Beyond the Biofilm: From Microbiology to Medical Devices

Navigating Science Without a Degree

When I was young, my interests were all over the map, from sports science and palaeontology to microbiology. When university offers came in, I had choices across these very different disciplines, but I ultimately chose Medical Microbiology at Nottingham Trent University. That decision set me on a path I’m still walking today, though not quite in the way I expected.

Fast forward 20 years, and my scientific career has taken me through microbiological testing, molecular biology, contract water testing, and analytical chemistry. Along the way, I’ve worked with clients across public health, contract testing laboratories, healthcare, academia, medical device manufacturing, homeland security, and defence.

What surprises many people is that I never actually graduated from university. Personal circumstances forced me to leave after my second year, and in an industry where postgraduate degrees are the norm, not having even a bachelor’s degree has been a challenge. There were times when opportunities were simply closed off because I couldn’t tick the “degree” box.

But if science teaches us anything, it’s persistence.

I channelled that persistence into proving my technical skills and leadership through results. In 2021, I became Director of Science & Innovation at a microbiological testing SME, where I led the development of next-generation sequencing (NGS) solutions for pathogen detection. That innovation helped the company scale its capabilities and achieve multimillion-pound turnover.

Then, in 2023, I took the leap into entrepreneurship and founded Hygieiatech Ltd, a biotechnology start-up developing rapid, portable pathogen-sensing technologies for healthcare and biosecurity. Our mission is simple but ambitious: to make pathogen detection faster, easier, and more reliable, wherever it’s needed.

The Hidden Risk in Hospitals: Contaminated Endoscopes

Our current focus is on a critical, but often overlooked, problem in healthcare: the reprocessing of flexible endoscopes.

Endoscopes are invaluable medical devices used in everything from gastrointestinal investigations to respiratory diagnostics. But their design, long, flexible tubes with narrow internal channels, makes them notoriously difficult to clean. After procedures, bacteria, proteins, and other organic residues can remain trapped deep within these channels. Over time, these residues can form biofilms, tough, adhesive microbial communities that resist both manual cleaning and automated disinfection.

The implications are serious. Each year, hundreds of thousands of patients worldwide are diagnosed with infections linked to contaminated endoscopes. These infections can be caused by pathogenic bacteria or even antimicrobial-resistant strains that persist within biofilms.

Despite this risk, hospitals currently lack a direct, reliable way to test endoscopes for residual contamination. Instead, they monitor automated endoscope reprocessors (AERs), the machines that clean and disinfect endoscopes, using process challenge devices (PCDs). These PCDs mimic endoscope complexity and are “soiled” with test debris to assess whether cleaning cycles work effectively.

However, most PCDs today only provide a qualitative, pass/fail result based on whether visible soil was removed. None offer quantitative, rapid measurement of residual biofilm or protein removal, both of which are critical indicators of cleaning effectiveness under international standards.

Quantitative, In-Situ Cleaning Validation

At Hygieiatech, we’re developing next-generation quantitative PCDs that directly measure the removal of biofilm and residual proteins. These devices are designed to be used on-site by endoscopy unit staff, providing rapid, measurable feedback without the need for external laboratory testing.

Our goal is to empower healthcare teams with real-time data on cleaning performance, allowing them to immediately respond to failures, quarantine affected endoscopes, and ultimately reduce the risk of patient infection.

We anticipate that our quantitative PCDs will reach the market in early 2026, marking an important step forward in infection prevention and quality assurance for endoscopy services worldwide.

The Road Ahead

Getting to this point hasn’t been easy. Like many early-stage start-ups, we’ve navigated accelerator programmes, business incubators, and countless funding applications. Recently, our perseverance paid off, we received our first UKRI funding award to begin formal product development.

In a poetic twist, we’re now collaborating with Nottingham Trent University, where my own scientific journey began, to help bring Hygieiatech’s first product to market.

The road ahead is exciting. We’re building technology that could make a tangible difference to patient safety, infection control, and the future of pathogen monitoring in healthcare.

At Hygieiatech, we believe that innovation in biosensing and decontamination assurance can save lives, and we’re just getting started.

Find out more

If you are interested in learning more about James’ work or working with Hygieiatech Ltd, please contact NBIC at nbic@biofilms.ac.uk or email info@hygieiatech.co.uk.

James Clarke, Co-Founder and Director of Science, Hygieiatech Ltd.