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Bacterial pathogen identification in blood samples with electronic nose technology in a clinical setting - An early medical technology assessment of the μDtect

Koning, Reinder (2012) Bacterial pathogen identification in blood samples with electronic nose technology in a clinical setting - An early medical technology assessment of the μDtect.

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Abstract:	Introduction: The use of antibiotics can cause undesired side effects for patient and on the micro-flora. Most infections are initially treated with a broad spectrum antibiotic until the causative agents and their susceptibility profile is known. Shortening the time to identification of the microorganism makes it possible to specify the treatment at an earlier point in time and reduce the risk of undesired side-effects. A new microorganism identification device is in development which has the potential to shorten the time to identification. The device makes use of an electronic nose which can detect volatile compounds. At the early stage of development it is uncertain where in the clinical setting the device should be placed and which direction of development should be aimed at in order to have the highest expected clinical and commercial value. An early medical technology assessment (MTA) is a 'toolbox' designed to support in product development decisions. Methods: Within the framework of early MTA, a clinical case analysis, stakeholder analysis, early economic evaluation, and forces of entry analysis has been carried out. The clinical case analysis was carried out to identify the potential markets and the important bacterial pathogens. The stakeholder analysis was carried out to determine the professionals involved in the purchase and adoption process. This was followed by an early economic evaluation by means of a multiple criteria decision analysis (MCDA). Decisive attributes to adopt a new microorganism identification device were identified and evaluated. The performance of the μDtect and the competitors on the attributes was assessed. The last part of the early MTA was a forces of entry analysis to identify which threats and opportunities are present for the μDtect. The results from the four analysis parts were synthesized Results: The clinical case analysis indicate that the μDtect has the highest potential within a microbiology laboratory. The Staphylococcus Aureus, Staphylococcus Epidermidis, Streptococcus Pneumoniae, and the Eschericha Coli, were identified as important pathogenic bacteria. The microbiology physician, laboratory manager, head of the department, hospital management, were identified as key stakeholders in the adoption of technology. The clinical performance is deemed most important (0,56) category of attributes, compared to the cost of ownership (0,20), and the impact on workflow (0,24). The most important attribute for a microbiology identification device is accuracy (0.274). The μDtect performs well within the category cost of ownership and impact on workflow. On the attribute accuracy the μDtect has a low performance compared to the alternatives. On time to identification is the μDtect scores average. Certificates, proof of principle, and competitors are identified as critical forces of entry. The introduction process in a hospital and time to identification are identified as high priority forces. Conclusion: The μDtect has potential in a clinical microbiology laboratory. Entering the Dutch market will be difficult for two main reasons; first, there is not much room for improvement due to the high standard set by the current state of the art. Second, the clinical market demands that a microbiology identification device can identify a broad range of microorganisms with high accuracy (95% or higher). Proof that the μDtect can perform accurate identification with patient materials has to be delivered. It is recommended that the development focuses on increasing the accuracy and delivering proof. The strategic choice of which pathogens to target for further development depends on the market the eNose company prefers to enter.
Item Type:	Essay (Master)
Faculty:	BMS: Behavioural, Management and Social Sciences
Subject:	85 business administration, organizational science
Programme:	Industrial Engineering and Management MSc (60029)
Link to this item:	https://purl.utwente.nl/essays/62281
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