First company to be owned by an NHS Trust targets £380m potential market worldwide for muscle stimulators that help stroke patients to walkOdstock Medical: a CIPA case study
As a newly-independent spin-out company, Salisbury-based Odstock Medical now has the commercial flexibility to supply its patented disability aids to many more medical professionals and patients throughout the UK, Europe and North America. When the new management team at Odstock Medical were still part of Salisbury NHS Trust, they designed a sophisticated electronic device that was helping some of the hospital’s stroke and spinal injuries patients unit to walk. However, NHS operational constraints meant that it was difficult to make the device available to patients outside the Salisbury area. The new company now has the freedom to enter into a full range of commercial arrangements with patients, Primary Health Care Trusts and medical device companies or distributors, in the UK and abroad. Odstock Medical’s lead product, the Odstock Dropped Foot stimulator (ODFS), is a patented Functional Electrical Stimulation (FES) device. It is used mainly to correct ‘dropped foot’ – the inability to lift the foot properly when walking. The condition is generally the result of neurological disease or injury, such as Multiple Sclerosis or a stroke. The Odstock Medical device detects when the wearer’s heel leaves the ground and instantly applies a controlled burst of electrical pulses to the appropriate muscle, causing the foot to lift and greatly improving the user’s ability to walk. The ODFS electrodes can be attached to the skin or, in the STIMuSTEP version, can be surgically implanted.
Although FES devices have been around since the 1960s, early versions were crude and bulky and had very few users. New control circuitry and a more intelligent interface make the FES device smaller, more adaptable and much more reliable than its predecessors. To date, over 6,000 units have been sold worldwide and Salisbury NHS Trust has treated some 2,500 patients, using the FES device. There are millions more people in Europe and North America who could benefit from Odstock Medical’s technology. Intellectual property rights Ian Swain, now clinical director of Odstock Medical, and his colleague Paul Taylor developed the FES technology while running the Clinical Science and Engineering department at Salisbury District Hospital. Both are also members of the Design, Engineering and Computing teaching staff at nearby Bournemouth University, whose patent attorney Paul Cole filed the first patent for the ODFS controller interface. Ownership of that patent still rests with the NHS Trust, who grant a user licence to Odstock Medical. The IP rights for any new technology will be owned by the spin-out company, who are already working with their own patent attorney, Helga Chapman (of Salisbury-based Chapman Molony) on improvements to the STIMuSTEP, as well as a new device for use in treating partial paralysis of the arm. Although the new company relies heavily on its technical team and the hospital’s support, its commercial strategy is being driven by chief executive Jon Lewis, who was recruited from the private sector for his track record in developing other medical and healthcare businesses. “As an autonomous company, it’s crucial we are in control of our own intellectual property rights,” said chief executive Jon Lewis. “There’s been a lot of investment in getting the product to this point, where we believe it to be a market leader, and we want to make sure that we can control its quality and effectiveness. Our patent attorneys are now very much part of the team here. The value of their input is enormous – they understand the market and the technology, as well as giving us advice on all aspects of IP, such as patents and trade marks.” Odstock Medical contracts out its manufacturing, mainly to electronics companies in the South of England, but retains quality assurance and product R&D in-house, at its recently refurbished premises on the Salisbury District Hospital campus. Sales of the ODFS have been increasing at a rate of 47 per cent annually and this is set to accelerate. “We’re already up to a team of 24 people here,” says Ian Swain. “Now that we’re free to advertise and market our products, we plan to grow much faster.” Initially, scientific papers outnumbered patients Ian Swain first got involved in developing a Functional Electrical Stimulation (FES) device in the 1980s, while working with the Duke of Cornwall Spinal Treatment Centre at Salisbury. “Although FES had been shown to be beneficial to patients,” he recalls, “It was no exaggeration to say that there had been more scientific papers published than patients who had actually been helped.
“Once we got involved in designing and fitting devices that helped people to walk, it soon became apparent that we would be able to progress faster if we had access to many more patients. This was also important in order to get randomised trial results, which we needed for Department of Health approval. There are around 800 new serious spinal injury patients each year, as against 140,000 or so stroke patients. We very quickly found we were able to help a large number of stroke patients and, at the same time, dramatically increase the amount of feedback we were getting from users. This helped us to speed up the product development and the data was important in getting regulatory approval, such as an FDA licence in the USA.” The Salisbury Clinical Science and Engineering team has benefited from encouragement and financial investment from research-funding organisations, including Action Research, the Stroke Association and the Multiple Sclerosis Trust. In the new corporate structure, Salisbury NHS Trust owns 68 per cent and its hospital charity 18 per cent of Odstock Medical. Other shareholders are the staff, with 12 per cent, and Bournemouth University, with 2 per cent. The company has also been greatly helped by the encouragement of Dr Maire Smith, NHS Director of Technology and Product Innovation. “It’s an excellent demonstration of what we’re trying to create,” said Dr Smith. “We want the NHS to gain the confidence and the feeling of local empowerment to go ahead with this sort of venture.” Sales growth will lead to new and better technology for patients Jon Lewis has experience of working with some of the twelve NHS Innovation Hubs around the UK. “The hubs’ role is generally one of looking for potential licensees for technology that has been developed within the health service, he explains. “In general, the NHS Trusts are more interested in patients than patents and their ability to generate serious revenues from their inventions is limited. Odstock Medical is the first NHS-owned spin-out company that has the potential to earn a good income from its technology – income that will be ploughed back into more R&D, leading to new and better products which will help more and more patients to improve their mobility and the quality of their lives.” Written by Peter Prowse for the Chartered Institute of Patent Attorneys.
For more information, contact: Peter Prowse, CIPA: 01372 271234 Ian Swain, Odstock Medical Tel: 01722 429065, enquiries@odstockmedical.com or Helga Chapman, Chapman Maloney, Tel 01722 782559, helga@chapmanmolony.com
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