RED Group International is a Human Factors consultancy focused on helping medical device teams make sound, defensible decisions about safe and effective use.
The work is led by David Hirning, a Human Factors engineer with decades of experience supporting medical device development across the full product lifecycle. RED Group was intentionally structured to stay small, flexible, and deeply engaged with client teams.
About RED Group
Our Model
RED Group operates as a focused, hands-on consultancy rather than a traditional staffing firm.
Work is led directly by David, who remains engaged throughout each engagement. When additional execution support is needed, RED Group brings in trusted collaborators to support specific activities, while maintaining continuity, accountability, and a consistent approach.
This model allows RED Group to:
- Stay closely connected to the work
- Scale appropriately without diluting responsibility
- Focus on outcomes rather than headcount
- Adapt to the needs of each product and program
RED Group does not offer off-the-shelf solutions or fixed service packages. Engagements are shaped by the product, the program, and what will best support safe, effective, and defensible use.
What Clients Can Expect
Clients working with RED Group can expect:
- Direct access and sustained engagement
- Clear recommendations grounded in experience and regulatory expectations
- Honest assessment of tradeoffs and risks
- Respect for client ownership and decision-making
- Work that holds up under review