WHY QUALITY ISN'T JUST A BOX-TICKING EXERCISE (AND WHY IT LITERALLY SAVES LIVES)
By Tom Mullett, Quality Manager, Ingenion Medical
I know, you don’t have to tell me. "Quality Management" is not the phrase that gets people leaping out of bed on a Monday morning. I know this. My family knows this; their glazed-over eyes tell me this when I mention ISO standards. And yet, here I am, genuinely passionate about it. So, bear with me, because I promise quality is more exciting than it sounds. Especially when the product you're talking about works inside a human body.
Working in healthcare and the importance of quality has always been a strong focus in my career, from being a Sterilization Technician at Nuffield Health through to Quality Assurance Manager at Vernacare with many teachable moments in between!
My career has now led me to join Ingenion Medical as their Quality Manager, and my job is to make sure that everything we do, every material decision, every design tweak, every manufacturing process, meets the exacting standards required to put a medical device in front of a patient. And our device, cymactive™, is not your standard bit of kit.
What exactly is a Class IIB device and why should you care?
Medical devices are classified by risk. Class I covers the lower-risk end of the spectrum, such as bandages. Class IIa sits in the middle, and Class IIb is where things get more serious: these are devices that pose a medium-to-high potential risk, typically because they're invasive, implantable, or remain in the body for extended periods. Pacemakers, surgical implants, ventilators, and yes, long-term urinary catheters, all fall into this category. Although technically our cymactive™ is a Bladder Management Device, it does share a lot of similarities to a long-term urinary catheter and is also classified as Class IIb device (the Actuator Magnet is a self-certified Class I non-sterile).
The regulatory bar for a Class IIb device is significantly higher than for something you'd buy off a pharmacy shelf. It's not enough to say that we think it's safe. We must prove it through documented clinical evidence, rigorous testing, robust post-market surveillance, and a quality management system that can withstand scrutiny from a Notified Body (the independent organisation authorised to assess medical devices on behalf of regulators). And rightly so - get it wrong and, at best, your product never reaches patients. At worst, the consequences are unthinkable.
This is the world I work in every day, and honestly, I wouldn't have it any other way.
Getting the CE mark: what it actually means
In 2024, cymactive™ achieved it’s CE-mark, which is a huge deal. Firstly, let me explain what our Bladder Management System is. It's a patient-controlled urinary catheter designed for men with chronic urinary retention. Unlike a traditional Foley catheter, which sits passively in the bladder draining continuously into a bag, cymactive™ uses a patented magnetic valve that lets the patient control when they void, closely mimicking natural urination. It can remain safely in place for up to 30 days with a focus on restoring dignity and independence. It's genuinely brilliant technology.
Getting the CE mark for cymactive™ was a landmark moment. CE marking is the regulatory stamp that says a medical device meets the European Union's safety, health, and performance requirements. For a Class IIb device, that process involves independent assessment by a Notified Body, a full technical file, clinical data, and a Quality Management System certified to ISO 13485 (the gold standard for medical device quality systems). Without that CE-mark, cymactive™ never gets to change lives, which explains why we talk about it a fair amount!
Eleven extra tests. Because innovation demands it.
Here's where it gets particularly interesting for a quality professional like me. Because cymactive™ is a genuinely innovative device rather than just a slight variation on something that already exists, it can't simply sail through the standard testing regime applied to a conventional Foley catheter.
A standard Foley catheter has decades of established test methods behind it. The tests are well-defined, the benchmarks are known, and regulators have seen it all before. Our cymactive™, with its magnetic valve mechanism, its Malecot anchor system, and its controlled voiding function, is something categorically different. That means we had to develop and run an additional eleven bespoke tests designed to validate the unique aspects of this technology. Eleven tests that didn't exist off the shelf, because nothing quite like this has existed before.
We're talking tests that probe how the magnetic valve performs under real-world conditions; how the anchoring system behaves during the natural filling and voiding cycle; how the device acts over its 30-day lifespan. Each test had to be designed, justified, documented, and executed. The results had to satisfy our Notified Body that this novel technology was safe for the patients who need it most.
That's quality management in action. Not paperwork for the sake of it but a rigorous, creative, forensic process that gives clinicians, regulators, and patients the confidence to trust something genuinely new.
The bottom line
Yes, I spend a lot of time in spreadsheets and forms. Yes, I've read ISO 13485 more times than any person should reasonably admit. And yes, my dinner table conversations could probably use some work.
But every row in that spreadsheet, every validated process step, every one of those eleven additional tests, represents a patient whose life might just be a little better because we didn't cut corners. For a Class IIb device, quality isn't a department or a checkbox, it's the whole point.
That's why I love my job.
Find out more about cymactive™ by visiting our website here or using the below form to contact us!