As medical device designs become more compact and complex, the pressure to bridge the gap between innovation and manufacturability gradually increases. Nowhere is this more apparent than in the realm of high-volume production, where the failure to optimise component design can lead to elevated scrap rates and compliance setbacks.
To help avoid these pitfalls, we explore how specific design decisions for components like metal pressings, wire forms and springs can empower medical device manufacturers to bridge the design-for-scale gap effectively.
The challenge of high-volume device assembly
Designing a medical component is one thing, but designing it for mass production under strict regulatory scrutiny is quite another venture. The medical sector places unique pressures on device manufacturers that magnify the difficulties of scaling up. Several factors contribute to the challenge.
- Tight regulatory tolerances: Every medical component needs to meet stringent dimensional and material specifications to gain approval. Even minor deviations that may be acceptable in other industries can result in batch rejection, adding risk and cost to scaling efforts.
- Assembly tolerances and interdependencies: In multi-component assemblies, a single poorly designed part can disrupt an entire production line. High-volume environments demand absolute repeatability. This means components need to be geometrically optimised for fast, reliable integration without manual rework.
- Contamination risk and particulates: At scale, cleanliness becomes harder to control. Components with rough edges or inconsistent surfaces can harbour particulates that compromise sterilisation and fail regulatory inspections. This risk is heightened in drug delivery and reusable devices, where component integrity and hygiene are essential.
Strategies to optimise medical components for high-volume assembly
To overcome the challenges of scaling, medical components must be engineered with both performance and production in mind. The following considerations focus on design features that directly influence repeatability, manufacturability and seamless integration into high-throughput assembly environments.
Precision in component geometry and tolerance
Tightly defined tolerances and repeatable geometries are direct prerequisites for medical component scalability. Components need to integrate seamlessly within multi-part assemblies without requiring post-manufacturing adjustment.
For example, ultra-thin metal pressings, which are increasingly favoured for compact drug delivery devices, require micro-level precision. The use of micropressing technology and precision tooling helps create geometries with minimal tolerance deviation, leading to reliable performance even at volumes exceeding millions of units.
Material selection as the foundation of high-volume repeatability
Choosing the correct material is a foundational decision that significantly affects yield and compliance. Stainless steel remains a preferred choice for its balance of strength and corrosion resistance, but variants like Nitronic offer superior ductility and stress resistance for complex wire forms.
Material decisions should be driven by factors such as:
- Required shelf life
- Device reusability
- Exposure to sterilisation
- Risk of deformation during finishing or assembly
Surface finish and post processing to combat particulates
Surface roughness has an outsized impact when it comes to passing stringent medical trails. Deburring processes like laser deburring can drastically reduce surface imperfections, which are common sites for particulate accumulation, a leading cause of rejection in medical trials. Smooth surfaces also reduce friction, wear, and microbial adhesion, extending component life and improving compliance with sterility standards.
Simplified designs for streamlined assembly
Complex component geometries may appear optimal on the CAD screen but can create assembly bottlenecks at scale. Designing with assembly in mind (prioritising symmetrical features, self-locating shapes and interlocking tolerances) minimises manual alignment and enhances assembly line throughput. This design philosophy is particularly important for components like springs and wire forms that interact dynamically with other parts. Simplification here leads to fewer assembly errors and higher consistency across batches.
Packaging compatibility and protection as a final step
Even perfectly produced components can fail at scale if they are damaged in transit or misfed during assembly. Designing parts that are compatible with protective and efficient packaging formats like reels for wire forms or trays for delicate pressings safeguards against damage and supports automated assembly inputs.
Bridging the design-for-scale gap
True scalability stems from a component-level design philosophy rooted in repeatability and manufacturability. Advanex Medical partners with medical device innovators from the earliest design stages to ensure their components are both functional and ready to scale flawlessly.
Whether you're refining a next-generation inhaler or developing micro-precision components for diagnostic devices, we bring decades of specialised experience to ensure your designs bridge the gap between idea and industry. Get in touch with Advanex Medical today to unlock scalable success.
