Is Your MedTech Device Investment-Ready?

Get the usability evidence investors demand. Our 7-Point Usability Readiness Report identifies gaps before they become deal-breakers.

Usability Readiness

1

User & market input

2

User profiles & environments identified

3

Competitive benchmarking

4

Workflow & task analysis

5

Use related risk analysis

6

Critical task list

7

Validation plan

WHY THIS MATTERS

Investors evaluate key outcomes

Approvability

Alignment to FDA/EU MDR: URRA and critical tasks traced to design controls, with a submission-ready validation plan.

Approvability

Alignment to FDA/EU MDR: URRA and critical tasks traced to design controls, with a submission-ready validation plan.

Approvability

Alignment to FDA/EU MDR: URRA and critical tasks traced to design controls, with a submission-ready validation plan.

Marketability

Evidence that real workflows succeed—lower training burden, fewer steps, and known-use problems addressed.

Marketability

Evidence that real workflows succeed—lower training burden, fewer steps, and known-use problems addressed.

Marketability

Evidence that real workflows succeed—lower training burden, fewer steps, and known-use problems addressed.

Accessibility

Typical and edge-case users can operate the device safely and effectively in intended settings (abilities, language, PPE, environment).

Accessibility

Typical and edge-case users can operate the device safely and effectively in intended settings (abilities, language, PPE, environment).

Accessibility

Typical and edge-case users can operate the device safely and effectively in intended settings (abilities, language, PPE, environment).

"Skip early usability work and you risk turning an expensive validation into a failed formative test — when it’s too late and too costly to fix."

Kay Sim

Sr. Human Factors Consultant

Claim your free assessment

Limited-time offer. Reserve your spot and receive your 7‑point readiness snapshot plus a prioritized action plan.