Meet the brother-and-sister team whose invention, the Peezy Midstream, offers right-first-time urine specimen analysis and overcomes the common problem of sample contamination. Yet, despite its ability to save the NHS at least £30 million annually, the device has been overlooked time and again due to the chaotic approach of the NHS Supply Chain. Why aren’t we all pulling in the same direction, asks Kathryn Reilly?
A practising GP in Norfolk, Dr Vincent Forte regularly had a problem getting quality urine specimens from his patients in order to accurately diagnose their symptoms and treat them. So he designed a solution. His sister Giovanna Forte, a successful PR specialist, recognised the device’s potential, fundraised and brought it to market. Their company, Forte Medical, now offers a simple yet highly effective solution to a basic medical procedure. Despite the invention’s success abroad, this ‘no-brainer’ cost-cutting opportunity is still being overlooked by the NHS Supply Chain.
Analysis of urine samples can be as clinically important as blood testing, yet sampling standards are not as stringent, and between 15 and 30 per cent of the 65 million-plus specimens collected by the NHS annually could be contaminated. Fittingly, the Peezy’s strapline is ‘careless collection spreads infection’. Surprisingly, there’s no established protocol.
As Giovanna Forte puts it: ‘Urine analysis is a vital diagnostic tool in many clinical areas, so hit-and-miss collection is unacceptable. Sending a contaminated urine specimen to a laboratory is like asking a detective to solve a crime by looking through a dirty window.’
Many health and industry professionals were quick to recognise the device’s potential. Only two years after its invention, and a year after achieving patent, the Peezy Midstream won the 2003 Medical Futures Innovation Award. Its appeal lies in its simplicity. The ergonomic device is easy to handle; it rejects the often-contaminated first-flush urine into the toilet, captures and isolates midstream urine in its collection tub, and directs overflow back into the toilet. This minimises contamination, eliminates any contact between the patient and their urine, and any soiling of surrounding area, container, label and hands.
Using personal funds, Forte Medical conducted market research, explored business partnerships and began design development in earnest.
By 2006, £150,000 of seed funding was secured – half from the London Development Agency Early Growth Fund and half through angel investors. This, combined with investment from their manufacturing partner, allowed for research development, prototype tooling and concept trials to be undertaken. Approval was subsequently secured from the Medicines and Healthcare Products Regulatory Agency (MHRA). A second round of funding from existing shareholders and new angel investors allowed additional work on materials re-engineering to improve the device’s performance and manufacturing processes; and production eventually began in 2009.
Further accolades followed: the 2009 NHS Innovative Health and Social Care Technology award, and Design Week’s Best Industrial Product and Best of Show, even beating Apple and Microsoft. A third investment round followed and the first export sales were achieved, as was entry into the private healthcare sector. By 2012, the Peezy manufacturing process had been further refined and IP protection enhanced, and the device was listed on the UK’s Drug Tariff. A major breakthrough came when the product was made available on prescription and more finance was secured to enable the release of the latest version in 2013.
Meanwhile, in the background, clinical research was being undertaken to affirm the product’s efficiency including a peer-reviewed evaluation at Pennine Acute Hospitals NHS Trust that was presented at the 2013 Société Internationale d’Urologie and World Congress of Endourology conferences. A fifth round of funding that year supported the scaling up of production and sales and marketing. In the following year, sales grew across the UK from urology and haematology clinics, and ambulance, mental health, maternity and other services via the NHS Supply Chain contract. Things were looking good.
In truth, the relationship between Forte Medical and the NHS has had all the characteristics of an intense rollercoaster ride. The ups of being listed were soon negated. The NHS innovation award had been a real boost but ultimately hadn’t helped the company reach NHS buyers. Approaches to the Quality, Innovation, Productivity and Prevention (QIPP) were ignored, and applications to the Rapid Review Panel for Infection Control, the NHS Smart Solutions Healthcare panel and the NHS Innovative Technology Adoption Programme were all rejected. Giovanna’s feeling is that ‘there’s an “its only urine” view that prevails across the NHS despite the fact that urine can carry infection. They didn’t deem Peezy to be the kind of technology they were supporting – I think the medicine area in which it sits is unattractive to these kinds of initiatives – it’s just not glamorous.’
The struggle was further exacerbated in January 2016, when Forte Medical was informed that Peezy, despite improving sales, was being delisted from the NHS Supply Chain simply because the company didn’t know a new tender had been issued. This tender had not been communicated through the NHSCC portal, a direct means used by suppliers to communicate with customers and by NHS buyers to make smaller purchases that sit under certain limits, above which procurement must be involved. Even more frustratingly, Forte’s multiple attempts to update the ‘powers that be’ on its new positive research findings hadn’t got through. Then a seemingly positive suggestion in mid 2016 by the Category Manager of Urology Products for the NHS Supply Chain to submit an Innovation Scorecard application was subsequently rejected… by the very same manager.
All the while, contamination of urine samples was hitting an all-time high. The company sought figures via the Freedom of Information Act from 173 NHS trusts, which revealed contamination rates of anything between 0.46 per cent and 37 per cent, with a couple of trusts recording over 50 per cent, and one even hitting the 73 per cent mark. Further clinical evidence, including a recent study from Barts Health NHS Trust and The Royal London Hospital, and interim findings from studies by UCL School of Medicine, consistently demonstrated the efficiency and efficacy of the Peezy in reducing contamination and costs.
The £30-million saving mentioned earlier is borne out by the health economic model developed by independent health consultancy Richardson Research, and that amount is conservative because adding in the cost of repeat testing and the time and resources involved in additional appointments sees the cost soar significantly higher. Add to that the fact that contaminated samples are linked to high antibiotic prescribing, and we enter another financial dimension. And the Peezy unit cost is just 89p.
At a time when the NHS’s list of requirements include innovation, prevention, early intervention, right-first-time diagnosis, targeted prescribing, hand hygiene, infection control, patient safety and dignity, and the all-important cost and efficiency savings, the irony of its device being overlooked is not lost on Forte Medical. With strong sales building in the US, it seems unfair that this straightforward solution to a basic diagnostic problem – and a British one at that – is languishing on home turf. But will the NHS Supply Chain ever be coordinated enough to capitalise on easy healthcare solutions like this that could make a world of difference?
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