A spoonful of electronics

The NHS needs a shot in the arm. Soaring costs and increasing public expectations will only be met if the health service exploits automated electronic devices and develops tissue engineering, says David Fowler.

William Henry Beveridge must be turning in his grave.

Since he founded the NHS in 1948 healthcare costs in the UK have risen by 820 per cent. Yet demands on medical services are at an unprecedented high – and, with a growing ageing population and the public ever more demanding and educated, they will continue to soar.

Experts believe that new technologies and techniques are the only way the health service can realistically meet public demand, but automated electronic devices that could save resources and lives are slow to reach the market. More worryingly, public antipathy could hold back introduction of radical advances such as tissue engineering – the Holy Grail of the medical profession.

‘We urgently need technology to improve healthcare for less money,’ said Share Day, electronics manager of DCA Design International, a design consultant with a strong presence in the medical sector. But how will the medical technology industry meet this challenge? The answer is likely to lie in techniques that are less labour intensive and more automated, at the same time reducing patients’ stays in hospital, or eliminating the need to attend surgeries or clinics altogether.

Telemedicine – sending data automatically from patient to doctor over a phone line for remote diagnosis, to check the patient is sticking to a drugs regime, or for electronic record-keeping – will form an important element in healthcare. Likely applications could be monitoring people with heart conditions, diabetics’ glucose levels, or the performance of implants or pacemakers.

Such devices have been made possible by low-cost microprocessors, displays, batteries and actuators, says Day. He envisages that in future you will be able to buy health-management systems on the high street such as a ‘home health manager’, which would use an armband to monitor heart rate, blood pressure, temperature, blood glucose and so on, and a floor unit to tell you your weight and body mass index. It could be linked to a PC to keep records and for home diagnosis.

An ‘electronic doctor’ would again use an armband for diagnosis and treatment and could control drug delivery from an implant or skin patch via a transducer. It could link by phone or the internet to the pharmacy to order repeat prescriptions, or to the patient’s GP. It would make hospital appointments, call 999 in an emergency and access a central database to look at the patient’s records.

However, getting new medical technology on to the market is difficult. ‘A lot of technology to meet unmet clinical needs gets stuck because of bureaucracy, a lack of funding, or a lack of awareness of how to go about commercialising it,’ says Dr Faye Smith, technology translator at the recently inaugurated Medical Devices Faraday Partnership. The partnership, bringing together technology company TWI and five universities, aims to help new technology reach the market, as well as funding research and acting as a one-stop shop where firms can seek advice.

Meanwhile, one of the most promising areas of medical technology is in danger of never getting off the ground, warn experts. Tissue engineering – growing replacement organs – has long been the medical profession’s Holy Grail. The principle is now proven, and it is estimated that the market for tissue-engineered products could be as much as £60bn by 2010. But despite investment of £2.8bn since 1990, sales in 2001 were only £63m.

The two manufacturers whose products have received the approval of the US Federal Drugs Administration – normally the point at which serious profits would start to flow in – have struggled to cover their production costs. Organogenesis, maker of Apligraf, an artificial skin for treating non-healing venous and diabetic leg ulcers, went into administration last year.

The reason, says Dr Chris Mason, clinical research fellow in the department of biochemical engineering at University College, London, is that tissue engineering still uses cottage industry techniques. An estimated two million patients suffer from non-healing ulcers in the US but Apligraf was making its product in the same way as in the laboratory – growing each patch of skin in a petri dish in an incubator. This was highly labour intensive, requiring the staff handling and monitoring the petri dishes over the 20-day incubation period to wear head-to-foot protective clothing to maintain sterility. If any piece in a batch was contaminated, the whole batch had to be discarded.

Tissue engineering needs to adopt automation techniques if it is to realise its potential, says Mason. Automation would remove the risk of contamination, provide better consistency, be scaleable to greater production quantities, and would lower costs.

Mason’s team has been working on producing replacement arteries for heart by-pass operations which would be superior to veins from the patient’s leg, the current practice. In the method developed by the team, adult stem cells from the patient’s blood are added to a form of alginate and injected into a specially designed sterile container where they coat the inside of a tube. Exposure to calcium ions causes the alginate to turn from liquid to a gel strong enough to hold the cells in place as they grow. Tubes are connected to each end of the bioreactor to allow culture medium to flow round. The stem cells are ‘switched’ into the smooth muscle cells required for an artery using a patented technique.

A new scanning method is used to check daily that the arteries are growing uniformly. At the end of the process the bioreactor would be delivered to the operating theatre, to be opened when the surgeon needed it. Design group Ideo has confirmed that the bioreactor, designed by Mason’s colleague Martin Towns, could be made for $10-$20 (£6-12).

The system is covered by several patents and the plan is to seek venture capital funding when market conditions improve. ‘Tissue-engineered products hold the promise for true functional replacement – but only if the chasm between today’s labour-intensive practices and full automation is swiftly crossed,’ says Mason.

The crux for the future health of the NHS is how soon will these medical developments become reality? Mason estimates it may take around a decade for his tissue-engineered arteries to be approved. The technology to underpin telemedicine is here already: the main barrier will be public acceptance. Dr Mehdi Tavakoli, manager of the Faraday Partnership, warns that remote monitoring devices need to make a virtue of simplicity. ‘They must be easy to use for a 78-year-old, which means simpler than a mobile phone.’

DCA’s Day also sounds a note of caution: ‘Commercial and regulatory constraints will limit the speed of development and restrict integration, and the ‘Big Brother’ element of the approach may not be acceptable to everybody,’ he says.