Startups & DEveloping Companies

Digital Health

Diagnostic

Wearables

Health IT

Drug Delivery

Medical Device

SaMD

Project Medtech provides immersive consulting services to help startups identify their critical path to success. We embed in your team to deliver hands-on execution from regulatory strategy and FDA 510(k) submission support to a tailored reimbursement strategy. Our support ensures long-term viability through QMS implementation, commercial go-to-market planning, and fractional finance support, including proformas, bookkeeping, and investor-ready data rooms.

"As an early-stage medical device company, our engagement with Project Medtech allows us to access senior expertise in finance, accounting, financial modeling, pricing and reimbursement strategies related to our consumable and capital equipment products. The individuals with whom we interact regularly are so responsive that we see them as members of our team. This allows us to focus our precious capital and full-time human resources on value-creation through innovation and commercial success.”

David McNally, CEO

Xenocor Inc.

"Project Medtech's deep, sector specific expertise is frankly unmatched. Really they have helped us be efficient, and freed up a lot of our time and human capital to work on the important things: commercailizing the product.In addition, Duane, Rich, and everyone I have met from there is warm, collaborative, and just generally good people. It's great to know they have my back."

Ben Holmes, CEO

Nanochon

"Success in medtech starts at the product concept stage, where early decisions can shape everything from regulatory strategy to commercial adoption and long-term clinical outcomes. For an early-stage company, having that full breadth of expertise internally is incredibly unlikely, which is why Project Medtech has been such a valuable partner. Their depth of experience, broad network, and diversity of perspectives have been the perfect extension of our team. Their contributions have played a direct role in EndoShunt’s continued success from R&D through our path toward future clinical impact."

Tyler Zanon, MPH, PMP
CEO, Co-Founder
EndoShunt

Regulatory

BUILD A SMARTER PATH TO APPROVAL

Regulatory strategy should do more than support submission readiness. It should help shape business decisions, reduce uncertainty, and prepare your organization for what comes next. Project Medtech helps clients align regulatory planning with broader business goals to create a stronger path to market.

Core Services

Regulatory Pathway Assessment
Pre-Submission Support
Regulatory Submission Support for 510(k), De Novo, Premarket Approval, or PMA, and International Pathways

Quality

STRENGTHEN SYSTEMS, CLOSE GAPS, AND STAY AUDIT-READY

Quality is essential to compliance, trust, and long-term resilience. Project Medtech helps organizations assess their current state, improve processes, prepare for audits, and build quality systems that support both operational performance and regulatory success.

Core Services

Quality Gap Analysis
Quality Audit
Quality Management System (QMS) Implementation

Commercialization & Reimbursement Strategy

FROM MARKET OPPORTUNITY TO A PRACTICAL ROADMAP

A strong commercialization plan helps medtech companies understand the landscape, identify opportunity, incorporate reimbursement strategy, and reduce risk before scaling. Project Medtech supports organizations with market analysis, reimbursement and market access planning, pathway planning, and actionable strategies that connect innovation to revenue.

Core Services

Market Pathway Strategy
Commercialization Strategy
Go-to-Market Strategy

Reimbursement Assessment & Strategy
Clinical Evidence Strategy
Economic Value

Sales & Marketing

AWARENESS, ADOPTION, AND GROWTH

Medtech sales and marketing require more than promotion. They require strategic alignment, compelling messaging, and targeted execution. Project Medtech helps organizations shape their market presence through sales strategy, marketing leadership, and clinical-value-driven collateral.

Core Services

Marketing & Branding Strategy + Execution
PR Strategy
Website and Collateral Development
Sales Strategy

Finance

FINANCIAL CLARITY AND INVESTORY READINESS

Strong financial planning is the foundation of sustainable growth. Project Medtech provides the financial tools, reporting, and strategic guidance needed to support decision-making, fundraising, compliance, and long-term operational health.

Core Services

Financial Modeling & Forecasting
Capital Structure & Dilution Analysis
Bookkeeping
Finance Consulting

Fundraising

EMPOWERING YOUR PATH TO CAPITAL

Fundraising success requires more than numbers. It requires a compelling narrative backed by validated financials, regulatory readiness, and clinical credibility. Project Medtech helps companies prepare the materials, structure, and messaging needed to engage investors with confidence.

Core Services