Rapid Prototyping and the Future of Medical Component Manufacturing

Q: What role does rapid prototyping play in our engineering process today?

A: Customers are eager to see working models early, especially since development cycles can span one to three years. Every step of rapid prototyping helps accelerate their design intent and validation efforts.

At the same time, our team uses each prototype stage to ensure the part will be manufacturable consistently and for the long‑term. Rapid prototyping speeds customer progress while ensuring we stay focused on robustness and scalability.

Q: How has the availability of rapid prototyping tools changed collaboration with customers and internal teams?

A: Over the years, we’ve invested heavily in tool‑making capabilities, such as state‑of‑the‑art CNC (computer numerical control) machines, EDM (electronic discharge machining) systems, and high‑precision machining technologies. These advancements let us produce prototype molds and parts faster than ever.

While customers may bring 3D‑printed models, silicone 3D prints rarely achieve the accuracy needed for true form‑fit‑function evaluation. That’s why our rapid prototype molding is so important. We also use 3D metal printing in‑house to create mold cavities and cores quickly, allowing us to deliver functional silicone prototypes at unprecedented speed.

Q: Which new technologies or methods for prototyping are you most excited about?

A: 3D metal printing stands out. The industry has made major strides in the materials that can be printed, including stainless steels and other hard metals, with incredible accuracy.

This capability enables extremely fast development of prototype tooling and will continue to advance rapidly. It’s one of the most exciting technologies for meeting customer expectations for speed and precision.

Q: How do you balance speed with precision when moving from prototyping to production?

A: Before leaving the prototype phase, we need to be confident that the design and material selections are robust. If concerns arise, it’s far better to address them before building multi‑cavity production tools, which are costly and time‑consuming.

Risk assessment plays a huge role. We evaluate each element with the customer to make sure both sides are aligned. Only when design, performance, and manufacturability all meet expectations do we move into production tooling.

Q: Can you share an example where rapid prototyping helped accelerate a project or solve a design issue?

A: One project involved a part that worked effectively during prototyping and even through a small‑cavity pilot tool. But when we scaled to high‑volume production, we discovered a material compatibility issue related to timing between manufacturing steps.

It wasn’t a process flaw; it was a materials interaction that only became apparent in a full production cycle. The major lesson: whenever possible, replicate the full manufacturing sequence early. Don’t assume each step will behave the same at scale.

Q: What are the biggest changes you’ve seen in the medical component manufacturing industry over the past 30 years?

A: Thirty years ago, silicone was still relatively new in medical devices. We were pioneers with customers, using early prototyping methods to bring parts quickly to market.

What has changed most dramatically is accuracy, precision, and validation requirements. Today, validation (IQ/OQ/PQ) is one of the longest phases of a project. Instead of a few pages in a report, we now deliver hundreds of pages of capability data to demonstrate performance across the entire process.

The emphasis on documented, repeatable quality has transformed the industry and strengthened what we deliver.

Q: How do regulatory and quality requirements shape component design and manufacturing today?

A: Quality considerations begin immediately during the material selection and quoting phase. We must ensure every material meets regulatory and device requirements before prototypes are ever made.

From there, risk assessments occur at each stage to make sure our processes meet both internal and customer quality expectations. Validation protocols must align across organizations, and customer acceptance is required before moving forward. Quality is built in from day one.

Q: Looking forward, what technologies or trends will define the next decade?

A: Recent industry (trade) shows have highlighted promising developments in machining and rapid prototyping technologies for silicone. We’re also seeing innovative new material formulations entering the medical space, offering customers greater design freedom and expanded performance options.

Although the technology has yet to be developed, AI integration supporting material selection, DFM, and tool design will become a focus to accelerate the full process. The next decade will surely bring faster, more precise prototyping and more advanced materials, creating exciting new opportunities for medical device innovation.

Q: Looking back, what project are you most proud of?

A: One project from the mid‑1990s stands out. We went through 12 rapid prototype iterations to refine the design. The product then scaled from a single‑cavity prototype tool to a 12‑cavity mold, then a 64‑cavity tool, and ultimately a 258‑cavity high‑volume manufacturing tool. Ultimately leading us to successfully manufacture over 1 billion pieces without any FDA recalls related to the product or process.  

That product is still in the market 30 years later. Seeing it grow and supporting it through multiple generations of tooling without compromise to part and process quality has been incredibly rewarding.

Rapid prototyping has reshaped medical molding by enabling faster iterations, early risk reduction, and stronger overall design outcomes. With advances in tooling, machining, and 3D metal printing, customers now have unprecedented ability to validate concepts quickly and move confidently into production.

Chuck’s experience underscores a clear truth: speed and precision must work together. When combined with strong collaboration, material expertise, and thorough validation, rapid prototyping becomes a powerful catalyst for long‑term product success.