From Lab Bench to Point-of-Care: Developing Medical Devices

Developing medical devices for point-of-care (POC) use means transforming a lab assay into a tool that thrives in the real world—outside the controlled sanctuary of the lab and into the messy, unpredictable environments where it’s truly needed. It’s a journey filled with challenges, trade-offs, and moments of innovation.

While scientists rightly celebrate breakthroughs at the lab bench, the real impact lies in making those discoveries accessible where they can do the most good. This guide shares essential steps for developing POC devices and navigating the complex process of medical device development. Along the way, specialized partners like Gener8 can help bridge the gap between concept and real-world impact.

Step 1: Master Assay Metrics for Seamless Integration

Imagine you’ve developed an assay that detects disease markers with incredible accuracy. In the lab, it thrives under perfect conditions. But in the hands of a healthcare worker at a rural clinic? The story changes.

To prepare your assay for the real world, you need to understand its flexibility and robustness. Assays in controlled lab environments benefit from precise measurements, stable temperatures, and experienced operators. But in real-world settings, variability is inevitable. The key is to design your assay to tolerate these inconsistencies while delivering reliable results.

Consider these critical factors:

• Volume Transfer: How sensitive is your assay to volume variations? In the lab, precise pipettes control every microliter, but in the field, deviations happen. If your assay uses 25 µL of reagent A, will it still perform if someone accidentally uses 20 µL or 30 µL?

• Incubation Times: Time management in a clinical setting can be unpredictable. While your assay might require exactly 1 minute of incubation in the lab, will it remain accurate if it’s closer to 50 seconds or stretches to 1 minute 10 seconds?

• Mixing Efficiency: Effective mixing can vary greatly depending on available tools. Can your assay work with a simple hand shake or does it demand a specialized vortex mixer? The less equipment-dependent it is, the more adaptable it becomes.

Gener8’s Expertise: If identifying these variables feels overwhelming, Gener8 can help your team stress-test and refine assay parameters to ensure field-readiness.

Takeaway: The more adaptable your assay, the better its chances of thriving outside the lab—an essential factor in developing POC devices.

Step 2: Align Science with Engineering Early On

Scientists dream big. Engineers ground those dreams in reality.

Involving engineers early means fewer “back-to-the-drawing-board” moments later. It’s like having a map before starting a road trip—without it, you risk detours, delays, and costly mistakes.

Bringing engineering into the conversation early helps identify potential design challenges, ensures technical feasibility, and aligns scientific goals with manufacturing realities. Engineers can flag constraints, suggest more efficient processes, and propose alternative materials or methods that simplify production without compromising quality.

Early collaboration also streamlines decision-making. When scientists and engineers work side by side, they can quickly resolve questions like: Is this step critical, or can it be simplified? Is there a more scalable solution? This partnership avoids last-minute design overhauls and keeps development timelines on track.

Gener8’s Expertise: Gener8 excels at fostering cross-disciplinary collaboration, helping your team align scientific innovation with real-world engineering demands, reducing risks and accelerating timelines.

Here’s how to make that collaboration work:

• Identify Core Technologies: What’s the irreplaceable heart of your device? Pinpointing this ensures that essential functions are preserved throughout development.

• Map the Process Flow: Outline each step in the assay and device workflow. What’s essential for accurate results? What could be streamlined or automated?

• Assess Feasibility: Can this design be built affordably and at scale? Evaluate material availability, manufacturing complexity, and potential bottlenecks early in the process.

Takeaway: Early collaboration between scientists and engineers is crucial when figuring out how to develop POC devices without costly surprises. Gener8 is here to support your team every step of the way.

Step 3: Tackle High-Risk Functions Head-On

This is where potential disasters hide and where proactive planning can make all the difference.

Every POC device has critical functions that, if not addressed early, can derail the entire project. These high-risk areas often include manufacturability, reagent stability, and user experience. Identifying and tackling these challenges upfront reduces the chances of costly delays and ensures a smoother development path. Ask the tough questions early:

• Can the device be manufactured at scale without breaking the bank? Complex designs may look great but can drive up production costs or complicate assembly.

• Will the reagents survive months on a shelf in a hot warehouse? Real-world conditions aren’t always ideal. Stability testing ensures the device holds up in diverse environments.

• Is it intuitive enough for non-specialists? POC devices often end up in the hands of users with minimal technical training. The interface must be simple, clear, and error-resistant.

• What are the potential regulatory pitfalls? High-risk features could trigger more stringent regulatory scrutiny. Identifying these early helps streamline approval processes.

Gener8’s Expertise: Gener8 specializes in identifying and mitigating high-risk functions early, helping your team avoid costly pitfalls and navigate complex challenges.

The strategy? Prototype the riskiest parts first. Isolate and stress-test critical functions before full integration. This “fail fast, fix faster” approach saves time, cuts costs, and helps avoid major setbacks down the line.

Takeaway: Managing high-risk functions early makes point of care development smoother, more efficient, and far less vulnerable to unexpected roadblocks.

Step 4: Prototype, Integrate, and Validate

The moment of truth: time to bring all the pieces together.

Prototyping is where ideas take shape—and where potential flaws surface before they become costly mistakes. Seeing the first working prototype in action is a major milestone, but it’s just the beginning. Stress-testing, refining, and validating are essential steps to ensure the device performs as intended in real-world conditions.

Rapid prototyping is key here. At Gener8, we excel at quickly turning concepts into functional prototypes, enabling fast iteration and refinement. This speed allows your team to test multiple design variations, fine-tune user interfaces, and optimize device performance without lengthy delays.

Equally important is smart material selection. The materials chosen for prototyping should closely replicate the final product’s properties, ensuring accurate testing while considering factors like durability, biocompatibility, and cost-effectiveness.

Here’s how to make the most of the prototyping phase:

• Start with High-Risk Functions: Confirm critical features hold up under stress before integrating them into the full system.

• Use Real-World Materials: Replicate end-use conditions to ensure performance and reliability.

• Validate for Real-World Use: Run extensive user testing to confirm the device works as intended in diverse environments and use cases.

Takeaway: With Gener8’s expertise in rapid prototyping and material selection, your team can move from idea to market-ready product faster, smarter, and with fewer surprises.

Conclusion: Partner with Gener8 for Your Lab-to-POC Journey

POC devices aren’t just about science—they’re about people. They’re about a doctor in a remote clinic making a fast diagnosis. A parent getting instant answers for a sick child. They’re about bringing critical healthcare solutions directly to the point of need.

The journey from lab bench to point-of-care is complex, but the reward is life-changing. And you don’t have to navigate it alone.

At Gener8, we specialize in guiding innovators through every stage of point of care development—from early assay optimization to final manufacturing. Whether you need help drafting a Product Requirements Document, refining high-risk functions, or rapidly prototyping a market-ready device, our team is here to fill in the gaps and accelerate your path to success.

Why partner with Gener8?

• End-to-End Expertise: From initial concept to scalable manufacturing, we know what it takes to bring POC devices to market.

• Rapid Prototyping & Material Selection: Our advanced prototyping capabilities and material insights speed up development while ensuring real-world performance.

• Collaborative Problem-Solving: We work as an extension of your team, helping you navigate technical challenges and regulatory hurdles.

• Focused on Efficiency & Quality: We streamline development without sacrificing quality—because speed and precision can go hand-in-hand.

Ready to bring your POC device to life? Let Gener8 help you transform your laboratory breakthrough into a real-world solution. Reach out today to start your lab-to-POC journey with a partner who understands every step of the process.

Together, we can turn innovation into impact—faster, smarter, and with confidence.