Medical exoskeletons: advent of a new industry

A lire sur: http://www.paristechreview.com/2014/04/23/medical-exoskeletons/

Matthieu Masselin & Alexandra Rehbinder / Deputy CEO and Business Developer, Wandercraft / April 23rd, 2014
Initially developed for military uses, exoskeletons are now moving into civvy street, with applications under development for disabled senior citizens or handicapped persons. Business of this product calls for sophisticated technologies by also for a clear view at the end-users. In this technology-intensive, leading edge emerging market, start-ups are out front.

ParisTech Review – So, let us begin at the beginning: what exactly is an exo-skeleton?

Alexandra Rehbinder – Essentially, it is a medical mobility aid that takes the form of an external structure enabling users to reproduce movements when they walk. Exoskeletons today are aimed at persons with mobility deficiencies. Wandercraft is especially interested in cases of paraplegics and certain forms of myopathy. Subsequently, the product will be adapted to the needs of a much larger spectrum of patients: future models, for example, will enable partly disabled senior persons to benefit from a comfortable, discreet mobility compensation.

Matthieu Masselin – Exoskeletons can be classified among service robots, a rapidly expanding field. The concept existed as of the 1970s, but was only developed some 20 years later, for military possibilities, as often happened with leading edge technologies. The basic idea is to amplify movements and to provide infantry with added capacity. The models that were developed weighed several dozen kilograms. We are already into 2^nd generation models, providing spectacular progress: the XOS2, designed by the American group Raytheon, one of the exoskeleton benchmark companies, only weighs ≈10kg and uses twice less power than their XOS 1. It is used to physically manoeuver heavy loads, with a performance level tripled compared with that of an unequipped soldier.

The XOS-2

However, the exoskeletons we intend for medical use and currently under development are part of a very different world. By moving to civilian applications, functionalities change too: we no longer need to amplify, in a spectacular way, performance levels that are already excellent but more to offer persons with diminished mobility a chance to recover a normal life-style, or at least as close as is possible to ‘normal’. There are some real challenges here: remaining standing up, making various movements … all essential functions if they want to enjoy a social life. So performance is not the target, but mobility and autonomy and, on top of these, a degree of restored dignity.

ParisTech Review – What has become possible, technologically speaking, through the move from military to civilian applications?

Matthieu Masselin – Firstly, there is a drop in costs and miniaturization of the electronics. There is also the computer science input with the development of ‘on-board’ control systems, which alone represent a true technological breakthrough. Last but not least, there is phenomenal computation power we have today in the most common microprocessor chips. It is this data processing power that allows us, notably, to generate ‘in line’, straight locomotion.

All told, many components and functionality have ‘off the shelf’ availability, at reasonable prices. Just like our competitors, we use building bricks: for the batteries, the motors, sectors in which technologies are mature. There is no point in searching for something new when the item already exists and proves satisfactory. In other cases, for example, in mechanical engineering, we use existing technologies (CAD software packages, modelling software, for example), to design our own customized architecture. Lastly, we own the property rights for the automation/control and the architecture itself: that is exactly where our added value resides.

Alexandra Rehbinder – We shall also be adding composites to the structure, given that they are light and resistant. There has always been remarkable progress in modelling the human body and in questions of bio-compatibility. In the Arts & Metiers ParisTech incubator, we have been working only a short distance from Wafa Skalli’s Bio-Mechanical Engineering Laboratory, a world-class benchmark for these questions (cf. this interview published in 2012 on the ParisTech Review site).

Exoskeletons are at the interfaces of several worlds: state of the art knowledge in medicine, in mechanical engineering, in electronics but also in mathematics, data processing and computation. In our research and development work, we use these different knowledge bases. In more general terms, we are not just rethinking and developing a product, but also reflecting on the range of medical services it could offer, which takes us into the fields of ergonomics, comfort and other problem-areas for the users, for their safety concerns and for the intrinsic medical value of the instrument, the purpose of which, I recall, is to aid patients, and its legitimacy in avoiding creation of new pathologies, obviously!

Once the product is readied, we shall process with certification and associate clinical tests. That phase will last approximately a year, which in fact is much faster than the authorizations needed for medicinal drugs, but we have to include the time-to-market factor in our business development plan or, put more bluntly, in our future financial plans. This is not just a constraint, inasmuch as EC regulations in the health sector are very demanding; when a product is awarded the EC hallmark, it has access to the entire European marketplace and also to a certain number of other countries outside the EU who place their trust in the hallmark and EU standards.

ParisTech Review – Exoskeleton projects tend to monopolize scientific skills, and beyond that industrial know-how and, more largely, the kinds and extent of experience that you only find usually in major groups. We noted that all 3 founders of Wandercraft are under 30 and, all told, you have a team of 10; do you think you’ll reach your goals?

Matthieu Masselin – Our project is ambitious and all the more so that the 3 founders you mentioned launched the company as a start-up immediately after graduation from Ecole Polytechnique, at which time they had little to no experience. But they wanted to do something out of the ordinary and, when you think about it, it is easier to launch a business at the age of 25 rather than wait till you’re in mid-career.

Moreover, the basic skills needed for the project in hand correspond to the founders’ profiles: one is a specialist in mechanical engineering, one in mechatronics and the third in automation/control functions. Each founder had an original core group of skills round him and other skills joined us. Alexandra, for example, graduated from a school of commerce and knew perfectly how to “read” the specific marketplace that is of interest to us. It can prove useful to understand the reimbursement mechanisms in a given segment of the European markets, which helps us target the most attractive countries as potential market outlets.

Lastly, we have some excellent external support and this could make the difference in industrial terms. We are accompanied by experimented entrepreneurs who assure the contacts we need with potential investors and who also have a professional eye on what we are doing and our processes, plus the prototyping, the identification of subcontractors and the relationships we should develop outside the company. We also have a partnership going with Mines ParisTech and we are currently working in close association with potential patients’ associations. Wandercraft is not an isolated company; it is part of an eco-system.

Alexandra Rehbinder – Our Company’s viability, at this stage, was enabled by a fiscal and financial context favourable to development of innovative SMEs, especially the small enterprises. We can register our activities under fiscal measures such as the statute of the ‘recent innovative companies’ (start-ups) or from the French Government’s tax rebate for R&D expenditure (CIR) which together, when combined with support from both private and institutional investors, enabled us to work over the past year and will continue to do so throughout the coming year, but without making any turnover or profits. Confidence and mutual trust is an essential ingredient in this kind of business. Private investors are also very important: they attest that the project is reliable and solid financially and this serves as an encouragement for public investors such as France’s new Investment Bank followed by the Regional authorities.

Matthieu Masselin – Investors, above all other considerations, want results, not promises. We have already assembled a prototype and are in the development phases that will proceed in parallel with the product’s certification process before authorization to enter the market and launch industrialization. To give you some tentative figures, we plan for 20 units in the first year of sales, this being around mid-2016, rising to 100 units for 2017. Our ability to raise the production rates will therefore be tested fairly rapidly and we are already identifying sole sub-contractors that we think are among the most reliable. Note that we do not plan to become a plant-less or immaterial enterprise: part of our production and assembly will be in-house.

Some of the sub-contractors we have in mind are already certified for medical material and this will be an advantage. We shall be working in close collaboration with these companies, since product design features are primordial for our after-sales servicing. All parts must be readily accessible, but not by anyone! Reliability is also and obviously very important, notably when our product is used outside a hospital environment and becomes part of someone’s daily life equipment and accessories. This might take us to consider remote system monitoring, even though we shall not develop this option in the immediate future.

As you can see, we have resolutely taken an industrial approach. In addition, we must deal appropriately with the question of counterfeit risks, even if they are limited by the number of component parts involved, by the very specialized know-how, and above all by the software package, which is very difficult to access.

ParisTech Review – Who are your competitors and what do their products look like?

Alexandra Rehbinder – The French Defence authorities are not as yet active in this civilian area; they share a very different market with others clients like the US Pentagon. Medical exoskeletons is a barely emerging market and our competitors are also small businesses like us.

We can cite the Japanese company Cyberdyne and its founder Dr. Yoshiyuki Sankai, from the University of Tsukuba. They have developed an original concept with body patches to pick up nerve transmission signals. This solution, however, is not adapted to all patients, for example, for paraplegics who have lost their nerve transmission capacity.

Argo, an Israeli company, has sold a few copies of an exoskeleton associated with crutches for certain rehabilitation care centres.

Rex-Bionics, from New Zealand, has developed a model for paraplegics selling to private persons, for the moment some rich clients, at a price somewhere between 100 000 and 150 000 $US. The resulting locomotion is somewhat ‘robotic’ but the patient’s arms are free. It is a fairly unwieldy apparatus weighing nearly 40 kg and enables the patient to advance at 3 metres/min.

ParisTech Review – And what is Wandercraft’s position today?

Matthieu Masselin – Wandercraft, if you like, is positioned somewhere between Rex Bionics and Argo: use of the arms is safeguarded, the apparatus is light-weight and fairly discreet. Control for our exoskeleton is via inertial gyroscopes: the computing device aggregates and blends data (collective data from the MEMs and electro-mechanical micro-systems) to correctly interpret the upper body position and apply the desired motion.

We are trying to develop a light-weight, comfortable and discreet appliance, ideally not drawing more attention than a normal body organ. Questions of design and ergonomics are essential here and they are integrated very high upstream in the overall design process. It also represents a marketing challenge: not to scare off potential clients, rather give them the urge to try and master the apparatus; likewise, there is a social challenge: avoiding all forms of stigmatization. ‘Wearing’ an exoskeleton is not anodyne. It should enable a patient to reach a normal walking speed (3.5km/h) and operate continuously for 3hr at this speed; in short, a normal day’s walking.

We recently received a message from a person who had tested an exoskeleton, telling us that the experience had been “a psychological victory”. That is the real challenge, to come up with a product that fulfils this need and induces this feeling of ‘victory”. That is why we are spending considerable time thinking seriously about utilization scenarios: how, for example do you put on (or get into) an exoskeleton and how do you remove it (get out). How do you sit down on a chair? Etc. What we have is a tool that derives from the world of robotics, but it must not turn people into robots. If we think ahead, the horizon for the product is to see it become a sort of garment, something we can forget when we ‘wear’ it , something that makes us feel good when evolving in Society.