Pushing the frontiers

Tom Shelley reports on the challenges – and opportunities – involved with developing new medical device products

The rate of development of new medical products is massive. But as well as offering opportunities, there are also technical challenges to overcome. At the same time, there are signs that pharmaceutical majors are entering the market, which represents both opportunities and challenges for smaller players. The market is wide open for good ideas – but extreme persistence and determination are needed to get over the hurdles. On the one hand, opportunities are immense. The world market for point of care testing (POCT) is growing by 8% per year and is expected to reach $5.5 billion by 2009. On the downside, there are risks. In 2005, Boston Scientific had to withdraw its Enteryx injection kit to combat acid reflux in the oesophagus, after a patient death. This made a “$500 million product” almost worthless overnight. Pankaj Vadgama, professor of clinical biochemistry at the Interdisciplinary Research Centre in Biomedical Materials at Queen Mary College, told delegates at a recent Institute of Physics conference that, before going into heavy development, it is essential to ask whether the proposed new device would actually improve patient care. “You cannot predict success,” he said, citing the unlikely success of pulse oximetry. The technique uses a probe attached to a patient’s finger or ear lobe to determine the oxygen content of haemoglobin from the absorption of light at two different wavelengths. It is now a $2 billion annual business. Engineering involvement The involvement of engineers in the medical field is getting more complex. At the recent Medical Innovation Forum held at London Olympia, Paul Tomlins – project leader in the Engineering and Process Control Division at the National Physical Laboratory – told Eureka of work undertaken reproduce the function of the pancreas by placing healthy cells within a nano-structured membrane. This allows nutrients to get in and enzymes to get out, although protein molecules cannot gain access to trigger an immune response. According to Dr Tomlins, live patient trials in this have already begun. In view of the potential financial rewards, it is no surprise to learn that the pharmaceutical companies are taking a strong interest in medical devices. Dr Coulton Legge, head of novel analytical technologies at GlaxoSmithLine, said his company was developing a number of techniques, including molecularly imprinted polymers – to generate novel materials for chromatography and biosensors – which he described as “still immature for us to take on”. It is also working on its own “lab on a chip”; a method of using robotics to perform thousands of experiments at once; and two new developments in mass spectrometry. For smaller players, Prof Vadgama had some advice to help reduce business risks. “Get a friend, and combine science knowledge with business experience,” he said. “You have to get an end user, right up front. The customer is a complex mixture of the patient and the doctor.” Institute of Physics Emerging Technology Programme Medical Innovation Forum Medical determination Alexander Bushell, director of Sittingbourne company Global Medical Systems (Europe), has developed just such a new medical product in a challenging market. He has taken what many thought was a wildly ambitious goal – developing surgical kits for remote areas, such as the African Bush – and made it a commercial success. The ‘CompactOR Series 200’ is a low-cost ‘mobile surgery’ that is small enough to be dropped by air and carried on the back of a Land Rover. In a short space of time it has been CE-tested and MHRA-certified and will be launched at the Medic Africa event in Abuja, Nigeria this month. Because of its target market, it had to be low cost and use small amounts of power. Because of this, two new devices had to be developed. One, the ‘OxyOne’ portable oxygen generator, is a high-pressure, bottle-filling system developed with Norgren. The underlying technology is based on storage in zeolite crystals, with what it described as a “pressure swing” to separate oxygen from air. It has very low power consumption, so can be powered by solar cells. The other is the Ezeegen, a 100W, fold-away pedal generator that is 88% efficient but can be manufactured for £28 each in India. It can be used to recondition “poor quality” lead-acid accumulators, which then power the instruments.