Contextual Inquiry in MedTech: Observe Before You Build

Paul Charlebois and Eric Olson are seated across from each other at a white table in a modern office setting. The man on the left has curly brown hair and is wearing a light blue button-up shirt. He is smiling and looking toward the man on the right, who has short gray hair, glasses, and is wearing a dark patterned shirt with a small microphone clipped to his collar. The background is a bright, blurred open-plan office with desks and chairs, creating a soft focus effect behind the subjects. A blue pen and a blurred stack of folders or documents are on the table in the foreground.
Resources

Contextual Inquiry in MedTech: Observe Before You Build

YouTube video thumbnail

What makes a MedTech product truly successful? In this episode of Before the Build, Paul Charlebois and Eric Olson explore how contextual inquiry in MedTech drives smarter product design. By observing how users interact with devices in real settings, product teams can gather early insights that shape usability, adoption, and safety—long before development begins.

What Is Contextual Inquiry?

Contextual inquiry is a form of user research where developers observe users in their natural environments. For MedTech, this means watching clinicians, patients, or operators interact with technology in clinical or home settings. This research helps teams identify pain points, workflow gaps, and usability issues that traditional interviews may miss.

How Contextual Inquiry Supports Product Success

Applying contextual inquiry in MedTech allows teams to validate product concepts through real-world insights. Instead of assuming what users need, you observe how they think and behave. This method supports:

  • Reduced development risk
  • Better usability from the start
  • Evidence-based design decisions
  • Faster alignment with regulatory expectations

Before the Build: A Strategic Start

At StarFish Medical, contextual inquiry helps our teams and clients align early on product requirements, regulatory needs, and market fit. Paul and Eric discuss how this approach improves regulatory approval odds, speeds adoption, and supports commercial success.

From observing tool use in operating rooms to understanding home care routines, these insights guide MedTech design strategies with precision and purpose.

Engineers conducting pre-clinical testing of a novel medical device in a controlled laboratory environment

For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.

Medical device data management displayed on a connected healthcare tablet

When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.

Human factors and operational controls in a medical device cleanroom

With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.

AI-enabled medical device software interface illustrating FDA PCCP guidance for controlled algorithm updates

This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.