Medical devices
Insights for Life
Leading the Science in Usability 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 Testing 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:
Our Consulting Services
Medical Device Human Factors and Usability Engineering
The primary purpose of incorporating Human Factors & Usability Testing 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. We support medical device development through risk mitigation strategies that concentrate on user needs following a proven history of helping clients obtain FDA approval.
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 Testing process. At Improvita, we have a depth of experience having successfully completed Human Factors Testing for products across many sectors of the medical device, pharmaceutical and healthcare industries, contact us to discuss your specific needs.
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.
Labeling: Instructions for Use (IFU) in Human Factors
Labeling is one of the first things a user encounters when interacting with a medical product and can have a large impact on how a product is used and experienced. The focus of Human Factors & Usability Testing is to understand how people interact with products and how user interface design affects these interactions. At Improvita, we have extensive experience in medical device labeling and can help guide your company through the Human Factors process to learn more about the current or future labeling of your product.
Human Factors Participant Recruiting
One of the most important factors in a successful Human Factors & Usability Testing Program is to recruit participants for research that most closely represent the intended users of the product. 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. At Improvita, we work collaboratively with our clients to understand specific requirements to create effective recruitment plans that secure qualified participants on time and within budget.
