KnowledgeWhy Clean Room Injection Moulding Matters In Medical Device Manufacturing
In medical device manufacturing, cleanliness and precision are not separate requirements. Clean room injection moulding is where both are decided.
Read moreFrom Concept To Market: How Product Development Is Supported
Bringing a medical device from concept to market is a complex, multi-stage process. Most programmes fail at the joins between stages rather than inside them.
Published 2024-07-26 · Wisdom Industrial Group
Conceptualisation
The initial phase involves brainstorming and conceptualising the product idea, taking market needs, feasibility and regulatory requirements into account. Treating all three at once is harder than treating them in sequence, and it is the only way that avoids a concept that is desirable, buildable and not approvable.
Medical Product Development & Design
Design And Prototyping
The design team creates detailed designs and prototypes, allowing testing and refinement to confirm functionality and manufacturability. Manufacturability is the one that gets skipped, and it is the one that decides what the product costs for its entire life.
Testing And Validation
Rigorous testing and validation processes confirm that the product meets the necessary safety and performance standards before anything is committed to tooling.
Regulatory Approval
Navigating the regulatory landscape to secure the necessary approvals is part of the programme, not an afterthought at the end of it. Our French partner assists clients in obtaining FDA and CE certifications.
Production
Manufacturing facilities produce the final product under strict quality control measures, from low-volume batches through to full-scale production, with inspection against international tolerance standards applied throughout.
Working on something like this? Send the drawing and the annual quantity to an engineer and you will have a consultation within 24 hours.
Questions
Questions From This Article
At which stage can we engage you?
At any of them. Most customers join with a design in hand, but conceptualisation is equally workable.
Who supports the regulatory side?
Our French partner manages the quality system and assists clients in obtaining FDA and CE certifications.
More
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Regulatory compliance is what confirms that a medical device meets the safety and quality standards it claims to. It is a manufacturing question as much as a paperwork one.
Read morePut This Into Practice
We run the tooling, the clean room and the machining this article describes. Tell us what you are making and we will tell you how we would make it.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.