Joint Lecture at The Royal Society of Edinburgh Monday 4 march 2013

Growing Healthcare Technology Businesses – Bringing Engineering Inventions to Market with Limited Resources

Ian Stevens CEO Touch Bionics

The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 The Royal Society of Edinburgh
The Royal Society of Edinburgh (RSE) is Scotland’s National Academy of Science & Letters. It is an independent body with charitable status. The Society organises conferences and lectures for the specialist and for the general public. It provides a forum for informed debate on issues of national and international importance. Its multidisciplinary Fellowship of men and women of international standing provides independent, expert advice to key decision-making bodies, including Government and Parliament. The Society’s Research Awards programme annually awards over £2 million to exceptionally talented young researchers to advance fundamental knowledge, and to develop potential entrepreneurs to commercialise their research and boost wealth generation. Among its many public benefit activities, the RSE is active in classrooms from the Borders to the Northern Isles, with a successful programme of lectures and hands-on workshops for primary and secondary school pupils. The Royal Society of Edinburgh, working as part of the UK and within a global context, is committed to the future of Scotland’s social, economic and cultural wellbeing.

The Royal Academy of Engineering
"As Britain’s national academy for engineering, we bring together the country’s most eminent engineers from all disciplines to promote excellence in the science, art and practice of engineering. Our strategic priorities are to enhance the UK’s engineering capabilities; to celebrate excellence and inspire the next generation; and to lead debate by guiding informed thinking and influencing public policy." Strategic Priorities The Academy’s work programmes are driven by three strategic priorities, each of which provides a key contribution to a strong and vibrant engineering sector and to the health and wealth of society. Enhancing national capabilities As a priority, we encourage, support and facilitate links between academia and industry. Through targeted national and international programmes, we enhance – and reflect abroad – the UK’s performance in the application of science, technology transfer, and the promotion and exploitation of innovation. We support highquality engineering research, encourage an interdisciplinary ethos, facilitate international exchange and provide means of determining and disseminating best practice. In particular, our activities focus on complex and multidisciplinary areas of rapid development. Recognising excellence and inspiring the next generation Excellence breeds excellence. We celebrate engineering excellence and use it to inspire, support and challenge tomorrow’s engineering leaders. We focus our initiatives to develop excellence and through creative and collaborative activity, we demonstrate to the young, and those who influence them, the relevance of engineering to society. Leading debate Using the leadership and expertise of our Fellowship, we guide informed thinking; influence public policy making; provide a forum for the mutual exchange of ideas; and pursue effective engagement with society on matters within our competence. The Academy advocates progressive, forward-looking solutions based on impartial advice and quality foundations, and works to enhance appreciation of the positive role of engineering and its contribution to the economic strength of the nation.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013

Ian Stevens was born in 1963 in Belfast and educated at the city’s Royal Academy and then at the University of Edinburgh, gradua ng in economics in 1985. A er University Ian spent six years in The Royal Air Force and then joined KPMG, trained, qualified and worked as a Chartered Accountant in Oxford and Prague ending up back in Edinburgh in 1998

Between 1998 and 2007 Ian was employed by Optos plc, a medical technology company specialising in the imaging of the re na, firstly in the roles of CFO in Dunfermline, Scotland, and then from 2003 as General Manager, North America in Boston, USA.

From 2007 Ian was CEO of Mpathy Medical, a surgical medical device company and in 2011 he joined prosthe c hand manufacturer, Touch Bionics, as CEO.

Ian counts himself fortunate to have been associated with the development of three disrup ve and leading healthcare technologies over the last 14 years. Firstly the Optomap re nal scan from Optos, then Smartmesh for pelvic floor restora on with Mpathy Medical and, most recently, the I-limb mul -ar cula ng prosthe c hand from Touch Bionics.

In the 2013 Annual Joint Lecture, Ian explored how these inven ons were brought to market, describing some of the challenges overcome and discussing how the products evolved to meet the needs of their users.

Image on front cover: Touch Bionics were the ‘representa ve of innova on’ for the UK Government’s Olympic Campaign in 2012.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013

Growing Healthcare Technology Businesses – Bringing Engineering Inven ons to Market with Limited Resources
The main aim of this lecture was to illustrate some of the key decisions surrounding the introduc on and growth of: Smartmesh for pelvic floor restora on from Mpathy Medical; and Ian discussed the impact of these decisions on the engineering development of the products, especially in rela on to their physical appearance, range of func onality and, where appropriate, in the so ware and mechanical interfaces used to control them. He showed how the technologies were adapted to meet their users’ needs, to survive and then flourish as businesses. the i-limb bionic hand from Touch Bionics. the Optomap re nal exam from Optos;

OPTOS

The crucial career moment came for Ian in the summer of 1998 when he went to work at Optos, with Douglas Anderson in Dunfermline. He had met Douglas a few months earlier, who had then shared the Optos fledgling business plan. At that me there was one prototype imaging system, ten (mainly R&D) staff and absolutely no revenue. Ian had been working in corporate finance and part of his job was to assess the business plans of young companies looking for equity funding. The Optos business plan was the most compelling that he had ever seen: a massive unmet need, combined with clear intellectual property and a technology which was tricky, but possible to manufacture.

It took the third team hired by Douglas to solve his problem. To get an image of the re na, you have to shine light on it and then get that light back, in and out of an opening, the pupil, which fundamentally does not like too much light interfering with it, and constricts in those circumstances.

Optos was founded because Douglas’s young son, Leif, was unfortunate enough to suffer from re nal detachments. These le him blind in one eye and with reduced vision in the other. Douglas was determined that other pa ents and parents would not have to go through what he and Leif had. As Ian said, “it’s so much be er to invent something which solves a known problem, rather than stumbling across an interes ng technological discovery and then thinking, ‘well that’s interes ng, now what shall I do with it?’”

Douglas’s team reminded him that an ellipsoidal mirror has two focal points. The solu on to the problem was therefore to place the eye at one focal point, fire a low energy laser beam into it and then place the collec on device at the other focal point to collect the reflected energy. This gave no me for the pupil to constrict, meaning there was no need for uncomfortable contact with the cornea. Ian observed that the thing about clever inven ons like this one is that they always seem obvious, just a er they have been invented!

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 From an engineering point of view, there were some significant issues to be solved, such as scanning that laser light around the en re surface of the re na. That challenge required the use of a spinning polygon rota ng at exactly 27,356 revolu ons per minute. Then there was an ergonomic requirement to posi on the eye of the pa ent in precisely the right place to get the laser beam through the pupil in the first place. In addi on, there were extremely demanding manufacturing tolerances rela ng to the performance and posi oning of 15 or so mirrors and lenses to direct and collect that returning informa on. The bigger ques on was as yet unanswered. Once the technical problem was solved, “well then, so what really – how does it all get paid for – how do you make it a business?”

The highly skilled ophthalmologist had not, via his manual examina on, obtained enough informa on to sa sfactorily diagnose Leif’s condi on. He had admi ed that he was only ‘ge ng a glimpse’. By inven ng the Optomap technology, Douglas solved those two problems – they could get lots more informa on and could record it digitally so it was there for review, rather than accessible only via the prac oner’s memory. But the technology needed to do this was very expensive – tens of thousands of pounds for each device, even a er manufacturing volume reduc ons. So how could a viable business be created?

So Optos made several decisions very early on, before it ever earned a single dollar in revenue. Optos determined: • that it would sell the Optomap image, rather than the device itself, giving the prac oner the means to carry out the screening exam and building the confidence of the pa ent; • that the Optomap would be easily reviewable, saveable and available for comparison with subsequent images each year;

The answer relates to our desire to be reassured about our health. Condi ons of, or evident in, the re na, such as diabe c bleeding, macular degenera on, re nal detatchment, glaucoma and high blood pressure are o en a-symptoma c and can be detected at an early stage via regular and comprehensive examina on of the re na. Essen ally, when we have our eyes checked – and this should be annually – we want to be told only one thing – that we are fine. But we also want to have confidence that if we are not fine then our doctor will iden fy and recognise the visual signs promp ng an adverse diagnosis.

• that huge resources would go into the so ware to deliver that educa onal experience to the pa ent and the performance;

• that it would do all this mainly in the USA, where the medical side of optometry was already a service that pa ents were prepared to pay for, rather than in this country, for example, where we generally do not expect to pay an extra fee.

• that usage levels of the prac ce would all be recorded and transmi ed daily to Optos, so that they could proac vely help those prac oners who were not being successful in ge ng all or most of their pa ents to have an annual Optomap exam; and

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 Subsequent engineering was focused on the business objec ves of high usage levels, precise and easy image-taking by the pa ent themselves, and modular equipment design, for example: Dave Nelson, President of the American Optometric Associa on, who in 2006 was leading America’s 35,000 Optometrists, recognised how cri cal the early detec on capability was to his pa ents and he remains a customer today. Optos tended to find that once a customer had this sort of experience, and they did o en, that they would never give the equipment back – they were with Optos for the long run. And of course they were making significant revenue for their prac ce through the sale of the Optomap exam – which helped!

• the pa ent so ware was designed with minimum data input me and maximum educa onal opportunity, u lising libraries of disease images for comparison, allowing zoom and pan features to review areas of interest in greater detail;

• the alignment system was consistently refined so that the pa ent would know when they were exactly in the right posi on to get that ny laser beam through the ny pupil, first me, saving me;

• the original whole system unit was modularised in order to extend the life me of the equipment indefinitely. Rental contracts could be extended a er the ini al three-year term expired, without the need for expensive equipment replacement – both the equipment and the so ware were ‘evergreen’. And all of this went alongside the necessary con nuous improvements to the repeatability, shortening and cost-effec veness of the manufacturing process.

These engineering policies allowed the stakeholders and financial backers to feel confident in the future of the company. The shareholders could see the number of Optomaps and placements rising, thus jus fying their investment, the bank providing leasing finance could see that each system was financially self-sufficient, i.e., the prac oner was selling enough Optomaps to his pa ents to cover the lease payments, and the investment bank handling Optos’s eventual IPO could see that this revenue could con nue well into the future without the need for expensive equipment replacement.

To summarise, Optos raised its first invoice for $94.50, that’s six Optomaps at $15.75 each, on 31 August 1999, and floated on the London Stock Exchange 6½ years later in February 2006 at a market capitalisa on of c$250m, by which me revenue was up to $65m annually, with over 3,000 loca ons selling Optomaps. Renewal percentage rates were in the high 90s, remain high today, and the company con nues to grow, with revenue now heading towards $200m annually.
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The final comment rela ng to Optos was that it was the proximity and regular contact of staff with customers and pa ents that prompted huge amounts of feedback, driving the direc on of further hardware and so ware development. Optos built a direct sales force and as many clinical consultants, constantly visi ng and training in the loca ons in America. Since daily usage and performance data came from every single system, the company could act quickly to rec fy any customer issues. Ian said that these were big lessons for him. Ian had moved to the USA in 2003 as General Manager and stayed for a year a er the float to help keep the growth going. But his wife and children headed back to Scotland in 2006 for schooling reasons, so in April 2007 he le Optos and a couple of months later was lucky enough to meet another brave and visionary inventor.

The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013

MPATHY MEDICAL

James Browning is a consultant gynaecological surgeon who le his hospital post and joined Ethicon, a division of Johnson & Johnson in the mid 1990s. At the me, Ethicon were introducing a new surgical product for women’s health and James was recruited to lead the product development. Ethicon had adapted the polypropolene mesh used for male hernia repair, which by then was becoming the norm rather than repairing hernias using sutures. It was planning to use the same mesh for pelvic floor prolapse in women, a condi on o en caused due to old age, obesity or following child birth.

James knew the size of the ny par cles, called macrophages and neutrophyls, which are together responsible for new ssue growth. He believed that if the spaces between individual fibres making up the strands of the mesh could be restricted to approximately 100 microns, then this would be an ideal loca on for new ssue growth to commence. Since the spaces between the strands could now be bigger, there could be more air and less mesh per square metre. Mpathy’s mesh was therefore able to be patented at less than 19 grammes per square metre – less than half the weight of that of the leading compe tors, but in clinical trials approximately 60% stronger.

James was concerned that the hernia mesh was too heavy for the more delicate area it was now being asked to be effec ve in, and that problems would ensue were the body to reject this implanta on. So in 2001 he quit his job and a secure future, raised some money from Archangel and Sco sh Enterprise, and set about inven ng a lighter stronger mesh. James did invent his lighter mesh. He invented a way to promote much higher new ssue growth a er implanta on.

Having come up with the idea and prototype, James and a couple of colleagues spent six years inven ng, literally weaving, mesh, protec ng his inven on by registering his intellectual property, conduc ng clinical trials and obtaining the necessary CE marks, and FDA approvals.

Below is an image of the material. Compared to Ethicon’s mesh there was much more space and the mesh consisted of carefully woven fibres with ny distances separa ng them.

But by 2007, he was out of money, and the big compe tors in the market place, billion-dollar companies such as Ethicon, Tyco Covidien, Bard, Coloplast, Boston Scien fic and American Medical Systems, were happy with their less effec ve products and didn’t want to buy James’s technology.

So the first phase of the engineering was complete. The next phase involved se ng up a US corpora on, branding the new company and products as ‘advanced’ and ‘market leading’, and going head-to-head in a very focused way with these huge corpora ons. Mpathy Medical had a limited range of products, and chose to sell only in the US, to carefully targeted leading urologists and urogynaecologists, with again a direct sales force.

Just as with Optos, Archangel agreed and funded this further business development, and in early 2008 Mpathy Medical launched a range of pelvic floor prolapse and stress urinary con nence implantable medical devices, all manufactured in Prestwick, Scotland from this new, lightweight, physiologicallycompa ble material called, Smartmesh.
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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 Unusually for a new product in this area of medicine, at the me of final FDA approval and product launch, Mpathy had substan al and very posi ve clinical evidence on Smartmesh’s results. There was otherwise a general absence of favourable outcome data for polypropolene mesh used for this type of surgery. It appeared that James had been correct in his reason for leaving Ethicon. The other meshes were not performing very well. But Smartmesh had achieved outstanding results in over 200 fully documented cases performed by respected surgeons before a single piece was sold. Mpathy had learned that in addi on to Smartmesh’s low density per square metre, there were other important success factors for this type of surgery; such as the surface area of mesh le in the body, the means of securing the mesh within the body, and the actual shape of the mesh in rela on to the actual loca on of the prolapse. Historically, this type of surgery had typically involved the surgeon popping down to the back of the opera ng theatre with a pair of scissors, needle and thread and fashioning a bespoke device for that par cular opera on, with the pa ent already in the theatre under a general anaesthe c. Women were being cured of prolapse, but o en suffering complica ons and rejec on because of the intrusiveness of the heavy mesh.

In bringing Smartmesh to US hospitals, Mpathy focused on a prac cal and mesaving approach for the surgeon – customised mesh. Different shapes of mesh, and different means of fixa on.

Over the next two years, Mpathy annoyed their huge compe tors so much that one of them eventually sued for alleged patent infringement. This was code for ‘we would like to buy you so that we can use your technology to advance our business’.

As a result Mpathy was sold to the Danish wound management and male urology company Coloplast. With access to their wider distribu on capability, product sales were able to grow faster and thus outsourced manufacturing stayed in Scotland. So In March 2011, Ian was out of work again. Where next?

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013

TOUCH BIONICS

Next for Ian came the chance to work with the amazing inven on that is the i-limb hand, with the aim of bringing its benefits to as many suitable recipients as possible. Ian again was lucky enough to be associated with the best product in the world in its field – and again the challenge was, and is, to develop that product and its suppor ng organisa on so as to encourate wide adop on.

The roots of the Touch Bionics project went back to the early 1960s and to the tragedy that was Thalidomide. The project was evolved over many project teams, twists and turns, to eventually bring to pa ents who had suffered upper limb loss, a mul -ar cula ng, variably-gripping, self-esteem-eleva ng, prosthe c hand. Electric hands have been around for decades, but they have been clawlike in appearance. They were very strong in their grip, but their digits lacked the ability to conform around an object, to grip with sufficient force or to independently ar culate. Those features are necessary to truly confer to the user a significant restora on of their ability to perform a wide range of the ac vi es of daily living.

Ian stated that our hands are truly amazing things. He invited the audience to consider the range of movement possible, the precision with which objects can be grasped, the sensory feedback from touching something, the assistance to balance and posi onal awareness. And humans take them for granted.

Ian encouraged the audience to try pu ng their hands in their pockets and keeping them there for even a few minutes. He suggested that this demonstrates how the en re means of dealing with the world immediately changes. He then asked the audience to imagine that to be permanent, and reminded them that “everyone you meet will no ce this and form a view of you based on how you are different, not necessarily in a malevolent way, but just because we no ce these things. So how can an advanced electronic hand provide a conforming grip and dexterity? Inven on, shrewd observa on skills and innova ve engineering were required…” Ian had known about Touch Bionics before 2011. It would have been hard not to have been aware of David Gow’s inven on when the first i-limbs came to market in 2008. At that stage however, he didn’t know anything about the history.

One day in the late 1980s, David, an engineer working for the Sco sh NHS, was working out on his wife’s exercise bicycle. He no ced that the speedometer on the bicycle was loose, that the mechanism that transmi ed the speed reading was going round and round instead of being fixed, and that it had a par cular combina on of gearing called a worm wheel inside it, and he spo ed a solu on to the manufacture of prosthe c digits which he had been trying to perfect for ten years. It was that problem-resolving discovery that allowed David to con nue his research work, inser ng a small motor into each digit, thus achieving sufficient grip strength combined with miniaturisa on. That advance, along with gaining funds from Archangel & Sco sh Enterprise, eventually allowed him to found Touch Bionics in 2002.

The Royal Society of Edinburgh had last heard about the i-limb four years previously, at the RAE/RSE Joint Lecture in March 2009. At that me, Touch Bionics had introduced its prosthe c digits in the form of a full hand, called the i-limb hand, and also for pa ents with par al hand loss. At that me around 500 pa ents had been fi ed.

By the me of this lecture over 4,000 pa ents had been fi ed with i-limbs and this was now the third genera on of i-limb called the i-limb ultra.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 The main aim of Touch Bionics is the provision of a hand of which the pa ent can be proud, thus encouraging that person to use it for a wider range of ac vi es.

Ian said it was constantly evident that if pa ents feel less self conscious, more empowered and confident, and if they have been properly trained, then they wear and use their replacement limb more o en, especially when comple ng normal everyday living tasks such as holding a cup, using a camera, playing with a ball or picking up small objects. It had been focus on everyday tasks which was the defining features of the development of the i-limb over the previous four years.

Tapping favourite grips and features in a couple of seconds allows i-limb wearer more flexibility in what they can do – so they can easily pick up a plate in a restaurant or type on a key board using an extended index finger or e their shoelace.

Some of the tools for produc vity are obvious which, he said, is the whole point. Touch Bionics seeks to simplify the use of the i-limb, believing that the wearers already have enough challenging situa ons with which to deal. And that simplifica on and learning starts before the device is fi ed. It has been found that prac sing how to use the muscles which control the hand and ge ng used to the Biosim so ware before actually being fi ed, improves familiarity and encourages faster and more permanent adop on. Pa ents simply connect up to their computers – the virtulimb is another blue tooth device. And all of the control so ware available on the computer can also be provided on an ipod touch.
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In fact the limita on of the usefulness of an i-limb hand is not in the range of movement possible, but in the wearers physical ability to control those movements.

The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 There are 14 commonly available popular grips, although in prac ce the hand can move to any combina on of digit posi ons. The ipod, and lots of training help, but the new fron er is to come up with ways to provide the brain and the body more ways actually to access and control these features quickly. Ian then described two recent improvements that came about in responses to the wishes of the pa ents just to be ‘more normal’. reduces the types of repe ve stress injuries which otherwise occur when the shoulders for example are forced into awkward movements just to get the hands in the right posi on.

The first is called Autograsp. Because the hand does not confer a sense of touch to the user, some assistance is required to stop objects which have been grasped being dropped accidentally. This can happen if the user sends an accidental ‘open’ command to the hand. If this happens then the motors will instantly operate, reclosing the fingers around the object.

The second feature is the Varigrip. This was introduced to increase the strength with which the fingers can grip, essen ally by providing an extra por on of grip force through each finger, one at a me, much as we would when we grasp an object, our fingers conforming around it, ghtening just enough to hold it securely. By applying the force sequen ally to the fingers, the hand can be controlled much more sensi vely, more power can be available to each finger, and ba ery life can be conserved. So there is less anxiety about running out of ba ery, plenty of power available, but controlled and applied one digit at a me.

A lot of me is also spent coming up with simple li le things to ‘humanise’ the hand. For instance, allowing the hand to return to its natural posi on, “as you and I would do involuntarily, a er it has been used, without having to command it to do so”. All that’s needed is to set the me delay, and this will happen every me automa cally. The wrist is a very useful addendum to our hands, providing us with enormous posi onal flexibility for our hands and digits to grasp, press, point etc. But most whole hand amputa ons mean the loss of the wrist. To try to bring back some of that func onality a flexible powered mechanical wrist is supplied and also one which can con nuously rotate. These wrists can flex in all direc ons, and their introduc on

Ian went on to talk about i-limb digits. Whole hand amputa on or deficiency is less common than par al hand loss. Thus, Touch Bionics has introduced a ‘1 to 5’ digit solu on for those pa ents with par al hand loss. It’s a very demanding prosthe c challenge, with a unique solu on for each pa ent, because every injury is poten ally very different from the next. But an incredible degree of func onality can be restored, from workplace or DIY ac vi es to the ubiquitous playsta on and the independence of opera ng a mouse. And using the ipod, together with good rehabilita on therapy, can make all these daily ac vi es a reality again.

During and a er the fi ng of the first 200 or so pa ents with i-limb digits, Touch Bionics received significant feedback, which led to a set of criteria for the next itera on of i-limb digits.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 The most visible improvement needed, related to the size of the digits themselves, or more accurately, the distance from their base to the point of rota on of the digit. That needed to be reduced and, once that was done, because the digits rotate around a point much closer to the base of the amputa on, they look much more natural and its much easier to get the fingers and thumb to oppose easily. That is, for example, how we pick up objects.

Thus i-limb digits were developed which are lighter, smaller, stronger and with all the so ware features and manufacturing robustness improvements built in. In addi on they are controllable with an ipod and have removeable and replaceable ba eries. Ian reiterated that self confidence and reduced self consciousness are the keys to usage, and that this is an important feature of the cosme c appearance of i-limb. Whilst Touch Bionics is happy to provide the terminator look-alike, ta oos, bright red, etc, most pa ents are sa sfied with access to over 400 skin colour tones, matched freckles and hairs, and nails that can be painted.

And they learned other things about par al hand pa ents. For example, that they wish to have full wrist movement, that they want their par al hand to be lighter, and therefore less sweaty – we perspire a lot through our hands – and that they want the so ware to be increasingly easy to use and for the ba eries to be easily swappable so that there is no anxiety about running out of power.

In 2008, Touch Bionics actually purchased a company which makes these cosme c coverings and has spent a lot of me and money in developing new covering methods, an -slip coa ng to allow the covering to be put on and off easily, as well as more robust and consistent formulae for the consistency of the silicon gloves. The i-limb user can therefore be unno ced in public, just as we all are normally.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 In earlier men ons of Optos and Mpathy, Ian referred to the need to ensure that, as well as being focused on the needs of the pa ent, product development must also take into account the needs of the stakeholders, whether investors, bankers or corporate financiers.

This is all also true at Touch, and a further dimension is added by the requirement for outcomes evidence by the funders of these devices, who are most o en likely to be an insurance provider or public health authority. How are the pa ents actually doing; are they using the hands regularly; are they able to perform an increased number of everyday func onal acitvi es of daily living? So having manufactured the hands, another crucial ac vity is to ensure that their use is recorded and measured, in order to jus fy the expense to the payer.

And so to the future ....

High levels of usage can be monitored by a combina on of methods – including seeking regular and comprehensively documented pa ent feedback on how they are achieving their goals, on how many of the features of the hand are in use, on how soon and easily they have got back to work and on how well the hands are maintained by enabling them always to be available for use and not in need of repair or service. The development of the repor ng capability so ware and databases to hold this data has and will con nue to be a focus.

The i-limb is capable of doing more than the human body can command it to do. No ma er what TV or the newspapers might say or hope, we will never, well not in our life mes, make something as wonderful as a human hand. But we can do lots more to redress that balance. Ian described three contras ng examples of developments, each of which has their importance, in controlling the hand, in improving dexterity and in making it easy to switch between the different features, so that the dexterity can be accessed quickly and effortlessly.

This is done by ge ng ilimb wearers to connect over the internet, so that they can report in a consistent documented manner on how they are progressing. When they do that, the hand sends a log of every movement of the hand during that me, enabling a rich bank of data to be built up of what features they have been using most o en, and also how well the hand is working.

All of this informa on is key to jus fying the expense and providing input for future product development.

Control It has been discovered that gold pla ng the electrodes which carry those ny electrical signals from the arm muscles to the hand’s microprocessor, telling it what to do, improves the reliability and clarity of those signals enormously. And it was also recognised that lower profile electrodes allow the manufacture of a less obtrusive prosthe c socket – wearers just want not to be no ced. So these very low profile electrodes are very useful in both func on and in improving appearance.

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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture 2013 Dexterity Ian had talked about how incredible our hands are, but he went on to point out that 40% of our manual dexterity is es mated to come from our thumb. Un l then it had been very difficult to make thumbs that are electronically rotatable as well as open and close. But now the solu on had been found. This means that the wearer can now autom cally and precisely use powered rota on of the thumb for those fine motor ac vi es. So, for example, just ge ng the thumb out of the way to put on and take off clothes, or to carefully pick up small objects between thumb and index finger, can now happen with one i-limb hand movement followed by use of the other hand to get the thumb posi on just right. It seems unimportant but, Ian explained, “if you had one hand, were carrying a briefcase in it, and then wanted to use your i-limb to pick up a set of keys, well you wouldn’t want to have to put down your briefcase in order to posi on your thumb to do that would you?”

real hand and that informa on could be relayed to the i-limb. This work is underway in various research loca ons around the world by external organisa ons and Touch Bionics were hopeful that the results will eventually be accessible by pa ents using i-limb. Touch Bionics itself was working and collabora ng with leading universi es in the areas of pa ern recogni on and gyroscopic control.

Ease of use And finally, thanks to the brilliance of the Apple corpora on it is now possible to pull all the elements together, the responsiveness of electrodes, the choice of grips for different ac vi es, all in a simple app available in the app store. The objec ve is to make prothe c devices a ‘normal’ feature of our everyday lives – so amputees are comfortable withtheir adop on – not inhibited or under-confident in using them. Ian stated that this was what was coming out at that me or imminently from the Touch engineering group led by Hugh Gill. They were building on the key inven on – prosthe c digits which are independently ar cula ng, robust and strong, and trying to get them used as easily and unobtrusively as possible, because the users demand it! Before closing, Ian men oned some key development areas that are the next fron er for upper limb prosthe cs.

To explain – If microprocessors and so ware could together interpret certain signals from the electrodes, and/or related physical movements and gestures, as unique to certain, grips or features, then the hand could be commanded to respond accordingly – “think of an advanced Wii and you have the general idea”.

And of course we would like to get closer to the original intent of this whole project, to make a smaller hand, perhaps not suitable for very young children, but certainly aimed at smaller humans, whether they are of school age or from for example Asian countries. With the smaller digits, neater electrodes and smaller electronics this is perfectly possible. Ian Stevens could not be more enthusias c about the future course of these developments. The company is mo vated not only by its founder’s vision, but also by witnessing the hardships overcome by the amazing pa ents who restore their func ons, not fully, because the human hand is a truly wondrous tool, but by very significant amounts.

What if surgeons could reposi on nerves in ac ve muscle. Then the body could think it was moving a
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The Royal Academy of Engineering and The Royal Society of Edinburgh Lecture Sigmund Freud said, in his book Civilisa on and its Discontents, published in 1929: The image below shows a young man, Patrick Kane who was severely disabled by meningi s when he was just a few years old.

Man has, as it were, become a kind of prosthe c God. When he puts on all his auxiliary organs he is truly magnificent. But those organs have not grown on to him and they s ll give him much trouble at mes.

Yet he ran on his prosthe c legs, carried the Olympic torch and proudly held his arms alo in Trafalgar Square on the day before the opening ceremony of the Olympic Games.

“I am not sure about the prosthe c God statement, but those last two sentences could very neatly sum up our ambi on at Touch Bionics. Raise the self esteem of the wearer – make them feel magnificent, we all deserve the chance to feel good about ourselves don’t we? But at the same me my colleagues recognise the limita ons of a prosthesis, and we seek to minimise those limita ons by wringing every bit of u lity from the ilimb by training, by making it easy to use, by making its movements mechanically be er”.

Ian stated that Society must not deny Patrick, or others like him, the opportunity fully to par cipate in this world. Patrick is empowered by his own resolve and also by the devices that assist him, and this is the big mo va on to try to bring forward engineering advances more quickly so that his life can be improved further. Ian concluded by thanking the Royal Society of Edinburgh and the Royal Academy of Engineering for invi ng him to present this Lecture and repeated how privileged he felt to have had the opportunity to work with these great inven ons. “I know that for all of these inven ons there is much more to be done”.

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The Royal Academy of Engineering/ The Royal Society of Edinburgh Joint Lecture 2013 ISBN No 978 0 902198 71 5 © The Royal Society of Edinburgh March 2013

Contact: The Royal Society of Edinburgh – www.royalsoced.org.uk – 0131 240 5000 The Royal Academy of Engineering – www.raeng.org.uk – 020 7766 0600

The Royal Society of Edinburgh, Scotland’s National Academy, is Scottish Charity No SC000470 The Royal Academy of Engineering is Registered Charity No 293074

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