By Sean Fenske, Editor-in-Chief

Healthcare has embraced miniaturization for a variety of reasons. Smaller devices and instruments mean tiny incisions during surgical procedures, aiding in quicker recoveries. Wearable technologies are made portable and discreet by being fabricated at a size to accommodate these needs. Medtech used within the body or implanted needs to be of an appropriate size to fit in small areas.

Unfortunately, developing such solutions isn’t a simple matter. Components cannot be reduced to a smaller size using the same manufacturing techniques, materials, and processes as their larger counterparts. Medtech OEMs seeking to design devices that are shrinking in size must have the appropriate expertise in-house or work with partners with the required experience.

Fortunately, one such expert from Elevaris Medical Devices provided insights on critical considerations before embarking on this type of development project. In the following Q&A, Valor Thomas, Director of Business Development, spoke on a number of factors that should be determined prior to beginning a micro-component design.

Sean Fenske: Many say medical devices are getting smaller, but can you speak to the drivers of this trend?

Valor Thomas: Miniaturization in medical devices reflects a combination of key industry drivers—including the shift toward minimally invasive and robotic procedures, which require smaller, more precise instruments to help reduce patient trauma and improve recovery. At the same time, advances in specialties like neurovascular, structural heart, and peripheral interventions demand extreme navigation capability to access complex anatomy and treat conditions that were previously difficult or impossible to reach. This is driving the need to reduce device profiles without compromising performance.

Fenske: As components get smaller, how does that trend change the way you think about material selection?

Thomas: As components get smaller, material selection shifts from a standard choice to a highly engineered decision, where the material must not only meet performance requirements, but also enable manufacturability. At micro scales, materials behave differently, with greater sensitivity to grain structure, surface condition, and micro-defects, all of which can impact component strength, fatigue life, and consistency. This drives a greater reliance on high-performance materials like nitinol and specialty stainless steels that can maintain the necessary balance of flexibility, strength, and durability at very thin dimensions.

Fenske: What impact does miniaturization have on design? How is design for manufacturability (DFM) addressed?

Thomas: As device architectures shrink and expectations increase, engineering constraints intensify. Miniaturization increases design complexity by tightening tolerances and reducing material margins. At this scale, even minor geometric changes can significantly impact mechanical behavior.

That’s where DFM comes into play. Early-stage DFM engagement is critical for defining feasible feature dimensions, tolerance bands, and geometric constraints within established process windows. Late-stage DFM disconnect, which occurs when manufacturability considerations are deferred until late in the design cycle, can cause significant cost increases, schedule disruption, and yield instability.

Ultimately, successful miniaturized device design requires a tightly integrated approach between engineering and manufacturing, where design decisions are made with a clear understanding of process capability, trade-offs, and scalability.

Fenske: How do you go about making components smaller? What are the manufacturing steps that need to be adjusted, and what considerations need to be kept in mind?

Thomas: Bear with me here. There are a number of considerations when designing at micro scale, and I’ll do my best to summarize them.

I would first say that making components smaller is not just about scaling down an existing design; it requires rethinking both the manufacturing approach and the process controls from the ground up.

From a process standpoint, several steps need to be adjusted. Fixturing and part handling become more critical to prevent distortion or damage. Process parameters must be tightly controlled, especially in thermal processes where heat-affected zones and material changes can have a larger impact at small scales. Secondary operations such as deburring, cleaning, and surface finishing also require refinement to avoid altering critical features.

There is also a heightened need for advanced inspection and metrology, as verifying small features with tight tolerances becomes more challenging and often requires specialized equipment and techniques.

It is equally important to avoid over-engineering. Design complexity should be intentional and performance-driven, as unnecessary features can introduce cost, extend iteration cycles, and limit scalability.

As I mentioned earlier, material behavior must also be carefully considered, as the stability and performance of micro-scale components are highly sensitive to electrical, thermal, and mechanical properties.

Finally, stack-up control becomes critical. In multi-process builds, cumulative variation across steps can significantly impact final assembly performance, making early tolerance budgeting and stack-up modeling essential to maintaining alignment, concentricity, and functionality.

Fenske: Can you speak to testing and inspection? Is this handled the same as for more traditional components or are different protocols and equipment used for smaller components?

Thomas: Happy to explain. Component architectures should intentionally accommodate metrology access and functional verification requirements. At the micro scale, complex geometries and limited physical access can restrict measurement capability and increase validation risk. Establishing clear datum strategies, ensuring access to critical features, and defining measurable critical-to-quality (CTQ) characteristics enables robust verification, efficient validation, and sustained production control.

On the testing side, mechanical and functional testing must be adapted to account for lower force ranges, smaller displacements, and higher sensitivity to variation. Fixturing, load application, and data resolution all need to be scaled appropriately to generate meaningful and repeatable results.

Overall, testing and inspection at this scale require more specialized equipment, tighter process control, and a more integrated quality approach to ensure reliability and performance.

Fenske: How important is it to include manufacturing partners in micro-sized component development? When should they be brought into the process? What value should they bring?

Thomas: Earlier, I mentioned early-stage collaboration on design for manufacturing, and it really can’t be overstated. Direct, early-stage engagement accelerates learning cycles, improves predictability, and shortens time to market.

The value manufacturing partners bring goes beyond execution. Strong partners contribute process expertise, rapid prototyping and iteration, and insight into scaling from development into production. They also help establish realistic tolerance strategies, optimize process flows, and ensure that what works in early builds can be translated into stable, repeatable, and cost-effective manufacturing.

Ultimately, early and integrated collaboration reduces risk, shortens development timelines, and increases the likelihood of achieving a robust, scalable solution.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Thomas: Well, I’d first like to thank you for the thoughtful questions and rich discussion. However, since we were speaking at a higher level today, I would encourage any of your readers interested in the topic to check out the most recent article I’ve authored, “Precision in Med Tech Manufacturing: Best Practices for Micro-component Design.” While still a reader-friendly format, it allows for a bit of a deeper dive into some of the topics we’ve discussed today.

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