R&D: De-risking the Path Toward a Final Medical Device

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- How do we optimize design costs, speed, and resource allocation as a startup with a limited runway?

- What milestones do we need to hit — and how much funding is required to get there?

- How do we balance regulatory, technical, and go-to-market risks?

Milestone Misalignment

Startups often address regulatory, development, clinical, and fundraising efforts in isolation. This fragmented approach leads to slower progress, inefficient spending, and weak investor narratives — ultimately causing premature exits or unnecessary founder dilution.

Lack of Systems Engineering Processes

Without a structured systems engineering process, startups struggle to identify risks, define requirements, create testing strategies, and establish traceability from stakeholder needs to architecture and performance testing.

At Eliomedica, we leverage systems engineering principles to accelerate medical device development, minimize design errors, and ensure a smooth path to development. Our approach covers key pillars such as:

Milestone Setting: We map out the commercialization journey, defining critical milestones to secure funding or reach key business objectives.

Development Strategy: 

• Scientific and technical feasibility of the concept
• Technical review, feasibility assessment and trade-off study
• Usability testing strategy
• Requirements definition & risks management
• Performance testing strategy — from preclinical to clinical —  to demonstrate safety, effectiveness, and support reimbursement