DESIGN
Sensors and Instrumentation Knowledge Transfer Network, London, UK
Breaking down barriers
Sensing technology is increasingly finding application in cutting-edge medical devices and changing the way doctors diagnose, treat and monitor patients’ health. The Sensors and Instrumentation Knowledge Transfer Network (KTN) is a network of excellence supported by the United Kingdom’s (UK) Technology Strategy Board to develop innovation in sensing. The prospects for sensors in medicine are huge and the KTN is helping companies and academics work with medical practitioners to turn research and prototype into reality. But the companies all experience similar challenges when trying to bring new technologies to market.
The most pressing challenges are not scientific, because many of the sensing technologies have already been proven in other industries. They are regulatory, that is, obtaining the necessary approvals prior to adoption; and technical, that is, getting different technologies to work seamlessly together. These issues are particularly daunting for small, focussed, young technology companies without the experience or finances to break down the barriers. Without a clearer and better supported route from research to market, many of the most promising technologies may never benefit the patients they are intended to help.
Application potential
The current drivers for medical sensors are focused on the diagnosis and treatment of disease. The term “medical sensors” encompasses a broad range of technologies used for capturing, processing and accessing information. Many of the technologies can be applied across a range of platforms, including hospital- and clinic-based diagnostic devices, home test kits and patient monitoring equipment.
Future medical sensors will be networked devices that are capable of relaying information to central processing stations. Networked sensors are already finding application in other markets, and when applied to medicine, the technology will have a profound impact on the way patients access care. Devices measuring blood pressure, heart rate or motion will report to base stations by the bedside or, in the case of remote monitoring devices, many miles away at a local hospital or clinic.
Sensing systems can allow the safe self-monitoring of chronic conditions. Patients who have suffered life threatening blood clots or deep vein thrombosis are frequently placed on courses of drugs to regulate the thickness of the blood. This requires frequent visits to the doctor for blood tests to regulate the level of medication: too little and they risk a recurrence of the clot; too much and internal bleeding can occur. Home-based sensors could monitor the levels of blood clotting factor and help doctors and patients to adjust medication accordingly, not just weekly, but daily or hourly.
Collecting information is just one requirement. Managing and using that information quickly and effectively has become crucial. Some companies are already looking at new ways to apply it effectively. Biotronics3D (www.biotronics3d.com) has developed a way to combine a series of body scans into virtual three-dimensional (3D) models of patients’ bodies. Doctors can use these models to support diagnosis without extensive exploratory surgery.
Using magnetic resonance imaging, computer tomography or 3D angioscan images, the company’s software builds 3D models that can be manipulated in real time. The images are combined and rendered to produce colour models showing scale, volume, depth and contour. Although this information can be gleaned from sets of conventional 2D scans, by presenting information as a 3D map it becomes easier to spot abnormalities. The models can speed diagnosis and could be used by surgeons planning procedures to show up potential issues before the fact.
Regulatory challenges
Technologies for use in the medical arena must undergo a thorough and well defined testing and approval process before they can be adopted. This is the case even when technologies have proven their effectiveness in other fields and applications. Although this is to patients’ benefit, it does delay the return on investment for companies and makes the path to commercial success longer. This, in combination with the significant upfront investment required to develop, manufacture and trial new devices, may mean failure for many small companies as they wait months or even years for returns.
Oncoprobe (Manchester, UK) is a company currently experiencing this challenge. Its device senses electrochemical activity on the surface of a cell and correlates this with apoptosis (cell death). This allows oncologists to predict which chemotherapy will be most effective against a particular tumour. The technology offers a reliable method of determining response of a patient’s cancer cell to drug therapy. The lack of this information can lead to numerous unsuccessful and traumatic courses of treatment for cancer patients.
Through the Sensors and Instrumentation KTN, the company was able to form some important commercial relationships. One was with Uniscan (www.uniscan.co.uk) an already well established company in the market, which helped it to access the infrastructure needed to produce a robust prototype, safe and suitable for larger-scale tests. Other partnerships also helped it gain the support it needed from the medical community to begin clinical trials. The device is currently being trialled on renal carcinoma, working in parallel with treatment regimes to check predictions of the efficacy of chemotherapy drugs. Results are expected to be available in late 2007.
The particular challenge faced by Oncoprobe is that because it measures apoptosis, its approach could be applied to a range of cancers, as well as other diseases where treatment depends on cell response being assessed. But for each cancer, a separate approval is needed, which entails a new set of tests and the associated delays and expense. In addition, different geographical markets may require their own trials, thus duplicating the time and cost.
Entry via research
It is interesting to note that the rules governing the use of new technologies for medical research are much less stringent than those for treatment. Securing support from research scientists not only provides income earlier in the process, but also helps to generate interest in the technology. This can provide a more feasible path to commercialisation for some devices.
A scanning and imaging system based on optical coherence tomography developed by Michelson Diagnostics Ltd (www.md-ltd.co.uk) is a good example of this. It has applications in diagnosis and treatment as well as cancer research and can spot cancer tissue at higher resolution than is currently possible. By enabling surgeons to see the extent of cancer tissue as they operate, the technology could reduce the risk of recurrence following surgery to remove a tumour.
The system is currently undergoing clinical testing on cervical and oesophagus cancer tissue in the Biophotonics Department at Gloucester Royal Hospital, Gloucester, UK. The company expects to produce a commercial product for clinical application in 2009. The device has caught the attention of research staff at the Maxillofacial Research Group at University College London Hospital, UK, who are using it to test skin, lung and oral cancers. This paves the way for further trials and extended uptake of the technology.
Technical challenges
Another challenge for new medical sensors is the need to integrate them into larger systems that are already monitoring patients’ health. A number of European projects are focussing on this problem. One is the SmartHEALTH integrated project (www.smarthealthip.com), which has secured e12.3 million of European funding. The system, developed under this project will facilitate rapid point-of-care measurements and help move analysis to the doctor’s office or outpatient clinic away from centralised testing in the hospital laboratory.
Single-use sensors will be used to analyse patient samples and process the results on chip. The results can be communicated to specialist medical staff for interpretation at remote sites using mobile telephony or wireless Internet technologies. Initially, it is likely be especially valuable for monitoring the progress of cancer patients, who may need many years of follow-up care.
Each of the elements of the SmartHEALTH system is well established in their own sector: wireless communication, lab-on-a-chip samp-ling technologies and information management systems. Experts from each of these fields are developing the platforms and products needed to integrate them, not only with each other, but also with existing technologies and health-care delivery systems across Europe. Working alone, companies would face formidable technical challenges. By working together, companies can ensure that their products are available and compatible with larger systems, which helps to ensure uptake by the market.
Mutual benefits
There is no doubt that sensing technology shows enormous promise for improving access to health care, patient outcomes and quality of life. Yet, the challenges to breaking into this market are formidable. They can be daunting for small technology companies, which is why multidisciplinary projects such as those funded under the European Union’s Framework Programme and initiatives such as the Sensors and Instrumentation KTN are crucial.
If properly managed and supported, these programmes can be mutually beneficial. These initiatives bring researchers and device developers together to help ensure that small innovators are not priced out of the medical market. Large companies gain new ideas and innovative thinking from smaller companies, in exchange for expertise and infrastructure. The benefit to patients and medical practitioners is access to new technologies and medical devices that would not otherwise be available.
Dr. Simon Aliwell is Director, Sensors and Instrumentation Knowledge Transfer Network, National Physical Laboratory, Teddington TW11 0LW, UK, tel. +44 20 8943 6606, e-mail: simon.aliwell@sensorsktn.com, http://sensors.globalwatchonline.com.
