287 research outputs found

    An exploratory survey of current practice in the medical device industry

    Get PDF
    This article is (c) Emerald Group Publishing and permission has been granted for this version to appear here. Emerald does not grant permission for this article to be further copied/distributed or hosted elsewhere without the express permission from Emerald Group Publishing Limited.Purpose – This study seeks to examine the extent to which mainstream tools and strategies are applied in the medical devices sector, which is highly fragmented and contains a high percentage of small companies, and to determine if company size impacts on manufacturing strategy selection. Design/methodology/approach – A questionnaire was developed and disseminated through a number of channels. Responses were received from 38 companies in the UK and Ireland, describing 68 products taken to market in the past five years. Findings – Because of the limited scope of the survey, the findings are indicative rather than conclusive, and interesting trends have emerged. New to the world products were much more likely to exceed company expectations of market success compared to derivative products. It was found that the majority of these innovative products were developed by small companies. Large companies appear to favour minor upgrades over major upgrades even though these prove – on the data presented – to be less successful overall. Practical implications – These results provide those engaged in this sector with comparative information and some insights for further improvement. The reported trends with respect to company size and product complexity (or degree of novelty) are particularly illuminating. Academically, this sets some expected trends on a firmer footing and unearths one or two unexpected findings. Originality/value – It is believed that this is the largest survey of determinants of success in UK medical device companies and it provides a comparison with other sectors

    Meeting the four-hour deadline in an A&E department

    Get PDF
    This is the print version of the Article. The official published version can be obtained from the link below - Copyright @ 2011 EmeraldPurpose – Accident and emergency (A&E) departments experience a secondary peak in patient length of stay (LoS) at around four hours, caused by the coping strategies used to meet the operational standards imposed by government. The aim of this paper is to build a discrete-event simulation model that captures the coping strategies and more accurately reflects the processes that occur within an A&E department. Design/methodology/approach – A discrete-event simulation (DES) model was used to capture the A&E process at a UK hospital and record the LoS for each patient. Input data on 4,150 arrivals over three one-week periods and staffing levels was obtained from hospital records, while output data were compared with the corresponding records. Expert opinion was used to generate the pathways and model the decision-making processes. Findings – The authors were able to replicate accurately the LoS distribution for the hospital. The model was then applied to a second configuration that had been trialled there; again, the results also reflected the experiences of the hospital. Practical implications – This demonstrates that the coping strategies, such as re-prioritising patients based on current length of time in the department, employed in A&E departments have an impact on LoS of patients and therefore need to be considered when building predictive models if confidence in the results is to be justified. Originality/value – As far as the authors are aware this is the first time that these coping strategies have been included within a simulation model, and therefore the first time that the peak around the four hours has been analysed so accurately using a model

    Incorporating remote visits into an outpatient clinic

    Get PDF
    Copyright @ 2009 Operational Research Society Ltd. This is a post-peer-review, pre-copyedit version of an article published in Journal of Simulation. The definitive publisher-authenticated version Eatock and Eldabi (2009), "Incorporating remote visits into an outpatient clinic", Journal of Simulation, 3, 179–188 is available online at the link below.Most telemedicine studies are concerned with either the technological or diagnostic comparisons, rather than assessing the impact on clinic management. This has attributed to the retrospective nature of the studies, with lack of data being the main cause for not using simulation for prospective analysis. This article demonstrates the use of simulation to assess the impact of prospective systems by utilising data generated from clinical trials. The example used here is the introduction of remote consultations into an outpatient's clinic. The article addresses the issues of using secondary data, in terms of the differences between the trial, the model and future reality. The result of running the simulation model show that exchanging the mode of service delivery does not improve patient wait times as expected, and that a protocol change in association with the introduction of remote visits is necessary to provide a substantial reduction in patient wait times

    Simulating the use of re-prioritisation as a wait-reduction strategy in an emergency department

    Get PDF
    Background/aim Simulation modelling has proven a useful approach for capturing the dynamic nature of emergency departments (EDs) and informing improvements to clinical and operational processes alike. However, few models have simulated the impact of the UK Department of Health's 4 h operational standard, which arguably has placed pressure to improve standards and performance, promoting the use of wait-reduction strategies to cope with the target in practice. The aim of this study was to determine the impact a re-prioritisation strategy has on the 4 h target by simulating the operation of an ED using a model that represents the flow of patients through the department. Methods This study was based on a district general hospital in West London. To ascertain patients' length of stay, the hospital's historical records and staff rotas were used to obtain data on activities, timeframes and resources on three separate representative weeks and included all patients' arrival time, mode of arrival, whether the patient was referred to minors, majors, paediatrics or the resuscitation unit, and whether the patient was admitted or discharged, and at what time. Results The close correlation (r=0.98) in distributions between actual length of stay and simulated length of stay demonstrates that the model of the ED accurately replicates the 4 h peak caused by the use of re-prioritisation. Conclusion The model accurately reproduced the use of a dominant wait-reduction strategy to identify patients approaching the breach and re-prioritise them to expedite treatment and remove them from the department by the 4 h target.EPSRC Gran

    A phase II study of capecitabine and oxalplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract

    Get PDF
    Background: Advanced biliary tract carcinomas are associated with a poor prognosis, and palliative chemotherapy has only modest benefit. This multi-centre phase II study was conducted to determine the efficacy of capecitabine in combination with oxaliplatin in patients with inoperable gall bladder or biliary tract cancer. Methods: This was a Phase II, non-randomised, two-stage Simon design, multi-centre study. Ethics approval was sought and obtained by the North West MREC, and then locally by the West Glasgow Hospitals Research Ethics Com mittee. Eligible patients with inoperable locally advanced or metastatic adenocarcinoma of the gall bladder or biliary tract and with adequate performance status, haematologic, renal, and hepatic function were treated with capecit abine (1000 mg/m2 po, twice daily, days 1–14) and oxaliplatin (130 mg/m2 i.v., day 1) every 3 weeks for up to six cycles. The primary objective of the study was to determine the objective tumour response rates (complete and partial). The secondary objectives included assessment of toxicity, progression-free survival, and overall survival. Results: Forty-three patients were recruited between July 2003 and December 2005. The regimen was well tolerated with no grade 3/4 neutropenia or thrombocytopenia. Grade 3/4 sensory neuropathy was observed in six patients. Two-thirds of patients received their chemotherapy without any dose delays. Overall response rate was 23.8 % (95 % CI 12.05–39.5 %). Stable disease was observed in a further 13 patients (31 %) and progressive disease observed in 12 (28.6 %) of patients. The median progression-free survival was 4.6 months (95 % CI 2.8–6.4 months; Fig. 1) and the median overall survival 7.9 months (95 % CI 5.3–10.4 months; Fig. 2). Conclusion: Capecitabine combined with oxaliplatin has a lower disease control and shorter overall survival than the combination of cisplatin with gemcitabine which has subsequently become the standard of care in this disease. How ever, capecitabine in combination with oxaliplatin does have modest activity in this disease, and can be considered as an alternative treatment option for patients in whom cisplatin and/or gemcitabine are contra-indicated

    Dynamic integrated modelling of information systems and business process simulation

    Get PDF
    Business processes and information technology are two areas that are very closely related to the sustained competitive advantage in organisations. However, investment in information technology often leads to disappointment, which may in part be due to the non-alignment of the information system domain with the business process domain. Simulation modelling is an established technique often used in business process change projects, as it allows a comparison of different possible scenarios without the expense of physically implementing the system. However business process simulation fails to effectively capture the information systems perspective in the model. This thesis contends that by combining information systems modelling techniques with business process simulation the model will be able to capture all the four perspectives (functional, behavioural, organisational and informational) of an organisation, and the design of the business processes and the information system will be better aligned. Initially, attempts were made to integrate business process simulation with computer network simulation in a simple two- or three-layered simulation model, but this gave rise to significant problems the most significant being the underlying assumptions of the original hypothesis. This led to a refined hypothesis in which the layered models were discarded along with the network domain. The revised hypothesis aimed to capture the informational changes that occur in the information system and therefore combines prototyping with business process simulation. This overcomes the unsafe assumptions of the initial hypothesis about whether the system is 'correct' and provides a method of validating the design of the information system within the context of the business processes. The integrated model allows concurrent design of the information system domain and the business process domain and therefore ensures that the domains are better aligned. The framework is tested on a case study and the results indicate that it is an effective tool in the combined design of business processes and information systems.EThOS - Electronic Theses Online ServiceGBUnited Kingdo

    Multicentre phase II pharmacokinetic and pharmacodynamic study of OSI-7904L in previously untreated patients with advanced gastric or gastroesophageal junction adenocarcinoma

    Get PDF
    A two-stage Simon design was used to evaluate the response rate of OSI-7904L, a liposome encapsulated thymidylate synthase inhibitor, in advanced gastric and/or gastroesophageal adenocarcinoma (A-G/GEJA), administered intravenously at 12 mg m−2 over 30 min every 21 days. Fifty patients were treated. Median age was 64 years (range 35–82), 62% were male and 89% had ECOG PS of 0/1. A total of 252 cycles were administered; median of 4 per patient (range 1–21). Twelve patients required dose reductions, mainly for skin toxicity. Investigator assessed response rate was 17.4% (95% CI 7.8–31.4) with one complete and seven partial responses in 46 evaluable patients. Twenty-one patients (42%) had stable disease. Median time to progression and survival were 12.4 and 36.9 weeks, respectively. NCI CTCAE Grade 3/4 neutropenia (14%) and thrombocytopenia (4%) were uncommon. The main G3/4 nonhaematological toxicities were skin-related 22%, stomatitis 14%, fatigue/lethargy 10%, and diarrhea 8%. Pharmacokinetic data showed high interpatient variability. Patients with higher AUC were more likely to experience G3/4 toxicity during cycle 1 while baseline homocysteine did not predict toxicity. Response did not correlate with AUC. Elevations in 2′-dU were observed indicating target inhibition. Analysis of TS genotype, TS protein and expression did not reveal any correlation with outcome. OSI-7904L has activity in A-G/GEJA similar to other active agents and an acceptable safety profile
    corecore