Having been involved in building hundreds of startup medical device companies, patterns emerge year after year, especially in the very early-stage startups.

Installing the right leadership in place before it is needed is one of the critical survival insights I would drive home to every startup investor, entrepreneur, CEO, and team member.

Correctly done and timely executed, bringing in a new CEO should not be looked at as a replacement, but instead an addition to the skills that got the company where it is today.

While a startup has more phases, the observations and lessons shared below cover the initial three phases of the life of a company.

Phase / Activity – Ideation through to prototype

CEO Persona – Clinician, University PhD, Engineer

Financing – Self-funded, Friends & Family

CEO Liability – Does not know the difference between a legitimate product and a science project.

Overall Risk to the Organization of Sitting CEO – Low

Phase / Activity – Moving out of “R” into the early “D” stage of R&D

CEO Persona – Clinician, University PhD, Engineer

Financing – Angels, Friends & Family

CEO Liability – Not able to listen to the fact that their Baby is Ugly.
Underestimate the clinical workflow of the product.
Lack of team resources and internal organizational knowledge around regulatory pathway, reimbursement, quality systems, and manufacturing costs early in the journey.

Overall Risk to the Organization of Sitting CEO – Low to Medium

Phase / Activity – “D” stage of Full Platform Exploration – *First critical evaluation of current CEO

CEO Persona – Previous experienced early-stage CEO with technical skills indexing towards “D” and clinical, manufacturing, and team building.

Financing – A – B Round external professional investors

CEO Liability – The CEO doesn’t know what they don’t know.
Lack of evidence-based model around Work Flow and Economics at Point of Care.
Inexperienced BOD in startup medical devices
Over-indexed BOD of Clinicians / KOLs
Lack of CEO coach in place

Overall Risk to the Organization of Sitting CEO – Medium to High.

*This is the period where the initially unseen lack of experienced leadership is baked in and rears its head when / if the organization makes it to later funding rounds and the critical foundation and processes were ignored or improperly put in place. That leads to blown timelines, glaring product gaps, QA system remediation, FDA delays due to poor strategy and data, and the inability to secure funding due to the aforementioned “misses,” putting the organization at significant risk.