Zapyrus Blog

A Complete Guide to MedTech Funding Stages: What it takes to bring medical innovation to market

Written by Kevin Saem, Ph.D. | December 29, 2025

 

The path from a promising MedTech concept to a commercially viable product is long, capital-intensive, and heavily regulated. Unlike startups in many other industries, MedTech companies must navigate clinical evidence, FDA approvals, manufacturing standards, and reimbursement pathways—each requiring different levels of investment.

Understanding the full spectrum of MedTech funding helps founders, investors, and commercial teams align expectations and build realistic roadmaps for growth.

Below is a breakdown of the main funding stages in MedTech, what happens during each developmental milestone during each stage, and how MedTech companies progress through these stages to achieve market success. Depending on the business growth and trajectory, funding rounds can vary in monetary value and application given specific company goals and needs. The funding rounds and activities outlined below represent a typical progression for a MedTech company.

1. Pre-seed Funding: Identifying the problem and proving early feasibility

At the earliest stage, MedTech innovators are focused on deeply understanding the clinical problem (medical indication) they want to solve. Pre-seed funding exists to support problem validation and early technical feasibility—critical steps before any significant R&D or capital investment begins.

Why companies move to this stage

  • To verify the medical need and clinical workflow
  • To ensure the idea is technically possible
  • To build foundational IP and understand the regulatory pathways and requirements
  • To determine if the market is large enough to justify investment (problem-solution fit before product-market fit)

Typical activities in the pre-seed funding stage can include early prototyping, clinician interviews, regulatory research, and initial patent exploration. Funding often comes from founders, angel investors, or non-dilutive grants such as NIH SBIR programs.

2. Seed Funding: Building a working prototype and early validation

Seed funding helps MedTech companies move from concept to a functional prototype and begin basic safety and performance testing. This stage proves the device can realistically meet its intended use and is developmentally possible.

Why companies move to this stage

  • To demonstrate proof of concept to potential investors
  • To reduce technical risk before preclinical studies
  • To refine design based on clinician and user feedback
  • To confirm the regulatory classification (Class I, II, or III)

Seed-stage investors expect a working prototype, proven clinical need, and a well-defined regulatory plan. This stage is also when startups start building relationships with key opinion leaders (KOLs) and partners who will later play major roles in clinical trials and commercialization.

3. Series A: Preclinical studies and design for manufacturing

Series A funding enables companies to progress from prototype to preclinical validation. At this point, companies begin developing manufacturing-ready designs while strengthening quality and regulatory infrastructure required to progress further in the development process.

Why companies move to this stage

  • To generate robust, preclinical data for regulatory submissions
  • To ensure the product can be manufactured reliably and safely
  • To design early clinical trial protocols
  • To de-risk the technology before human testing and validation

Investors expect strong early data, a clear regulatory roadmap and timeline, and a product design that is viable and stable to support eventual clinical trials. The Series A stage is foundational for transitioning from early R&D to formal product validation.

4. Series B: Funding clinical trials, scaling manufacturing and regulatory preparation

Series B is one of the most significant stages in MedTech funding, because clinical trials are essential yet expensive for regulatory approval. Funds raised in this round typically support first-in-human studies, pivotal trials, and additional regulatory preparation.

Why companies move to this stage

  • To generate clinical evidence required by regulatory bodies
  • To validate safety and effectiveness in real patients
  • To build credibility with clinicians, payers, and potential acquirers
  • To prepare for commercialization

Investors at this stage look for strong preclinical results, well-designed clinical trial protocols, and a clear path to regulatory clearance. This is where costs can increase substantially, making Series B a major inflection point for many MedTech companies.

5. Series C: Regulatory submission and commercialization

Series C funding is used to navigate the final steps of regulatory approval and enter the market. Companies at this stage are focused on scaling operations, initiating early commercial deployments, and preparing for revenue growth.

Why companies move to this stage

  • To complete FDA submissions (ie: 510(k), De Novo, or PMA)
  • To scale up manufacturing and systems
  • To begin commercial pilots in hospitals or clinical settings
  • To build sales, marketing, and customer success teams

Investors expect to see a highly validated and de-risked product, near-term clearance or approval, and a solid commercialization strategy that can demonstrate how the business will achieve early revenue traction.

6. Series D and beyond: Scaling, expansion and market leadership

Later funding rounds fuel accelerated growth. This can include expanding product lines, entering new geographies, and strengthening reimbursement coverage. Many companies also prepare for acquisition or IPO at this stage.

Why companies move to this stage

  • To expand sales reach and market penetration
  • To seek global regulatory approvals (ie: CE Mark)
  • To broaden clinical use cases or indicators
  • To drive post-market studies and health economic outcomes

By this stage, investors expect strong revenue growth, repeatable sales processes, and definitive competitive advantage.

7. Exit: Acquisition or IPO

Most MedTech companies exit via acquisition rather than IPO, often by large MedTech and pharma companies and strategic partners. These companies acquire startups to fill portfolio gaps, expand into new therapeutic categories, or accelerate their innovation pipelines.

Why companies move to this stage

  • Major strategic partners can scale distribution far faster
  • Acquisitions provide liquidity for investors and founders
  • Acquirers gain proven, FDA-cleared technology with clinical traction

An IPO is less common in the MedTech industry, but possible for successful MedTech companies with strong recurring revenue and broad market adoption. Each stage of MedTech funding represents a critical milestone in transforming a scientific idea into an industry-leading, impactful healthcare product. Because the MedTech lifecycle requires rigorous clinical evidence and regulatory validation, strategic fundraising is essential—not optional. By understanding each stage, MedTech companies can better anticipate capital needs, set realistic timelines, attract the right investors, and ultimately accelerate the path to commercialization.