Medical Device Commercial Path

medical-device-commercial path-infographic

Launching a medical device in the next 1-3 years?

Seeking funding for your medtech startup?
Investing in a startup company?

Here are pivotal milestones and their significance.

  1. Commerical due diligence is essential at this stage to clearly prepare for accurate funding and resources. Sadly, many companies encounter funding challenges by milestone
  2. Reg and Clinical strategies are key by this stage as they are critical to be prepared for FDA pre-submissions and mitigate any potential risks.
  3. Engaging investigators and proactively gathering all required data are vital as FDA negotiations and site selections can consume up to a year.
  4. Be ready to kick off your clinical study as soon as receiving the FDA (or ethics committee) greenlight.

Complex Landscape of MedTech Startups


Let’s delve into the intricate landscape of MedTech startups.

Research indicates a daunting reality, with a staggering 75% of medical device startups in the United States meeting failure. Looking deeper into this statistic, a substantial 30% experience setbacks in their second year, while an even higher 50% succumb to challenges in their fifth year.

The journey of bringing a new medical device to market spans an average of 3-7 years, contingent upon device classification. Key milestones unfold in a strategic sequence over this period…

  • Year 1 – focuses on formation, market and risk analysis, along with fundraising efforts.
  • Year 2 – sees critical developments such as hiring key personnel, product engineering, and additional fundraising initiatives.
  • Years 3 & 4 – involve product validation, commercial strategizing, and Yep, continued fundraising.
  • Years 5 – and beyond, the spotlight shifts to clinical studies and securing FDA approval for market launch.
  • The final phase – encompasses manufacturing and full-scale commercialization.

Contrary to common belief, the primary culprit behind these
failures isn’t the innovation itself, but rather the challenge lies in assembling
the right team with the requisite expertise to navigate the intricate
processes. Issues also arise when funds deplete precisely during clinical execution or due to the failure to construct a robust study, leading to costly rework.

The key takeaway is a recommendation to allocate THREE MONTHS in the second or third year of operation for meticulous strategizing and planning, particularly in the realms of clinical and regulatory considerations for commercial launch.

This proactive investment proves to be invaluable, ensuring a smoother trajectory for startups in the complex medtech ecosystem.