The Space Between Manufacturing & Market Article # 1: Why Great Devices Still Fail

Most of my work exists inside a regulated environment where quality, documentation, and compliance are part of everything we do. There is a clear expectation to build things the right way while following established processes, aligning to standards like ISO 13485, and ensuring every detail is controlled, reviewed, and traceable. From where I sit, that work matters. It is what ensures safety, consistency, and accountability. It is what allows a product to move through development and into production with confidence. But something I’ve started to think more about lately is this; what happens after that? Because building something correctly doesn’t always mean it will succeed once it leaves manufacturing.

There seems to be a space that exists between the point where a product is built and the point where it is actually used in the real world. A space where factors like adoption, reimbursement, market demand, and clinical value begin to take over. And from what I’m starting to learn, those factors don’t always align with the way products are designed, developed, or even validated.

In regulated industries, success is often measured by compliance. Did we meet the requirements? Did we follow the process? Did we align to the expectations outlined in frameworks like FDA 21 CFR Part 820? If the answer is yes, then from a manufacturing and quality perspective, the product is ready. But readiness doesn’t always translate to success.

A device can be well-designed, fully compliant, and manufactured with precision and still struggle in the market. Not because it was built incorrectly, but because the conditions surrounding its use weren’t fully aligned. Whether that’s how it is reimbursed, how it fits into clinical workflows, or how it compares to existing solutions, those factors ultimately determine whether it is adopted. That’s the part that isn’t always visible from inside manufacturing.

And to be clear, I’m not speaking from deep experience in commercialization or reimbursement. My background is rooted in systems, documentation, and quality within a regulated environment. But that’s exactly what makes this gap interesting to me. From where I sit, there is a clear structure around how products are built, but less visibility into how those products actually perform once they leave that structure. It raises a bigger question; are we building products that are not only compliant, but also positioned to succeed outside of the environments they were created in?

This isn’t about pointing out flaws in the process. If anything, it highlights how strong manufacturing and quality systems are at doing what they are designed to do. But it also suggests that success in the real world depends on more than just building something correctly. There are other variables at play, and they don’t always get the same level of attention.

This article is the starting point for a series I’ll be exploring over the coming months called “The Space Between Manufacturing & Market.” My goal is to better understand what happens in that gap from where manufacturing ends, and real-world outcomes begin. Because from what I can see so far that space might matter more than we think.

#MedTech #RegulatedIndustry #QualitySystems #ISO13485 #Commercialization #Reimbursement #HealthcareInnovation #Governance #DataIntegrity #DigitalTransformation #eQMS #BridgingTheGap

Katie Casteel works in a regulated medical device environment and is currently pursuing a PhD in Information Technology with a cyber engineering focus. Her research interests include IT governance, cybersecurity, and organizational risk management.

This article is part of The Space Between Manufacturing & Market series, which explores the gap between building compliant, high-quality products and achieving real-world success in the market.