Medical device prototyping

Consonance

Poland

Service ID:

EP172S1
Service description
Prototyping acts as a critical test for ideas, allowing design flaws to be spotted and corrected early. This process ensures that the final medical devices are not only functional but also excel in their intended purpose. Our approach to medical device prototype design helps our clients to move from an idea to a real product. Detailed knowledge of medical certification is embedded into the process, so we make our clients feel confident about regulatory compliance. We can complement knowledge, be a part of your team, or deliver prototypes on time and budget as external partners. Our process is divided into two prototyping stages: Alpha prototypes are usually non-functioning, reducing the cost of and time required for production. We use 3D-printed prototypes to test product dimensions. Beta medical device prototyping works with more refined manufacturing techniques. These prototypes are functional but usually do not meet the aesthetic design of the final product. We implement them into the process to test functional medical product design and manufacturability flaws. This is also a great moment to get client/consumer feedback.
Sector
Biotechnology
Health and medical care
Technology Readiness Level
TRL 1 – Basic principles observed
TRL 2 – Technology concept formulated
TRL 3 – Experimental proof of concept
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
Financial requirements

Technical Feasibility Study covering requirements analysis, regulatory compliance analysis and certification strategy, risk assessment, technical solution concept, budget and development recommendations. Stage duration: up to 10 weeks. Price is 15 k Euros. Based on the research results, we estimate a R & D fixed-price budget to achieve expected prototype advancement. The final budget depends on the project complexity, level of innovativeness, a timeline and required technologies.

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Prototyping & PoC

Application Period:
N/A, as the service is upon demand and open on a continuous basis.
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