Human Factors and Usability Engineering

At Innovenn, we are committed to delivering innovative, end-to-end solutions that bridge the gap between health technology and human experience. As part of this mission, in 2019, we founded Improvita, a specialized division of Innovenn, dedicated to Human Factors (HF) testing and usability engineering (UE). Improvita embodies our focus on developing products, systems, and interfaces that are not only safe and effective, but also intuitive, easy to understand, and easy to use. By integrating deep expertise in human behavior, cognitive science, and design principles, Innovenn helps our clients develop products that truly address the user’s unmet need.

Our Services

Innovenn offers a comprehensive suite of services that can be utilized throughout the product’s lifecycle, from concept to launch and beyond. Whether you’re developing medical devices, digital apps, SaMD, or combination products, our experienced team can assist so that your product meets the highest standards of usability and safety.

Usability Engineering and Testing

Through rigorous testing protocols, we evaluate how real users interact with your product, identifying pain points and opportunities for improvement. From early stage, iterative testing, to complex validation testing, we can support study design and execution.

Human Factors Research and Testing

We conduct in-depth studies to understand user needs, behaviors, and challenges, providing actionable insights to guide product development. After study execution, we go deeper and provide root cause analysis with a study report, which will be data that’s used for your FDA submission.

Threshold Analysis & Comparative Use Studies
Formative Testing
Summative Validation Testing
Labeling and Instructions for Use
Participant Empathy Program (PEP)
- To emphasize the human element of research, PEP seeks to create an environment where participants genuinely feel safe, comfortable, and valued during studies, empowering them to fully engage in the research process.

Medical Device, SaMD, and Digital Therapeutics Consulting

Innovenn provides expert consulting for medical devices, Software as a Medical Device (SaMD), and digital therapeutics, so our client’s products meet stringent usability and regulatory standards.

Regulatory Compliance Support

For industries like healthcare and medical devices, we help clients navigate complex regulatory requirements, including FDA Human Factors guidelines.

User-Centered Design Consulting

Our experts work closely with your team to integrate user-centered design principles into every stage of the development process.

Patient-Centric Approach to Design Development

At Innovenn, we are redefining what it means to put people at the heart of innovation.

By combining Innovenn’s innovative spirit with Improvita’s specialized Human Factors expertise, we empower our clients to develop products that are not only cutting-edge but also deeply aligned with the needs of their users. To learn more about our HFE division, Improvita, and our dedicated HFE services, visit Improvita.com.

Frequently Asked Questions

What is Innovenn’s approach to Human Factors and Usability Engineering?

Innovenn is driven by a deep commitment to patient outcomes. Our approach goes beyond compliance; we work with a profound sense of responsibility so that the products we help bring to market truly meet patient needs. By integrating patient-centric design and approach to every stage of product development, we establish that the end user’s experience is always at the forefront.

How does Human Factors fit into the regulatory process?

The FDA requires that medical device submissions should “demonstrate that the needs of the intended users were considered in the device design and that the device is safe and effective for the intended users, uses, and use environments”¹. Thus, regulatory submissions should include Human Factors information, including information and data on the presence or absence of critical tasks, validation testing for risk mitigation strategies, a description of residual risk, and more.

Where do I conduct a Human Factors test?

Innovenn has our own lab and facilities located in Madison, Wisconsin, USA. Our lab is a comfortable and welcoming test environment that is highly adaptable to unique participant and study needs. Innovenn also has the capability to travel and execute studies in other areas and regions when recruiting, or when participant access presents a challenge. Overall, our specialized recruiting team will get the right participants to the right location; we work with our clients to provide customized solutions that best fit their needs, as well as the unmet needs of the patients and users.

Why Choose Innovenn’s HFE Division, Improvita, for your Human Factors and Usability Engineering Services?

Our mission is to harness the power of precision medicine, combining advanced data insights with cutting-edge technology to provide personalized healthcare solutions that fit each person’s unique journey. Whether through digital health innovations, Software as a Medical Device (SaMD), or thoughtful Human Factors engineering, we strive to make healthcare more intuitive, accessible, and effective.

To learn more about Innovenn’s Human Factors and usability engineering services, contact us directly to discuss your specific needs.

Contact an Expert

References:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions

Where healthcare innovation intersects with improved patient outcomes

Contact Innovenn

Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada

6410 Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com

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