Let’s say your start-up is now over 2 years old - the battle scars are starting to accumulate! Starting from institutional R&D, to creating a match with an unmet clinical need, to translation into a product concept and then proving the concept in a compelling fashion… countless hours in planning and execution have been both gruelling and exciting.
The stress of having survived to this point is now beginning to segue into the stress of execution and performance. The entrepreneur has now moved on from selling dreams to delivery of concrete business milestones.
The “one person show” has now become a cohesive, high-performing team crossing the key disciplines of science, regulatory, engineering and business. The ultimate proof of success, a “first-in-human”(FIH) clinical study has now been successfully performed. Value growth now starts to become evident and your MedTech Ecosystem is beginning to take notice!
You have managed to get to this point through sheer determination and persistence. The early financings and investors have been difficult to come by - often requesting or demanding short-term sales milestones that are distracting and frustrating for the entrepreneur to deal with. (In a future post, I will delve into this dilemma that is clearly evident in the Quebec MedTech Ecosystem - where this challenge is creating the single largest impediment for growth).
You’ve been through several financings, likely in the form of non-dilutive government support (to get off the ground) and convertible debentures (to convert your product concept into a business). You have also hit the first Seed Round, where the smart VC money has now entered the scene and human clinical validation is around the corner, so to speak. You’ve got to be patient here.
The successful FIH study has now catapulted you and your start-up into the real world of MedTech, with the emerging challenges of customer acceptance and competitive retaliation.
A Series A financing in the millions of dollars with a pre-money value (the value of the technology before the financing) many times greater than in the earlier Pre-Seed phases now becomes a looming reality.
Your business world now faces the most significant transformation of its very short life: turning your focus from product development to strategic commercialization. It’s a highly targeted and strategic method of generating business validation that potentially positions your start-up to a successful and lucrative strategic exit!
As we head into 2020, we’ll continue to look at the MedTech commercialization process, as well as a variety of topics related to MedTech in general.
I’m always happy to hear from the readers of this blog – if you feel there’s a topic you’d like me to write about relating to MedTech, feel free to leave a comment below and I may well add it to the list for a busy and exciting new year!