The Oulu Neuronavigation
Project -- and Beyond
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.
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) .
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 , EEG analysis, computer-guided laser and
since 1988 neuronavigation . At the same time, methods for technology
assessment have been developed, including the cultural adaptation of the
Nottingham Health Profile  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.
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  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 /
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].
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
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
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" .
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.
 "The future of medicine," The Economist, (Survey Article), March 19th, 1994.
 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.
 J. Koivukangas, Y. Louhisalmi, J Ala-kuijala and J. Oikarinen, "Ultrasound-controlled neuronavigator-guided brain surgery," J. Neurosurg., vol. 79, pp. 36-42, 1993.
 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).
 J.P. Van Der Meulen, "Can academic health centers survive health care reform?", Neurosurgery, vol. 35, no. 4, pp. 725-731, 1994.
 J.K. Iglehart, "The American health care system - Teaching hospitals (Health Policy Report)", N. Engl. J. Med., vol. 329, pp. 1052-1056, 1993.
 D.F. Thompson, "Understanding financial conflicts of interest (Sounding Board)", N. Engl. J. Med., vol. 329, pp. 573-576, 1993.
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