Designing for Scalability: Why Manufacturability Should Be Considered from Day One
Scalability isn’t a job for tomorrow – it’s something engineers need to be building into design processes from the very start. Why and how to do this is a huge theme in our collaboration with partners – and the topic of this article.
Your medical device works in the lab? Good. That means you’ve completed the very first step towards a successful commercial product.
When it comes to milestones, this feels like a big one. It is, to a degree. But often engineers still have a lot to do before they can start relaxing.
The fact is, the real test is yet to come: manufacturing at scale. Can the same precision and performance be achieved not just once, but thousands or even hundreds of thousands of times? If not, then back to the lab. Because scalability shouldn’t be left to the team responsible for the next stage of development; it’s an engineering challenge that must be built into product development from the very beginning.
This article will look at where this perspective matters in product development, and why.
How can tolerances and process capability affect scaling?
One of the most overlooked flaws in early designs is how a ‘finished’ design may only work due to manual shortcuts.
When it comes to tolerances, a prototype with ultra-fine features or sharp radii may only function so well because engineers can compensate through manual rework or custom setups. But once the product moves to a team designing for large-scale production, those geometries with manual or custom fixes may be impossible to repeat. Not within robust, repeatable process windows, at least.
That’s why scalable design is not only about function, but about process capability. Tools like Statistical Process Control (SPC) help determine whether a geometry can truly be produced at scale. Engineers who adopt this mindset early avoid the costly redesigns that happen when tolerances meet production reality.
What material scales best?
Depending on the boundary conditions and performance requirements of a device, the right choice of a material – and said material’s mechanical properties – can be sink or swim.
While our customers’ material choices are often already set in stone (or Nitinol, as it were), our worldwide-recognized material experts can still provide advice that takes the scalability of said material into account. Because in terms of scalability, not all metals are made equal.
Surface treatments are just as critical. They’re not only cosmetic – they can be directly tied to fatigue resistance and product safety – especially in terms of biocompatibility. Even small plastic deformations of the material or microscopic defects caused by non-ideal manufacturing parameters, only visible under a scanning electron microscope (SEM) or not visible at all, can lead to device failure.
Material processing, heat treatment, and surface refinement; all must be designed for not just technical feasibility but for stable and reproducible manufacturability.
Thinking in process chains – from day one to final shape
No process in MedTech stands alone. Laser cut ting and each subsequent process step have influence on the final characteristics of the component, which in turn affects its performance in the final device.
Consider this: too much energy input during laser cutting enlarges the heat-affected zone. Too many heat treatment steps increase production times, leading to inefficiency. Too much mass removal at electro-polishing drives up cost unnecessarily.
Scalable design means finetuning each isolated step, and considering how they interplay with each other. The question is never just, “Can I make this part once, twice, a hundred times?” but rather, “Can I manufacture this part at high volumes, each time consistently, efficiently, and for a reasonable cost?”
Simulation and pilot builds – proof of scalability
Modern digital tools are changing the way engineers validate manufacturability.
Take FEA (Finite Element Analysis), which can simulate not only how a stent expands in a vessel, but also how residual stresses distribute after shape setting.
These simulations are not replacements but predictive extensions of physical testing that we have available. When combined with pilot builds, they provide a powerful proof of scalability:
- Can the design hold up under typical production tolerances?
- How does it behave during millions of cycles ?
- What issues can be foreseen and what do we need to reiterate?
- Can production volumes reliably hit specifications?
Pilot production runs are more than “small series.” They are a technical stress test for scalability and a source of hard data for regulatory validation (IQ/OQ/PQ). Done well, they act as a bridge between prototype and commercial production, mitigating risks before they escalate.
Best Practices – Engineering for Scale
- Keep designs as simple as possible. Unnecessary complexity drives process risk and costs .
- Validate your design against your entire specification ranges, not just nominal. A design that only works under ideal lab conditions is not scalable.
- Leverage cross-functional reviews. Involving manufacturing, quality, and design teams early uncovers hidden risks before they become costly issues.
- Iterate small, iterate early. A minor design tweak during prototyping may save months of revalidation in validation phases and commercial production .
- Use data as prediction, not just verification. Simulations and pilot data should be treated as early forecasts of serial performance, not as afterthoughts.
- Choose a partner with experience. Involving process experts like ADMEDES at the right time – early – will save trial and error iteration costs and accelerate time-to-market
Conclusion
Your idea isn’t meant to be a one-time product. It’s meant for large-scale, commercial success.
So, embed scalability from the start, into your processes, materials, tolerances, and simulations. Scalability is a measurable engineering property that can be tested even while prototyping. With ADMEDES’ Rapid Response prototyping , this doesn’t even have to slow down the early creative processes.
ADMEDES consultants, engineers, and all-round experts know it: every early design choice affects large-scale manufacturability. So, avoid costly redesigns and work with ADMEDES from the start. Together, we can build the foundation for reliable, compliant, and cost-competitive products that will take the marketplace by storm.
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