As we continue along the commercialization path, it’s worthwhile to do a quick summary and to set the stage for what lies ahead.
As a start-up, we’re at the stage where your Pre-seed and Seed phases have been successfully achieved. Your business and financing milestones - synchronized to keep your investors and business partners satisfied – have been executed precisely and convincingly.
The compelling proof-of-concept milestone created the response that we all need to get the financing processes into gear. You, the entrepreneur, then set your sights on building the team necessary to install a Quality Management System that would support the formidable transition from a functioning prototype to a completed a fully verified and validated alpha product ready for human use!
This team also included a carefully selected and constructed Scientific Advisory Board, comprised of Key Opinion Leaders strategically located in key North American (and perhaps EU) markets.
With all this in place, you then closed a Seed Round (in the millions of dollars) to execute your “first-in-human” prospective feasibility. Ideally, this is a minimum 3-site study, amounting to a total of 30-50 patients. This study should be aided by your regulatory and clinical advisors, along with clearly demonstrated safety of the product, as well as its likely efficacy. This takes 6-12 months , and can catapult you and your start-up into the limelight - with expectations, excitement and values soaring!
As you look back, raising the critical amounts of capital was a formidable task. If this was your first MedTech start-up venture, it often seemed impossible.
But you made it this far, and a bigger challenge lies ahead! It involves transitioning your start-up from an R&D culture and mentality to a customer- and business-focused organization.
We’ll explore this challenge in next week’s blog, where we start looking at Series A and Series B financing.
Good to be back in action for 2020 and beyond…