Early-Stage Consulting for Medical Device Development

Medical device development begins with discovery

Some call it Phase 0. Some call it Discovery. Some call it working at the Fuzzy Front End. We call it the best opportunity you have to uncover opportunities, identify users’ needs and establish the right direction for new product development.

Applying a collaborative approach, we can help you chart a path forward. Perhaps you want to explore possibilities to enhance the user experience through innovative solutions. Perhaps you need a defined strategy to guide project prioritization or align business stakeholders to a common vision. Perhaps you want to survey the market landscape for the next big trends or determine where you can create a new trend. In all cases, understanding the opportunity space — including unmet user needs, underserved markets or emerging trends — will be key to your success.

We recommend that you diligently study the area of interest before you start to create, and we can serve a crucial role as your partner in this phase. Specifically, we can provide the right cross-functional team from our large pool of researchers, designers, human factors specialists, engineers and regulatory experts to clarify the following:

• Outstanding user needs and unfulfilled desires
• Development opportunities and value propositions
• Competitive landscape and analysis
• Trend reports
• Exploration of early solutions, including ideation and evaluation
• Use-related risk potential
• Regulatory pathways and strategy

Our approach to the medical device development process

• Explore: Research and analyze impacts to the user experience, including safety, scope, feasibility and unresolved user needs.
• Diverge: Lead collaborative design sessions to explore the “design space” and, ultimately, produce a wide range of practical to blue-sky concepts.
• Evaluate: Present concepts, such as sketches or prototypes, to prospective users and stakeholders to collect impressions and recommendations.
• Converge: Select and refine the most promising concept(s) as a starting point for focused product development or broader product strategy.
• Confirm: Conduct a cross-functional review of concepts with key stakeholders to confirm feasibility and gain alignment on selected directions. This review might determine the need for further research or development to inform decision-making, noting that a design iteration is not a negative outcome but an opportunity to drive excellence.

We approach our work in a practical manner that emphasizes substance and usability over style alone. As such, we see ourselves as the right partner to drive a discovery process leading reliably to winning concepts that promise to meet or exceed functional needs and deliver a great user experience.

Our Discovery activities have crossed a wide variety of applications, for example: