key questions should address several important areas. First, the team must understand how the user currently conducts the specific medical procedure and whether the new device can improve the process. Second, the team should determine the critical attributes of the product that would make it useful and beneficial for the customer. Discussions should also explore trade-offs around key product performance attributes, such as form factor, speed, complication rates, cost, and reimbursement. These “attribute tensions” will help the team understand what customers are willing to compromise on and prioritize features for the minimum viable product.

By focusing the discussion on how the product will impact patient outcomes, the team can gain clarity on the device’s potential value. This process of understanding trade-offs and refining priorities will guide decisions about the product’s development.

Conducting Customer Interviews

Customer interviews are the next critical step in the market validation process. One challenge companies often face is customers may not have a direct reference product to compare with the new device, making it harder for them to envision its use. To address this, it is important to guide customers through a “virtual journey” of how the product would fit into their workflow. This can be done through mock-ups, prototypes, video demonstrations, and other visual aids that help the customer imagine the product in action.

The focus of the interview should be on gathering feedback about how the device would integrate into the customer’s existing workflow. It’s essential to avoid defending the product if feedback doesn’t align with expectations. Instead, the goal should be to listen and gather insights that can be used for further refinement. Collecting feedback from a variety of customers is also critical to ensure the insights gathered reflect broader market trends, rather than just individual opinions.

When selecting customers for interviews, it’s important to consider whether they represent organizations with the knowledge and purchasing power to influence the market. It’s also beneficial to engage with customers who could generate buzz around the product and establish long-term relationships that could improve patient treatment outcomes.

Integrating Market Validation Feedback into Product Design

After conducting the customer interviews, the next step is to analyze the feedback and identify actionable insights. The team should look for patterns in the data, drawing conclusions that will inform the next steps in product development. It is helpful to quantify the conclusions and integrate them into the product’s design strategy. Regular interactions with executive management are essential to ensure buy-in and to align the product development efforts with customer feedback.

Customer information is often the most influential factor in moving projects forward, especially when it comes to securing funding and making key product development decisions. Integrating customer feedback into the product design process is an ongoing effort that continues throughout the product lifecycle. While initial feedback from interviews is critical, continuous engagement with customers is necessary to refine the product and ensure it meets their needs.

The timing of these customer interactions is also key. They should align with important decision-making milestones throughout the product lifecycle. These milestones typically include determining whether the product is viable, understanding if it solves a critical unmet need, defining key performance features, and assessing whether the product is ready for market introduction. Additionally, as the product moves toward scale-up, feedback from customers should continue to inform decisions on production and market readiness.

Case Study: Shifting Focus Based on Market Validation

Consider the case of Company A, which was developing a capital equipment solution designed to assess tissue abnormalities. Initially, the company targeted pathology labs, with the pathologist as the primary user. However, early discussions with customers revealed the most effective use case for the product would be in the operating room, where the surgeon would be the primary user. This feedback prompted the company to pivot, adjusting the form factor of the device to a “handheld” solution better suited to the operating room environment.

By engaging in market validation early, Company A was able to refine its product strategy, avoid a costly misdirection, and ultimately create a more effective solution that met the needs of its target users.

Conclusion

The market validation process is an essential tool for any company developing complex medical devices. It helps refine product strategy, identify key market needs, and ensure development resources are allocated efficiently. By following a structured approach to market validation, companies can better align their products with customer needs, reduce risk, and increase the likelihood of a successful product launch.

Amir Lev has over 35 years of experience in technology leadership, business management, and growth in the medical device and semiconductor industries. He has led the creation and deployment of key products generating multi-billion-dollar revenues across companies such as Intel, KLA, and Veeco. Lev co-founded and led a medical device company focused on real-time margin assessment of breast tissue during cancer surgery and currently works with various technology and medical device firms on business development and growth through his company, ALEV Ventures.

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.