The hidden cost of failing to design medical devices for manufacture

Medical innovation begins with design. But when that design isn’t engineered for manufacture, costs inevitably rise, delays increase and compliance risks multiply. The leap from prototype to production is where the pressure mounts and even minor design flaws can lead to exponential complications.

Designing medical devices without accounting for manufacturing realities results in high scrap rates, inefficient assembly and components that may never pass regulatory scrutiny at scale. This article explores the cascading impact of early-stage design oversights and why designing for manufacture must be a foundational priority in medical device development.

The illusion of a successful prototype

A working prototype can look like success. It proves the concept and meets the functional brief to a complaint and satisfactory standard. This alone doesn’t guarantee manufacturability. Once transferred into volume production, even the smallest inefficiencies become amplified. Features that looked viable in isolation can easily turn out to be unscalable, costly or incompatible with regulatory expectations.

Common pitfalls in prototype-led design include:

• Tolerances too tight for scalable production, raising costs and reducing yield rates
• Overly complex geometries that hinder reliable assembly
• Surface roughness or untreated edges that trap particulates and compromise sterility
• Material choices that wear down tooling or deform under volume production cycles

Rejection rates and ripple affects

High scrap rates in medical manufacturing signal deeper regulatory risks and cost inefficiency. In an industry where compliance relies on tight tolerances and batch consistency, design flaws result in full-batch rejections.

For instance, a single component with untreated surface edges can increase particulate risk. In one example, a high-volume drug dose counter component suffered up to 40% rejection due to particulates originating from poor edge finishing. By introducing in-line laser deburring, rejection dropped to near-zero, preserving both margins and throughput.

Assembly bottlenecks and yield loss

When devices are built from components without manufacturing in mind, assembly lines become bottlenecks. At volume, every second matters and features that require manual alignment or post-processing create inevitable slowdowns and lower yield.

This is particularly relevant for components like wire forms and springs, where minor design tweaks can dramatically improve how easily they slot into automated assembly processes. Simplified, symmetrical designs, self-locating shapes and appropriate packaging formats all contribute to the uninterrupted flow manufacturing.

Compliance risks can multiply with volume 

What passes visual inspection in a prototype build can easily fail to withstand the scrutiny of regulatory inspection at volume. Compliance issues frequently emerge from overlooked factors like:

• Surface irregularities that trap particulates or resist sterilisation
• Tolerances that exceed acceptable deviation when scaled
• Material inconsistencies that affect biocompatibility or structural performance

Design decisions that delay or jeopardise validation trials lead to stalled launches and reputational risk. In regulated markets, the time lost correcting poor manufacturability can be far more damaging than any design iteration delay at the outset.

Key design actions to safeguard manufacturing efficiency

To avoid these hidden costs, manufacturers need to embed a number of key manufacturability principles from the start of the design cycle. 

• Define tolerances based on actual production capability, using tools like FEA and SPC to model outcomes at scale.
• Select materials with known behaviours in high-volume manufacturing, balancing formability, strength and tool wear over time.
• Design for surface integrity using appropriate finishing strategies such as vibratory or laser deburring to minimise particulates and wear.
• Simplify geometries to improve repeatability, reducing dependency on manual processes and ensuring smooth integration into high-throughput assembly.
• Plan for scalable tooling and automation, considering how components will be handled, packaged and fed into final device production lines.

Maintain manufacturing efficiency with an industry expert

When a medical device needs to be redesigned to meet manufacturability or compliance needs, the costs quickly pile up. The lost momentum from reworking design choices can delay go-to-market timelines and place clinical partnerships at risk.

Manufacturing efficiency begins at the drawing board. That’s why a design-for-manufacture (DfM) mindset is so important.

Advanex Medical works at the interface of medical design and scalable manufacturing. Our teams help device innovators ensure their prototypes aren’t just functional, but ready for real-world production. From springs and wire forms to ultra-thin pressings and bespoke components, we design for volume, repeatability and compliance from day one.

With global, medical-grade facilities and decades of experience navigating regulated manufacturing environments, we help medical device manufacturers reduce risk, accelerate validation and protect long-term profitability.