Biomedical Engineering (Scholarly Articles)

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  • Publication
    The sustainable impact of the use of science based targets in organisations
    (Sciendo, 2023-12-06) Carvalho, Afonso; Sá, José Carlos; Correia, Florbela; McDermott, Olivia; Dinis-Carvalho, José; Fonseca, Luís
    Due to the increase in gas emissions and the growth of environmental problems globally, companies are striving to reduce their emissions and waste products in order to become more sustainable and preserve the environment. In order to solve this problem, an initiative called Science Based Targets has been created with the aim of defining targets and paths for companies to follow in order to reduce their carbon footprints. This article will analyse the impact that adherence to this initiative has had on companies' sustainability. To obtain the data, a survey was sent to Portuguese companies. It was concluded that in general Science Based Targets contribute to the sustainable development of organisations, however it is still a very recent initiative which has had low uptake by Portuguese companies.
  • Publication
    A study on Ishikawa’s original basic tools of quality control in healthcare
    (Emerald, 2022-08-30) McDermott, Olivia; Antony, Jiju; Sony, Michael; Rosa, Angelo; Hickey, Mary; Ann Grant, Tara
    The main objective of this study is to investigate Ishikawa¿s statement that ¿95% of problems in processes can be accomplished using the 7 Quality Control (QC) tools¿ and explore its validity within the healthcare sector. The study will analyse the usage of the 7 QC tools in the healthcare service sector and the benefits, challenges, and critical success factors for the application of the 7 QC tools in this sector. Design/methodology/approach ¿ In order to evaluate Ishikawa¿s statement and how valid his statement is for the healthcare sector, an online survey instrument was developed, and data collection was performed utilizing a stratified random sampling strategy. The main strata/clusters were formed by healthcare professionals working in all aspects of healthcare organisations and functions. A total of 168 participants from European healthcare facilities responded to the survey. Findings ¿ The main finding of this study is that 62% of respondents were trained in the 7 QC tools. Only 3% of participants in the healthcare sector perceived that the seven tools of QC can solve above 90% of quality problems as originally claimed by Dr Ishikawa. Another relevant finding presented in this paper is that Histograms, Cause & Effect diagrams and check sheets are the most used tools in the healthcare sector. The least used tools are Stratification and Scatter diagrams. This paper also revealed that the 7 QC tools proposed by Dr. Ishikawa were most used in hospital wards and in administration functions. This work also presents a list of Critical Success Factors required for the proper application of the 7 QC tools in Healthcare.
  • Publication
    The impact of Industry 4.0 on the medical device regulatory product life cycle compliance
    (MDPI, 2022-11-07) McDermott, Olivia; Foley, Ida; Antony, Jiju; Sony, Michael; Butler, Mary
    The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many changes within the MedTech Industry. The MedTech industry is changing from interconnected manufacturing systems using cyber-physical systems to digital health technologies. The purpose of the study is to establish how Industry 4.0 can understand the impact Industry 4.0 is having on product lifecycle regulatory compliance and determine the effect Industry 4.0 is having on product lifecycle regulatory compliance. A qualitative research approach was utilised to gather data from the MedTech industry by conducting interviews with Medtech industry leaders. This research demonstrates that Industry 4.0 is easing product lifecycle regulatory compliance and that the impact is more positive than negative. Industry 4.0 offers many benefits to the MedTech Industry. This research will support organisations in demonstrating how digital technologies can positively impact product lifecycle regulatory compliance and support the industry in building a business case for future implementation of Industry 4.0 technologies.
  • Publication
    Implementing a customised Lean Six Sigma methodology at a compound animal feed manufacturer in Ireland
    (Emerald, 2023-01-27) Trubetskaya, Anna; McDermott, Olivia; Brophy, Padraig
    This study aims to propose a tailored Lean Six Sigma framework providing an accessible Lean Six Sigma methodology for compound feed manufacturers with the aim of mitigating rising costs and increasingly complex demands from customers. A Lean Six Sigma framework was designed combining Lean value stream mapping and Six Sigma structured problem-solving with a case study in an Irish compound feed manufacturer. The study found that the Lean Six Sigma implementation framework provided a simplified approach, which fitted the resource availability within compound feed manufacturing. The study is limited by the constraints of a sole case study in providing empirical evidence of the effectiveness of the framework. Nevertheless, a conceptual Lean Six Sigma model is proposed, which will assist compound feed manufacturers implementing a continuous improvement approach. This paper proposes a simplified approach to the implementation of Lean Six Sigma in agricultural compound feed manufacturers and in small and medium-sized organisations. This is the first such study in Ireland and will add to the body of work on Lean in agriculture and aid other agri-businesses and compound feed manufacturers in understanding how Lean Six Sigma can benefit.
  • Publication
    Implementation of a Lean 4.0 project to reduce non-value add waste in a medical device company
    (MDPI, 2022-11-22) Foley, Ida; McDermott, Olivia; Rosa, Angelo; Kharub, Manjeet
    The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many changes within the manufacturing industry. The purpose of the study is to demonstrate how an Industry 4.0 project was scoped and deployed utilising Lean tools to reduce non-value add wastes and aid regulatory compliance. A case study research approach was utilised to demonstrate how the Lean Industry 4.0 project was implemented in a Medtech company to enhance Lean processes while increasing digitalisation. This research demonstrates that Industry 4.0 can enhance Lean, improve flow, reduce nonvalue add waste, and facilitate product lifecycle regulatory compliance to reduce defects, enhance quality, improve cycle time, and minimise reworks and over-processing. Lean and Industry 4.0 combined offer many benefits to the MedTech Industry. This research will support organisations in demonstrating how digital technologies can synergistically affect Lean processes, positively impact product lifecycle regulatory compliance, and support
  • Publication
    Global study into the pros and cons of ISO 18404: a convergent mixed method study and recommendations for further research
    (Emerald, 2021-01-24) Antony, Jiju; McDermott, Olivia; Sony, Michael; Powell, Daryl; Snee, Ronald; Hoerl, Roger Wesley
    Purpose The paper aims to investigate the pros and cons of having a standard for lean six sigma developed in 2015. The study follows up on a previous study by Antony et al. (2021) in more depth and aims to provide a more detailed investigation of various aspects of the standard. Design/methodology/approach A sequential mixed methodology was utilised by interviewing a panel of leading academics and practitioners familiar with lean six sigma followed by distributing a survey questionnaire to continuous improvement and operational excellence (OPEX) personnel. Findings The findings indicate that continuous improvement and OPEX professionals have conflicting views of International Standards Organisation (ISO) 18404. A majority of the participants of the qualitative study suggested, whilst supporting the requirement for a lean sigma standard, voiced concerns about the auditability of the standard and whether it is currently “fit for purpose” and proposed that it needs to be revised. Within the quantitative survey, 42% had never heard of the standard, and of the 58% who had heard of it, 90% had read it. Just 10% stated that they had or would apply the standard within their organisations. Just fewer than 50% felt that the standard was fit for purpose which suggests for further refinements of the standard in the future. Finally, 85% of respondents of the quantitative survey suggested for the revision of the standard whilst just 15% felt it should be removed. Research limitations/implications Other than a previous study by Antony et al. (2021), implementation of ISO 18404 in organisations and its benefits as well as empirical study looking into the impact of the standard on corporate performance in the literature were limited. An opportunity to review lessons learnt from a case study on the ISO 18404 standard implementation within an organisation would further enhance the research. Originality/value The paper provides a valuable resource for organisations to obtain insight into a standard in lean six sigma and whether to implement it or not. Furthermore, the results can form the basis of a case for the future revision of the standard by consolidating and strengthening the findings from the first study with more detailed quantitative and qualitative study.
  • Publication
    Multi-response modelling and optimisation of mechanical properties of Al-Si alloy using mixture design of experiment approach
    (MDPI, 2022-11-01) Poornesh, M.; Bhat, Shreeranga; Gijo, E. V.; Bellairu, Pavana Kumara; McDermott, Olivia
    The research aims to produce, model, and optimise the mechanical properties of novel composite material through a structured multidisciplinary approach. The primary objective is to combine materials science, mechanical engineering, and statistical concepts to ensure Design for Manufacturability (DFM) from the industrial perspective. More specifically, the article is intended to determine the optimal mixture components and predictive model of Al-Si alloy with Al2O3 by accommodating multi-responses that enable DFM. The study adopted ASTM standards to prepare and test the novel composite material. Additionally, the Mixture Design of Experiment (DOE) approach was used to design the experimentation and subsequent analysis. In addition, microstructural images, Cox Response Trace plot, and Response Optimiser plot are effectively utilised to draw robust inferences. For multi-response modelling and optimisation, the composite material¿s mechanical properties, like impact strength, hardness, density, and tensile strength, are considered. The study determines that innovative composite material will yield better results when Al-Alloy is 94.65 wt% and Al2O3 is 5.35 wt% from a multi-responses perspective. Further, it provides predictive models with a high level of predictability. Besides, the research shows that novel composite material has better mechanical properties from a practical perspective. The article not only provides the mechanical properties of a new class of material but also shows the effective utilisation of material science and statistical concepts to develop the novel material in a structured manner. This composite material can be used as a replacement for various parts of automobiles and aircraft. Additionally, researchers can use the article¿s modelling and optimisation approach as a paradigm to create durable composite materials.
  • Publication
    How do organizational performances vary between early adopters and late adopters of Quality 4.0? An exploratory qualitative study
    (Emerald, 2023-08-24) Jiju, Antony; Swarnakar, Vikas; Sony, Michael; McDermott, Olivia; Jayaraman, Raja
    This study aims to investigate how early and late adopters of Q4.0 differ in terms of organizational performance. The authors employed a grounded theory approach for interviewing 15 senior managers from diverse organizational contexts throughout the globe as part of their qualitative research methodology. The research's findings were analyzed based on four types of performance: operational, financial, environmental, and social. It was clear that early adopters of Q4.0 were sustaining superior performance in quality over time, even though their investment was significantly higher than that of late adopters. From a financial viewpoint, it was evident that early adopters had a competitive edge over their rivals compared to late adopters. Late adopters have utilized the notion of the circular economy (CE) more effectively than many early adopters in the context of environmental performance in order to establish a green economy and sustainable development. Although the results of the interview indicate that Q4.0 is having some positive effects on social performance, in the authors' view, it is still least understood from an empirical standpoint. The study's findings assist organizations in comprehending the performance differences between Q4.0 early adopters and late adopters.
  • Publication
    Industry 4.0 benefits, challenges and critical success factors: a comparative analysis through the lens of resource dependence theory across continents and economies
    (Emerald, 2023-06-21) Antony, Jiju; Sony, Michael; Garza-Reyes, Jose Arturo; McDermott, Olivia; Tortorella, Guilherme; Jayaraman, Raja; Sucharitha, Rahul; Salentijin, Wilem; Maalouf, Maher
    The study ranks benefits, challenges and CSFs across economies and continents. Further, the benefit of Industry 4.0 helping to achieve organizational efficiency and agility differed across the developing and developed economies. Further, the benefit improves customer satisfaction significantly differed across continents; in terms of challenges, Employee resistance to change had a higher proportion in developing economies. Future viability of Industry 4.0 also differed across the continents. Regarding CSFs, there was no difference across the developing and developed economies. Finally, change management and project management vary across the continents.
  • Publication
    Designing online delivery of lean education during COVID-19
    (Emerald, 2023-08-23) McDermott, Olivia
    This study describes how two organisations transitioned to teaching Lean online during and post Covid-19. The study aims to establish how Lean teaching and training can be designed and delivered effectively online without adverse effects on the student learning experience of Lean concepts. Design Methodology/Approach. A case study approach was utilised to review the design, application and results of the transition to online Lean teaching and training. Qualitative and quantitative methods were deployed to assess the results. Findings: Online Lean learning and application were assured via the design of practical problem-based teaching environments aided by utilising the virtual classroom as an obeya room and as a kaizen environment where students worked in teams. Students were enabled to learn and apply Lean tools practically and reflect on their learnings.
  • Publication
    The effect of medical device regulations on deploying a Lean Six Sigma project
    (MDPI, 2022-11-05) McGrane, Vincent; McDermott, Olivia; Trubetskaya, Anna; Rosa, Angelo; Sony, Michael
    This paper investigates the differences in timelines involved in Lean Six Sigma (LSS) project deployment in a regulated industry versus in an unregulated one. Two case studies utilising Lean Six Sigma methods¿in order to compare the transfer of manual manufacturing lines within a medical device and electronics manufacturing site¿are discussed and utilised. This research aims to show the effects of regulatory procedures on LSS project implementation and timelines. This study particularly highlights how a regulatory environment can be a barrier, or bottleneck, to project management, continuous improvement, and engineering changes in the MedTech or medical device manufacturing industry. The results of this study represent an important first step towards a full understanding of the influence of regulations on operations in medical devices and, by extension, on pharmaceutical manufacturing industries on a global scale. The research limitations are that the data collected were from two specific case study comparisons alone.
  • Publication
    The impact of serialisation on operational efficiency and productivity in pharmaceutical sites: A literature review
    (Taylor & Francis, 2023-07-04) O' Mahony, Daniel; McDermott, Olivia; Lynch, Alan; Cormican, Kathryn
    Serialization technology was introduced to protect the pharmaceutical supply chain from falsified and substandard medicines infiltration. The implementation of serialization systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of Serialisation on operational efficiency and productivity in the pharmaceutical industry. A literature review demonstrated limited publications on Serialisation concerning its costs and effects on packing line operational efficiency and productivity. Therefore, a literature review was carried out to assess the relationship between Serialisation, operational efficiency, and productivity. The study revealed that Serialisation had the potential to impact pack line Operational Equipment Effectiveness negatively and line availability, as well as the unit cost of packaged pharmaceuticals and that actual capital costs of Serialisation were greater than the costs originally outlined by policymakers. In addition, the study identified a trend where pharmaceutical sites move away from smaller batch production and toward larger batches to gain greater efficiencies. This is the first study of Serialisation literature from a manufacturing viewpoint.
  • Publication
    An enhanced phenomenological model to predict surface-based localised corrosion of magnesium alloys for medical use
    (Elsevier, 2023-01-05) Quinn, Conall; Van Gaalen, Kerstin; McHugh, Peter E.; Kopp, Alexander; Vaughan, Ted J.; Irish Research Council; Horizon Europe
    This study developed an enhanced phenomenological model for the predictions of surface-based localised corrosion of magnesium alloys for use in medical applications. The modelling framework extended previous surface-based approaches by considering the role of β-phase components throughout the material volume to better predict spatial and temporal aspects of surface-based corrosion in magnesium alloys. This enhanced surface-based corrosion model offers many advantages as it (i) captures multi-directional pitting, (ii) captures various pit morphologies, (iii) eliminates mesh sizing effects, (iv) reduces computational cost through custom time controls (v) offers control of pit sizing and (vi) produces corrosion rates that are independent of pitting parameter values. The model was fully implemented in three dimensions within the finite element framework and shows excellent potential to enable robust predictions of the long-term performance of magnesium-based implants undergoing corrosion.
  • Publication
    The use and application of the 7 new quality control tools in the manufacturing sector: a global study
    (Emerald, 2023-03-15) McDermott, Olivia; Antony, Jiju; Sony, Michael; Fernandes, Marcelo Machado; Koul, Rajesh; Doulatabadi, Mehran
    The main objective of this study is to investigate the 7 new quality control or the 7 new management tools and their use in manufacturing organisations. This research investigates the understanding, knowledge of the tools and the level of application of the tools within the manufacturing sector. In addition, this paper aims to identify the benefits, challenges and critical success factors (CSFs) for the application of the 7 new quality control (QC) tools. Design/methodology/approach ¿ An online survey instrument was developed, and data collection was performed utilising a stratified random sampling strategy. The primary strata/clusters were formed by quality professionals working in all aspects of manufacturing organisations and functions. A total of 86 participants from different countries responded to the survey. Findings ¿ The main finding of this study is that 10% of participants within the manufacturing sector perceived that the 7 new QC tools could solve above 80% of organisational problems. Another relevant finding presented in this paper is that tree diagrams were the most utilised of the 7 new QC tools within the manufacturing sector. The least utilised tools are arrow diagrams. The common benefits of using 7 new QC tools in the manufacturing sector are helping people define, measure and analyse the problem areas or even prioritises them and providing some form of structure to the problem-solving efforts. This paper also revealed that the 7 new QC tools were most used in the manufacturing area but least utilised in the new products and research and development (R&D) functions. This work also presents a list of CSFs and challenges required to properly apply the 7 new QC tools in the manufacturing sector. Research limitations/implications ¿ This study was just carried out in manufacturing organisations. It would be interesting to try and expand to services sectors and compare use within the services sector. Originality/value ¿ Authors understand that this is the very first empirical study analysing the use and understanding of the 7 new QC or management tools within the manufacturing sector. The results of this study represent an important first step towards a complete understanding of the applicability of these tools in continuous improvement programs on a global scale and the context in which they can be utilized.
  • Publication
    Application of design for Lean Six Sigma to strategic space management
    (Emerald, 2023-02-28) Trubetskaya, Anna; McDermott, Olivia; Ryan, Anthony
    This paper outlines how Design for Lean Six Sigma methods aided a medical device manufacturing company in developing a new strategic space management and approval process for its manufacturing site. The project was validated in one manufacturing department, and the Design for Lean Six Sigma methodology resulted in creating 15% new space for that area, with opportunities identified to free up 44.7% of the total manufacturing floor space and realise over ¿2.2 million cost savings as well as start to manufacture new products launched.
  • Publication
    The development of a lean six sigma and BIM framework for enhancing off-site manufacturing
    (Emerald, 2023-05-12) McDermott, Olivia; O Dwyer, Kevin; O'Dwyer, Kevin; Noonan, John; Trubetskaya, Anna; Rosa, Angelo
    This project aims to improve a construction company's overall project delivery by utilising Lean Six sigma methods combined with Business Information Modeling (BIM) to design, modularise and manufacture various building elements in a controlled factory environment off-site. A case study in a construction company utilised Lean Six Sigma methodology and BIM modelling to identify non-value add waste in the construction process and improve sustainability. An Irish-based construction company manufacturing modular pipe racks for the pharmaceutical industry utilised Lean Six Sigma to optimise and standardise their OSM partner's process and leverage BIM to design skids which could be manufactured off-site and transported easily with minimal on-site installation and rework required. As a result, productivity was improved, waste and defects were reduced, and less energy was consumed. The case study focused on one construction company and product type. Further case studies would ensure more generalisability. This is one of the few studies on implementing OSM utilising Lean Six Sigma and BIM in an Irish construction company. The detailed quantitative benefits and cost savings calculations presented, as well as the use of the LSM methods & BIM in designing an OSM process, can be leveraged by other construction organisations to understand the benefits of OSM.
  • Publication
    Leading the transformation: Agile success factors in an Irish manufacturing company
    (Taylor & Francis, 2023-06-01) Coimbra, Henrique; Cormican, Kathryn; McDermott, Olivia; Antony, Jiju
    This study aims to assess the challenges and critical success factors for agile transformation in an Irish manufacturing organisation. Mixed-methods approaches were used to collect data for this study. A quantitative survey utilising the novel Kano model and qualitative analysis using semi-structured interviews with middle and senior managers were employed as part of a case study. Critical success factors are identified, analysed and prioritised based on the opinions of members of the organisation studied. The conclusions of this study show that factors such as people, culture, and leadership are critical to agile transformation. The most important components, in particular, are team empowerment, team flexibility, competency development, and creating and communicating a vision.
  • Publication
    Six Sigma application in an Irish meat processing plant to improve process yields
    (Emerald, 2023-05-22) Gilligan, Rebecca; Moran, Rachel; McDermott, Olivia
    This study aims to utilise Six Sigma in an Irish-based red meat processor to reduce process variability and improve yields. This is a case study within an Irish meat processor where the structured Define, Measure, Analyse, Improve and Control methodology was utilised along with statistical analysis to highlight areas of the meat boning process to improve. Findings: The project led to using Six Sigma to identify and measure areas of process variation. This resulted in eliminating over-trimming of meat cuts, improving process capabilities, increasing revenue, and reducing meat wastage. In addition, key performance indicators and control charts, meat-cutting templates and smart cutting lasers were implemented.
  • Publication
    The challenges for manufacturers of the increased clinical evaluation in the European medical device regulations: A quantitative study
    (Springer, 2023-05-17) Kearney, Breda; McDermott, Olivia
    The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers¿ biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the E.U.
  • Publication
    An empirical study into the use of 7 quality control tools in higher education institutions (HEIs)
    (Emerald, 2022-09-13) Mathur, Swati; Antony, Jiju; McDermott, Olivia; Lizarelli, Fabiane Letícia; Bhat, Shreeranga; Jayaraman, Raja; Chakraborty, Ayon
    Ireland has developed a highly successful medical device cluster. Most of the industry started from USA multinationals that moved to Ireland in the 1990s. An ecosystem has now developed with strong linkages between universities, start-ups, multinationals, venture capital, suppliers, and supporting industries. This paper explores the Medical Device cluster in Ireland. It characterizes the industry through the companies, innovation, products, markets, and regulatory framework. It concludes that the Irish MedTech industry is successful but has been highly dependent on USA multinationals that established themselves here in the 1990s. Based on this, we summarize the opportunities and threats the industry now faces. This is one of the first studies that categorized the MedTech industry in Ireland. This study will provide valuable insights to aid government policy to sustain the medical device cluster in Ireland as well as provide insights into other countries