Every now and then, we get a project that doesn’t just test our engineering muscle—it tests our character.
This is one such story.
It’s a story of promises broken, time and money wasted, and a client on the brink of giving up. But it’s also a story of second chances, extraordinary teamwork, and what happens when engineering meets urgency with unwavering discipline.
The Call That Started It All
It started with a phone call. A seasoned entrepreneur—tired, frustrated, and nearly out of options—reached out to us. His words were sharp but honest:
“I’ve spent a year. I’ve spent lakhs. And I still don’t have a working product. Can you fix this? Or should I shut it down?”
He was building a Body Warmer Medical Device—a product with real clinical potential. Designed to maintain a patient’s core body temperature during transport or recovery, it was supposed to be simple, safe, and effective. Instead, he was left with non-functional prototypes, broken firmware, and a hardware architecture that looked like it had been designed without a system-level view. Regulatory documentation? Barely started.
What he had was a dream. What he lacked was a team that could make it real.
What We Found
When we received the device, we knew immediately—this wasn’t a salvage job. It was a complete teardown and rebuild.
-
- Firmware Issues: The firmware was unstable, with patchy PID temperature control and critical safety functions missing.
-
- Hardware Flaws: The hardware had fundamental design flaws, with no clear separation between power and logic domains.
-
- User Interface Problems: The user interface was inconsistent and confusing for a clinical setting.
-
- Documentation Gaps: There was no traceability matrix, no risk analysis, and no documented software architecture.
-
- Regulatory Misalignment: Zero regulatory alignment.
And the worst part? The client had promised to launch this year. He didn’t have another 18 months. He barely had 9.
The 9-Month Mission
We gathered the team. Hardware engineers, embedded software developers, QA specialists, regulatory consultants, and program managers. We drew a hard line in the sand: nine months. Not for a prototype. For a market-ready, certified medical device.
The stakes were enormous. But so was the commitment. What followed was nothing short of a sprint marathon:
-
- Hardware Redesign: Hardware was redesigned from the ground up with reliable thermal sensors, precise fan and heating control, and component-level safety redundancies.
-
- Firmware Re-architecture: Firmware was re-architected with a robust state machine, diagnostics, real-time safety checks, and persistent logging.
-
- Calibration System: A new calibration and HEPA filter usage tracking system was implemented.
-
- User Interface Development: We built a simple, intuitive UI—LED-based feedback for clinicians, tactile keys for gloved operation, fault indicators, and temperature set-point confirmation.
-
- Regulatory Documentation: Regulatory documentation was built side-by-side with development—risk management, traceability, verification protocols, and usability engineering.
-
- Compliance Management: We managed IEC 60601 compliance, safety, EMC, and BIS certification.
And we did it with zero compromise on quality.
The First of Its Kind
Exactly 9 months later, the first certified, production-grade Body Warmer Device rolled out. Today, that same client—the one who was ready to walk away—is already selling the device across hospitals in India. He called us last week to say:
“You didn’t just deliver the product. You rebuilt my faith in engineering.”
This was India’s first rapid medical device overhaul of its kind—from failed prototype to certified product in under a year.
The Story Is Just Beginning
This wasn’t just a project. It was a reminder of why we do what we do. Medical devices are not gadgets. They are promises—of safety, of care, of better outcomes. When those promises break, we step in. Not just to build products, but to restore trust.
Our client’s success is our biggest reward. And we’re not done yet. The next generation of the Body Warmer is already in early R&D. Expansion to new markets is underway. Accessories, telemetry, mobile app integration? Coming soon.
Because when engineering meets purpose, even the darkest stories can find a bright beginning.
If you’ve got a dream that’s been derailed, we’re here to help you rebuild—not just the product, but the momentum.
Let’s talk.