Blog - Kapstone Medical

Smart Capital Strategy: Validating Your Medical Device Before Dilution

Written by John Kapitan | Feb 5, 2026 2:30:06 AM

The intent of this article is to consider the differences between flexible partnership models and venture equity in early-stage medical device development. We encourage founders to think about their long-term goals as they choose which model is right for them.

Key Takeaways:

  • Strategic Equity Use: Giving up equity early is expensive. Retaining options for hybrid partnerships later keeps you in control.
  • Phase 0 Reduces Risk: A dedicated Feasibility Study provides objective data on viability before you commit to full-scale spend or equity deals.
  • Integration Creates Speed: A single-source Contract Development Manufacturing Organization (CDMO) eliminates handoff delays between design, regulatory, and manufacturing.
  • Alignment Over Dilution: Proving the concept first allows for right-sized partnerships based on proven value, not speculative risk.

For medical device innovators, the path from concept to commercialization is capital-intensive. It requires engineering expertise, rigorous quality systems, and complex regulatory navigation.

Founders often feel forced to choose between two extremes: either personally funding everything alone or handing over a massive chunk of equity to a "Venture Studio" just to get started. But there is a middle ground—a strategic approach that prioritizes validation over dilution.

At Kapstone Medical, we believe in a flexible partnership model: prove the concept first, then structure the deal.

 

The Cost of Upfront "Partnership-for-Equity"

Some incubators provide resources in exchange for a significant upfront equity stake. While this solves immediate cash flow problems, it creates a permanent tax on your success. If your device becomes a market leader, that early stake could mean you paid millions for initial support.

As illustrated above, while Kapstone may engage in equity sharing in later phases to align incentives (the hatched gold sliver), it is vastly different from the aggressive early dilution of the Venture model. 

Strategic De-Risking: The Phase 0 Feasibility Study 

To offer a strategic alternative to the financial strain of self-funding or the high cost of early equity dilution, Kapstone advocates for a Phase 0 Feasibility Study.

Phase 0 is a low-cost, fee-based "gate" designed to answer hard questions quickly. Instead of guessing whether a device will work, Phase 0 provides the data to prove it—or disprove it—before major capital is deployed.

Don't mortgage your company's future for today's development costs. Validate feasibility first, then scale the spend to meet the desired timeline.

Why Start with Phase 0?

  1. Technical Proof-of-Concept: We move beyond theory to build functional prototypes and test critical features, ensuring the device performs as intended before locking in a design.

  2. Regulatory Pathway Definition: We identify the likely FDA classification and predicate devices, clarifying exactly what testing data will be required for submission.

  3. Strategic Roadmap & Budget: We deliver a comprehensive project plan with accurate cost and timeline forecasts for full development, eliminating the guesswork from your fundraising asks.

 

The Hybrid Option: Earned Equity vs. Upfront Dilution

We understand that not every startup can fund a full Class III development program on cash alone. We also value long-term relationships where incentives are perfectly aligned.

That is why Kapstone offers a flexible model. Once a Phase 0 study validates the technology and we have established a working relationship, we are open to exploring hybrid partnership structures.

This equity is discussed after value is proven. It is a partnership based on data and mutual trust, not a requirement for entry. This ensures the founder retains control while still gaining a partner with a shared interest in project success.

Conclusion

Your medical device company is your vision. While it can be tempting to trade equity for immediate help, the most successful founders play the long game. By utilizing a Phase 0 Feasibility Study, you can de-risk your technology, preserve your cap table, and structure a partnership that fits your specific needs.