The readiness gap

Breakthrough medical technologies rarely fail because of innovation. They fail when readiness lags behind capability particularly once a device leaves controlled development and enters the operating room.

In surgery, readiness means more than technical performance. It requires evidence that reflects procedural variability, workflows that align with how surgical teams actually operate, clear accountability for safety, and risk management that anticipates real-world use rather than ideal conditions.

Clarity Surgical Advisors works with leadership teams and boards at these inflection points, where regulatory expectations, clinical reality, and operational risk intersect.

What I advise on

Regulatory and evidence architecture
Shaping claims, evidence strategy, and regulatory pathways that reflect how surgical technologies are actually used and reviewed.

Readiness for clinical use
Identifying workflow, training, human factors, and safety-accountability dependencies before devices enter routine clinical practice.

Executive and board advisory
Supporting leadership and boards at regulatory, clinical, and reputational inflection points where judgment matters more than process.

When organizations call

Organizations typically reach out when:

A novel or disruptive surgical technology is approaching its first regulatory or clinical inflection point and early decisions will shape everything that follows
Regulatory feedback raises fundamental questions about claims, evidence, or pathway
Evidence plans no longer reflect real surgical practice or procedural variability
Transitioning from controlled settings into routine clinical use introduces new risk
Safety signals prompt questions of responsibility, oversight, or public communication
Leadership or the board needs an independent perspective grounded in regulatory and surgical experience

This work often spans portfolios, helping organizations apply consistent decision frameworks across multiple surgical platforms and technology classes.

Discuss your next 90-day decision