Transitioning IVD Device Prototype Parts to Mass Production

Whether it’s a molecular diagnostic device for PCR or NGS, an immunoassay, or a single-cell analysis product, in vitro diagnostic (IVD) device engineers often struggle to preserve their IVD device performance while transitioning to a mass-producible design with lower material and production costs.

With more than 20 years of experience working with market-leading IVD manufacturers, here are some challenges Enplas has helped engineers overcome—and tips on how we’ve done it.

Challenge 1:

“How can we maintain our diagnostics component’s performance while switching material to meet mass-production price targets?”

Gearing up your design for mass production often means you must give up high-cost, high-functionality materials for more cost-effective ones. Transitions may include silicone to TPE or PDMS/glass/metal to plastics.

Silicone to TPE

For leak-free fluid sealing between components, thermoplastic elastomer (TPE) is a reliable and cost-effective material option. However, choosing the right TPE and the proper overmold design can drastically affect the sealing performance. Some TPEs are suitable for heat around or over 95°C for PCR, but some are not. Your material choice should consider other possible risks such as inflation, compression set, and hardening.

Glass to Plastics

Transparent plastics may be your choice for mass production consumables, but, unlike glass, autofluorescence may interfere with your detection.

With TPE and transparent plastics like COP, COC, PMMA, or other medical grade plastics such as PC and PP, our injection-molding engineers and suppliers have a wealth of knowledge in these materials. We will also provide guidance to help mitigate effects, including TPE compression set and transparent plastic autofluorescence.

Challenge 2:

“How can we safeguard fluid and droplet performance when adjusting the design for mass production?”

Designs tested with machined or 3D-printed prototypes require design adjustments to be effectively manufacturable by injection molding. However, for IVD device components or consumables, considerations to maintain or improve functionality (not just manufacturability) are critical.

Efficient Fluid Transfer

To efficiently transfer fluids and minimize reagent dead volumes, precise through-hole locations and strict part alignments are necessary. Enplas conducts thorough failure mode and effects analyses (FMEA), focusing on essential functions to mitigate misalignment risks. In addition, we can incorporate performance checks such as leak tests in your quality plan according to specific project needs.

Droplet Performance

Small DFM design changes can influence microfluidic channel performance (e.g., droplet generation). Enplas optimizes channel designs for mass production as we conduct DFM. Enplas identifies the channel optimization required to reduce droplet size variation or improve oil sample ratio for consistent droplet generation using proprietary data and software.

Challenge 3:

“How can we make smart investment choices when transitioning from prototype molds to mass-production molds?”

Final product validation requires a production-grade prototype mold to produce parts as close to those made with a mass-production mold as possible. The final production mold is an additional investment since prototypes with one or two cavities have different structures from a multi-cavity mass-production mold.

You might think, “Isn’t there a way to streamline the mold constructions to avoid fully investing in two completely separate sets of tooling and molds?”

The answer is “Yes.” If you are in the prototyping stage and eyeing transition to mass production, Enplas can create efficiencies in the process. For example, prototype molds can incorporate part of the upgrade required for mass production. In addition, proactive planning can make your prototype and mass-production mold construction faster and more cost-effective.

Challenge 4:

“How can we meet our aggressive launch date while dealing with unexpected product development issues?”

The ultimate challenge, of course, is that you must meet all the challenges listed above on a tight schedule. This pressure is becoming stronger as the need for rapid development of COVID-19 diagnostics has accelerated the development speed of all IVD products. A reliable manufacturing partner can guide you to the most efficient path to product launch and alleviate stress through fast and flexible problem-solving, preventing product quality issues, and avoiding unnecessary iteration.

Engineers should work with a mass-production supplier that understands and meets the needs of IVD product development by offering:

• Absolute product quality while moving with speed
• The engineering knowledge to mass produce complex, functional IVD components or consumables without performance variation
• The long-term support often required for medical device development
• Flexible responses to changing needs

Conclusion

If you’re transitioning your IVD device components or consumables from prototype to mass production, Enplas can make the process easier, smoother, and more cost efficient.

Enplas is responsive, transparent, and flexible throughout the prototyping and mass-production process, whether your need is urgent, unexpected, or part of a long-term vision.

Enplas provides problem-solving ideas, implements parts and tool designs that prevent future issues, and is there when you need support—no matter how long development takes.

For questions, contact Enplas today.