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.

Engineer assembling electronic components during medical device design transfer process.

Your team is ready for design validation. The prototype performs well, test plans are in motion, and everything points to a smooth handoff to manufacturing. Then your partner calls with bad news: they can’t build the device as designed.

Contract Manufacturer Rejection - Engineering team reviews early-stage medical device design and manufacturability during a design transfer meeting at StarFish Medical.

You’ve cleared the toughest engineering hurdles and proven your design works. Then, just as you prepare to scale, your contract manufacturer turns you down.

Black cubes with white arrows changing direction, symbolizing strategic pivots and disciplined commercialization in MedTech exit optimization.

In Medtech, a successful exit isn’t just about having an innovative device, it’s about building a business that potential buyers and investors can clearly see a future in.

Engineer interacting with digital blue gears, symbolizing manufacturing readiness alignment and scalable MedTech commercialization.

Being ready to build is not the same as being ready to scale. Successful market introduction requires manufacturing readiness that evolves alongside market readiness.