Our Approach
3fD stepped in as both design rescue and manufacturing integrator. We redefined the entire product development strategy:
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Conducted a full DFM audit of existing concepts.
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Rapidly redeveloped the design from first principles, optimising for tooling, assembly, and regulatory compliance.
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Leveraged our integrated design-manufacturing model to collapse lead times and reduce administration overhead.
- Engaged tooling partners immediately, ensuring parallel path development and avoiding typical handover delays.
Our “design-to-box” methodology ensured that every decision — from material selection to assembly method — was made with manufacturing and market-readiness in mind.
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Engineering & DFM Decisions
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Material Selection: Medical-grade polymers certified for BS 13485 and FDA standards.
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Tooling: Clean-slate tooling strategy to avoid compounding prior design errors.
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Assembly: Components engineered for simplified, high-reliability assembly processes.
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Testing: Rigorous pre-production testing to validate device performance under clinical and home-use conditions.
Outcome
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Delivered fully functioning, off-tool samples ahead of the 6-month deadline.
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Enabled Béa to meet critical investor milestones, securing further funding.
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The product successfully passed rigorous testing protocols, aligning with BS 13485 and FDA requirements.
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Product now launched, transforming accessibility to fertility treatment, with sales continuing to climb.
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Scalable manufacturing solution in place, supporting ongoing market expansion.
What We Learned
Early supplier involvement and integrated design-manufacturing control are non-negotiable for medtech success. By unifying design and production, we eliminated delays and de-risked the project at every stage.
