When people think about quality in manufacturing, they often think of processes—like certifications, checklists, and forms. Those tools matter, but what really drives quality is culture: how people work, how they think, and whether the system around them helps them succeed or sets them up to fail.
I began my career in the medical device industry, where the standards for quality are exceptionally high. Since then, I’ve learned how to uphold that same commitment to quality in fast-moving startup environments at the forefront of technology—where speed is critical and formal quality frameworks haven’t kept up with the state of the art.
What medical devices taught me about quality
Before joining Lumafield, I worked in a highly regulated environment under ISO 13485, which is the quality standard for medical device manufacturers. In that world, trusting that someone makes a good product isn’t enough; you have to prove it, every step of the way.
The medical device industry doesn’t certify the individuals designing a product, like the PE credential in civil engineering. Technically, anyone can sketch out a medical device. Instead, certification controls how that product gets built and tested. That means heavy documentation: from ideation and risk analysis, to design verification and validation, to production release and traceability. Every requirement needs to be documented, and every product needs to be tested against those requirements, with a full paper trail to back it up.
I spent a lot of time in that environment, and while some aspects of the system felt rigid, I also learned how robust a good quality system can be. Every step builds confidence, minimizes risk, and creates repeatability. The experience gave me a foundation for how I think about quality now, even in a startup where we aren’t subject to the highly-formalized quality systems that govern medical device development.
What quality looks like at a startup
X-ray equipment is regulated at multiple levels of government for safety, and we exceed the required safety standards in all of our products by a wide margin. Beyond that, there’s no certifying body that examines the paper trail for every step in our product development process. At Lumafield, we’ve had to define our own standard of quality without a formal external structure.
Our focus is always on improving quality where the action is happening, not somewhere buried deep in a stack of SOPs. We want our operators to have the tools and information they need to build high-quality products consistently and safely.
Instead of a formal quality management system (QMS), we rely on a culture where every individual who works on our hardware prioritizes product quality, and we empower those individuals with practical tools like detailed work instructions, in-process checks, and a responsive noncompliance report (NCR) process. Our focus is always on improving quality where the action is happening, not somewhere buried deep in a stack of SOPs. We want our operators to have the tools and information they need to build high-quality products consistently and safely.
That may sound simple, but we’ve come a long way since our first prototypes began the buildup process. At that point, we hadn’t defined our quality structure yet—we had no standard for how instructions were written, no consistent way to track build issues, no process for root cause analysis. We’ve since built all of that from the ground up.
What we catch, and when
Ideally, we’d catch every problem before it gets to the floor. That’s the goal of first article inspections and incoming quality checks. But at this stage, with a lean manufacturing team, we’ve had to make strategic tradeoffs. We can’t inspect every single part, so we carefully model the likelihood of noncompliance and its potential impact, and target inspections where they’re needed. We’ll pay a little more for extra parts or expedited shipping if it means we can stay flexible and move quickly to meet our customers’ needs.
...our culture—where everyone, at every step of the way, is invested in making quality products—will remain the bedrock of our manufacturing.
Eventually, that will change. As we scale, it’ll make more sense to increase our investment in prevention. But right now, we pick our battles. Some parts are high-risk or high-cost, and we’ll spend extra time checking those. Others we monitor downstream. That balance will evolve as we grow, but our culture—where everyone, at every step of the way, is invested in making quality products—will remain the bedrock of our manufacturing.
Helping assembly technicians check their work
We introduced our second CT scanner family, Triton, earlier this year. On the manufacturing side of this new product line, we’re giving our assembly technicians the ability to check their own work earlier. Our team members have always been good at understanding how the core assembly goes together, because good mechanical design communicates that on its own. But when we get into more complex subsystems, like motion platforms wrapped in shielding and packed into tight spaces, things get murky. If a technician makes it to the end of the assembly process and finds that the machine doesn’t work, there are too many places to look.
Instead of having our technicians assemble continuously all the way through, we’re building in subsystem testing to enable them to “check their own work” and learn from their mistakes. If we can test a motion platform before it’s wrapped up in the system, we can isolate any issues and fix them while the problem area is still accessible. It saves us a lot of time, and it makes debugging much more predictable.
Designing quality in
Design is the first step in our quality control system. We always think about Murphy’s Law: “if something can go wrong, it will.” In hardware that means if a part can be installed incorrectly, it will be installed incorrectly. It’s just a matter of time, and we need to design the part so that incorrect installation isn’t possible. That may sound like just common sense, but it’s a core principle in any good quality system.
At Lumafield, our hardware engineers put themselves in the positions of our assembly technicians: they’re on the floor turning wrenches, seeing which steps feel intuitive and which ones don’t, and quickly making improvements to designs. That feedback loop is gold.
Building systems, not just scanners
At Lumafield, we’re building scanners. But more importantly, we’re building the system that builds the scanners, and it’s a system that will have to scale, adapt, and improve over time. Now, we’re hiring more manufacturing engineers to build systems and practical tools that make it possible to deliver high-quality products over and over again.
What matters most is taking pride in the little things that bring joy to our customers. It’s about making right-sized solutions so those on the front lines can do their jobs well and get better over time.
That’s what quality really is. Compliance and control are just the beginning. What matters most is taking pride in the little things that bring joy to our customers. It’s about making right-sized solutions so those on the front lines can do their jobs well and get better over time. Manufacturing teams often lose sight of this and let paperwork overshadow the simple goal of getting the product right. Only through thoughtful systems, good design, and people who care can you consistently deliver quality to your customers.