The GP, his sister and a low-tech, perfectly targeted medical invention.
Giovanna Forte is Managing Director of Forte Medical, a company specialising in medical device innovation. In the first of PRN's Innovations in Healthcare series, Giovanna talks us through conception to realisation of The Peezy - a midstream urine specimen collection device - which in turn began her own journey from working in Design PR to the glamorous world of urology.
In Spring 2002 NHS GP Dr Vincent Forte picked up a card that landed on his surgery desk. It was a call for entries from the new Medical Futures Awards the timing of which struck him as fortuitous; just days earlier he had pondered a routine diagnostic problem and felt certain he had a solution.
Dr Forte’s dilemma was this. A high proportion of his UTI patients were returning with recurring symptoms and the women among them were not shy in berating him for the messy method of delivering the required midstream into the small Universal tube provided.
A twofold problem: firstly he was diagnosing from unreliable specimens and prescribing broad-spectrum antibiotics that often did not work leading to costly repeat visits, repeat analyses and more than likely another course of antibiotics. Secondly, his patients were faced with an undignified process that was messy for them and for his surgery toilet. Every transmissible disease - new or old - arrives courtesy of a bodily fluid so even then infection control was a high priority.
Dr Forte phoned his sister to chew the cud on the matter. “You’ve always made things,” she said. “You used to set Mum’s kitchen on fire a lot. Make something.”
Vincent soon met his Urethra Moment. The idea came to him of a paper funnel to which a Universal tube would attach. A void at the base would allow the first pass of urine to escape and somehow then close, diverting midstream into the tube. He made a rough paper model, called it the Female Freedom Funnel and dispatched it to the people at Medical Futures.
Some weeks later he received a call asking if his design was patented because it had been shortlisted. It wasn’t, so he found a patent agent in the yellow pages and duly won the Medical Futures Innovation Award, receiving his gong at a glitzy do in London.
Amazed and delighted, he asked his sister along. She was proud and impressed with what he had achieved. They decided to find an Industrial Agent to help him take his Female Freedom Funnel to market. Sister interrupted her own work with many hours, days and weeks seeking out such an agent for her brother, talking to manufacturers to see if they might be interested in his invention (“we have our own ideas” they said), and working out what his next steps could be. After three fruitless years, Vincent suggested that perhaps she might be the very person they were looking for.
And there, dear reader began my journey from Design PR into urology, product and market research, development, manufacturing, quality systems, regulatory matters, patient care, infection control, evaluations, trials and eventually product launch. For I am the sister of the inventive and diligent GP whose concern for his patients led to a low-cost, low-tech, perfectly targeted urine collection system and eventually much more.
The journey began with renaming Vincent’s funnel the Peezy Midstream. So far, so good. Then, making our unwitting first major error we incorporated the company Funnelly Enough Ltd (amusing company names are not something that the medical world take seriously).
Vincent and I researched the urine “market” in our spare time; we came up with facts and figures that chime with similar investigations to this day. Simply, of the 65m urine specimens delivered to the NHS each year, between 15-30% are contaminated. With up to 22m urine samples being unreliable, the extent of the problem was far greater than we thought and demonstrated the need to tackle the expensive and wasteful business of repeat appointments, antibiotics and testing, not to mention questionable hygiene practices. Above all, our findings demonstrated the need for simple diagnostic accuracy and diligent infection control around this most common process.
We pooled our own financial resources and briefed a paper engineer to perfect Vincent’s environmentally sound, flushable design. We asked a leading paper industry research body to help identify the right material and were recommended to commission our own grade of short-fibre paper that could also somehow be moulded.
A product design studio concurrently analysed the detail: how should we “plug” the void at the base? How should we create a reliable attachment for the Universal Container? How should we prevent the funnel from overflowing?
None of this was happening fast; things were not looking good, or cheap.
Having drawn a blank on the paper route we explored the world of materials and encountered a new flushable, natural cornstarch polymer an apparently perfect solution. An address on a sandwich pack I read on a train one day led us to a manufacturer interested in this polymer and prepared to assist us with product development in return for a small share in our business.
With new areas of research and development opening up we needed more money, for our own limited resources had run dry. We pulled together a business plan and a pitch for funding to friends, family and a handful of business angels. To make our opportunity watertight, we needed to be sure that Peezy worked.
Vincent spent a weekend hand-making 100 prototypes; I invited 15 friends to a drinks party, asking them each to bring two people I didn’t know. On arrival everyone was given two large glasses of water, one Peezy with Universal tube and a questionnaire, then we directed them to the loo. Only when we had our candid but detailed feedback did they get the sparkly stuff and canapés. They were happy; we had our first third party evidence that Peezy could be easily and successfully used.
Our initial funding of £150,000 was spent on researching our buyers and how to reach them, whilst also solving critical areas of product design. We explored ways to complex injection mould and sonic weld the novel polymer that no-one – including its manufacturers - had much information about. This stage of development required tooling, machinery, labour, persistence, time and a whole lot of love. Putting pride to one side, I personally reality tested every single proposed funnel design: an act of simple devotion.
Eventually 1000 prototype cornstarch Peezys were produced and sent to hospitals up and down the land for evaluation and here dear reader, we encountered our first disaster. The cornstarch sent for this important production run was made with different water content to the batch we had tested so rigorously. Every single Peezy crumbled, arriving at hospitals in bits. 1,000 perplexed nurses received shards of polymer with a universal container, polite letter and prepaid response slip. We were devastated.
We took a deep breath, raised more funding, revised our materials and methods, amended our quality processes, wrote a new sales and marketing plan and forged ahead. We were able to use the same tooling to make the new Peezy out of polypropylene, the most common polymer found in healthcare products. In confirmation and reward of our efforts, the reinvented Peezy beat both Microsoft and Apple to a major Design Week Award and won an NHS Innovation prize to boot.
Through our loyal base of early customers we gathered market intelligence to assess and improve our product, leading to more design work, testing and retooling. In 2012 Peezy Mark II was launched, reduced from four components to two. Our price skirted under the £1 mark; with a retest in the region of £8, our cost savings model started to fall into place.
A successful peer reviewed and published Abstract from a trial conducted at the Pennine Acute Hospitals NHS Trust also appeared in 2012; feedback from nurses and patients inspired some final improvements and new instructions designed by specialist agency Luto. Meanwhile, a request from one of London’s leading NHS labs prompted us to adapt the connector so that Peezy now collects into either the Universal or 10ml Primary tube. The Primary fits directly into automated urine analysers: no more messy decanting in the lab, saving time and money there too.
It has taken over £2m and colossal determination to get where we are today, for a new medical product however low-tech requires product and market research, development, tooling, engineering, prototypes, quality control to meet stringent regulatory standards, trials, redesigns, branding, sales and marketing. We are assured by the medical multinationals that we’ve done well for the money.
Over the last four years I have visited hundreds of Urology, Gynaecology and Antenatal Clinics across the UK. I never quite know what or whom I will meet. I have spoken to many nurses who value the integrity and accuracy we bring to their work and disappointingly, some who don’t. I have been applauded, thanked - and accused of profiteering.
Currently the growing partnership between NHS Trusts and private laboratories is our biggest challenge; Peezy has been rejected by one of the major players on the grounds that reduced retesting will reduce profits. Right-first-time treatment and cost savings cut no ice when it comes to building a healthy bottom line.
Happily, the majority of nurses, Urologists and GPs I meet encourage us to persevere because they know that powerful persuasion is needed to show the accountants – and Government - how generic adoption of a clever 89p collection system can lead to seismic long term improvements in healthcare because the quality of a diagnosis depends on the quality of the sample. Hygienic collection controls infection; prompt, accurate treatment can reduce waiting lists and quite possibly unnecessary antibiotic prescribing too.
We are pleased: Peezy Midstream does exactly what it says on the tin. It is on the NHS Supply Chain and available on prescription, making it invaluable and cheap for the treatment of antenatal and elderly patients. It is made in the UK, by a medical devices manufacturer capable of delivering the volumes we need for domestic and export markets. Our customer base is growing exponentially with evaluations underway at major institutions in the USA, Europe and Middle East.
What next? Early stage urine tests for Prostate Cancer, Chlamydia and perhaps even Cervical Cancer testing are on our radar, together with two other areas of specimen collection.
I am proud to say that from observations within his surgery and by listening to his patients my GP brother succeeded in taking this essential yet overlooked area of medicine firmly in hand.
Thank you Vincent: another fine mess you got me into.
Watch Giovanna's TEDX talk below.