Designing drug delivery devices for ultra high-volume production

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

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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 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.

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 - Control Scaling Risk

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.

Inherent Performance by Design - DfM 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.

Let's explore fit

Talk to an expert

Our outside-in approach brings new perspectives to traditional designs and typically results in radically new ideas. Get in contact with a RD8 Robust Design specialist to hear how we help you – either by our consulting or tolerance analysis software.
Talk to an expert engineer to understand real value and ROI.
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