Our Approach
3fD applied our full end-to-end design-for-manufacture expertise to rebuild the product from scratch, this time with the correct emphasis on both clinical function and high-volume manufacturability.
Key actions:
Conducted a rapid teardown and failure analysis of the defective initial batches.
Redefined the product design to meet stringent ISO 13485 medical standards.
Engineered for mass production scale, with precision tooling and process control.
Balanced quality and cost to achieve the required price point — critical for high-volume consumables.
Engineering & DFM Decisions
Tooling: Invested in high-quality multi-cavity tooling designed for millions of cycles without degradation.
Material selection: Medical-grade stainless steel / polymer (specify material if possible) optimised for reliability and compliance.
Process optimisation: Designed for automated assembly and packaging to support high throughput and consistent quality.
Compliance: Designed to meet ISO 13485 standards from the outset, ensuring regulatory confidence.
Outcome
Delivered validated production-ready design, moving from failure to full-scale production.
Secured MagicTrix’s position as OEM supplier with reliable, compliant stock.
Achieved target unit cost without compromising quality, enabling competitive market pricing.
Production now scaled to millions of units, with tooling capacity designed for ongoing high-demand fulfilment.
What We Learned
For high-volume consumables, there’s no shortcut to quality tooling and proper design-for-manufacture. Early savings through cheap suppliers can become costly failures. Investing correctly from the outset delivers sustainable commercial success.
