The Inovus difference in medical education. Martin (Dim) Jones reports.
When I was asked by my revered CEO to visit a small medical simulation company in St. Helens, I gently pointed out that my area of expertise – such as it is - lies in military aviation. What I knew about medical simulation at that point could comfortably have been inscribed on the back of a fourpenny postage stamp with room to spare; happily, there is now marginally less free space on the stamp and, in pursuit of this commission, I discovered a story of a start-up company with a difference. I am conscious of the fact that, although there may be a few who are equally uninformed, the specialist knowledge of the majority of MTM readers is vastly wider than mine, and I would crave their forgiveness if I am perceived as ‘teaching granny to suck eggs’.
I had never been to St. Helens; it is an industrial town of a little over 100,000 souls, just north-east of Liverpool in the industrial north-west of England; it is renowned, among other things, for its glass-making industry and its Rugby League team. Inovus Medical, the object of my visit, occupies a deceptively large unit in an urban industrial complex, sandwiched between a glass manufacturer and a motor service and repair outfit – not the location I would have anticipated for a high-tech medical company, but typical of their practical approach to business.
The story starts in 2012. One of the Inovus co-founders, Elliot, was approaching the end of medical school in Manchester, planning a career in surgery, and the other, Jordan, had just completed a degree in psychology in preparation for post-graduate medical studies, and was looking at the utility of psychometric testing to predict success in surgical training. For this, he needed a simulator to evaluate skill at laparoscopic surgery, in which a fibre-optic light source, camera and surgical instruments are inserted, via ports, through the abdominal wall in order to inspect, and perform surgery on, the internal organs. Light source and camera are normally inserted close to the navel, and instruments through other tiny incisions in appropriate positions. These procedures originated in the late 70s, became more widespread in the 80s, and the first simulators appeared in the 90s. The most basic low-fidelity ‘box-simulator’ allows the insertion of instruments through pre-made holes into a space which represents the abdominal cavity, with the image of the internal aspect of the box displayed live on a screen. Its purpose is to permit the practice of basic tasks, such as picking things up, cutting and suturing, and it replicates the challenges faced in real laparoscopic surgery: depth perception, exacerbated by the transfer of a 3D image on to a 2D screen; triangulation, the result of the tips of the instruments being at least 30cm from the operator’s hands; and the ‘fulcrum effect’, whereby a movement of the operator’s hand in one direction generates an opposite movement in the instrument.
However, Jordan found that the simulators he needed were not accessible in the medical institutions, and too expensive to purchase privately. Neither were existing simulators very functional – the cameras were fixed, so there was no opportunity to practice camera manipulation, and there was no real replication of the insertion of ports through the abdominal wall – one of the most demanding and hazardous procedures. Nevertheless, they cost upwards of £3000, and that did not include the instruments themselves.
Understandably, the only people able to afford them were the hospitals, and the price tag limited the number of units purchased, even by an organization the size of the National Health Service (NHS). This contributed to a lack of availability and, therefore, utility when shared between multiple trainees; there was no opportunity for trainees to conduct private practice or study. High-fidelity simulators, which allowed full procedures, could create effects such as bleeding, track performance and, through virtual reality (VR), create immersion, at that time cost around £80-100K. Faced with this challenge, as a first step, Jordan built his own box-simulator, fitted with a webcam.
Meanwhile, Elliot – who knew Jordan through a mutual friend – had observed similar deficiencies in the surgical training system, the disconnect between modern learning and teaching techniques, and the limited access for trainees to both simulation and live practice. The time-honoured ‘see one, do one, teach one’ process was no longer viable; there was a need to shift away from live surgical practice towards simulation, but this was hampered – even in teaching hospitals - by lack of access. Jordan and Elliot recognized the business opportunity this presented, but acknowledged that, at that point, they had ‘no money, no contacts and no knowledge’. What they did have was an empathetic insight into the requirement, and an innate understanding of some of the problems, and how to address them; in short, they weren’t commercially well-placed, but their entrepreneurial brains were turned on. Their aim was to make the world’s first ‘low-cost, take-home’ laparoscopic simulator, for purchase by trainees themselves, recognizing that a surgeon should not only be able to increase his medical knowledge through private study, but also practice his or her raw skill. In this regard, laparoscopic surgery also includes the more recent robotic variant; someone has to learn to control the robot.
It is worth digressing for a moment, to reflect on how this situation arose. Simulator training (ST) was not then, and is not now, mandated during surgical training in the UK. Indeed, although simulation had been mandated in the US for other medical procedures, such as CPR and advanced life-support training, it has only recently been a requirement for some surgery. There was, therefore, no pressing need to introduce it; there may also have been an element of ‘we didn’t do it that way’ amongst senior medical professionals and decision-makers, and a resistance to the perceived threat of evaluation which simulators might bring. The NHS also suffers from the inertia inherent in such a large organization and, notwithstanding its size, even low-cost ST devices present a budgetary problem for cash-strapped NHS Trusts. This lack of mandation will be surprising to anyone raised in civil or military aviation; one reason may be that aircraft accidents, with attendant multiple casualties, collateral damage and financial implications, are more expensive and newsworthy than surgical mishaps, and have historically attracted a greater degree or regulation. However, it is also worthy of note that surgical error is not always a matter of life and death, and that minor instances can result in increased operation time, risk of complications and post-operative care – at a cost to both patient and taxpayer. Indeed, in the sole case of the 1.5 million laparoscopic appendectomies performed in the UK each year, a 10% reduction in both operative time and instances of complications would save the NHS £117m annually.
Back to the scene in 2012. Even the basic box-trainers then available had clearly demonstrated the capacity to improve skills in basic laparoscopic procedures; there was no negative training – the simulator replicated the difficulties of the real thing. Lack of mandate and access reduced the positive effect, but mandate was anticipated, and access would therefore be required. Furthermore, advances in technology over the previous five years – notably software and USB cameras – made the affordable, take-home device more feasible. This would include all necessary instruments and equipment to practice basic skills. The next challenge was how to get it into the hands of potential users.
Medical students are all what those in the civil aviation business would call ‘self-improvers’, i.e. they are accustomed, for lack of a sponsor, to paying for all their own training; they are also used to buying stuff on-line. The sums involved in medical school, licences, insurance, post-graduate exams and revision for them, are eye-watering, especially on a starting salary of less than £30K. Nevertheless, Elliot and Jordan perceived a massive unmet need which required action from people who understood the problem; informal research suggested that trainees would be willing to spend up to £900 on a single item or training experience, and even making their own simulators would cost this much. The first step would be to test the hypothesis by producing a take-home box-simulator. However, with start-up capital of £400 – the unfortunate consequence of starting the venture as students such as outlined above - contract manufacture would not be possible, and the partners had no accurate idea of customer demand.
They therefore decided to become the manufacturers and, working from Jordan’s grandparents’ garage, they made the box using sheets of plastic, a heat-gun, the side of a refrigerator and a power-drill. They sourced a suitable camera, used surgical instruments available on the open market, and used a laptop as a visual display.
The idea was to get the device in front of customers, get them to buy and use it, obtain feedback and use the sale proceeds to develop the business. Jordan created a basic website and, within two months, they had their first sale. By this time, Elliot was about to sit his finals and Jordan was working in the pharmaceutical industry.
The next step was to approach senior surgical educators, and they received positive feedback from the consultants. The average teaching hospital could only afford a couple of devices at £3000 apiece which, with often 20+ surgical trainees, resulted in insufficient hands-on time and consequent skill fade. The ‘take-home’ software set-up and laptop configuration was not suitable for institutional use, but a plug-and-play version, with its own screen, for half the current price would double the number available and with it the trainees’ access; better still if this new device could remedy the functional shortcomings in the existing equipment (no ports, camera limitations and unrepresentative insertion membrane). Six months after forming the company, Inovus had its first sale of an institutional simulator; they had halved the price and doubled the functionality. Furthermore, the two levels of device were entirely compatible with a ‘hub-and-spoke’ system, the institutional variant as the hub, and the take-home as the spokes. The foundations of success had been laid; Inovus had challenged the ‘take-it-or-leave-it’ status quo and started to progress towards their ultimate aim of providing a vertically integrated ‘one stop shop’ for laparoscopic simulation.
Fast-forward to 2015. Jordan was still working in the pharmaceutical industry; Elliot had passed his finals and completed two years as a junior hospital doctor in Oxford, while doing the sales and marketing for the company in his ‘spare time’. This point generally marks a hiatus in a doctor’s professional training, before embarking on specialised training, and Elliot used it to leave Oxford and run the company full-time, while maintaining his clinical practice at weekends – a solution which was good for him and good for the company. The heat gun and plastic sheets had been replaced by a heat-forming jig (I have no idea whether the refrigerator still had a part to play), space had run out in the grandparents’ garage, and the company had moved to the basement of a pub in St. Helens. The focus was now on developing the company, systemising manufacturing and Sales & Marketing, and improving the equipment offerings.
Fast-forward again to the present day. Inovus has moved to its new premises, which afford ample space for office, manufacture and assembly, with room to expand. The injection of venture capital has allowed them to grow the commercial team and, among other things, funded a state-of-the-art 3D printer, of which there are only three in the UK. This is used for both prototyping and production, reduces hardware manufacture time, and offers sufficient spare capacity to offer bureau services to other companies at competitive prices, thus offsetting the investment. The 3D printer is also used to produce realistic surgical tissue models for use with the simulators, the added revenue from these offsetting software costs. These models permit real-feel tissue tension, enhancing the haptic effectiveness of the devices. There is also a range of non-laparoscopic devices, such as ‘Sellick’, a cricoid pressure trainer, and the ‘Bozzini’ hysteroscopy simulator.
Elliot is Inovus’s CEO, and Jordan the CTO and problem-solver who, together with Alex, the award-winning software and electronics whizz, converts training requirements into functional and affordable solutions. A third co-founder, Edward, played a crucial role in the early conception of the Pyxus laparoscopic simulator, liaising with surgeons and surgical trainees in order to develop a customer centred product. Although still important to the Inovus team, he has taken a step back from daily operations in order to pursue a career in surgery. Some software engineering is out-sourced, but the plan is to bring it in-house very soon. The ethos of the company remains the supply of equipment and, crucially, the provision of advice on requirements and usage from people who are in the profession and understand the issues. The customer base is the individual and the medical institutions, the structure of which in the UK is too complex to address here; this complexity is exacerbated by a lack of communication between the organisations, and Inovus is ideally placed and qualified to assist with this. There is no problem convincing the customers of the need – they understand the benefits and are happy to buy at the right price; contacting enough of them is the main issue. Nevertheless, Inovus equipment – mainly take-home box simulators – is already in use in 67 countries worldwide. The medical simulation industry is rapidly expanding, but the portfolios of many companies are fragmented, and functionality and affordability (and, therefore, accessibility) are key. Mandating of simulated surgical procedures is on the way, and Inovus are well positioned to capitalize on it.
Elliot and Jordan’s initial goals have been met, but the Inovus portfolio – and, therefore, their ultimate aim of becoming a one-stop-shop for laparoscopic surgery simulation - is not yet complete. Three products are on the market, full details of which are on the Inovus website: Pyxus HD, the basic take-home box with a fixed internal camera is currently priced at £420, and an enhanced version with a port-entry camera which can be fixed or manipulated (Pyxus HD Move) at £500. The institutional variant, Pyxus Pro Move has its own visual display, and offers the unique ability to practise realistic trocar insertion under view from the laparoscope; the penetration of the peritoneum is a most critical part of the procedure, since failure to anticipate ‘peritoneal pop’ can allow the trocar to continue straight through to the viscera. There will also be two high-end, high-fidelity Augmented Reality (AR) devices, which are expected to come to the market in early 2020. Finally, the Bozzini Laparoscopic package is also high-fidelity, in that it miniaturises a full surgical stack system, and uses real cameras, light leads and scopes. The AR devices create immersive effect by putting real or replicated tissue in the simulator, and building the rest of the digital anatomy around it, rather than using software, instruments or motors to create artificial feel. They will also embody tracking of full procedures to allow real-time feedback and evaluation of decision-making and instrument/camera handling.
I could not leave Inovus without trying my hand at some basic laparoscopic tasks. The practical problems rapidly became evident, and I have to report that I made the correct career choice; the world of surgery is none the worse for my absence, and the general public much the better.
Mandation of simulator training is not yet with us, but will be soon, and with it an increased ST requirement, particularly for the less frequent surgical procedures. Simulators are not thus far used for aptitude testing or vetting, but that too may come. Elliot stated that the company started up with ‘no money, no contacts and no knowledge’. I have to say that the lack of money may, in the event, have shaped their approach to the problem, driven innovation and thus proved a godsend. The contacts are something they can work on. More importantly, from where I stand, knowledge was not only a non-issue, but – enhanced by professional empathy – has been the key to their success, which I suspect will burgeon in the coming years.
Originally published in Issue 3, 2019 of MT Magazine.