Turning a design concept into a manufacturable instrument isn’t just a phase on a Gantt chart, it’s a pivot point.
It’s where possibilities get tested. Where complexity becomes tangible. And where the best-laid plans are either accelerated or undone.
At HiArc, we’ve seen it time and again: the distance between “approved design” and “ready-for-market product” is where momentum can stall or soar. That’s why we treat the transition from design to build with the care it deserves. Not as a generic checklist, but as a precise, deeply collaborative process—engineered around you.
Here’s how we help clients do exactly that.
1. Plan for production at the start
It may seem obvious but make all final changes to the medical device design before the transition to manufacturing begins. This will save additional costs and avoid time delays.
As Frank Lloyd Wright famously said “You can use an eraser on the drafting table or a sledgehammer on the construction site.”
Planning for transition must begin in the product development stage, well before the software and system verification and validation efforts have been completed. The timing is critical because manufacturability, testability, and serviceability must be considered during the design phase.
We see it as one seamless process. The design process isn’t separate from manufacturing. The best transitions begin when manufacturability is built into every design decision. That means asking early:
- How will this be tested?
- How will this be assembled?
- How will this be supported in the field?
We begin those conversations from day one. Because you don’t want to realize a part can’t be built after it’s been beautifully designed.
2. Form cross-functional teams—then keep them close
The fastest route from idea to device is a straight line between disciplines. That’s why we embed mechanical, electrical, systems, software, quality, and production experts into a single, focused team. We call this HiArc Together.
When the people who design your product also understand how it’s built, you get fewer surprises, fewer compromises, and a lot more momentum. Combining their proven expertise and wide knowledge base enables a holistic approach for manufacturing and regulatory compliance. During each phase of development, the team minimizes obstacles and adheres to FDA regulations, bringing the product quicker to market.
3. Break the journey into precision checkpoints
Implement checkpoints throughout the product design and development process to ensure everything is on track and there are no hidden obstacles.
Big leaps are safer when they’re broken into steps. At HiArc, we guide clients through three structured reviews:
- Critical Design Review (CDR)
Validates that hardware, software, and system requirements align before pilot production begins.
- Pilot Production Readiness Review (PPRR)
Confirms that the product, documentation, and team are ready to build test units—without guesswork.
- Manufacturing Readiness Review (MRR)
Final sign-off for full-scale manufacturing, with every department aligned and risks de-risked.
These aren’t bureaucratic hurdles—they’re tools to protect your timeline, your budget, and your reputation.
4. Transfer knowledge, not just files
You can’t build what you don’t understand. That’s why we don’t treat the design-to-manufacturing handoff like a clumsy baton toss, but more like meshing gears, engineered to move in sync without friction.
We translate engineering intent into real-world workflows, visual instructions, and production tools that make sense to those on the shop floor. Every manufacturing partner is brought up to speed—not just on what the device is, but why it matters.
5. Build with the human impact in mind
An interesting aspect of our industry is that we are designing and building things that ultimately help people live healthier, longer lives. But for the most part we are a few steps removed. We build to enable other companies and teams to do important work that helps people. But the positive human impact is less evident to us.
What we have learned is we build better when teams are connected to the human mission behind it: the lives these instruments touch, the diagnoses they accelerate, the care they make possible.
Purpose is more than a nice-to-have, it’s a productivity tool. A reminder that we are working in healthcare, if a few steps removed. Because of that, our teams care more, because they know what’s at stake.
That care is built into every component, every process, every product we ship.
