Inovus – A Start-Up Company With A Difference

The Inovus difference in medical education. Martin (Dim) Jones reports.

When I was asked by my revered CEO to visita small medical simulation company in St. Helens, I gently pointed out that myarea of expertise – such as it is - lies in military aviation. What I knewabout medical simulation at that point could comfortably have been inscribed onthe back of a fourpenny postage stamp with room to spare; happily, there is nowmarginally less free space on the stamp and, in pursuit of this commission, Idiscovered a story of a start-up company with a difference. I am conscious ofthe fact that, although there may be a few who are equally uninformed, thespecialist 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 tosuck eggs’.

Dr. Elliot Street, Co-Founder & CEO, Jordan Van Flute, Co-Founder & CTO, Inovus Medial and Dr. Mark Wright, Investment Director, Mercia Asset Management. All Images: Inovus Medical.

I had never been to St. Helens; it is anindustrial town of a little over 100,000 souls, just north-east of Liverpool inthe industrial north-west of England; it is renowned, among other things, forits glass-making industry and its Rugby League team. Inovus Medical, the objectof 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, buttypical of their practical approach to business.

Beginnings

The story starts in 2012. One of the Inovusco-founders, Elliot, was approaching the end of medical school in Manchester,planning a career in surgery, and the other, Jordan, had just completed adegree in psychology in preparation for post-graduate medical studies, and waslooking at the utility of psychometric testing to predict success in surgicaltraining. For this, he needed a simulator to evaluate skill at laparoscopicsurgery, in which a fibre-optic light source, camera and surgical instrumentsare inserted, via ports, through the abdominal wall in order to inspect, andperform surgery on, the internal organs. Light source and camera are normallyinserted close to the navel, and instruments through other tiny incisions inappropriate positions. These procedures originated in the late 70s, became morewidespread in the 80s, and the first simulators appeared in the 90s. The mostbasic low-fidelity ‘box-simulator’ allows the insertion of instruments throughpre-made holes into a space which represents the abdominal cavity, with theimage of the internal aspect of the box displayed live on a screen. Its purposeis to permit the practice of basic tasks, such as picking things up, cuttingand suturing, and it replicates the challenges faced in real laparoscopicsurgery: depth perception, exacerbated by the transfer of a 3D image on to a 2Dscreen; triangulation, the result of the tips of the instruments being at least30cm from the operator’s hands; and the ‘fulcrum effect’, whereby a movement ofthe operator’s hand in one direction generates an opposite movement in theinstrument.

However, Jordan found that the simulatorshe needed were not accessible in the medical institutions, and too expensive topurchase privately. Neither were existing simulators very functional – thecameras were fixed, so there was no opportunity to practice cameramanipulation, and there was no real replication of the insertion of portsthrough the abdominal wall – one of the most demanding and hazardousprocedures. Nevertheless, they cost upwards of £3000, and that did not includethe instruments themselves.

Understandably, the only people able toafford them were the hospitals, and the price tag limited the number of unitspurchased, even by an organization the size of the National Health Service(NHS). This contributed to a lack of availability and, therefore, utility whenshared between multiple trainees; there was no opportunity for trainees toconduct private practice or study. High-fidelity simulators, which allowed fullprocedures, 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 ownbox-simulator, fitted with a webcam.

Meanwhile, Elliot – who knew Jordan througha mutual friend – had observed similar deficiencies in the surgical trainingsystem, the disconnect between modern learning and teaching techniques, and thelimited access for trainees to both simulation and live practice. Thetime-honoured ‘see one, do one, teach one’ process was no longer viable; therewas a need to shift away from live surgical practice towards simulation, butthis was hampered – even in teaching hospitals - by lack of access. Jordan andElliot recognized the business opportunity this presented, but acknowledgedthat, at that point, they had ‘no money, no contacts and no knowledge’. Whatthey did have was an empathetic insight into the requirement, and an innateunderstanding of some of the problems, and how to address them; in short, theyweren’t commercially well-placed, but their entrepreneurial brains were turnedon. Their aim was to make the world’s first ‘low-cost, take-home’ laparoscopicsimulator, for purchase by trainees themselves, recognizing that a surgeonshould not only be able to increase his medical knowledge through privatestudy, but also practice his or her raw skill. In this regard, laparoscopicsurgery also includes the more recent robotic variant; someone has to learn tocontrol the robot.

It is worth digressing for a moment, toreflect on how this situation arose. Simulator training (ST) was not then, andis not now, mandated during surgical training in the UK. Indeed, althoughsimulation had been mandated in the US for other medical procedures, such asCPR and advanced life-support training, it has only recently been a requirementfor some surgery. There was, therefore, no pressing need to introduce it; theremay also have been an element of ‘we didn’t do it that way’ amongst seniormedical professionals and decision-makers, and a resistance to the perceivedthreat of evaluation which simulators might bring. The NHS also suffers fromthe inertia inherent in such a large organization and, notwithstanding itssize, even low-cost ST devices present a budgetary problem for cash-strappedNHS Trusts. This lack of mandation will be surprising to anyone raised in civilor military aviation; one reason may be that aircraft accidents, with attendantmultiple casualties, collateral damage and financial implications, are moreexpensive and newsworthy than surgical mishaps, and have historically attracteda greater degree or regulation. However, it is also worthy of note thatsurgical error is not always a matter of life and death, and that minorinstances can result in increased operation time, risk of complications andpost-operative care – at a cost to both patient and taxpayer. Indeed, in thesole case of the 1.5 million laparoscopic appendectomies performed in the UKeach year, a 10% reduction in both operative time and instances ofcomplications would save the NHS £117m annually.

Laparoscopic simulator.

Improving Skills

Back to the scene in 2012. Even the basicbox-trainers then available had clearly demonstrated the capacity to improveskills in basic laparoscopic procedures; there was no negative training – thesimulator replicated the difficulties of the real thing. Lack of mandate andaccess reduced the positive effect, but mandate was anticipated, and accesswould therefore be required. Furthermore, advances in technology over theprevious five years – notably software and USB cameras – made the affordable,take-home device more feasible. This would include all necessary instrumentsand equipment to practice basic skills. The next challenge was how to get itinto the hands of potential users.

Medical students are all what those in thecivil 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 usedto 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 andJordan perceived a massive unmet need which required action from people whounderstood the problem; informal research suggested that trainees would bewilling to spend up to £900 on a single item or training experience, and evenmaking their own simulators would cost this much. The first step would be totest the hypothesis by producing a take-home box-simulator. However, withstart-up capital of £400 – the unfortunate consequence of starting the ventureas students such as outlined above - contract manufacture would not bepossible, and the partners had no accurate idea of customer demand.

They therefore decided to become themanufacturers and, working from Jordan’s grandparents’ garage, they made thebox using sheets of plastic, a heat-gun, the side of a refrigerator and apower-drill. They sourced a suitable camera, used surgical instrumentsavailable on the open market, and used a laptop as a visual display.

The idea was to get the device in front ofcustomers, get them to buy and use it, obtain feedback and use the saleproceeds to develop the business. Jordan created a basic website and, withintwo months, they had their first sale. By this time, Elliot was about to sithis finals and Jordan was working in the pharmaceutical industry.

Next Steps

The next step was to approach seniorsurgical educators, and they received positive feedback from the consultants.The average teaching hospital could only afford a couple of devices at £3000apiece which, with often 20+ surgical trainees, resulted in insufficienthands-on time and consequent skill fade. The ‘take-home’ software set-up andlaptop configuration was not suitable for institutional use, but aplug-and-play version, with its own screen, for half the current price woulddouble the number available and with it the trainees’ access; better still ifthis new device could remedy the functional shortcomings in the existingequipment (no ports, camera limitations and unrepresentative insertionmembrane). Six months after forming the company, Inovus had its first sale ofan institutional simulator; they had halved the price and doubled thefunctionality. Furthermore, the two levels of device were entirely compatiblewith a ‘hub-and-spoke’ system, the institutional variant as the hub, and thetake-home as the spokes. The foundations of success had been laid; Inovus hadchallenged the ‘take-it-or-leave-it’ status quo and started to progress towardstheir ultimate aim of providing a vertically integrated ‘one stop shop’ forlaparoscopic simulation.

Fast-forward to 2015. Jordan was stillworking in the pharmaceutical industry; Elliot had passed his finals andcompleted two years as a junior hospital doctor in Oxford, while doing thesales and marketing for the company in his ‘spare time’. This point generally marksa hiatus in a doctor’s professional training, before embarking on specialisedtraining, and Elliot used it to leave Oxford and run the company full-time,while maintaining his clinical practice at weekends – a solution which was goodfor him and good for the company. The heat gun and plastic sheets had beenreplaced by a heat-forming jig (I have no idea whether the refrigerator stillhad a part to play), space had run out in the grandparents’ garage, and thecompany had moved to the basement of a pub in St. Helens. The focus was now ondeveloping 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 capitalhas allowed them to grow the commercial team and, among other things, funded astate-of-the-art 3D printer, of which there are only three in the UK. This isused for both prototyping and production, reduces hardware manufacture time,and offers sufficient spare capacity to offer bureau services to othercompanies at competitive prices, thus offsetting the investment. The 3D printeris also used to produce realistic surgical tissue models for use with thesimulators, the added revenue from these offsetting software costs. Thesemodels permit real-feel tissue tension, enhancing the haptic effectiveness ofthe devices. There is also a range of non-laparoscopic devices, such as‘Sellick’, a cricoid pressure trainer, and the ‘Bozzini’ hysteroscopysimulator.

Bozzini hysteroscopy simulator.

Elliot is Inovus’s CEO, and Jordan the CTOand problem-solver who, together with Alex, the award-winning software andelectronics whizz, converts training requirements into functional andaffordable solutions. A third co-founder, Edward, played a crucial role in theearly conception of the Pyxus laparoscopic simulator, liaising with surgeonsand surgical trainees in order to develop a customer centred product. Althoughstill important to the Inovus team, he has taken a step back from dailyoperations in order to pursue a career in surgery. Some software engineering isout-sourced, but the plan is to bring it in-house very soon. The ethos of thecompany remains the supply of equipment and, crucially, the provision of adviceon requirements and usage from people who are in the profession and understandthe issues. The customer base is the individual and the medical institutions,the structure of which in the UK is too complex to address here; thiscomplexity is exacerbated by a lack of communication between the organisations,and Inovus is ideally placed and qualified to assist with this. There is noproblem convincing the customers of the need – they understand the benefits andare happy to buy at the right price; contacting enough of them is the mainissue. Nevertheless, Inovus equipment – mainly take-home box simulators – isalready in use in 67 countries worldwide. The medical simulation industry israpidly expanding, but the portfolios of many companies are fragmented, andfunctionality and affordability (and, therefore, accessibility) are key.Mandating of simulated surgical procedures is on the way, and Inovus are wellpositioned to capitalize on it.

Elliot and Jordan’s initial goals have beenmet, but the Inovus portfolio – and, therefore, their ultimate aim of becominga one-stop-shop for laparoscopic surgery simulation - is not yet complete.Three products are on the market, full details of which are on the Inovuswebsite: Pyxus HD, the basic take-home box with a fixed internal camera iscurrently priced at £420, and an enhanced version with a port-entry camerawhich can be fixed or manipulated (Pyxus HD Move) at £500. The institutionalvariant, Pyxus Pro Move has its own visual display, and offers the uniqueability 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 continuestraight through to the viscera. There will also be two high-end, high-fidelityAugmented Reality (AR) devices, which are expected to come to the market inearly 2020. Finally, the Bozzini Laparoscopic package is also high-fidelity, inthat it miniaturises a full surgical stack system, and uses real cameras, lightleads and scopes. The AR devices create immersive effect by putting real orreplicated tissue in the simulator, and building the rest of the digitalanatomy around it, rather than using software, instruments or motors to createartificial feel. They will also embody tracking of full procedures to allowreal-time feedback and evaluation of decision-making and instrument/camerahandling.

I could not leave Inovus without trying myhand at some basic laparoscopic tasks. The practical problems rapidly becameevident, and I have to report that I made the correct career choice; the worldof surgery is none the worse for my absence, and the general public much thebetter.

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.