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Medical Device Innovation: The integrated processes of invention, diffusion and deployment
Linköping University, Department of Medicine and Health Sciences, Health Technology Assessment. Linköping University, The Institute of Technology.
2006 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

An increased use of medical devices has been assumed to be a major cause of rising healthcare expenditures. Nations around the world are trying to keep costs down, but strong incentives still exist for the development and use of new devices. Innovation is, however, never exclusively good or bad and it is not easy to evaluate the net effect. Theories and empirical research on innovation have been produced for more than 100 years. In this, the diffusion of innovations has attracted the most interest, while other areas, such as the integration of technologies, have been less thoroughly researched.

This thesis presents a model of medical device innovation in hospitals – from the first idea and invention effort to regular use of a new technology. The suggested model is built on three fundaments: (1) academic innovation literature, (2) empirical studies, and (3) observations of on-going innovation processes. The model is a synthesis of the accumulated knowledge in different innovation research traditions, and of empirical studies of the Swedish healthcare system and the medical device industry. The aim is to give a comprehensive picture of the innovation process, and to provide a theoretical model, which can be used for studying and influencing the paths of medical device innovations into healthcare practice.

In order to achieve a balanced rate of change, with long-term societal benefits, an inter-disciplinary approach is necessary in the planning and regulation of medical device innovation. The new model combines academic views with political/entrepreneurial and healthcare views. Innovation, in this model, is suggested to occur in three integrated activity domains: invention, diffusion, and deployment. A great number of factors that influence these activities are investigated and described, and different roles and incentives are discussed. Deviations from traditional innovation theory are for example: (a) integration of invention activities as having an impact on later events; (b) inclusion of the inventor/developer as a main actor also in the diffusion and deployment domains; (c) increased focus of the concept of technology cluster innovation, and (d) the rationality of use and abandonment of knowledge as factors to be included in the estimation of consequences of innovation.

Finally, the thesis suggests a number of model and methodology improvements and policy implications for management of innovation in hospitals.

Place, publisher, year, edition, pages
Institutionen för hälsa och samhälle , 2006.
Series
Linköping Dissertations on Health and Society, ISSN 1651-1646 ; 9Linköping Studies in Science and Technology. Dissertations, ISSN 0345-7524 ; 1040
Keyword [en]
Innovation, Medical technical products, Spread, Technique use, Technical development, Social change
Keyword [sv]
Innovation, Medicintekniska produkter, Spridning, Teknikanvändning, Seknisk utveckling, Social förändring
National Category
Medical Laboratory and Measurements Technologies
Identifiers
URN: urn:nbn:se:liu:diva-7717ISBN: 91-85523-16-X (print)OAI: oai:DiVA.org:liu-7717DiVA: diva2:22712
Public defence
2006-11-02, Aulan, Hälsans hus, Campus US, Linköpings Universitet, Linköping, 09:00 (English)
Opponent
Supervisors
Available from: 2006-11-13 Created: 2006-11-13 Last updated: 2009-03-10
List of papers
1. Transfer of health care technology in university-industry research collaboration environment
Open this publication in new window or tab >>Transfer of health care technology in university-industry research collaboration environment
2001 (English)In: Engineering in Medicine and Biology Society. Proceedings of the 23rd Annual International Conference of the IEEE, 2001, Vol. 4, 3938-3941 p.Conference paper, Published paper (Refereed)
Abstract [en]

The traditional innovation research has focused on the diffusion process and adoption of new technologies. This paper deals with health care technology in the early innovation stages preceding targeted development and marketing. A model of early research processes in the biomedical field and determinants of technology transfer will be presented. The study material is eleven projects in the Competence Center Noninvasive Medical Measurements (NIMED), Linkoping University, which is a collaboration center where academic researchers cooperate with industry and clinical departments. Data collection was made through semi-structured interviews. A qualitative approach has been adopted for data analysis. Research initiatives of the investigated projects do in most cases originate in the academic knowledge base and earlier connections in industry and health care play an important role in the formation of cooperation constellation. A number of internal factors are perceived as positive to project advancement, such as stable economy, proximity to clinical departments, and positive feedback from collaboration partners. Significant negative factors are all related to changes in cooperation structure. Clusters of related projects seem to be beneficial to research work and is an evident external factor which has to be added in a new model of technology transfer.

National Category
Medical Laboratory and Measurements Technologies
Identifiers
urn:nbn:se:liu:diva-14140 (URN)
Available from: 2006-11-13 Created: 2006-11-13
2. A New Fiberoptical Respiratory Rate Monitor for the Neonatal Intensive Care Unit
Open this publication in new window or tab >>A New Fiberoptical Respiratory Rate Monitor for the Neonatal Intensive Care Unit
Show others...
2005 (English)In: Pediatric Pulmonology, ISSN 8755-6863, Vol. 39, no 2, 120-126 p.Article in journal (Refereed) Published
Abstract [en]

A new technique for respiratory rate measurement in the neonatal intensive care unit, fiberoptic respirometry (FORE), was tested using a specially designed nasal adapter. The aim was to investigate the system's accuracy and compare it to the transthoracic impedance (TTI) method and manual counting (MC). Further, the relationship between accuracy and degree of body movement was investigated. Seventeen neonates of median gestational age 35 weeks were included in the study. Video recordings (synchronized with data recordings) were used for classification of body movement. Breaths per minute data were obtained for 23-32-min periods per child, and a subset of these included MC performed by experienced nurses. A Bland-Altman analysis showed low accuracy of both FORE and TTI. A >20% deviation from MC was found in 22.7% and 23.8% of observations for the two methods, respectively. Both methods had accuracy problems during body movement. FORE tended to underestimate respiratory rate due to probe displacement, while TTI overestimated due to motion artefacts. The accuracy was also strongly subject-dependent. The neonates were undisturbed by the FORE device. In some cases, though, it was difficult to keep the adapter positioned in the airway. Further development should, therefore, focus on FORE adapter improvements to maintain probe position over time.

Keyword
respiratory rate, neonatal monitoring, prematurity, optical sensors, intensive care, apnea
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-14141 (URN)10.1002/ppul.20137 (DOI)
Available from: 2006-11-13 Created: 2006-11-13 Last updated: 2009-05-29
3. Home informatics in healthcare: Assessment guidelines to keep up quality of care and avoid adverse effects
Open this publication in new window or tab >>Home informatics in healthcare: Assessment guidelines to keep up quality of care and avoid adverse effects
2003 (English)In: Technology and Health Care - European Society for Engineering and Medicine, ISSN 0928-7329, Vol. 11, no 3, 195-206 p.Article in journal (Refereed) Published
Abstract [en]

Due to an ageing population and improved treatment possibilities, a shortage in hospital beds is a fact in many countries. Home healthcare schemes using information technology (IT) are under development as a response to this and with the intention to produce a more cost-effective care. So far it has been shown that home healthcare is beneficial to certain patient groups. The trend is a widening of the criteria for admission to home healthcare, which means treatment in the home of more severe conditions that otherwise would require in-hospital care. Home informatics has the potential to become a means of providing good care at home. In this process, it is important to consider what new risks will be encountered when placing electronic equipment in the home care environment. Continuous assessment and guidance is important in order to achieve a safe and effective care. Based on a review of current knowledge this paper presents an inventory of risks and adverse events specific to this area. It was found that risks and adverse events could stem from technology in itself, from human-technology interaction conditions or from the environment in which the technology is placed. As a result from the risk inventory, this paper proposes guidelines for the planning and assessment of IT-based hospital-at-home schemes . These assessment guidelines are specifically aimed at performance improvement and thus to be considered a complement to the more general guidelines on telehomecare adopted by the American Telemedicine Association (ATA) in October 2002.

Keyword
assessment, home informatics, hospital-at-home, telehomecare
National Category
Medical Laboratory and Measurements Technologies
Identifiers
urn:nbn:se:liu:diva-14142 (URN)
Available from: 2006-11-13 Created: 2006-11-13
4. Adoption of medical devices: Perspectives of professionals in Swedish neonatal intensive care
Open this publication in new window or tab >>Adoption of medical devices: Perspectives of professionals in Swedish neonatal intensive care
2007 (English)In: Technology and Health Care, ISSN 0928-7329, Vol. 15, no 3, 157-179 p.Article in journal (Refereed) Published
Abstract [en]

Advances in biomedical engineering enable us to treat increasingly severe conditions. This implies an increased need for regulation and priority setting in healthcare, to ensure appropriate safety cautions and to avoid accelerating expenditures. This interview study investigates the mechanisms behind the adoption and use of medical devices through the subjective experiences of hospital staff working with devices for neonatal intensive care. The adoption was found to be primarily initiated by vendor activities, but professionals preferably sought information about functionality from close colleagues. Full integration of devices was sometimes not achieved, and even though the adopting units had good introduction routines, there was no systematic follow-up of how adopted devices had been integrated in the work practices. Diffusion variations were, however, mainly found for temporarily tested devices and not for permanently available technologies. Three factors were found to be the major explanatory variables of the adoption of medical devices: (1) the subjective expected value of the device, (2) information and learning, and (3) the innovativeness of the adopting unit.

Keyword
Diffusion, innovation, adoption, medical devices, neonatal intensive care, decision-making, healthcare management
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-14143 (URN)130.236.83.89 (DOI)
Available from: 2006-11-13 Created: 2006-11-13 Last updated: 2009-05-12

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