How We Work
Improvita is a specialized human factors consultancy focused on Human Factors Engineering (HFE) and usability testing for regulated healthcare products. We help medical device, pharmaceutical, and digital health teams complete evidence gathering by generating the usability and safety data required for regulatory approval.
We understand that clients come to us at different stages of the medical device and Software as a Medical Device (SaMD) design and development process, seeking varying levels of support. Many companies reach a critical point in product development when regulators require Human Factors validation. At that moment, teams need trusted human factors specialists who can design and conduct compliant studies, recruit appropriate users, and produce defensible data for regulatory submissions.
With over 50 years of combined experience and hundreds of projects, the Improvita team guides clients in bringing safe and effective health products to market and beyond.
Mary E. Dixon, CEO/President with team
Our Mission: Improve Life
The name Improvita reflects our core mission: Improve Life.
We strive to improve and save lives by helping healthcare innovators develop products that are safe, effective, and intuitive for the people who rely on them. With a broad and deep background in drug, digital and device development, and testing, Improvita’s team of experts is committed to helping optimize usability and safety of medical devices or SaMD.
The regulatory landscape for medical devices, combination products, and medical device software (SaMD) is complex and dynamic. Guided by the principles of integrity, transparency, adaptability, and excellence, Improvita specializes in custom research and testing solutions. Our goal is to help clients navigate this complexity, and successfully yield product development insights, and Human Factors regulatory compliance, while managing risks to facilitate device approval.
Let’s empower health, together.
Our Human Factors Approach
Improvita provides a full Human Factors program designed to support companies preparing for regulatory approval. Our services can be delivered as a standalone engagement or as part of an integrated development program through our parent company, Innovenn.
Our human factors consultancy services include:
- Medical Device Human Factors & Usability Engineering – Includes Validation of DHTs, System Usability Scale, Threshold Analysis & Comparative Use HF Studies
- Human Factors Testing – Review the difference between Formative vs Summative Usability Testing, assess risk in Human Factors Validation and perform custom testing and environments in our Medical Device Testing Lab
- IEC 62366 Consulting – Helps medical device and combination product manufacturers comply with the international standard.
- Labeling – Instructions for Use (IFU) – Development of products involving the device-user system: device users, device use environments, and device user interfaces.
- Human Factors Participant Recruiting – Find participants for research that most closely represent the intended users of the product.
Why Improvita Exists
Improvita was formed to give Human Factors Engineering the dedicated focus it deserves.
Many organizations searching for human factors engineering companies or human factors experts are looking for specialized usability testing capabilities.
By establishing Improvita as a dedicated human factor division of Innovenn, we developed a clear entry point for teams seeking Human Factors support such as a specialized HF testing partner and a standalone service provider.
Our Human Factors Lab
At the core of Improvita is our dedicated usability testing lab, where we conduct custom testing and environments to give your team the best opportunity to effectively demonstrate the safety and effectiveness of your medical device, SaMD, SiMD or drug/device combination product.
Our lab allows us to:
- Simulate real-world healthcare scenarios
- Observe authentic user interactions
- Identify usability risks early
- Generate reliable data
Our Relationship with Innovenn
Improvita operates as a specialized Human Factors division within the broader Innovenn ecosystem. While Improvita focuses on Human Factors Engineering and usability testing, Innovenn provides end-to-end consulting across regulated healthcare product development, supporting clients across the full product lifecycle—from early concept development to regulatory approval and market success.
Who We Work With
Whether clients arrive early in planning or at the final stages of development, we help them produce the Human Factors evidence required for regulatory approval.
Organizations typically engage Improvita at any stage of product development. Our clients include:
- Medical Device Companies Developing diagnostic or therapeutic devices that require usability testing and HF validation.
- Digital Health & SaMD Developers Ensuring software-based healthcare solutions are safe and intuitive for patients and providers.
- Pharmaceutical and Combination Product Teams Testing drug-delivery devices such as autoinjectors, infusion systems, and wearable drug delivery technologies.
- Biotechnology Companies Developing complex technologies that require patient-focused usability evaluation.
- Healthcare Startups Preparing products for FDA review and needing experienced human factors experts to guide validation studies.
