Engineering Confidence Into MedTech Devices

RD8 helps medical device teams design safer, more reliable, and easier-to-manufacture products by managing variation early in development - from concept to clinical readiness.

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Med-tech

Precision, Compliance, and Zero Tolerance for Failure

Medical devices demand more than functional performance - they require design traceability, regulatory compliance, and extreme reliability. Requirements are high and so is production volume, which increased risk for variation and late-stage surprises.

RD8 works with mechanical engineers to build products that can handle variation and perform predictably from testing to production and end-use environments.

Our expertise includes:

Design of interfaces and systems with optimized constraints

Design for injection molding in high-volume manufacturing

2D design concepting for assembly steps and functional states

3D design maturing with top-down skeleton modeling

Tolerance and variation management optimization for functionality and manufacturability

Root-cause analysis of failure modes (e.g. force, wear, misalignment)

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purpose

Why Robust Design Matters in MedTech

In medical device development, there’s no room for guesswork. For injection devices with critical dose management or mechatronic produts with extreme precision requirements for sensors, robust mechanical design helps you control variation. This allows you to build systems that perform reliably - from first prototype to final production.

Reliable Function in Compact, Critical Assemblies

What we solve
Mechanical performance issues caused by variation in tight, space-constrained assemblies — common in handheld and disposable devices.
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‍What you get
Designs that tolerate production and material variation without loss of function or usability.

Fewer Issues During Verification and Validation

What we solve
Late-stage test failures and rework driven by unclear design limits or unstable mechanical behavior.

‍What you get
‍Early insight into design sensitivities, supporting faster and more confident verification and validation.

Designs Ready for Regulatory Scrutiny

What we solve
‍Gaps in traceability, unquantified risk, and undocumented robustness during audits or submissions.

‍What you get
‍Data-backed design decisions and robust logic chains - making documentation and compliance easier.

Smooth Ramp-Up and Scalable Production

What we solve
‍High scrap rates, difficult-to-control tolerances, and complex change request with multiple dependencies.

‍What you get
Interfaces, geometries and tolerances decoupled and optimized for manufacturing - reducing rework, QA friction, and cost per unit.

Robust Design Principles

1. Design for Variation

No part is ever made perfectly - variation is inevitable. Robust design anticipates this by ensuring that critical functions remain stable despite production differences and tolerances. The goal isn't to eliminate variation, but to make designs that can allow it.

Uncover hidden variation issues before they lead to reliability problems or performance loss.

2. Control through Interfaces

Interfaces are where most real-world problems occur - where parts meet, move, interact. By focusing on interface behavior, constraints, and contact surfaces early in the design process, engineers can avoid misalignment, friction, and overconstraint issues that often go unnoticed until testing.

Improve yield, reduce cost, and avoid overengineering by balancing robustness of interfaces.

3. Simplify to Strengthen

Complexity invites risk. Robust design emphasizes simplicity: fewer dependencies, clearer tolerances, and more forgiving designs. This leads to fast development, easier manufacturing , and more reliable products - without over-engineering.

Incorporate robustness from the first sketch and ensure designs without unnecessary complexity.