Demystifying Medtech Innovation from Start (Clinical Unmet Need) to Finish (Strategic Commercialization & Exit)

Welcome to the Fall 2019 blogging series - welcome to my blog subscribers and LinkedIn network, the 10 Propulsion graduates, two Techstars mentorees, and the Centech Acceleration Fall cohort of 14 new Medtech start-up teams!

MedTechDiagrams_Sept2019-05.jpg

Over the summer, I worked diligently with “thought experts” from the world of Medtech innovation, from successful entrepreneurs to regulatory, legal and IP experts and VC’s across both the USA and Canada. To paraphrase Steve Jobs: before you start speaking, blogging and asking, you have to listen thoroughly!

I learned that Medtech innovation ecosystems around North America have significant variations and interpretations of the necessary stages, steps and business and financing milestones required to successfully execute innovation and start-ups. This was especially true from some of the newer Medtech ecosystems, including here in Quebec. Duplicating efforts, conflicting goals and and an unclear path can create confusion for the young entrepreneurs that our system is designed to serve.

The Fall 2019 blog series will begin with a “Big Picture” look – a schematic of the steps, flow and thinking processes that all blend into the formulaic roadmap leading to disruptive successes in a rapidly changing healthcare arena. The graphic pictured above sequentially describes the critical steps from start to end, including the critical synchronization of the technical, regulatory and business milestones with the financial milestones needed to empower the entrepreneurial and innovative process.

The financial and business phases of the process need to be clearly defined and easily understood by the investment community. From Phase 1’s government financing through Phase 6’s Series B considerations, this is a step-by-by overview of what I consider to be the path to Medtech startup success.

If you play the game precisely and intelligently, a start to finish experience can be achieved in 6 years or less, and with minimal risk! Paid in capital can range from $25-100 million, depending on the clinical validation processes required.

The key themes overriding the whole process can be boiled down to:

1.   Initial focus on the customer and the unmet need

2.   Follow the systematic process that the quality and regulatory guidelines help define (no cutting corners, no assumptions!)

3.   Synchronizing business and financing milestones (most critical)

4.   Always raise more money than you think you need during each of the phases (at least 50-100% more for unimaginable surprises)

5.   Always pursue a simple and clear path to commercialization

In the coming weeks, I will do a “deep dive” into Phase 1 of the graphic – the goals, hazards, misunderstandings, and key success factors. I’ll also continue to blog on other areas of interest to all the stakeholders within the ecosystem.