— HUMAN FACTORS & USABILITY ENGINEERING
Where usability evidence meets regulatory confidence
We design and execute the human factors program your device needs, from early user research through FDA-submission-ready summative validation, with the rigor that today’s regulatory environment demands.
FDA HF Guidance (2016)
IEC 62366-1:2015
ISO 14971
AAMI HE75
21 CFR Part 820
ISO 13485
510(k) Submissions
PMA Applications
De Novo Requests
Combination Products
Drug Delivery Systems
EU MDR / CE Mark
Post-Market Modifications
— THE CASE FOR RIGOR
Device failures at the point of use are not accidents — they are design outcomes.
The majority of use-related adverse events in healthcare are traceable to design decisions made without adequate user input, and if caught before clinical use, are frequently identified far too late in development to address efficiently. FDA’s Human Factors guidance reflects this reality. So does the industry’s steady rise in deficiency letters tied to incomplete or underpowered usability documentation.
At Avasys, human factors engineering (HFE) is not a submission deliverable we produce at the end of development. It is a structured discipline we bring into your program early when user research shapes design decisions, when formative testing catches problems before they calcify, and when summative validation confirms what the evidence already supports.
The result is a defensible HF file built on methodology, not a documentation exercise assembled after the fact.
— STRUCTURED FROM THE START
The Avasys HF Program Framework
Every HF engagement begins with a planning phase that establishes scope, maps your regulatory pathway, and aligns the study program with your development timeline. Here is how we build the program.
1 | HF Program Scoping & Planning We review your device, intended use, user population, and regulatory pathway to define the scope of the HF program, including which study types are warranted, what the submission documentation architecture will look like, and where the highest use-related risks are concentrated. |
2 | User Research & Task Analysis Before any study is designed, we characterize the users, use environments, and critical tasks. This may include contextual inquiry, ethnographic observation, interviews, or surveys depending on what your program requires and what gaps currently exist in your user knowledge base. |
3 | Use-Related Risk Analysis (URRA) We develop or review your URRA in alignment with ISO 14971 and FDA expectations, identifying critical tasks, potential use errors, hazardous situations, and risk controls that the usability study program must address. The URRA is the connective tissue between risk management and study design. |
4 | Formative Studies & Design Iteration We design and execute formative evaluations structured to surface design vulnerabilities while changes are still inexpensive. Findings feed directly into design iteration. We document these activities to support the HF Engineering report and demonstrate the full development arc to FDA reviewers. |
5 | Summative (Validation) Test When your device and labeling are near-final, we execute the summative study with representative participants and representative devices in a robust simulated use environment, following a rigorously developed protocol, moderated by experienced HF professionals, and documented to FDA’s evidentiary standard: no coaching; no participant guidance; just clean, defensible data. |
6 | HF Engineering Report & Submission Package We can produce a complete, submission-ready HFE report that summarizes the full program, including user research, URRA, formative activities, summative results, and residual risk conclusions structured to anticipate the questions FDA reviewers ask most frequently and minimize the likelihood of an additional information request. |
What makes a defensible HF file?
- Documented user research that traces to design decisions
- A URRA that covers all known use scenarios and user groups
- Formative study record that shows iterative design improvement
- Summative protocol with clear acceptance criteria and sample rationale
- Root cause analysis for every use issue
- HFE report with explicit residual risk conclusions
WHERE WE INTEGRATE
We can lead the full HF program or integrate at any point (e.g., gap assessment, protocol review, study execution only, or report writing). Our engagement structure is built around your timeline and where your current capability ends.
— STUDY TYPES & METHODS
Research methods matched to your development stage
Not every HF question requires a formal summative study. The right method depends on where you are in development, what you need to learn, and what your regulatory pathway demands. We match the method to the moment.
GENERATIVE
Contextual Inquiry
Structured observation and interview conducted in the actual or simulated environment of use: ICU, home, clinic, operating room, etc. The goal is to understand how users actually interact with devices in context, not how they describe it in a conference room. Surfaces latent use patterns, workflow integration challenges, and environmental hazards that no interview alone will reveal.
- Recommended by FDA HF Guidance (2016) for early user needs identification and URRA development.
GENERATIVE
Ethnographic Field Studies
Immersive observation in real care settings designed to document how devices are used, misused, and adapted by clinicians and patients in the course of actual work. Uncovers workarounds, environmental constraints, team dynamics, and use patterns that controlled settings cannot replicate. Particularly valuable for combination products and high-acuity device categories.
- Provides foundational input to task analysis, URRA, and use scenario development.
GENERATIVE
Focus Groups
Structured group sessions with representative users to explore perceptions, unmet needs, mental models, and reactions to early concepts or labeling. Particularly effective for capturing shared clinical vocabulary, training gaps, and use environment expectations across a diverse user population. Outcomes directly inform design inputs and IFU development.
- Supports user needs documentation, user group characterization, and labeling development.
ANALYTICAL
Heuristic Analysis
Expert-led evaluation of a device or interface against established usability principles; used for identifying potential failure points, cognitive burden, and design inconsistencies without recruiting external participants. Cost-effective for early-stage design review, IFU audits, and rapid identification of use-related risk candidates prior to formative testing.
- Effective for early design review and IFU evaluation; not a substitute for participant-based testing in regulatory submissions.
ANALYTICAL
Cognitive Walkthrough & Task Analysis
Systematic decomposition of user-device interaction into discrete steps, decision points, and knowledge dependencies. Identifies where users must apply critical or non-obvious knowledge, where procedural errors are most probable, and which tasks carry the greatest consequence for patient safety. Forms the analytical backbone of the URRA and summative study design.
- Required input to use-related risk analysis and summative study protocol development.
ANALYTICAL
HF Gap Assessment
A structured review of your current HF file against FDA expectations, current deficiency patterns, and IEC 62366-1 requirements. Identifies what is missing, what is underpowered, and what needs to be remediated before submission. Delivered as a prioritized action plan. Particularly valuable for teams inheriting a prior HF program or preparing for a pre-submission meeting.
- Entry-level engagement suitable for teams at any development stage; clear path to formative or summative report.
FORMATIVE
Concept Evaluation Studies
Exploratory research with intended users designed to assess early concepts (e.g., prototypes, sketches, or storyboards) before significant engineering investment is made. Generates user-grounded evidence for design decisions, helps teams avoid building toward the wrong interface, and creates a documented user needs foundation for the HF Engineering report.
- Supports early design input development and user needs documentation under design controls.
FORMATIVE
Formative Usability Studies
Iterative, protocol-driven evaluations with representative users designed to expose design vulnerabilities and generate actionable findings for the design team. Conducted at multiple points in the development cycle as design evolves, typically with 5–9 participants per distinct user group. Findings are documented to support the HF Engineering report’s development arc narrative.
- Required under IEC 62366-1 and strongly expected by FDA as evidence of iterative design refinement.
SUMMATIVE
Summative Usability Validation
The primary evidentiary standard for demonstrating safe and effective use under FDA HF guidance and IEC 62366-1. Conducted with final or near-final device and labeling, with representative participants per user group (minimum 15 per significant group). No coaching, no correction—clean simulated-use conditions. Pass/fail criteria established in advance. Root cause analysis required for all use issues.
- Primary submission evidence for 510(k), PMA, and De Novo regulatory pathways.
— OUR FACILITY
Purpose-built for regulatory-grade HF research
Located in Hunt Valley, Maryland, our HF facility is designed for the full spectrum of medical device and combination product usability testing. From early formative exploration through summative validation, we have two dedicated testing suites with high-fidelity audio and video capture, with adjacent observation rooms. Each room offers flexible simulation capability.
Suite A – Clinical Environment
Configuration | Dedicated ICU / ER simulation environment (room dimensions 11′ x 15′-5″) |
Video | 3 state-of-the-art full HD PZT cameras with 12x optical zoom and 72.5° horizontal field of view |
Audio | Beamforming array microphone with ambient and close-capture capability |
Recording | Full session recording with synchronized multi-angle video and audio |
Observation | One-way observation window and dedicated observation room with client seating for up to 8 |
Flexibility | Reconfigurable for OR, procedure suite, outpatient clinic, or point-of-care environments |
Access | Participant waiting area with separate client entry (no cross-traffic) |
Suite B – Home Health & Community
Configuration | Home healthcare simulation environment also configurable for focus group format (room dimensions 17′ x 15′-7″) |
Video | 3 state-of-the-art full HD PZT cameras with 12x optical zoom and 72.5° horizontal field of view |
Audio | Beamforming array microphone with ambient and close-capture capability |
Recording | Full session recording with synchronized multi-angle video and audio |
Observation | One-way observation window and dedicated observation room with client seating for up to 6 |
Flexibility | Reconfigures for pharmacy, patient-caregiver simulations, and more |
Access | Participant waiting area with separate client entry (no cross-traffic) |
PARTICIPANT EXPERIENCE
Dedicated participant waiting and check-in area, separate from client and observation zones. Private and professionally appointed to maintain participant comfort.
CLIENT EXPERIENCE
Clients and sponsors can access the testing suites through a separate entrance to help preserve participant blinding and maintaining study integrity. Observation rooms are equipped for real-time notetaking and sponsor participant where appropriate.
— A SPECIALIZATION, NOT A FEATURE
Human-technology & AI interaction: A defined frontier in device usability
As artificial intelligence is embedded into clinical decision support, diagnostic imaging, infusion management, and patient-facing therapeutic devices, a new category of use-related risk is emerging: one that most HF consultancies are not yet structured to address with rigor. We are.
AI-augmented clinical interfaces
Usability of AI-generated alerts, recommendation overlays, and diagnostic outputs in high-stakes clinical workflows, where alert fatigue, automation bias, and trust calibration are active safety concerns.
Human-automation teaming in devices
Study design and URRA methodology for devices that distribute decision-making between the user and an automated system, such as evaluating handoff clarity, mode confusion risk, and appropriate reliance on algorithmic outputs.
Patient-facing AI interfaces
Usability evaluation of AI-driven patient engagement tools, home monitoring systems, and conversational health interfaces designed to the unique cognitive, literacy, and health literacy profiles of non-clinical users.
AI in HF workflows
We apply AI-assisted analysis to accelerate formative analysis without compromising regulatory defensibility or proprietary data, yielding faster turnaround and at the same evidentiary standard.
We are not a generic HF vendor that added AI to our services list. We are building a defined practice around the HF implications of human-AI interaction in healthcare, grounded in the same regulatory framework that governs all device usability, applied to a device category that most of the industry is still figuring out.
— LOCATION & RECRUITMENT
Hunt Valley, MD — built for participant access and sponsor convenience
Where your study is conducted matters for recruitment depth, participant experience, and the logistics of getting your team to the table. Hunt Valley is purpose-suited for all three.
Sponsor & client access
✈ | Light Rail to BWI Airport Hunt Valley Station is a direct stop on the MTA Maryland Light Rail line, connecting to BWI Thurgood Marshall Airport without a transfer. Out-of-town sponsors and visiting clients have a seamless, low-friction travel option. |
🏨 | Immediate hotel access Multiple hotel options within 1–2 miles of the facility suitable for multi-day study sessions requiring sponsor overnight stays. |
🍽 | Dining and amenities Hunt Valley Town Centre and nearby corridor provide a full range of dining options for sponsor teams, participant meals, and end-of-day debrief gatherings. |
🚗 | I-83 corridor access Convenient from Baltimore City, Towson, Bel Air, and greater Central Maryland, we are accessible to a broad participant draw area without urban parking burden. |
Participant recruitment network
Participant recruitment is one of the most chronically underestimated challenges in HF study execution. Avasys benefits from proximity to one of the most concentrated healthcare and academic ecosystems in the United States, providing access to clinical professionals, patient populations, caregivers, and lay users across a wide range of device categories and experience levels.
ACADEMIC MEDICAL
Johns Hopkins University
Medicine, Nursing, Public Health
UNIVERSITY
Towson University
Health professionals & lay user access
HOSPITAL SYSTEM
Mercy Medical Center
Clinical professionals & specialty care
HOSPITAL SYSTEM
LifeBridge Health
Sinai, Northwest, Carroll, Levindale
ACADEMIC MEDICAL
University of Maryland
UMB Schools of Medicine & Pharmacy
HOSPITAL SYSTEM
GBMC Healthcare
Clinical professionals & specialty care
HOSPITAL SYSTEM
MedStar Health
Good Samaritan, Harbor Hospital
REGIONAL NETWORK
Greater Baltimore
Broad lay and patient user pool
— HOW WE ENGAGE
Structured to fit your program
We meet teams where they are. Entry points vary by development stage, regulatory moment, and internal HF capability. Every engagement is scoped explicitly before work begins.
01
Discovery call
20–30 minutes. You describe where you are; we describe what we do. Honest assessment of fit, no soft sell.
02
Scoping & proposal
Written scope defining deliverables, timeline, participant plan, and fixed-fee or time/materials structure.
03
HF plan & protocol
Program-level HF plan and study protocol developed collaboratively; reviewed and approved before participant recruitment begins.
04
Study execution
Expert-moderated sessions in our facility or at your site. Sponsor observation welcome. Real-time debrief available.
05
Deliverables
Submission-ready documentation and reports delivered on agreed schedule. Review cycles built in. No surprise scoping at the end.
Start with a conversation, not a contract
Most engagements begin with a 20-minute call. You describe where you are in development and we tell you honestly whether we can help and what that looks like.