April 22, 2009      

Summery: Scotland based Touch Bionics has released the first commercial fully-articulated artificial hand – the well regarded and award winning i-Limb. The product itself, which is the result of more than 20 years of R&D work, looks and acts like a real human hand. As such, the i-Limb is a major advance in bionics and patient care. The advanced functionality and first-to-market advantages of the i-Limb hand, along with the company’s emphasis on upper body prosthetics (arm and hands), differentiates Touch Bionics from other prosthetics firms. While the market for prosthetic hands is limited, Touch Bionics has a three year lead over competing commercial products. Throughout 2008 and continuing into 2009, Touch Bionics has expanded into the North American and Chinese markets through distribution deals and the founding of local offices. It is also investing into R&D and releasing new upper body prosthetic devices.

Keywords: prosthetics, i-LIMB, Touch Bionics, bionics

“…the hand is the instrument of instruments.” Aristotle

Prostheses, artificial substitutes or replacements for a part of the body, have a long history. The earliest mention in literature of a prosthesis is in the Rig Veda, an ancient Hindu text written around 1200 BC. Other prostheses that predate the time of Jesus include artificial toes found in Egyptian tombs (made from a form of paper Mache) and a Roman leg dated 300 BC. In the early 16th century, Ambroise Pare, a French barber and battlefield surgeon, invented the first artificial leg articulated at the knee and ankle. The movable knee joint was controlled by a piece of string and a flexible spring operated the foot.

Artificial hands have a similar history. In fact you can see Pare’s design for an articulated artificial hand, made over 400 years ago. It was mechanical and relied on springs and triggers. The fingers moved independently, although there was one trigger that opened all four fingers.

Today, many upper body amputees employ a cosmetic artificial hand that looks real but is not functional. The main ‘working’ prosthetic hand in use is referred to as the ‘split hook’. Introduced by D. W. Dorrance just before WWI, the split hook includes a single hook and a second stationary piece that works in opposition to the side of the hook. The hook is body powered, operated through tension created with an over-the-shoulder cable and a spring. The hook is rugged, simple and low cost.

The New Generation
It was not until the latter half of the 20th century that companies began design more functional articulated hands. The introduction of new types of materials and micro electronics in the form of sensors, motors and microprocessors, combined with the advent of myoelectric control, a technology developed in the 1970s where electrodes pick up potentials emitted during contraction of a muscle, amplify them, and then transmit these as control signals to the prosthetic device, made it possible to build prosthetic devices with low power consumption and sufficient strength to be useful.

Touch Bionics
One prosthetics company that has been drawing a good deal of attention lately is Livingston, Scotland-based Touch Bionics, the developer of the first commercialized fully-articulated artificial hand – the i-Limb. The history of Touch Bionics prosthetic solutions begins in the 1960s, but it was in 2003 when the company was formally spun out from the Scottish National Health System (with funding from Archangel Informal Investments) as Touch EMAS, only to be renamed Touch Bionics in 2005. Touch EMAS was formed under joint ownership of i-Limb inventor David Gow and Scottish Health Investment Limited (SHIL). Over the years, Touch Bionics has received multiple rounds of funding from a variety of sources.

Over the past year, the i-Limb has won a number of prestigious awards including the UK’s Royal Academy of Engineering MacRobert Award (June 2008), the Multiple Sclerosis Society’s da Vinci Award (July 2008), the Limbless Association’s Prosthetic Product Innovation Award (December 2008), the Chicago Athenaeum’s GOOD DESIGN award (January 2009), and the Edison Best New Product Award (April, 2009). The i-Limb was also named Time Magazine’s top innovations of 2008.

The primary reason for the i-Limb’s prominence is that it is a commercially available product (brought to market late in 2007). Other sophisticated designs like the i-LIMB exist, but to date none have been commercialized.

The Market for Prosthetic Hands
It is commonly believed that injured soldiers are the major source of demand for artificial hands. Not so. Counting all amputees, not just hands, there were 700 Americans amputees by 2007 for both the war in Iraq and that in Afghanistan, of which 150 needed hand replacements. In WWII the total number of American amputees was 14,912 and in WWI, 4,403.

According to the Amputee Coalition of America, approximately 1.7 million Americans that have lost a limb because of illness or trauma, and relatively few (100,000 or 6%) required a replacement arm or hand. In the U.S, there are approximately 18,000 new upper limb (finger to shoulder) amputees annually. Touch Bionics estimates that in the United States alone the number of patients that would require prosthetics include 16,000 for finger and partial hand devices and 1,600 for prosthetic hands.

Reliable counts for the number of upper limb amputees worldwide are lacking. However, if one uses the Touch Bionics figures and extrapolates from the US figures (using 300M and 6,770M for the US and worldwide populations, respectively), the number comes to approximately 406,200. Other estimates put the figure closer to 1 million.

One can argue that even if the number is one million, many live in countries and circumstances that prohibit buying an expensive prosthetic solution. In other words, there is a limited market for manufacturers and the demand is relative statistic, i.e., no amount of advertising is likely to significantly increase the demand. In such cases, it becomes very difficult to justify the research and development costs necessary to bring advanced prosthetic devices to market. The business case cannot be made to recover the investment (the moral case is another matter, particular with veterans). Traditionally, companies have used university resources and governmental financing for early stage development efforts.

Advanced Functionality…
The primary commercial competitors to the i-Limb Hand are myoelectric devices that consist only of a thumb and two fingers. As noted earlier, myoelectric solutions use signals from sensors that pick up muscle movement signals elsewhere on the amputees body. Using two sensor sites, one myoelectrode site will be used to start closing the fingers of a hand, while the second site will signal to open the hand. The same movement can be accomplished with only a single sensor site, in which case the first signal is interpreted as “close” and the following signal (after a given delay, e.g., two seconds), is interpreted as an “open” command.

In the past, two viable electrode sites have been necessary to use the i-LIMB Hand. In January 2009, however, Touch Bionics announced that the i-Limb could now accommodate either one or two sites, thereby making the product available to a whole new class of users.

The i-LIMB moves all four fingers and has a thumb that can be rotated into different positions. This is an important and novel feature as it allows the i-Limb hand to support common grip configurations, some of which have not been available to amputees before. In addition to being fully articulated, the i-LIMB has something called resistance back-drive that allows the on-board microcontroller to tell each finger to stop closing when a defined level of resistance is achieves. Thus one finger may stop at the bowl of a wine glass while another stops at the stem.

The i-LIMB does not currently use pattern recognition from multiple muscles, but the company is currently working on this next area of control strategy. What type of grip the hand makes as it closes is determined by how the user places the fingers. One signal starts the closing of all four fingers and the powered thumb. Any finger that does not encounter resistance will close fully. The i-LIMB, itself, attaches to an industry standard wrist connector.

Feedback from end-users make it clear that they prefer the i-Limb over traditional prostatic hands and consider it a genuine breakthrough. Many end-users cite the product’s ease-of-use, range of activities and natural, precise movement.

… But at a Cost
The full i-LIMB prosthesis is significantly more expensive than other competitive solutions. An average i-LIMB solution for an amputee is roughly $50K (but can reach $70K). For the near term, funding for an individual i-LIMB is limited to a few specific sources – insurance companies processing claims for car accidents or work-place accidents (covered by workman’s compensation insurance) or the government (primarily the U.S. government in the form of the military or the Veteran’s Administration).

The $50K figure cited above includes the costs associated with custom tailoring the prosthesis and training the amputee. Fitting any prosthesis is analogous to a dentist’s role in making dentures or creating and fitting a crown. As a result, the prosthetist becomes the gatekeeper with regard to adoption of any new technology, such as the i-LIMB.

Touch Bionics sells to the prosthetists both through its direct sales force and via its channel partners. Using its own program, it has already accredited 400 prosthetists in the U.S., plus another 120 in 30 other countries. Prosthetists are enthusiastic about the advanced functionality incorporated in the i-Limb hand as it provides a higher level of function to the user. They also understand the same functionality equates to higher margins for their practices.

The i-Limb’s high price, together with Touch Bionics focus on upper body prosthetics means, of course, that Touch Bionics is pursuing a niche market. For the moment, since it has the only solution of its type, it is happy doing this. But to its credit, it does acknowledge that this niche is a limited market. It is fully aware of its strategy and is not resting on its laurels.

Technical Initiatives
Touch Bionics is well funded and profitable. Moreover, it is funneling its profits back into R&D with the intent of staying a few steps ahead of its eventual competition. While there are many companies developing prosthetic devices, most are focused on the 97% of amputees that are lower-body amputees. Touch Bionics has targeted the 3% that are upper-body amputees. The company has announced plans to release a smaller version of the i-LIMB hand that is more suitable for females and smaller males. In addition, it has already moved on to the sub-market for fingers with its ProDigits product (short for Prosthetic Digits). ProDigits, designed for individuals that have lost part of their hand or finger(s), are individually powered and controlled. The product is now in beta with 50 amputees.

It is planning to move up the arm, literally, to wrists first, then elbows and shoulders. It is also refining its flagship hand product to reduce the overall cost and make its cost more attractive to the Medicare/Medicaid market in the U.S.

The LIVINGSKIN Acquisition and Other Business Initiatives
Touch Bionics has made a number of moves to increase its international reach. In January 2008 the company incorporated in the United States as Touch Bionics Inc. and set up a North American headquarters in Boston, MA. The company has also set up a regional managers for major U.S. regions and signed a distribution agreement with orthotics and prosthetics distributer Southern Prosthetic Supply (Touch Bionics will still offer products to directly to clinics).

Touch Bionics’ May 2008 acquisition of New York based LIVINGSKIN, opened up the “artificial skin” market for future expansion. LIVINGSKIN produces the lifelike prosthetic skin that is supplied with the i-Limb hand. That acquisition, as well as an expansion of its development and manufacturing facility in Scotland, increased the company’s pre-launch head count from 4 to the 75 employees. It was also a key enabler of its U.S. customer support as well, since LIVINGSKIN had a fully developed customer support organization based in the U.S (Aesthetic Concerns Prosthetics, Inc.). In April 2009, Touch Bionic announced that it was expanding the LIVINGSKIN manufacturing facility in upstate New York.

Also in April 2009, Touch Bionics entered the Chinese market by signing s distribution agreement with ENJOYLIFE Prosthetics & Orthotics Company, the largest, private Chinese company in the prosthetics and orthotic industry. While the price of the Touch Bionics solution, coupled with China’s immature healthcare reimbursement infrastructure, might limit sales in China, the country’s sheer size, along with early market entry benefits, make the ENJOYLIFE distributor agreement a notable ‘win’.

Other Markets
It should be noted that the construction of an artificial hand has not been of much interest to those working in the field of industrial robotics. But it certainly will be for those working consumer robotics and humanoid robotics. The hand can be thought of as a very efficient, but generalized design, created through evolution to be multipurpose. Industrial robots are usually tailored or optimized to a specific single task.

A 3 to 4 Year Lead
In a mere two years, over 600 amputees have been fitted with an i-LIMB Hand. That is quite an achievement, and Touch Bionics believes it will be a while before it exhausts the potential of the higher priced niche even though its solution is three times as expensive as the less capable alternatives.

Robotics Business Review believes Touch Bionics has three or four years before another serious commercial solution can compete for market share. Perhaps the most interesting eventual competitor will spin out of one of DARPA’s most recent projects, the $18.1 million Revolutionizing Prosthetics program launched in 2007, which does not expect to have testable solutions for another two years, after which any product would still have to be commercialized. The company leading that effort is Deka Research and Development Corp., of Manchester N.H. led by Dean Kamen, the entrepreneur behind the Segway and the FIRST robotics competitions. DARPA has Deka, John Hopkins and others working to perfect a human arm prosthetic controlled by the brain. Yes, the brain, with feedback from the arm to the brain. What’s next?

– Steve McClure