Once an entrepreneur has identified an unmet clinical need through multiple encounters with KOL users, the exciting process of translating it into a unique and compelling value proposition can now begin.
The entrepreneur must first understand why this unmet need has not already been addressed by existing Medtech players in a particular “space”.
Have new scientific learnings only recently surfaced? Was the niche too small to capture the attention of bigger players? Were there technical limitations that your potential solution can now overcome? Whatever the reason, it must be credible to you, your team, and the knowledgeable investment community.
Please allow me to give you a personal example that changed my career and my life.
In 1996, while I was building CryoCath (a cardiac cryoablation technology), the initial unmet need we were addressing was for a safer electrophysiology (EP) catheter ablation system. (In short, replacing radiofrequency ablation technology - freezing rather than burning arrhythmogenic endocardial tissue, particularly in pediatric cases).
This was the most obvious unmet need that cryoablation technology could uniquely address. Unfortunately, it was a small niche with minimal growth potential; therefore it was difficult to arouse the interest of the bigger American VC’s.
Then in 1998, a French electrophysiologist, Dr Michel Haissaguerre, published a landmark scientific paper in the New England Journal of Medicine, identifying the triggers of atrial fibrillation originating in one or more of the four pulmonary veins, and the likely strategies, like pulmonary vein isolation (PVI), to ablate them and effectively treat AF for the first time.
The AF market opportunity dwarfed anything else in the EP field, and opened the door for CryoCath to quickly become a major player in the EP world. Instead of a market potential of thousands of cases per year, we were now targeting millions of cases per year!
In discussions with my KOL network around the world, I immediately saw the unmet need for a new catheter ablation system that could safely and simply isolate (electrically) the pulmonary vein. There were no technologies from the strategic players (Medtronic, St Jude, J&J, Boston Scientific) capable of performing these tasks.
I quickly rallied my development team - clinicians, engineers, and scientists - around the challenge and came up with a revolutionary cyroballoon ablation system that safely and effectively performed PVI in less than 25% of the time, and required less skill and effort.
This opened the door to all electrophysiologists (EP’s) performing the procedure rather than a select few and highly skilled ones. The video above shows how it works.
Within one year of 20 German EP centers pooling and reporting their clinical results with the Arctic Front cryoballoon system, Medtronic acquired CryoCath.
The moral of this story: as an entrepreneur, listen well to new science surfacing from KOL’s and translate it into new and bold engineering solutions in a timely and effective manner!