Medical device research 

Trusted research partners for every stage of medical device development

Whether you’re designing a wearable injector or a robotic surgical system, we help you build safer, more effective experiences for patients and healthcare professionals. Our research spans discovery, design, validation, and post-market evaluation, delivering the insights and evidence you need to make confident product decisions and accelerate regulatory approvals.

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Medical device research

Where human-centered design meets regulatory depth

You don’t need another vendor. You need a partner who understands the stakes. 

We combine regulatory fluency with usability research to de-risk your product, support global submissions, and bring innovation to life. We’ve helped hundreds of teams move from concept to clearance with data that stands up to FDA, EMA, and NMPA scrutiny. 

What we do

We tailor our approach to your product class, user profiles, and regulatory path: 

Early-stage discovery & concept evaluation

Identify unmet needs, assess risk, and shape product vision through contextual inquiry, ethnography, journey mapping, and foundational research.

Formative usability testing

Optimize workflows, interfaces, and labeling by identifying use-related risks early in development.

Human factors validation (HFE/UE)

Conduct FDA- and 62366-1-aligned summative studies to demonstrate safe and effective use.

IFUs, secondary packaging, & training effectiveness

Evaluate clarity, retention, and performance to support labeling claims and onboarding plans.

Post-market studies

Monitor usability in the field and identify improvements for next-gen versions.

Marketing claims & ecosystem design

Test the end-to-end experience, from app to device to training, to build claims and product roadmaps grounded in real user insight.

Where we work

We test where your product is used. From ORs and infusion suites to in-home simulations and high-fidelity labs, our research environments are designed to reflect real-world conditions. 

Explore our labs

We run studies in:

  • Hospitals and long-term care facilities 
  • Global in-home and outpatient settings 
  • Simulated-use labs
  • Specialized simulated surgical suites 
  • Remote and hybrid contexts 

What makes us different

Medical is our backbone
60% of our work is in medtech, digital health, and combination products.
Regulatory expertise, proven results
We’re fluent in FDA guidance, IEC 62366-1, AAMI HE75, and MDR documentation, and we’ve helped teams facilitate a smooth submission.
Global scale, local rigor
We’ve conducted research in over 100 markets with vetted local experts. Our ISO 9001:2015–certified system ensures quality, consistency, and compliance across borders.
Participant reach
Our healthcare panel includes 10,000+ patients and 1,000+ healthcare professionals, from certified diabetes educators to surgeons and pharmacists.

Let’s bring your next product to life

Whether you’re designing for at-home self-administration, refining training, or navigating regulatory submission, we’re here to help. Partner with a team that brings human-centered thinking and real-world expertise to every stage of device development.

Talk to our healthcare research team