When "Complaint" Doesn't Mean Complaint: Why Quality Systems Save Medical Device Companies Millions

A software company was using Zendesk to track customer feedback. Every issue, from "can't log in" to actual product defects, was automatically categorized as a "complaint." Thousands of them. When Kyle Rose, president of Rook Quality Systems, showed up for their first internal audit, he found exactly what FDA reviewers would've found: a massive compliance gap that could've killed their regulatory submission.

This wasn't a careless startup. This was a functioning medical device company with a product on the market and real customers. They just didn't know that "complaint" has a specific regulatory definition, one that requires formal investigation and documentation. The off-the-shelf software they trusted was using consumer-grade terminology, not medical device language.

Kyle has spent 13 years helping medical device companies avoid exactly these kinds of blind spots. As founder of Rook Quality Systems, he's built a consulting firm around a contrarian philosophy: quality systems shouldn't slow companies down. They should make innovation faster, not harder.

The Efficiency-First Approach to Quality

Most medical device companies think of quality as bureaucracy, something that slows them down on the path to market. Kyle sees it differently. His entire business model is built on making quality management systems as efficient as possible while staying fully compliant.

"A lot of companies think of quality and sometimes regulatory as a burden or something that slows them down," Kyle explains. "But we really want to take the approach of making this process as efficient as we can and helping improve innovation and speed up innovation while still being compliant to the regulations."

This philosophy stems from Kyle's previous work in industry, where he saw both small and large companies struggling with quality management. The turning point came when he started applying his personal obsession with efficiency, something that affects everything from his morning routine to how he manages his consulting projects, to the world of medical device compliance.

When Quality Systems Reveal Product Failures Before Customers Do

The real value of quality systems isn't just passing FDA audits. It's knowing your product so intimately that you can predict and prevent failures before they reach patients.

Kyle tells the story of a smart pill dispenser that seemed straightforward enough, until his team started building out the quality documentation. Standard pill bottles are amber-colored for a specific reason: that particular shade blocks light wavelengths that would damage medications. The startup had chosen a plastic material without testing whether it provided the same protection.

"We realized after making thousands of these that we didn't have the right light blocking features and it wasn't doing what it was supposed to," Kyle explains. The issue only surfaced because the quality system forced them to define requirements and specifications for every component, then trace those requirements through testing and validation.

→ Quality systems force you to know everything about your device → Every component needs defined specifications and tolerances → The more you know upfront, the faster you can identify and fix failures → This knowledge pays off when something inevitably goes wrong at scale

The Hidden Cost of Skipping Quality System Work

Some founders see quality as "checkbox compliance", something to defer until right before regulatory submission. Kyle has watched promising companies with strong funding fail because they didn't buy into the quality framework early enough.

"If you don't put enough focus on it, you're not going to get through," he says. He's worked with wearable monitoring device companies that didn't understand there are specific accuracy thresholds, defined barriers you must meet to sell as a medical device. You can't claim to measure respiratory rate or pulse oximetry unless you pass standardized tests. No exceptions.

The companies that succeed with Kyle's team are the ones who understand this from day one. He recalls a brain surgery planning software project where the physician founder immediately grasped the stakes: "We can't be wrong by a millimeter. This has to be as accurate as possible because we're giving a recommendation for someone on a surgical bed."

That level of buy-in meant the entire software development process, every line of code, every validation test, aligned with the regulatory burden from the start.

The Acquisition That Proved Quality Systems Pay

One of Kyle's standout success stories involved a company transitioning from an internal quality resource to external support. They needed to modernize their entire system, move out of Dropbox and Google Drive, implement a proper electronic quality management system (EQMS), and prepare for something bigger than an FDA audit: acquisition due diligence.

"The actual process of getting acquired in due diligence is much more intense than your typical FDA audit," Kyle explains. "They have millions of dollars on the line wanting to ensure that all the testing, all the initial complaints, all the feedback, all the manufacturing, all of this is going to translate to a product they can then roll out to the rest of the world."

Within 18 months of taking over quality management, Rook helped the company through: → Complete QMS modernization and EQMS implementation → Successful acquisition due diligence → ISO certification for all their suppliers → Their first FDA audit as the acquired company

The exit was significant. The quality system didn't just enable the acquisition, it protected the acquiring company's investment by proving the device could scale safely.

Where Quality Systems and AI Collide

Kyle is now applying AI to quality system management itself. His team is building tools that can review electronic submissions before they go to FDA, catching inconsistencies across thousands of pages of documentation. They're testing AI-powered audit support using the MDSAP (Medical Device Single Audit Program) framework, which defines exactly what procedures and records need to exist.

But he's also watching how AI affects the devices his clients build. FDA reviewers are asking for more detail on cybersecurity risk plans and post-market monitoring than what's in published guidance documents. Kyle's team stays ahead of these shifts because they always have multiple submissions under review, when reviewers ask for something new in one submission, they immediately incorporate it into the next.

"That's something that aligns with our relationship with FDA reviewers," Kyle says. "We do the best we can to present information that we believe is to the requirement."

The FDA Tool That Could Change Everything

Kyle is particularly interested in FDA's Medical Device Development Tool (MDDT) program, a framework that could make regulatory review more efficient by pre-qualifying testing methods, datasets, and frameworks.

Currently, there are MDDTs like Apple's image analysis tool that allow companies to test their products against approved datasets. Kyle sees potential for this approach to expand beyond device-specific testing into broader compliance tools.

"There are opportunities outside of device-specific testing for more broader compliance tools for quality and regulatory," he explains. "Showing how parts of your cybersecurity or your AI tool meet the requirements of FDA without them having to go through thousands of pages of documentation, you already have a tool that's aligned with this."

He's thinking about electrical safety testing (IEC 60601) and biocompatibility testing, areas where external accredited laboratories already compile reports that get submitted to FDA. An MDDT tool could quickly verify these reports meet requirements, freeing reviewers to focus on predicate justification and actual device comparison rather than reading hundreds of pages of test data.

What Regulators Should Do Next

If Kyle could make one request of FDA reviewers, it would be this: push more devices to over-the-counter (OTC) status.

"The use of technology and use of AI will allow people to have more home health," he says. "If you are sick, you don't need to go to a doctor's office and get ten more people sick. You can have telehealth and an at-home test and get your prescription."

He points to the work Rook did during COVID with the RADx program, helping get diagnostics to market so people could test themselves before seeing friends and family. That same model should apply to more diagnostic categories, expanding access while maintaining safety.

The Bottom Line

Quality systems aren't just about passing audits. They're about knowing your device well enough to scale it safely, prevent failures before they reach patients, and prove to acquirers that your innovation can withstand scrutiny.

The companies that treat quality as a strategic advantage, not a compliance burden, are the ones that move faster through regulatory pathways and command higher valuations at exit.

Listen to the full episode with Kyle Rose: https://creators.spotify.com/pod/profile/shannon-lantzy

Connect with Kyle Rose: https://rookqs.com/ | https://www.linkedin.com/in/kyle-rose-rook

Want to discuss quality systems for your device? Shannon Lantzy helps medtech companies navigate regulatory pathways: https://www.shannonlantzy.com/ This article was created from the full episode transcript using AI to capture key insights and stories from the conversation.