Transparent 3D image of a human body with organs highlighted

Your Human Factors Partner in Improving the Healthcare Experience

Insights for Life

Leading the Science in Human Factors Testing

At Improvita, we uncover critical user insights to support the design, development, and validation of medical devices, combination drug devices, and software as a medical device (SaMD).

Conducting comprehensive Human Factors/Usability and User Experience studies early and throughout the development process can provide essential data necessary for FDA regulatory approval upon the first submission.

The goal of the Improvita team is to optimize the user experience while ensuring device efficacy and patient safety.

Improvita drives development and validation of:

  • Medical devices
  • Combination drug/device products
  • Digital medical devices (SaMD/SiMD)

Our Consulting Services

Medical Device Human Factors and Usability Engineering

The primary purpose of incorporating Human Factors/Usability Engineering process into developing medical devices, software as medical devices, and combination products is to reduce use-related hazards and risks so that the end users can use the product safely and effectively. Learn more about Human Factors/Usability Engineering and how Improvita can guide you through the process.

Doctor looking at patient information on her phone
Doctors utilizing medical devices

Human Factors Testing

Medical products can be complex and challenging to use and this can lead to human mistakes, also known as use errors, which may cause injury to patients or users. To mitigate errors, manufacturers strive to demonstrate that new products can be used in a safe and effective manner through the application of Human Factors/Usability Engineering process. Learn more about Human Factors Testing and how Improvita can guide you through the process for those in the medical device, pharmaceutical, and combination product industries.

IEC 62366 Consulting

Some regulatory authorities (e.g., Food and Drug Administration, European Union, etc.) have recognized or harmonized to IEC 62366 for Usability Engineering; and therefore, require conformance. IEC 62366 Consulting is a specialized service that helps medical device and combination product manufacturers comply with the international standard. Learn more about the IEC 62366 standard and how Improvita can help you stay compliant with the standard.

Man holding holographic image of a checkmark among other icons
People utilizing a medical device

Labeling: Instructions for Use (IFU) in Human Factors

Labeling is one of the first things a user encounters when interacting with a medical product; labeling can have a large impact on how a product is used and experienced. The focus of Human Factors/Usability Engineering is to understand how people interact with products and how user interface design affects these interactions. Learn more about evaluating Human Factors labeling and how Improvita can guide you through the process.

Human Factors Participant Recruiting

Human Factors/Usability Engineering plays a critical role in bringing medical devices, software as a medical device (SaMD), and combination products to market. It starts with a deep understanding of the intended user population; when you take time to learn about the user needs, limitations, and abilities, you can bring true insights to the build, design, and development process. Learn about the importance of the Human Factors recruitment process and how Improvita can guide you through the recruitment process to fulfill your recruitment needs.

Group of coworkers at their computers