How does RD8 reduce variation sensitivity in scaling production?

As production ramps up, variation multiplies. RD8 works with your tolerance management system (or provides a proven framework) to minimise sensitivity and ensure designs can absorb unavoidable variation — reducing scaling risk and keeping production stable.

Ultra High-Volume Production

Designing drug delivery devices for ultra high-volume production

Q: What are the key challenges in high-volume production of drug delivery devices?

Three key challenges: Complex functionality and system interactions creates unpredictable failure modes that are hard to spot in early testing. Higher volume will drive increased variation. At scale, this pushes performance to functional limits, amplifying design risks. Isolated trade-offs between functionality and manufacturability lead to costly tooling iterations and delays.

Q: What is DFMAI for high-volume injection moulding?

Design for Manufacturability and Assembly for Injection moulding. Using Robust Design principles, RD8 preserves critical functional surfaces while optimising for high-volume injection moulding. This reduces costly iterations and embeds reliability directly into the design.

Scaling production reveals issues hidden below the surface in prototypes and verification testing. Rare failure modes, sensitivity, and long-tail performance issues emerge as volume grows. RD8 helps teams address these challenges - avoiding late delays, costly surprises, and non-conformities in mass production.

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Drug Delivery

Ultra High-Volume Production

The Problem

High-volume production exposes sensitivities that smaller scale volumes rarely reveals. Without the right approach, teams face unexpected failures and escalating costs.

Three key challenges:

Complex functionality and system interactions creates unpredictable failure modes that are hard to spot in early testing.

Higher volume will drive increased variation. At scale, this pushes performance to functional limits, amplifying design risks.

Isolated trade-offs between functionality and manufacturability lead to costly tooling iterations and delays.

RD8’s approach to de-risking ultra high-volume production

Our methods systematically increase predictability, reduce variation sensitivity, and embed manufacturability into the design - ensuring devices scale reliably.

3D CAD transparent model of a piston rod and piston hook assembly with interface analysis constraints displayed on the left panel.

Increase Predictability - Eliminate Failure Modes

Complex architectures can hide failure modes that only appear at scale. We use Robust Design principles to improve interface design, simplify tolerance chains, and remove superfluous specifications — increasing predictability and enabling faster, more confident decision-making.

Reduce Variation Sensitivity - Contain Scaling Challenges

As production ramps up, variation multiplies. We work with your tolerance management system (or provide our proven framework) to minimise sensitivity and ensure designs can absorb unavoidable variation — reducing scaling risk and keeping production stable.

Screenshot of engineering software showing radial overlap tolerance analysis for an espresso machine gasket, with a detailed parts list, tolerance values, influence percentages, and a 2D CAD cross-sectional diagram labeled with dimensions.

Large stainless steel bowl filled with many orange plastic capsules in a pharmaceutical production facility.

Inherent Performance by Design - DFMAI for High-Volume Injection Moulding

Optimising functionality and design for manufacturability must happen in sync. Using Robust Design principles, we preserve critical functional surfaces while optimising for high-volume injection moulding. This reduces costly iterations and embeds reliability directly into the design.

Is your device ready to scale without surprises?

Not every design is built for the manufacturing volumes your business needs today. If scaling is your next step, let’s discuss whether RD8’s approach is the right fit to secure reliability at scale.

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Martin Bue Bertelsen

Co-Founder

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Frederik Langvad Lintrup

Robust Design Medical Device Expert

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