Enriching lives through better design

Our human-centered approach puts people and their needs at the heart of the design and development process. We create devices that are not only safe to operate and effective under real-world conditions, but also desirable, intuitive, and easy to use.

A team of passionate collaborators, THRIVE works alongside you to progress your project, fill in resource gaps, and guide you and your Human Factors Engineering work. Our Human Factors Usability Engineering approach is based on ANSI/AAMI/IEC 62366 and FDA Guidance, ensuring safe and effective device design with efficient regulatory approval.

Our Experience

We have extensive Human Factors Engineering experience ranging from combination products used by laypeople in their homes to surgical devices used by healthcare professionals. Our Human Factors experts work alongside our Design Researchers, Product Developers, and User Experience Designers to integrate stakeholder and user needs throughout the design and development process. Whether you need guidance interpreting industry standards, applying the Human Factors/Usability Engineering process, or conducting a Human Factors study — we’re here to help.

Our Full-Service Approach is to Your Advantage

THRIVE is a full-service consultancy with a diverse team working to solve your problems at any stage of the medical device design process. Working as an integrated extension of your team, we expand your ability to develop innovative medical devices through a seamless process that spans capturing user needs and defining requirements to product definition and detailed device design. Our consultants are particularly adept at integrating Human Factors into large organizations' design processes, bringing the objectivity and expertise needed to navigate regulatory hurdles and achieve full compliance successfully.

Achieve First-time FDA Approval

We make it easy for the FDA to approve your submission the first time. Our Human Factors validation testing approach generates the correct data to give you peace of mind that your regulatory submission is comprehensive and successful. We eliminate the need for multiple summative validation studies, using data strategically throughout the design and development process, pinpointing critical tasks, and expertly creating a Human Factors Engineering Report — explicitly tailored to meet the current FDA requirements.

Advising to Help You Succeed

THRIVE provides custom training and educational programs to ensure your team has the knowledge to incorporate Human Factors into the device design process successfully. Our consultants offer expertise in interpreting, setting up, and executing on regulatory requirements and integrating Human Factors into a quality management system. We also help organizations to understand and apply these concepts practically while highlighting leadership's role in promoting this approach — building capacity amongst staff members and ensuring the right tools and processes are in place so they can put theory to practice.

what our clients are saying

THRIVE is a joy to work with. Always standing in our shoes, aligning with our vision, and creating innovative designs that improve the treatment more patient-centric products.

Yusuf Oni Associate Director of Drug Product Development Bristol-Myers Squibb

THRIVE is an extension of our team. Whatever challenge we present to them, they always go above and beyond. Getting up to speed quickly and becoming true subject matter experts.

Nick Wright R&D Program Manager, Oncology Becton Dickenson

I’m a big fan of THRIVE and love working with them! They own the problem and perform more like a key employee, not a hired hand. I always thank them for their help and appreciate how much time and money we save since we’re not trying to do this alone.

Jeff Beale Senior Principal R&D Engineer Medtronic

The THRIVE team is outgoing, fun, and great communicators. Throughout the project, they were accessible and worked seamlessly with my team. I couldn’t have asked for a better group of conusultants.

Rafael V. Andino VP - Engineering & Manufacturing Clearside Biomedical, Inc.

Let Us Help You:

Strategize and scale Human Factors activities for your device
Plan and conduct formative and summative Human Factors validation testing
Leverage our state-of-the-art usability testing suites to deliver seamless and integrated research experiences
Conduct relevant analyses to inform safe and intuitive device design
Document Human Factors work using our validated processes and templates
Prepare for regulatory submission and advise on regulatory questions
Conduct post-market device evaluations

human factors engineering

Enriching lives through better design

Our Experience

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THRIVE is trusted by the world's leading medical device and pharmaceutical companies.

Our Full-Service Approach is to Your Advantage

Identify the Critical Insights Needed for Better Device Design

Achieve First-time FDA Approval

Advising to Help You Succeed

what our clients are saying

Let Us Help You:

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