Human Factors leadership when it actually matters.
Medical device teams often discover Human Factors problems too late. It’s usually during submission, audit, or remediation, when decisions are exposed and consequences are real.
RED Group helps teams get Human Factors right early, fix it when it’s not, and defend it when regulators are watching.
The Problem
In practice, teams often complete many of the right Human Factors activities, but the work does not connect in a way that clearly supports decisions when it is reviewed, questioned, or relied upon.
Human Factors issues rarely stem from a lack of effort or intent.
As a result, the Human Factors work that was completed often does not form a clear, defensible story when decisions are exposed to review.
What usually goes wrong is:
- HF activities exist, but they don’t support a clear regulatory case
- HF, risk management, and design controls aren’t aligned
- Use-related risks are identified late, when options are limited
- Ownership across engineering, risk, and quality is unclear or inconsistently applied
- Usability work satisfies process requirements but doesn’t hold up under review
These problems rarely appear in isolation. They tend to surface when decisions are exposed and flexibility is limited — during submission, regulatory questioning, or remediation.
Why RED Group
When Human Factors work must hold up under review, teams need experienced leadership that can connect the work, the risk story, and the regulatory expectations.
RED Group International is led by David Hirning, a Human Factors engineer with decades of experience building, reviewing, remediating, and defending HF programs across the full product lifecycle.
David works hands-on with clients, bringing judgment and clarity to complex HF challenges. He works directly with teams — not as a vendor delivering stand-alone deliverables, but as a partner who stays engaged, rolls up his sleeves, and helps get the work done. The focus is not on producing more HF artifacts, but on helping teams make decisions, align stakeholders, and build HF programs that are integrated, traceable, and regulator-ready.
When additional execution support is needed, RED Group scales to meet the need. Trusted collaborators are brought in under David’s direction, while David remains accountable for the overall HF work and outcome.
How We Work
Human Factors work is most effective when it is integrated into how teams actually make decisions during development.
RED Group works alongside client teams, not around them.
The work starts by understanding where a program really is — not where it was planned to be. From there, the focus is on what actually needs to happen for HF work to hold up under review.
Our approach emphasizes:
- Regulatory alignment with FDA Human Factors Guidance, IEC 62366-1, ISO 14971, IEC 60601-1-6, and related standards
- An understanding of how devices are actually used, including where use breaks down in real settings
- Integration across HF, risk management, and design controls
- Clear linkage between user needs, identified risks, and validation activities
- Pragmatic execution that fits the product, the timeline, and the regulatory reality
The work is collaborative, direct, and iterative. Tradeoffs are discussed openly, and recommendations are grounded in what will best support a safe, effective, and defensible outcome, with final decisions made by the client.
Whether the engagement involves early planning, mid-development course correction, or late-stage remediation, the objective is the same: Human Factors work that holds up under review and supports confident decision-making.
If your Human Factors work needs to hold up when decisions matter — whether early, mid-development, or during remediation — let’s talk.