Want to Get Funded? Here’s Your MedTech & Biotech To-Do List.
What investors expect healthcare startups to prove at every funding stage — and why reaching milestones is only part of the equation.
Raising capital in MedTech and Biotech is fundamentally different from fundraising for traditional software companies.
While SaaS investors often focus on product-market fit, recurring revenue, customer acquisition costs, and growth rates, healthcare investors must evaluate additional layers of scientific, clinical, regulatory, and commercial risk.
A promising technology is not necessarily a viable medical product. Regulatory approval does not guarantee reimbursement. And successful clinical trials do not automatically translate into commercial adoption.
For founders, the challenge is not simply reaching the next funding milestone. It is demonstrating that each milestone meaningfully reduces risk and increases the company’s potential value.
What Investors Expect at Every Funding Stage
Although funding expectations vary by technology, geography, capital requirements, and development pathway, five broad stages provide a useful framework.
1. Pre-Seed: Prove the Concept
The investor’s question: Can the science or technology work?
At pre-seed, investors are primarily evaluating the credibility of the underlying innovation, the unmet medical need, and the team’s ability to execute.
For MedTech companies, this typically means demonstrating:
* A clearly defined clinical need and target indication.
* Technical feasibility or an initial proof of concept.
* A preliminary intellectual property strategy.
* An understanding of the regulatory pathway and development requirements.
For Biotech companies, investors generally expect:
* A strong scientific rationale and validated biological target.
* Early proof-of-concept evidence, whether in vitro or in vivo.
* Foundational intellectual property.
* A credible preclinical development plan.
At this stage, comprehensive clinical validation is rarely expected. What matters is whether the scientific hypothesis is credible, the proposed solution is differentiated, and the next development milestone is achievable.
2. Seed: Demonstrate Feasibility
The investor’s question: Can the concept be translated into a viable product or therapeutic candidate?
Seed-stage capital typically supports technical development, preclinical validation, and early regulatory preparation.
For MedTech:
* Prototype development and usability testing.
* Relevant preclinical or early clinical evidence.
* Defined clinical endpoints and intended use.
* Initial regulatory engagement and a clearer development pathway.
For Biotech:
* Robust, reproducible preclinical data.
* Mechanism-of-action validation.
* Biomarker and translational development strategies.
* Manufacturing feasibility and early CMC planning.
* Regulatory strategy, including IND-enabling studies where applicable.
Investors want evidence that the innovation can progress beyond laboratory or prototype conditions toward a clinically relevant application.
3. Series A: Validate Clinical Value
The investor’s question: Does the innovation deliver meaningful clinical value?
By Series A, investors typically expect stronger evidence supporting the product’s safety, performance, or therapeutic potential.
For MedTech:
* More substantial clinical evidence.
* Demonstrated differentiation from the standard of care.
* Progress toward relevant regulatory milestones.
* A credible reimbursement and market access strategy.
For Biotech:
* Clinical Phase I/II evidence, where appropriate to the development pathway.
* Early safety, pharmacology, or efficacy signals.
* Dose selection and proof of mechanism.
* A defined clinical development strategy and regulatory milestones.
Importantly, Series A expectations are not uniform. A diagnostic platform, implantable medical device, digital therapeutic, and novel biologic will follow different evidence-generation and development timelines.
The relevant question is whether the company has produced sufficient evidence to justify the next significant investment.
4. Series B: Advance Toward Market Readiness
The investor’s question: Can the company navigate the remaining development and commercialization risks?
At Series B, the emphasis increasingly shifts toward regulatory execution, clinical adoption, manufacturing readiness, and commercial strategy.
For MedTech:
* Regulatory clearance or approval, or credible progress toward it.
* Manufacturing readiness and appropriate quality management systems.
* Reimbursement, pricing, and market access planning.
* Clinical adoption and commercial partnerships.
For Biotech:
* Pivotal clinical evidence or meaningful progress toward pivotal development.
* Manufacturing scale-up and quality systems.
* Regulatory filing strategy or a defined path toward approval.
* Commercialization, licensing, or strategic partnership planning.
Not every Biotech company will be commercially ready at Series B. Some may still require substantial clinical development and capital before regulatory approval.
Investors assess whether the next phase of development is sufficiently funded, strategically justified, and capable of creating additional value.
5. Series C and Beyond: Scale and Create Sustainable Value
The investor’s question: Can the company generate sustainable returns on invested capital?
Later-stage investment focuses on scaling validated businesses or financing advanced development programs with significant commercial potential.
For MedTech:
* Commercial traction and revenue growth.
* Scalable manufacturing and operations.
* Broader reimbursement and market access.
* International expansion and strategic partnerships.
For Biotech:
* Regulatory approval and market launch, where applicable.
* Advanced clinical development or additional indications.
* Commercial traction or strategic licensing agreements.
* Pipeline expansion and long-term portfolio value.
A Biotech company may reach Series C without generating commercial revenue. Its valuation may depend primarily on clinical development progress, intellectual property, addressable markets, and licensing or acquisition potential.
Conversely, a MedTech company may already have regulatory clearance but struggle to generate meaningful revenue because hospitals are slow to adopt the technology or reimbursement remains uncertain.
Funding stage does not automatically determine commercial maturity. The Critical Distinction: Milestones Do Not Eliminate Risk
One of the most common fundraising mistakes is treating milestones as evidence that the business has been substantially de-risked.
Consider three examples:
Regulatory clearance is not commercial validation. A medical device may be legally marketable but still face significant barriers to clinical adoption, procurement, reimbursement, or integration into existing workflows.
Successful early clinical trials do not guarantee late-stage success. A promising Phase II result may support further development, but Phase III trials can introduce additional efficacy, safety, operational, and financial risks.
Strong science does not automatically create a scalable business. Even highly differentiated technologies require viable development economics, appropriate market access, and a credible path to generating returns.
This is why sophisticated healthcare investors evaluate more than completed milestones.
They want to understand:
* Which scientific, technical, clinical, regulatory, and commercial risks have been reduced?
* Which material risks remain?
* How much capital is required to reach the next value-inflection point?
* What evidence will that capital generate?
* Does the potential value creation justify the investment and remaining development risk?
What This Means for Founders Raising Capital
An effective fundraising strategy should connect capital requirements directly to measurable development milestones and value creation.
Rather than simply stating that a company needs CHF 3 million to complete its next phase of development, founders should explain what that capital will accomplish.
Will it generate pivotal clinical evidence? Demonstrate a differentiated clinical outcome? Achieve regulatory clearance? Establish reimbursement? Validate commercial adoption?
And, critically, how will achieving that milestone change the company’s risk profile and investment attractiveness?
Investors are not only financing activities. They are financing the potential to create value by reducing uncertainty.
The FemTech Capital Perspective
At FemTech Capital, we focus on advancing innovation across women’s health, sex-specific medicine, and longevity.
These fields present significant opportunities for scientific innovation and clinical impact, but they also require rigorous evaluation of evidence, unmet medical need, development feasibility, and commercial potential.
A startup developing a diagnostic for endometriosis faces fundamentally different development and commercialization challenges from a company developing a novel therapeutic for menopause-related conditions or a medical device addressing pelvic health.
A one-size-fits-all approach to evaluating these companies is insufficient.
We believe investment readiness must be assessed in the context of the technology, clinical indication, regulatory pathway, development stage, and capital requirements.
The objective is not simply to identify promising innovations. It is to understand what it will take to turn those innovations into clinically meaningful, commercially viable, and scalable healthcare solutions.
Final Thought: Funding Stages Are Labels. Evidence Is What Matters.
Pre-seed, Seed, Series A, Series B, and Series C are useful reference points, but they are not universal definitions of company maturity.
In MedTech and Biotech, the most meaningful measure of progress is the evidence generated, the risks reduced, and the value created along the way.
For founders preparing their next round, the question is worth considering:
Are you raising capital to reach the next milestone — or to meaningfully increase the value of your company?
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About FemTech Capital
FemTech Capital is an investment platform advancing innovation across women’s health, sex-specific medicine, and longevity. Through investment, specialized expertise, and ecosystem collaboration, we aim to support the development of clinically relevant and commercially viable healthcare innovations.
Advancing the Future of Women’s Health