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.
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Contextual Inquiry in MedTech: Observe Before You Build

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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.

Black alarm clock disintegrating into particles beside the bold text ‘Faster launch?’ on a yellow background, symbolizing accelerating medical device development timelines.

Ariana Wilson and Mark Drlik explore how teams can reduce the device development timeline without compromising quality or compliance.

Gloved hand holds fluorescent liquid over a UV-lit surface with green glow and red arrow pointing to the light, captioned ‘See the Clean?

Nick Allan and Nigel Syrotuck explore a creative approach to visualizing cleaning validation using a fluorescent soil load.

Gloved hands insert a swab into a sealed vial beside a crossed-out O₂ symbol with the text “No Oxygen Allowed?” illustrating anaerobic sample collection.

Nick Allan joins Nigel Syrotuck to explore how anaerobic sample collection works and why it’s vital for studying bacteria that cannot survive in oxygen.

icons representing different medical device classes

Understanding medical device classifications is critical for compliance, risk management, and time-to-market success. Whether you’re designing a wearable sensor or a life-sustaining implant, knowing how your device fits into FDA Class 1, 2, or 3 categories is essential.