Clinically-Driven Innovation
Human-Centered Design & Development for Medical Devices
Our Capabilities
Human Factors & Usability
Formative and summative studies, URRA/UERA, protocol development, and submission-ready HF Engineering reports aligned with FDA guidance and IEC 62366.
Product Development
Concept generation through validated engineering testing, prototyping, DOE, and design controls supporting every phase of the product development lifecycle.
Usability Engineering for the Healthcare Industry
Medical devices fail at the point of use more often than at the point of engineering. At Avasys, we apply structured human factors methodology to close that gap by building the evidence that regulatory bodies expect and the confidence your team needs before product submission.
Most use errors are predictable. Most are preventable.
The majority of use-related adverse events in healthcare trace back to design decisions made without adequate user input. We bring rigorous human factors engineering into your development process early, when interventions are still inexpensive, and carry it forward through every phase of development through regulatory review.
Talk to our team about conducting a quick review of your usability file to see if there are critical gaps that should be addressed before regulatory submission.
From Use-Related Risk to Regulatory Clearance
Effective human factors engineering is not a single study, it is a structured program of evidence built across the development lifecycle. We design and execute that program for you, or integrate into your existing process at any point.
Identify critical tasks, intended users, and use environments before testing beings.
Iterative testing to identify design vulnerabilities early, while changes are still relatively inexpensive.
Rigorous human factors validation demonstrating safe and effective use for your regulatory submission.
Submission-ready documentation structured for FDA review, anticipating common deficiency patterns.
From Clinical Need to Market Impact
We do not start with a prototype. We start with the problem, with the clinical need. Every engagement at Avasys begins with a thorough understanding of the clinical context — the real users, the actual use environments, and the specific failure modes that put patients and operators at risk. That foundation shapes everything: the study design, the participant profiles, the task scenarios, and the regulatory argument we help you build.
This approach does not slow development. It helps prevent late-stage redesigns, additional information requests, and study repetitions that can significantly impact market launch.
Built for Medical Device and Combination Product Teams at Every Stage
Whether you’re preparing for a first 510(k) or managing a multi-product portfolio, we structure our engagements to fit your timeline, development status, and risk profile.
You have a compelling You have a compelling device concept and a regulatory clock, but human factors engineering often gets treated as a late-stage checkbox rather than an early advantage. We help early-stage teams build a defensible HF program from the ground up, so your first summative study isn’t also your most expensive lesson.
Engagements are scoped to match your stage and budget, with a clear path to expand as your pipeline matures.
Established device companies often have active pipelines, regulatory timelines under pressure, and HF obligations that exceed internal bandwidth. Avasys integrates directly into your development process, extending your team’s capacity without the overhead of a full-time hire.
We work alongside your regulatory and quality functions, producing submission-ready documentation aligned with FDA’s HF guidance and IEC 62366.
Drug delivery systems and combination products carry a distinct HF burden, and one that sits at the intersection of pharmaceutical regulation and device usability requirements. We bring deep experience in autoinjectors, prefilled systems, inhalers, and other combination product categories where use-related risk directly affects patient safety and regulatory acceptance.
Our work is designed to satisfy both FDA’s HF guidance for devices and the usability expectations embedded in combination product review pathways.
University technologies with device applications often stall between proof-of-concept and commercial viability—not because the science is weak, but because the regulatory and market development case has never been fully built. We work with technology transfer offices to assess commercialization readiness, structure SBIR/STTR submissions, and define a path from promising IP to fundable program.
Engagements begin with a focused feasibility assessment that is structured to give your office an honest answer before committing to a full sprint.
Independent inventors often arrive at the device development process with strong clinical insight and limited visibility into the regulatory and usability requirements that will ultimately determine their path to market. We help individual innovators understand what FDA will require, identify where their current concept is most vulnerable, and build a development plan grounded in commercial and regulatory reality.
If you have an idea worth pursuing, we will tell you honestly what it will take and where to start.
Start with a Conversation, not a Contract.
Most engagements begin with a 20-minute call. You describe where you are in the development and what is keeping you from moving forward. We’ll tell you honestly whether we can help and what that looks like. No proposal required to have that conversation.
Our Facility
We operate a purpose-built human factors and prototyping facility in the Hunt Valley, Maryland area, designed to support the full arc of device development from early ideation through regulatory-grade usability validation. Our usability testing suites are dedicated test rooms configured for naturalistic use simulation, participant observation, and state-of-the art recording capabilities.
Who We Are
Avasys was founded in 2014 with a commitment to improving patient safety and outcomes through every opportunity and interface we have with the medical community. We have worked with startups, established manufacturers, and research institutions, bringing the same passion and analytical standard to each engagement, regardless of size.