Medical emergency

Many important and innovative medical technologies that could save both NHS costs and lives are failing to reach UK patients. Julia Pierce and George Coupe report.

THE UK’s hospitals are not reaping the benefits of the wealth of new medical technologies being developed in this country, and thousands of patients are suffering as a consequence. Insufficient money is being invested into companies researching new medical devices. Technology that has been developed in the country’s top laboratories is failing to filter through to our hospitals. So UK-developed equipment that could save lives and NHS funds is going to waste.

By their own admission, the country’s top academics and innovators are currently labouring within a system that thwarts the transfer of medical device designs from laboratory to use. At the same time it puts almost insurmountable obstacles in the path of companies, often small start-ups, set up to produce new devices, making their very survival a lottery.

The two main barriers to the transfer of technology are gaining funding to develop the device to a stage at which industry or venture capitalists will be prepared to invest, and gaining the CE mark which in Europe certifies a product is safe for use.

Gaining a CE mark requires a dossier to be submitted, including clinical trial results, to a body accredited by the Medical Devices Agency (MDA), an NHS regulator that investigates adverse incidents and safety issues relating to all medical devices.

But achieving a CE mark is no guarantee of success. As many experts complain, clinical trials may not give a complete picture of the effectiveness of devices, leaving doctors’ questions unanswered. This breeds mistrust and conservatism among consultants, who are unwilling to risk implementing technologies they may view as fundamentally unproven.

Only a fraction of innovations make it even this far. Carrying out clinical trials takes time and money. The length of the process can make finding and retaining financial backing all but impossible. ‘Attracting venture capitalists and keeping them interested is a problem,’ says Mike Cane, a founder of AstronClinica, developer of the Siascope which detects early-stage skin cancer and shows promise in identifying retinal diseases leading to blindness. ‘A lack of clear milestones for the early stages of development makes it difficult for investors to evaluate how far a product has come.’

Meanwhile, the National Institute of Clinical Excellence (NICE), set up by the government to assess the cost-effectiveness of technologies and aid their passage into the NHS, is too far removed from the development process to help innovators. ‘NICE stands as a gatekeeper between proven technologies and their wide use in the NHS, but there is nothing to mark their early progress before they reach this point,’ says Cane.

The costs associated with setting up and running a medical technology firm are prohibitive. Companies must pay out for patents and safety certification for individual countries (outside the EU). Then throughout the company’s life there is the cost of protecting its patents against infringement, as well as the need to fund ISO9000 certification and other regulation.

‘You must be prepared to invest £20,000 to £30,000 on things unconnected with the quality of your product.’ This is too much, says auditory biophysics professor David Kemp of University College London’s Centre for Auditory Research, and founder of Otodynamics.

Regulation and funding are not the only problems. Gaining access to the crucial market of the NHS can be difficult, to say the least.

In 1977, Kemp invented a system for testing a child’s hearing within a few hours of birth, by measuring the internal vibrations that a healthy ear makes as it processes sound. When children are born with a hearing problem it is very important that they develop an awareness of sound early on so that their language and communication skills grow. But conventional tests are crude and carried out only after around eight months.

With Kemp’s system problems can be addressed by fitting the child with an implant or hearing aid from as early as three months. But though this is a British invention, only 20 per cent of UK children are due to be screened by this process by the end of 2003 – whereas by 1997 75 per cent of infants in the US were being tested using the equipment.

Given his own experience, Kemp is critical of the current model for technology transfer. ‘The government puts money into university research with the motive that ideas will be sold to industry and the product will be produced. But it isn’t that simple,’ he says. ‘Technology transfer groups at a lot of universities don’t have the money to push ideas so it’s a dead loss. While academics may be excited about a system, it is hard to get heads of industry interested. People are constantly finding new ways to monitor the body, but you really don’t get much transfer.’

He believes that the problem lies with the funding of technology transfer units, and says it would be better to provide a pot of funding allocated via a competitive system. ‘Universities can’t afford to employ high-fliers, so staff tend to go down well-trodden paths when marketing devices. The unit is seen as a way of clawing back investment in research, so it doesn’t get the investment capital that could be used to get ideas off the ground.’

While saving money might appear to be at the top of the NHS agenda, technologies to achieve this are having difficulty reaching their target, as Dr. Harshad Navsaria, deputy head of the department for wound healing and tissue engineering at Queen Mary’s School for Medicine, has found. Along with researchers from Italy and Germany he developed a silicone dressing that mimics conditions in the womb to reduce the healing time and scarring of burns patients and those with chronic leg ulcers.

The EU-funded design consists of a thin outer layer of silicone containing epidermal cells taken from the patient and an inner layer of sponge-like hyaluronic acid derivative called Hyaff11. This contains dermal cells, which absorb any secretions from the burn to form a bioactive gel. Although it has proved more effective than existing products in trials and has the potential to drastically reduce the length of time patients stay hospitalised, only a few hospitals in the UK are using it.

According to Dr. Navsaria, educating healthcare professionals about the new device and persuading them to use it is a major barrier. He says that comparing the new device to existing systems through controlled trials would help to combat this by providing reliable data on its performance. However, resistance from manufacturers would have to be overcome. ‘If a company has 20 per cent of the market and the rest is shared by another four products, they are unlikely to risk losing that through holding comparative trials,’ he explains.

‘We in the UK are far behind other countries in this regard. Surgeons might hear about a product but they do not have enough information about it to be confident to use it properly,’ he says.

Clive Bray, head of Device Technology and Safety at the Medical Devices Agency, adds: ‘One of the main problems with getting a device to market is convincing the users that there is a need for change. If surgeons are comfortable with the technique for installation and performance of, for example, a hip replacement, they often don’t want to change.’

Testing the life of implants subjected to high levels of stress can be difficult. ‘It takes a long time to plot the survival rate for an artificial hip,’ says Dr. David Jefferys, chief executive of the MDA. ‘Surgeons don’t want to have to carry out a raft of replacements if something goes wrong.’

Navsaria says one solution would be for the government to provide hospitals with enough cash to do their own trials of different products that arrive on the market. That way the best technologies would have a chance of rising quickly to the top and enjoy wider and more prompt use in the NHS.

But a different solution is now being proposed. Brunel, Ulster and Nottingham Universities, under the banner MATCH, are currently bidding for the EPSRC funding to establish a centre aimed at reducing the time taken for a device to progress from concept to market acceptance. The consortium plans to improve manufacturers’ business processes to help them understand users’ needs, in the hope of producing better products and providing a remedy to the problem of supporting a technology once in use.

‘Sometimes people contact us with the grain of an idea but don’t understand that you have to be able to support the technology once it is in use, especially if a large number are to be sold,’ says Jefferys. ‘The Health Service operates 24/7 and operates on a tight budget. If a device goes wrong they need to correct this rapidly.’For a technology to find its market clinicians must be convinced of its abilities using a universal system that makes comparisons between alternatives clear.

‘In the past the NHS has bought plenty of new devices which are not up to the job,’ says Oliver Wells, vice-chairman of the Association of British Healthcare Industries. ‘What doctors need are better, more explicit models that reveal not only how a technology has performed in a single hospital, but how it would work across the board. Doctors can then take these to the hospital administrators and make a strong case for buying a new technology.’

But even if MATCH is successful, unless a fundamental change in the funding and transfer process takes place, many promising systems will still fail to reach a marketable stage. The true cost of this to patients and the NHS is impossible to tell.

Sidebar:product development – a long and expensive process

The founder of a successful UK medical technology group warns that attempts to ‘short-circuit’ the current development process could backfire.

Colin Goble – an engineer who set up medical systems specialist Gyrus with his surgeon brother Mark in 1989 – claims that a unilateral bid by the UK to assess new technologies at an early stage risks undermining their credibility, especially in the international arena.

‘The problem with that approach is that if you short-circuit the present lines of development, you inevitably reduce confidence in the technology in question,’ he says.

Goble claims the very fact that a new technology has overcome the many obstacles in its way gives it kudos with users and investors. ‘You really do need people cheerleading for you,’ says Goble. ‘You need them standing up and saying ‘this is a good product’.’

According to Goble, for those advocates to be listened to they need to be credible figures within the medical profession. Such people, he argues, will not lightly put their own reputation on the line in support of an unproven technology.

Despite these reservations Goble, Gyrus’s technical director, admits the current development process is fraught with difficulties. He says he is sure that potentially useful medical technologies are failing to reach patients.

It took Gyrus a decade to find its way through the development maze. The company, which manufactures specialist surgical systems based on radio frequency technology, has a turnover of over £50m a year and employs almost 200 people. It has a stock market listing and even snaps up US rivals operating in the same field.

But Gyrus had no backing for several years before securing the all-important US approval for its first product. Until then, says Goble, the company was kept going by ‘re-mortgaging ourselves up to the hilt’.

Innovating in the intensely competitive medical sector is made even harder by the problems of protecting the intellectual property in new technology. ‘In our sector there are 25 patents filed each week in the US alone,’ he says.

Goble believes the fragile state of the stock markets has closed off important sources of funding for many young medical ventures, which could once have raised money through a share listing fairly early in the development process.

That makes the role of the private equity community even more vital. However, venture capitalists are no less rigorous than the medical profession in their assessment.

Patrick Lee, a partner at Advent Venture Partners, says a new technology project is already likely to have needed significant amounts of money spent on it before its developers can talk seriously to equity firms like his own, whose average investment is £10m.

‘I would guess that sums in the hundreds of thousands would already have been spent,’ he says. ‘We will always look at any good idea, but because of our criteria it is unlikely we would invest in something straight off the drawing-board.’

Funding for pure start-ups is available, but not widely. That leaves many new medical ventures dependent on the goodwill of university labs or government research grants – or, like the Goble brothers, a friendly bank manager.

Sidebar: Match – an economical supply of effective equipment to the NHS

If new medical technologies are taking too long to reach our hospitals, part of the problem can be blamed on the fragmentation of the industry and the difficulty of running effective clinical trials.

The medical devices sector is the poor relation of the pharmaceuticals industry in many senses. At the top there are several successful large companies which are followed by a long tail of small operators. The majority of these small firms have neither the means nor experience to pay for trials or tread the difficult path towards market acceptance of their device.

According to the Association of British Healthcare Industries, start-up companies develop a significant proportion of new technologies. Often the people running these companies, mostly academics, have no track record of promoting their inventions.

They may promise a radical improvement in patient care, or to cut NHS costs, but unless the developers also have large amounts of cash to see them through the lengthy development and acceptance process, their inventions run the risk of never leaving the laboratory.

The converse problem is that there are plenty of devices that make it into hospitals and are found later to be not up to the job, according to Oliver Wells, vice-chairman of the ABHI. ‘Doctors often point out that there are a lot of bad technologies around. They sound good in theory, but when you get them into practice they don’t work as well as they should.’

However, there are now plans to change all this. Wells is co-ordinating an initiative by the EPSRC to establish a Multidisciplinary Assessment of Technology Centre for Health, MATCH. Its aim is to reduce substantially the time and cost from concept to market acceptance for devices and technology that will ‘bring real benefit to patients, users and healthcare providers’.

The EPSRC is putting up £2.5m and is evaluating a bid from a group of universities and industrial partners who must contribute a similar sum.

Wells said it became clear that it was necessary to help doctors make the right decisions on which technology to buy. The move in the NHS towards evidence-based medicine in the 1990s meant data on new technology must be collected in a much more rigorous manner.

‘The question was how do you do that for all the new technology that is being developed? There are 10,000 categories of product in this sector alone,’ says Wells.

What is required is a new set of techniques for the timely assessment of each new device. Unlike pharmaceuticals, new medical devices do not lend themselves readily to statistical analysis. A drug can be tested on hundreds or thousands of people and placebos be mixed into the test to reduce bias.

None of this is possible with new medical technologies. Devices may be used only once a week in two or three hospitals that specialise in certain treatments. What doctors need are better, more explicit models that reveal not only how a technology has performed in a single hospital, but also how it would work across the board.Prof. Terry Young of Brunel University is co-ordinating the bid for MATCH, with partners Ulster and Nottingham Universities. In his draft proposal he claims that MATCH will ensure an economical supply of effective technologies to the NHS.

He agrees that conventional randomised control trials, RCTs, are not appropriate for evaluating a new medical device. ‘Designing and running full-scale RCTs will be beyond the means of many companies. Furthermore, the size of product runs often makes it hard to obtain meaningful statistics. Finally, technology often continues to develop over the period during which the trial would be run.’

An alternative is the ‘tracker trial’ which allows the new device to be assessed as it is being developed, and Prof Richard Lilford, professor of clinical research at Birmingham University, who has proposed this concept, is a key member of the MATCH team.

‘The more the uncertainty about new products can be reduced before they come to human testing, the smaller and quicker an appropriate trial can be made,’ says Young.

Bayesian statistics can be used to combine information from different sources along with trial results to get a better overall decision, often within a shorter or smaller trial.

MATCH will also research ways to improve manufacturers’ business processes to reduce costs and speed the route to market. One possibility might be to exploit trends in mass customisation, looking for instance to the automotive industry. The third strand of research is to help manufacturers better understand what the user actually wants or needs. ‘Users often lack a voice, which can lead to both the provision of inappropriate technology, and a lack of effective products,’ says Young.

Sidebar: Thwarted Innovation

August 1977 Prof David Kemp’s discovery of physiological phenomenon of sound emission from the inner ear or oto-acoustic emissions (OAEs) at the Royal National Throat, Nose and Ear Hospital, now associated with UCL.

December 1977 Paper on discovery declined by Nature.

April 1978 Medical research grant awarded to Kemp. Prototype instrument demonstrated to the National Research and Development Corporation, and patents for hearing test device filed by NRDC.

1978 EC study confirms that more than one in 1,000 babies have a hearing problem and 50 per cent go undetected for a year.

Sept 1979: International scientific conference called by Kemp to discuss the new auditory phenomenon.

1982 First media interest in new hearing test from Thames News and Tomorrow’s World.

1983 Other scientists track down the cell making OAEs.

1984 Kemp assists NRDC in presenting prototype OAE instrument to major players in the field. After a long search NRDC/BTG licenses technology to ailing UK company Peters.

1985 Peters instrument AP200 flops: it is not well engineered, the company is technically weak and it goes into bankruptcy shortly afterwards.

1986 NRDC fails to find another backer. No major firm in the field is ready to invest in the ‘new’ technology.

1987 Kemp and colleagues build new prototypes at RNTNE/UCL based on a PC expansion card that allows anyone with a PC to do the new test.

1988 UCL’s technology transfer unit decides it cannot invest or help Kemp find a backer and recommends he markets it privately. Kemp and his wife buy back patent for £15,000 and form Otodynamics. Initial order from France for 20 systems at £3,000 each.

1989 Worldwide sales of instrument ILO88 begin from a garage in Hatfield, marketed by word of mouth between specialists. US Food and Drug Agency clearance gained as ‘equivalent’ to early forms of hearing test.

1989 Otodynamics’ ILO88 adopted as key instrument in a major US study of practical universal newborn hearing screening (UNHS) methods.

1992 First attempts at infringement of patent by competitors, a continuing problem and drain on resources until the original NRDC patent expires in 2000.

1993 Otodynamics wins Queen’s Award for Outstanding Export Achievement by a small company (£1m per annum with four employees).

1993 NIH in the US recommends all babies be screened using the new technology.

1994 NHS commissions a study of UNHS for UK.

1997 Report to NHS by MRC recommends UNHS.

1997 Austria buys Otodynamics products and develops a UNHS programme that covers 80 per cent of births. USA coverage reaches around 50 per cent.

1998 Otodynamics wins Queen’s Award for Technology, for Echoport which connects to a laptop computer.

1999 Handheld Echocheck hearing screener selected as a Design Council Millennium Product.

2000 Patent ends and international competition intensifies. Annual turnover peaks at £2.9m.

2001 NHS begins selecting instruments for its UNHS programme. Majority of instruments bought by NHS for first phase (20 per cent coverage) are Otodynamics’.

2002 Economic factors plus growing competition limit sales to around £2.3m per annum. Rapid advances in digital technology require revisions of hardware so that all profit has to be reinvested in R&D. Shortage of experienced hardware and software engineers hampers speed of product development.