Reprinted from "TECHNOLOGY TRANSFER BETWEEN RESEARCH INSTITUTES AND INDUSTRY, June 7 - 8, 1996, Oulu and Rovaniemi, Finland, edited by Eero Kouvalainen, Timo Jämsä and Kalevi Kiviniitty, published by the Biomedical Engineering Program, University of Oulu, 1996. ISBN 951-42-4409-5"

The Oulu Neuronavigation Project -- and Beyond
 

John Koivukangas

Department of Neurosurgery, University of Oulu

FIN-90220 Oulu, Finland
 
 

Abstract: The Oulu Neuronavigation Project is presented as a recent case of work in the field of clinically oriented biomedical engineering during the past 15 years. The concept of the Innovative Clinic is presented as a way to identify and resolve issues related to technology transfer. In this model, innovations are identified, scientifically researched and transferred to industry, but the model also accomodates clinical implementation and technological assessment, resulting in new services and even products.
 

INTRODUCTION
 

The Oulu region has become increasingly conducive to medicine and the natural and engineering sciences. The City of Oulu established the first hi-tech industrial park in Scandinavia in 1982. The University of Oulu was established in 1958 and has grown to a student population of about 11.000. It is the only university in Finland with the faculties for medicine and technology under the same administration. This is the intellectual basis for a growing interest in biomedical engineering in this region. Other reasons include the ageing of the population (gerontechnology), the digital revolution (digital imaging and telemedicine), the economic situation (need for exports) and the rising cost of health care (shift to minimally invasive and day surgery and ambulatory service) [1].
 

The field of biomedical engineering is a very practical one: it draws on the natural and engineering sciences for solutions to challenges in health care. Time from innovation to industry and time to market is relatively short, about 8 years according to experience at the University of California. This generates a specific need for procedures dealing with ethics, intellectual rights and conflicts of interest, to foster the innovative work done at modern clinics.
 

The Department of Neurosurgery has participated in several major biomedical engineering projects, dealing with ultrasound holography [2], EEG analysis, computer-guided laser and since 1988 neuronavigation [3]. At the same time, methods for technology assessment have been developed, including the cultural adaptation of the Nottingham Health Profile [4] and the development of the latent variable approach for quality of life research.
 

Problems encountered early on included lack of appropriate industry, adequate research engineering and technology assessment staff at the medical center (including the medical faculty and university hospital), long-term funding and especially a coordinated doctoral program in biomedical engineering. Work within the framework of the Biomedical Engineering Program has brought solutions to these problems.
 

THE OULU NEURONAVIGATOR PROJECT
 

The Oulu Neuronavigator Project has comprised two main subjects: The Oulu Neuronavigator System (Fig. 1) and the research in the science of technological assessment (TA). The Oulu Neuronavigator System (ONS) enables the neurosurgeon to relate imaging information to the surgical field, in other words to use imaging data to guide the movement of instruments and the removal of pathological tissue. It is among the earliest first-generation systems in the world, and the surgical strategy and software have been successfully transferred to routine clinical use and industry. The first phase, ONS-1, was commercialized as an EUREKA project during 1991-93. The system consisted of three basic surgical functions: orientation, suction-irrigation and ultrasound imaging control. The second system, ONS-2, consists of neuronavigational endoscopy and laser control, and it is in the research phase.
 
 

Neuronavigator

The ONS-1 phase resulted in a clinical neuronavigator that is used in routine neurosurgical procedures such as surgery of small brain tumors at the Department of Neurosurgery. It is currently being assessed in several other clinics in Europe.
 

TECHNOLOGY TRANSFER RESULTS
 

In addition to the clinical results summarized elsewhere [3] and license agreements, the biomedical engineering projects leading to the clinical neuronavigator have resulted in patterns of publication and job creation typical of this field:
 

The publications (N=77) of the researchers can be divided as follows:

42 scientific publications

11 M.S. theses

14 Lisenciate / Ph.D. theses

10 Patent applications / copyrights
 

The job creation and employment statistics for involved researchers (N= 25) are as follows:
 

Own company 4 (16%)

SME employment related to acquired scientific know-how 10 (40%)

Public sector: 6 in leading positions, 5 in other capacities (46%)
 

THE INNOVATIVE CLINIC
 

The basic role of a tertiary hospital clinic is to provide the highest quality in patient management. The operative specialties, especially neurosurgery, are dependent on advanced technology to supplement--and help apply--the clinical skills and knowledge of the clinicians. The scientific discipline of neurosurgery can be divided into three lines of research: disease-oriented (with collaboration of especially molecular biology and other biosciences), epidemiology and randomized clinical trials, and surgical technique. It is in the realm of the latter that the concept of the Innovative Clinic is proposed. The process of innovation can be summarized as follows (Fig. 2): Surgical and other clinical management is the source of the needs for technological solutions. The clinically defined problem is specified for interdisciplinary research. The resulting technology is transferred to industry, which in turn relies on scientific assessment of the product. The clinic benefits by being able to provide better service. Thus, the "by-products" of the innovative process are scientific publications, exported goods and improved clinical service. It is the level of sophistication of clinical services that definestertiary care [5,6].


 

DISCUSSION
 

Technology transfer is the result of successful interaction of scientists from many disciplines working together around the same specified problem. Essential factors are thorough comprehension of one's own scientific discipline, teamwork and a common scientific language. The University of Oulu now has a Biomedical Engineering Program with 18 research projects and over 30 students enrolled in the 1996-97 doctoral seminar. Also, OuluTech, Ltd., has been formed to provide technology transfer service to university researchers. Finland joined the European Union last year, so all of the European science and technology programs are now open for participation. The definition of a Welfare Cluster in Finland, and especially its pilot project in Oulu, helps to coordinate the activities of academia, industry and especially the health care sector, and adds the input of the public health sector and government administrations. Future development will center on the general framework of technology transfer:
 

Strategic funding of science: To identify rising technology, to provide the right kind of funding at the right time, including the European principle of subsidiarity. The main difference between American federal funding and European funding is the requirement of the European dimension, the need for multinational cooperation. This implies that national funding policy is ever more crucial. While the principle of subsidiarity says that nothing that can be arranged nationally should be arranged through the European system, the logic of national funding leads to the notion that nothing that can be funded through the European system should be funded only nationally. The true sign of excellence in major scientific research programs is the degree of involvement of federal/international funding. This involves discussion of scarcity of resources and of opportunity costs.
 

Intellectual property rights policy: The role of the academic researcher and public funding changed dramatically in 1988 in the United States. The Finnish system and the American system offer two different models. In the field of biomedical engineering the difference is practical: in the Finnish system the researcher owns the intellectual rights but up to now has not had the procedural framework that American universities have had to install to protect the rights of researchers. In the American system, the researcher has lost independent control of intellectual rights developed under public funding, but judging from the increased number of patents issued annually he has gained something in return. The issue involves not only the rights of the individual but also the interests of society, which after all is making the investment. It also has implications for the valuation of intellectual rights in academia [7].
 

CONCLUSION
 

The Oulu Neuronavigation Project is a case study of the multifaceted research and development that is typical of clinically oriented biomedical engineering. At the engineering level the challenge is to apply knowledge and skills in a difficult environment to a biological system, at the clinical level to interpret signals and effects at the interface between the physical and the biological, at the administrative level to develop adequate safeguards and procedures, at the national level to strategically fund and exploit the results of research. The Innovative Clinic Model is presented as a synthesis of experience: a modern approach to accomodate clinical possibilities, academic advancement and commercial interests. The goal has been stated earlier by Thompson: "Physicians and scholars could then concentrate more fully on their main missions - treating patients, teaching students, and conducting research" [7].
 

ACKNOWLEDGEMENTS
 

The scientific work described in this paper has been funded mainly by the Academy of Finland and the Technological Development Center in two major projects: The Ultrasound Holography Project and the Neuronavigator Project. Also the generous help of the Office for Research and Technology Transfer Administration (ORTTA) at the University of Minnesota, Minneapolis MN is appreciated.
 

REFERENCES
 

[1] "The future of medicine," The Economist, (Survey Article), March 19th, 1994.

[2] J. Koivukangas, O. Tervonen, E. Ala-saarela, J. Ylitalo and S. Nyström, "Completely computer-focused ultrasound imaging," J. Ultrasound Med., vol. 8, pp. 675-683, 1989.

[3] J. Koivukangas, Y. Louhisalmi, J Ala-kuijala and J. Oikarinen, "Ultrasound-controlled neuronavigator-guided brain surgery," J. Neurosurg., vol. 79, pp. 36-42, 1993.

[4] P. Koivukangas, J. Koivukangas, A. Ohinmaa, S-L. Kivelä and K. Krause: "NHP - a method for measuring health-related quality of life in health services evaluation," J. Social Medicine, vol. 29, pp. 229-235, 1992 (in Finnish with English summary).

[5] J.P. Van Der Meulen, "Can academic health centers survive health care reform?", Neurosurgery, vol. 35, no. 4, pp. 725-731, 1994.

[6] J.K. Iglehart, "The American health care system - Teaching hospitals (Health Policy Report)", N. Engl. J. Med., vol. 329, pp. 1052-1056, 1993.

[7] D.F. Thompson, "Understanding financial conflicts of interest (Sounding Board)", N. Engl. J. Med., vol. 329, pp. 573-576, 1993.

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