The Case for Quality Management
Paperwork That Matters
Novelty is essential in research. It’s what drives academic inquiry and keeps the wheels of discovery turning. But in healthcare innovation, novelty alone isn’t enough. The real measure of success isn’t just a new idea—it’s whether that idea can translate into something meaningful for patients and providers. That’s where rigor, real-world evidence, and insights from academic medical centers come into play.
This recent LinkedIn post from Ricky Spero, a UNC startup founder (and all-around great human) made an interesting distinction: academia is driven by novelty, while industry is driven by customers.
That’s true in many ways, but what if we could borrow from industry without losing academia’s strengths? What if there was a way to blend the best of both worlds—maintaining the intellectual curiosity of research while ensuring the systematic rigor needed for commercialization?
I’ve seen so many research projects angle towards commercialization, but rarely have I seen an academic project with phase-gate processes, a quality management system or other approaches to help streamline exit from from the university.
I believe that a Quality Management System (QMS) is one of those industry best practices that has a place in academia. We’ve explored it before, but now, we’re building one. And it was partly inspired by the University of Utah’s Center for Medical Innovation which recently supported a product through regulatory approval using their QMS—a great achievement.
The Case for Quality Management
Ask an industry partner about their biggest pain points when working with academia, and you’ll hear a common set of frustrations:
Slow, bureaucratic processes
Misaligned incentives
A lack of structured knowledge transfer
One of the biggest gaps? The know-how to efficiently transfer ideas from academia into commercialization.
A well-implemented QMS can help bridge this gap. It’s not just about compliance—it’s about enhancing rigor, design, and knowledge transfer in a way that benefits both the research and the real-world application.
Building a QMS from Scratch
Developing a QMS at an academic medical center requires a mindset shift. It’s a time commitment, it can slow progress in the short term, and for the uninitiated (i.e., me), it feels daunting.
Our goal is to build a structured yet flexible process—one that enables us to deliver better, not just build more.
While it’s not fully online yet, we’ve begun partial adoption to test the overall process. Here’s what we’ve learned so far:
Design Reviews keep projects on track—establishing crystal-clear expectations and creating transparency with predefined GO/NO-GO criteria.
Templates eliminate scope creep—allowing the team to focus on what’s essential and deliver more efficient results.
Document control and shared directories take effort to set up, but the payoff is huge—a clear audit trail and high-quality documentation that’s critical if the project gains traction.
Drafting a Quality Manual forces us to answer important, often overlooked questions—who holds decision-making authority? What’s our approach to risk management? What metrics define each stage of development?
Why It Matters
Ultimately, our goal is to fully implement an ISO 13485-compliant process. While we’re not manufacturing or engaging in commercial-stage activities (yet), having a QMS enables us to:
Lay the groundwork for future regulatory approvals.
Save time (and $$$) when working with external partners.
Build credibility with clinical collaborators and industry stakeholders.
Future partners—whether startups, product development firms, or industry sponsors—won’t have to sift through incomplete PowerPoints, scattered Word docs, or email chains. Instead, they’ll have a complete, structured picture of the project from start to finish.
For us, quality management isn’t about adding bureaucracy—it’s about setting the foundation for scalable, impactful innovation.
Final Thoughts
Academia and industry may operate under different incentives, but the best innovations happen when we combine the strengths of both. Our QMS is an “industry-lite” approach that allows academics to maintain their strength of novelty while ensuring their work is rigorous, transferrable, and commercially viable.
By bringing structure to our innovation pipeline, we’re not just discovering new things—we’re ensuring they have a real path to impact.