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The position paper will address the following points:
Position paper Slide Show
Life support/Medical instrumentation; InfoSam 2020(Position Paper)
Working group: Reinold Ellingsen, Optomed AS; Mikael Hammer, NTNU; Magnus Lie Hetland, NTNU; Kjell Arne Ingebrigtsen, GE Vingmed/NTNU (chairperson); Bjørn Olstad, Fast S&T ASA/NTNU; Øyvind Stavdahl, Sintef/NTNU
1. The socioeconomic priorities
Medical instrumentation includes equipment for diagnostic, therapeutic, and monitoring purposes. Diagnostic equipment stands for about half of the commercial value. Therapeutic devices include implants such as pace makers, prostheses, and artificial organ support devices and replacements. Most of the technical development will be carried out through private companies. The 10 most R&D intensive medical companies are all pharmaceutical. They spend more than $30 bill in R&D annually from a sale of $220bill. The R&D spending in medical instrumentation is less than $4bill out of a sale of almost $40bill. ICT represents an important enabling technology in medical instrumentation. The priorities of the companies will be based upon return on investments. In general terms this is determined by the ability and willingness to pay for treatment and cure, and the frequency of appearance of the disease. A typical example from past decades is heart diseases in the western world. The growing cost of health care is subject to political concern all across the world. This impacts the priority of investments into new technology. Whereas substantial attention previously was devoted to “prestigious diseases” prevalent in economic wealthy societies, emphasis is turning towards efficiency in treatment, or – more health for the buck- also in these parts of the world. This trend is enforced by economic priorities such as reimbursements. The concepts of “point of care” medicine and more recently “personalized” medicine have been raised to develop more efficient and better patient care. “Point of care” medicine aims at making the right diagnosis and start the right treatment immediately in the first contact with the patient. By this substantial savings are expected from escalating fewer patients through the medical hierarchy. In primary care today most patients are being referred to specialists for thorough examination and treatment. For the general practitioner to be able to do more, better tools will have to be provided to assist in making the right decisions. “Personalized” medicine aims at customizing an optimum treatment based upon detailed and specific genetic information about the patient. Important studies are being carried out among pharmacologists to better be able to tailor the medication to the individual needs. Work is carried out from the instrumentation side to narrow the gap between gene technology and anatomy. One company has introduced the terminology “molecular imaging” to promote its developments in magnetic resonance (MR) imaging.
2. The medical needsThe dominating health problems are related to life style. These are heart diseases, various cancers, and diabetes. They are all influenced by nutrition, stress in daily life, and reduced physical activity. Whereas these diseases previously were dominant in the western communities, they have more recently accelerated in frequency in the highly populated regions in Asia, and they are now more frequent here than in the industrialized countries.. With economic growth comes change in life style, and the health problems prevalent of the western world 30 years ago are now those of China and India. Since these countries are becoming economically capable of meeting the challenges, it is obvious that this will impact the priority of investment into new and better technology for the next decades. With increasing age of the population comes an increasing demand for prostheses and maintenance of physical capability and mobility. Growth in car traffic has raised the frequency of accidents with human injuries and permanent disability to a level of significant economic impact. Globalization of the economy causes more travel and transportation, and spread of contagious diseases increase. It seems also that new aggressive viruses appear with increasing frequency. Heart failure is the major cause of sudden death in the western world (about 5 mill every year). Whereas many heart problems can be treated and cured today (almost 15000 each year in Norway at an average cost of perhaps 50000 NOK per treatment), the major remaining issue is early detection of coronary infarction, an issue addressed by multiple companies and researchers globally. Although admirable progress has been made over the last decade in treating cancer, it remains increasing in frequency and demand for treatment. Characteristic is the growth in female breast cancer, and male prostate cancer. Each one of these now stand for around 3000 new cases every year in Norway. Various new surgical techniques are being developed together with improved radiation and biochemical therapies. The rapid increase in diabetes is perhaps the most directly life style related curse of the wealthy society. Important risk factors for diabetes type 2 are nutrition and physical inactivity. The economic impact is significant, and large resources will be spent on information about nutrition, and to develop effective life support means for diabetic patients. Higher average life length, increasing average body weight, and reduced physical activity all contribute to growing demands for physical mobility support.
3. Enabling technologyInformation and communication technology (ICT) may contribute in several ways to meet the needs described above.
3.1 Heart diseasesMore than half of the heart procedures performed today are balloon angioplasty (PTCA) of the coronary arteries. Inflammation in the coronary artery wall is an important factor in heart failure and stroke. There is no adequate method available to precisely identify and localize the inflammatory lesion. The current professional state of opinion is that the next level of technology should incorporate intra coronary imaging in combination with sensors for identification of the inflammation. For the general practice physician to contribute more to the diagnosis and care of heart patients, tools are required which makes the decision more reliable. Today ECG is available with some decision support available on the equipment. The next level will be ultrasound imaging. However, this requires even more expertise in making the right decision. Tools which help reducing false negative decisions, and which help making the right decision for referral, will require advanced image interpretation technology, and also access to “specialist support”. This will address the issue of “point of care” technology for heart patients. Improved individual care and treatment for these patients will come as a result of the general physician having access to data bases with more accumulated detailed knowledge of the patient, and of similar patient problems. The active use of “learning data bases” will be an important contributions in the development and practicing of “personalized medicine”. Minimally invasive techniques will accelerate restitution and reduce secondary effects from heart surgery. Improved surgical procedures on the beating heart using refined robot procedures will become feasible. This is facilitated by improved real time image processing for motion estimation in combination with tactile feedback devices in the surgeon/robot tool interface.
Critical enabling ICT:
3.2 CancerThe most successful way of treating cancer today is by surgery. The limitations of surgical procedures are the ability to remove the complete tumor. In order to be certain the general rule is that too much is better than too little. In many cases the tumor is so entangled and complex that total removal is impossible or unlikely. Radiation and/or chemotherapy are then the only alternatives. Improved specificity and more detailed outline of the tumor will help to better plan a successful surgery. The development of “molecular imaging” by MR is aimed at this. Robotic surgery may help in a more precise removal of malignant tissue. Open surgery may be dramatic for the patient and lead to long and painful recovery. The more recent laparoscopic techniques will help to reduce this problem to the benefit of the patient and the society. Better sensors such as tactile feedback devices will help to refine and expand the use of minimally invasive techniques further. The main technical challenge in cancer treatment is the ability to diagnose it at an early state. This improves the outcome of the treatment, it reduces the severity of the surgery, and it reduces the recovery time. Today there is no affordable technique available, which can be applied widely in “point of care” approaches. Inexpensive, specific, and highly sensitive sensors for early detection of cancer are major challenges for the future. Critical enabling ICT:
3.3 DiabetesTreatment of diabetes is reasonably well controlled. Implanted devices may help diabetic patients to keep better control and thus improve their life. Artificial pancreas tissue for insulin production is another area of research . The main problem for the society is the growth in frequency of the disease, which can best be met by control of the nutrition in combination with physical activity. A significant achievement will be an affordable and reliable non-invasive sensor for easy measurements of blood sugar. Critical enabling ICT:
3.4 Reduced physical abilityThere will be a growing demand for better technical solutions to help physically disable patients. This will require better prosthetic designs based upon improved biomechanical models. The results of this will be less pain, more normal mobility, and more complete and rapid restitution after surgery. Recent advances in neural signal interface technology give promise of a revolution in the interaction between the user and motor assisted multi-function prostheses. Critical enabling ICT:
3.5 Molecular BiologyIn April 1953 Watson and Crick published the “Molecular structure of nucleic acids”. The paper was published in Nature, and has been considered to be the most significant breakthrough in “finding the secret of life” through its presentation of the double helix structure of DNA. 50 years later, in February 2001, the sequencing of the human genome was published as two parallel works in Nature and Science. This opened the possibility to advance into the post-genomic era in which genetic information could be examined in multiple health care situations throughout the lives of individuals. Currently, newborn babies may be screened for treatable genetic diseases. The extent to which this will be applied is subject to substantial ethical debate. For the purpose of illustrating the possibilities and the coming difficult decisions, a few scenarios are as follows: In the near future, children at high risk for coronary heart disease may be identified and treated to prevent the pathological changes in their vessel walls during adulthood. Potential parents will have the option to be told their carrier status for many recessive diseases before they decide to reproduce. For middle-aged and older populations, the ability will be there to determine the risk profiles for numerous late-onset diseases, preferably before the appearance of symptoms, which at least could be partly prevented through dietary or pharmaceutical interventions. Soon, genetic testing will comprise a wide spectrum of different analyses with a host of consequences for individuals and their families. In its wide consequence, the perfectly controlled molecular biology’s impact on health care will reduce the needs for sensors and actuators, as action will be taken on the genetic end for correcting the disturbances leading to disease. However, it is likely that the practical approach will require extensive chemical and physical monitoring of body processes along with the possibilities of genetically based treatment and repair, thereby increasing the need for sensing systems both external and internal to the body. Critical enabling ICT:
4. The NTNU perspectiveNorway represents about 1/10 per cent of the population that will have access to medical technology in the future. Our investment into R&D for the development of new technology in this field is also less than one per cent of the total. It is important therefore to make the right priorities and make certain that it becomes relevant on an international scale. NTNU has decided to prioritize medical technology. This has been supported also by national political authorities through the establishment of national centers of competence at the medical school and at the university hospital. In a recent evaluation of the medical research in Norway, groups at NTNU in medical technology were given very good rating, notably in areas where there was tight cooperation between medical and technical researchers. The work in these groups should be further supported. There is a growing activity in sports medicine at NTNU. It seems attractive to couple this activity to the research in orthopedics and prostheses, and to the research in robotics and bio-cybernetics. Thereby one might create a research environment of mutual incitement to all these activities. Most of the novel sensor technology is based upon microelectronic and optical systems for signal conditioning and processing. Research in this field therefore relies upon access to such facilities. The plan to establish a research laboratory in nanotechnology at NTNU may become of significant interest for the research in medical technology. This facility offers a unique possibility to carry out research in novel biochemical and biophysical sensor technologies in combination with microelectronic and optical signal processing. 5. Sources
1. IEEE Proc Jan 2004, 2. mst/news February 2004, International newsletter on micro-nano integration, Special issue on Biomicrotechnology <www.mstnews.de> 3. Time Magazine March 2004, 4. EU 6th framework programme - Life Science in focus 5. Life Sciences and biotechnology- A strategy for Europe. Prepared by th European Commission. ISBN 92-894-3388-4 6. IEEE Spectrum Nov 2000, Special Issue on Gene Sequencing’s industrial revolution 7. BRAINSTORM, Newsletter of Stanford University’s Office of Technology Licensing(OTL), Vol 12.NO2, on The Bio-X program: A Merger of Knowledge. 8. Interview with medical professionals 9. Science, Vol 291, 16 February 2001 Members of the working group: Professor II Kjell Arne Ingebrigtsen, Department of Electronics and Telecommunications |