“The science worked. The prototype worked. The team was brilliant. And still, the product never made it.”

We’ve heard this story too many times. At 2B Consulting, we’ve lived it from the inside — and we will help to prevent it from happening again.

While diagnostic technologies are booming with innovation — from rapid molecular POCT platforms to smartphone-based lateral flows — most never make it to meaningful market impact. And no, it’s not just about technical failure.

So what’s really going wrong?

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1. The Missing Bridge Between Innovation and Integration

Many diagnostic devices are built in R&D silos. The science team delivers great performance in the lab — but the result doesn’t integrate well with manufacturing, clinical workflows, or user behavior in real-world settings.

What’s often missing?

• Early assay-instrument co-design
• Clear pathways to scale
• Realistic sample types and use cases

It’s not just about a working device — it’s about one that fits into the world.

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2. IP Comes Too Late — Or Is Too Broad to Be Useful

We’ve seen it over and over:
Patents are filed too early, too broad, or without a strategic anchor. By the time a true product-market fit emerges, the IP no longer protects what matters — or worse, blocks your own next steps.

Effective IP doesn’t just “protect ideas.” It shapes platform thinking, licensing leverage, and freedom to operate in fast-moving diagnostics fields.

If your IP team isn’t embedded in your R&D thinking early, you’re running with one engine off.

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3. Regulatory “Success” is Misleading

Getting a CE mark (or even FDA clearance) is often treated like a finish line. It’s not.

Many diagnostic products hit the market only to learn that user trust, distribution channels, and clinical behavior haven’t caught up. Sometimes the problem is cultural. Sometimes it’s that the device isn’t as “rapid” or “simple” as users expected.

True success requires aligning regulatory readiness with real-world acceptance.

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So What’s the Fix?

We believe success in diagnostics comes from working across boundaries:

• R&D + IP + usability + market logic
• Tech realism + manufacturing foresight
• Not just invention — but translation

At 2B Consulting, we help companies navigate these intersections from day one. With deep experience in diagnostics, IP strategy, electronics, and embedded systems, we help you design things that don’t just work — but work out.

Let’s talk before your great idea becomes another cautionary tale.