Helping Medical Device Startups
Break Into the UK, EU, USA & GCC Markets

Turning an idea into a thriving business takes expertise, strategy, and connections. At Simplimedica, we provide medical device startups with the tools and insights they need to successfully navigate market entry, secure funding, and achieve commercial success.

Market Analysis & Competitive Intelligence

Gain a deep understanding of your target market and competition with our expert insights.

  • Market Sizing & Demand Forecasting: Assess market potential, adoption rates, and revenue opportunities.
  • Stakeholder Mapping: Identify key decision-makers, from healthcare providers and hospital procurement teams to investors and payers.
  • Competitor Benchmarking: Analyse the competitive landscape, pricing strategies, and key differentiators.
  • Go-To-Market Strategy: Develop a roadmap for entry and expansion based on healthcare infrastructure and funding mechanisms.

Clinical & Real-World Evidence (RWE) Strategy

Ensure your device gains traction with solid clinical validation and real-world data.

  • Clinical Trial Strategy & Site Selection: Identify the best trial locations and research institutions in the UK, Gulf Cooperation Council (GCC), and USA.
  • Real-World Data Collection & Health Outcomes Research: Support post-market studies to enhance adoption and payer engagement.
  • Health Economic & Outcomes Research (HEOR): Build economic models to demonstrate cost savings and improved patient outcomes.

KOL & Physician Engagement: Connect with key opinion leaders (KOLs) to drive credibility and market penetration.

Regulatory Roadmap

Simplimedica will write a Regulatory Roadmap, which typically includes ensuring the device fits the definition of a Medical Device and then looking at the classification of the device in various geographical locations.

Based on this, a strategy is developed to enter those markets with an estimated timeline to entry with estimated costs and a description of the regulatory requirements to overcome those hurdles. The regulatory roadmap serves as a key document for potential investors and shareholders for private funding where there is clarity on the company’s roadmap to success. This provides the potential investors with the confidence they need to invest.

Simplimedica will start with the intended use statement being as clear and precise as possible at the outset to then lay the foundations for market access.

For further details on what a Regulatory Roadmap includes see here.

Grant Writing & Funding

Secure grants and alternative funding to fuel innovation and commercialization.

  • UK & EU Grants: Expertise in Innovate UK, NIHR, Horizon Europe, and Biomedical Catalyst applications.
  • USA Grants: Support for NIH, NSF, BARDA, and SBIR/STTR grants.
  • GCC Government & Healthcare Initiatives: Identify regional government-backed funding opportunities.
  • Proposal Development & Submission: Craft and submit competitive grant applications tailored to funder priorities.
  • Post-Award Grant Management: Ensure compliance, reporting, and proper fund utilization.

Fundraising & Investment Support

Raise capital and secure strategic investments to accelerate growth.

  • Investor Pitch Development: Create compelling pitch decks and financial projections.
  • Venture Capital & Private Equity Support: Connect with MedTech-focused investors in the UK, USA, and GCC.
  • Public & Private Funding Strategy: Secure funding from angel investors, family offices, and institutional funds.
  • Financial Modelling & Valuation: Develop robust financial models to strengthen investment negotiations.

Strategic Partnerships & Licensing Deals: Facilitate key partnerships with healthcare providers, distributors, and MedTech leaders.

Contact Simplimedica

Which services are you interested in discussing with Simplimedica?*
Have you performed feasibility studies? *
Do you have an MVP (Minimum Viable Product)?*
Have you filed your IP (Intellectual Property)? *
Do you have an Intended Use with a Medical purpose?*
Have you received any seed funding? *
Are you at the pre-clinical stage? *
Do you require funding for Regulatory costs? *

Why Choose Simplimedica?

We provide end-to-end support to ensure your medical device startup succeeds in competitive markets. With our expertise, you can:

✅ Optimize market access & reimbursement strategies

✅ Build compelling health economic cases for payers & providers

✅ Secure funding through grants, venture capital, & partnerships

 ✅ Generate clinical & real-world evidence for commercialization

✅ Accelerate growth in the UK, EU, GCC, and USA markets

Let’s turn your vision into reality. Contact Simplimedica today!