Launch with confidence, minimize costly mistakes

Our ISO-certified quality system ensures the rigor with which we conduct research will help identify potential issues early in your development cycle when corrections are still affordable. By revealing use-related risks before they become expensive problems, we protect your investment while enabling the bold innovation that drives category leadership, customer loyalty, and safe and effective use. 

Case studyAccelerating innovation with confidence in a regulated industry

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Challenge

A pharmaceutical manufacturer set out to bring a novel drug delivery system to market—a move aimed at reshaping how patients manage treatment. But with any high-stakes innovation, the challenge was clear: how to move fast without cutting corners. The team needed confidence that the product would meet both user needs and stringent regulatory expectations. Missteps at any point in the design process could result in delays, added costs, or even post-launch failures.
Challenge

Solution

We were brought in as a strategic partner, not just to test usability but also to design a comprehensive research program that would surface use-related risks early and support informed decision-making throughout development. Our approach emphasized early, iterative design studies, enabling the team to address critical issues while corrections were still low-cost and low-risk.
Over the course of multiple research phases, we developed a robust data set that informed all aspects of the device design—interface, packaging, instructions—and was suitable for FDA submission, providing additional regulatory confidence. Each study built on the previous, creating a feedback loop that helped the client refine the product while protecting their development investment.
Solution

Impact

This partnership did more than validate a product concept; it enabled a confident go-to-market strategy. Our research identified design issues early, before they became costly to fix. It ensured the device would be intuitive and safe for patients, minimizing the risk of user error. And because the data was generated under an ISO 9001-certified quality system, the client had assurance that their innovation journey was backed by the rigor required for medical device approval and commercialization.

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Impact

Key outcomes included:

  • Early detection of use-related risks through iterative human factors studies.
  • Risk mitigation before submission, reducing the likelihood of regulatory delays or post-market corrections.
  • Efficient investment of development resources via a phased, insight-driven research program.
  • Regulatory-ready deliverables aligned with FDA expectations for combination products.
  • Informed design decisions across all aspects of the drug delivery system, supporting category leadership.
      Key outcomes included

      Result

      By combining speed with confidence, we enabled the manufacturer to bring an innovative new drug delivery system to market safely, successfully, and with a clear competitive advantage. This case illustrates how our behavior-focused, ISO-certified approach minimizes costly missteps and helps companies launch groundbreaking products with clarity and control.

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      Result