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Medical Device Research Experience

Human-Centered Insights to Improve Product Safety, Usability, and Outcomes

Medical products need to perform in high-pressure environments, often with critical consequences. I’ve led research for medical device manufacturers focused on understanding how clinicians and patients actually use their products, and where design can reduce risk, improve clarity, and support better outcomes.

Every project is built around context. I’ve spent time in clinics, hospitals, and surgical centers observing real use, uncovering unspoken needs, and translating insights into actionable product improvements.

This research aligns with IEC 62366 usability standards and follows ANSI HE75 human factors guidelines to ensure products meet both clinical and regulatory expectations.

Paul Miklautsch of BOLDR Product Management sitting in an office and smiling

Where the
Research Happens

  • Ambulatory surgical centers (ASCs)

  • Primary care clinics

  • Emergency departments

  • Specialty and outpatient clinics

  • Animal health and veterinary clinics

Who I Talk To

  • Surgeons and physicians

  • Nurses and clinical staff

  • Procurement and supply chain teams

  • Patients and caregivers

  • Executives in health systems

What This Work Has Delivered

  • Safer and easier-to-use medical devices

  • Reduced use errors and training time

  • Research-backed design decisions

  • Clearer labeling and instructions for use

  • Input for 510(k) submissions and human factors reports

If you’re working on a medical product or need support gathering insights for human factors, usability, or early-stage design, let’s talk about how I can help.

Schedule a Call To Discuss Next Steps