START-UPS

Bringing a new medical device to life is a multi-phase, highly regulated journey. Early teams typically have the clinical vision, which is often the strongest part of the entire value proposition, but progressing from concept into a well-defined, testable, and ultimately approvable device requires structure: design control and traceability, risk management, regulatory pathway planning, and manufacturability decisions that hold up under investor and regulator scrutiny.

Many early medtech ventures stall or lose momentum here, not because the idea is weak but because technical development, regulatory strategy, and documentation must move forward together. Without alignment, teams end up re-designing hardware late, retrospectively producing documentation under pressure, or entering fundraising rounds multiple steps behind already.

SechMed works with startups to bridge this early-stage gap. We integrate directly into your team, bringing decades of hands-on experience in device development, regulatory strategy, and manufacturability, allowing you to move faster, avoid costly mistakes, and demonstrate credible progress to investors and strategic partners

In short:
We help founders de-risk development, accelerate progress, and protect early capital while building the foundations of a device that can be safely and successfully brought to market