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Publication Intermittent actuation attenuates fibrotic behaviour of myofibroblasts(Elsevier, 2023-12-19) Ward, Niamh A.; Hanley, Shirley; Tarpey, Ruth; Schreiber, Lucien H.J.; O'Dwyer, Joanne; Roche, Ellen T.; Duffy, Garry P.; Dolan, Eimear B.; Science Foundation Ireland; Irish Research CouncilThe foreign body response (FBR) to implanted materials culminates in the deposition of a hypo-permeable, collagen rich fibrotic capsule by myofibroblast cells at the implant site. The fibrotic capsule can be deleterious to the function of some medical implants as it can isolate the implant from the host environment. Modulation of fibrotic capsule formation has been achieved using intermittent actuation of drug delivery implants, however the mechanisms underlying this response are not well understood. Here, we use analytical, computational, and in vitro models to understand the response of human myofibroblasts (WPMY-1 stromal cell line) to intermittent actuation using soft robotics and investigate how actuation can alter the secretion of collagen and pro/anti-inflammatory cytokines by these cells. Our findings suggest that there is a mechanical loading threshold that can modulate the fibrotic behaviour of myofibroblasts, by reducing the secretion of soluble collagen, transforming growth factor beta-1 and interleukin 1-beta, and upregulating the anti-inflammatory interleukin-10. By improving our understanding of how cells involved in the FBR respond to mechanical actuation, we can harness this technology to improve functional outcomes for a wide range of implanted medical device applications including drug delivery and cell encapsulation platforms.Publication NK cell line modified to express a potent, DR5 specific variant of TRAIL, show enhanced cytotoxicity in ovarian cancer models(Elsevier, 2024-07-25) Sheedy, A.M.; Burduli, N.; Prakash, A.; Gurney, M.; Hanley, S.; Prendeville, H.; Sarkar, S.; O'Dwyer, J.; O'Dwyer, M.; Dolan, Eimear B.; Science Foundation Ireland; Irish Research CouncilObjective Ovarian cancer is a lethal gynaecological malignancy with unsatisfactory 5 year survival rates of 30–50 %. Cell immunotherapy is a promising new cancer treatment where immune cells, such as Natural Killer (NK) cells, are administered to enable the patient to fight cancer through direct cytotoxicity. NK cells orchestrate an adaptive immune response by enabling the release of tumour antigens. NK cell cytotoxicity and effector responses are largely driven by TRAIL engagement. In this study we investigated the cytotoxic potential of a human NK cell line that were modified to express a potent DR5 specific TRAIL variant. We hypothesised that this modification would enhance NK cell cytotoxicity against TRAIL sensitive and resistant ovarian cancer cell lines in vitro. Methods KHYG-1 human NK cells were modified with a TRAIL variant targeting DR5 (TRAILv-KHYG-1). Human ovarian cancer cell lines, OVCAR-3 and SKOV-3, were cultured with modified or non-modified NK cells at different effector:target (E:T) ratios for 4 or 16 h. Apoptosis was assessed by Annexin-APC and 7-AAD and measured using flow cytometry. Apoptotic cells were defined as annexin V 7-AAD double positive. Cytokine expression was measured by multiplex ELISA, and analysed by flow cytometry. Results Modified and non-modified NK cells significantly reduced OVCAR-3 cell viability as compared to OVCAR-3 cells that were cultured alone after 4 and 16 h treatment. OVCAR-3 cell viability was reduced after treatment with 1:1 E:T ratio with TRAILv-KHYG-1 cells after 16 h. On the contrary, neither NK cell line had any effect of SKOV-3 cell viability despite SKOV-3 cells having more DR5 surface expression compared to OVCAR-3 cells. Conclusions TRAILv-KHYG-1 cells significantly reduced OVCAR-3 cell viability as compared to non-modified NK cells. However, no significant reduction in viability was observed when SKOV-3 cell were cultured with either NK cells, despite having more DR5 surface expression compared to OVCAR-3 cells. These data indicate that mechanisms other than DR5 expression drive TRAIL resistance in ovarian cancer.Publication Exploring therapy transport from implantable medical devices using experimentally informed computational methods(Royal Society of Chemistry, 2024-04-22) Trask, Lesley; Ward, Niamh A.; Tarpey, Ruth; Beatty, Rachel; Wallace, Eimear; O'Dwyer, Joanne; Ronan, William; Duffy, Garry P.; Dolan, Eimear B.; Irish Research Council; Science Foundation IrelandImplantable medical devices that can facilitate therapy transport to localized sites are being developed for a number of diverse applications, including the treatment of diseases such as diabetes and cancer, and tissue regeneration after myocardial infraction. These implants can take the form of an encapsulation device which encases therapy in the form of drugs, proteins, cells, and bioactive agents, in semi-permeable membranes. Such implants have shown some success but the nature of these devices pose a barrier to the diffusion of vital factors, which is further exacerbated upon implantation due to the foreign body response (FBR). The FBR results in the formation of a dense hypo-permeable fibrous capsule around devices and is a leading cause of failure in many implantable technologies. One potential method for overcoming this diffusion barrier and enhancing therapy transport from the device is to incorporate local fluid flow. In this work, we used experimentally informed inputs to characterize the change in the fibrous capsule over time and quantified how this impacts therapy release from a device using computational methods. Insulin was used as a representative therapy as encapsulation devices for Type 1 diabetes are among the most-well characterised. We then explored how local fluid flow may be used to counteract these diffusion barriers, as well as how a more practical pulsatile flow regimen could be implemented to achieve similar results to continuous fluid flow. The generated model is a versatile tool toward informing future device design through its ability to capture the expected decrease in insulin release over time resulting from the FBR and investigate potential methods to overcome these effects.Publication In vitro evaluation of bioabsorbable poly(lactic acid) (PLA) and poly-4-hydroxybutyrate (P4HB) warp-knitted spacer fabric scaffolds for osteogenic differentiation(IOP Publishing, 2025-01-09) Caronna, Flavia; Limem, Skander; Do, Ly Dang Khoa; Ronan, William; Dolan, Eimear B.Bioabsorbable textile scaffolds are promising for bone tissue engineering applications. Their tuneable, porous, fibre based architecture resembles that of native extracellular matrix, and they can sustain tissue growth while being gradually absorbed in the body. In this work, immortalized mouse calvaria preosteoblast MC3T3-E1 cells were cultured in vitro on two warp-knitted bioabsorbable spacer fabric scaffolds made of poly(lactic acid) (PLA) and poly-4-hydroxybutyrate (P4HB), to investigate their osteogenic properties. Scaffold structure and yarn properties were characterized after manufacturing. Cells were seeded on the two scaffolds and treated with osteogenic media for up to 35 days. Both scaffolds supported similar cell growth patterns, featuring a higher cell density on multifilament yarns, which could be beneficial to drive cell proliferation or related phenomena in localized area of the construct. The increase in ALP activity and the calcium deposition observed on some PLA and P4HB scaffolds after 28 and 35 days of culture, confirm their potential to support MC3T3-E1 cells differentiation, however inconsistent mineralization was observed on the scaffolds. Due to their structural and morphological features, ability to support cell attachment and growth, and their limited osteogenic potential, these PLA and P4HB bioabsorbable textile scaffolds are recommended for further investigation for bone tissue engineering applications.Publication Manufacturing, characterization, and degradation of a poly(lactic acid) warp-knitted spacer fabric scaffold as a candidate for tissue engineering applications(Royal Society of Chemistry, 2022-05-24) Caronn, Flavia; Glimpel, Nikola; Paar, Georg-Philipp; Gries, Thomas; Blaeser, Andreas; Do, Khoa; Dolan, Eimear B.; Ronan, William; European Union's Horizon 2020Three-dimensional bioabsorbable textiles represent a novel technology for the manufacturing of tissue engineering scaffolds. In the present study, 3D bioabsorbable poly(lactic acid) (PLA) spacer fabric scaffolds are fabricated by warp-knitting and their potential for tissue engineering is explored in vitro. Changes in physical properties and mechanical performance with different heat setting treatments are assessed. To characterize the microenvironment experienced by cells in the scaffolds, yarn properties are investigated prior to, and during, hydrolytic degradation. The differences in yarn morphology, thermal properties, infrared spectra, and mechanical properties are investigated and monitored during temperature accelerated in vitro degradation tests in phosphate buffered saline (PBS) solution at 58 °C and pH 7.4 for 55 days. Yarn and textile cytocompatibility are tested to assess the effect of materials employed, manufacturing conditions, post processing and sterilization on cell viability, together with the cytocompatibility of the textile degradation products. Results show that the heat setting process can be used to modify scaffold properties, such as thickness, porosity, pore size and stiffness within the range useful for tissue regeneration. Scaffold degradation rate in physiological conditions is estimated by comparing yarn degradation data with PLA degradation data from literature. This will potentially allow the prediction of scaffold mechanical stability in the long term and thus its suitability for the remodelling of different tissues. Mouse calvaria preosteoblast MC3T3-E1 cells attachment and proliferation are observed on the scaffold over 12 days of in vitro culture by 4′,6-diamidino-2-phenylindole (DAPI) fluorescent staining and DNA quantification. The present work shows the potential of spacer fabric scaffolds as a versatile and scalable scaffold fabrication technique, having the ability to create a microenvironment with appropriate physical, mechanical, and degradation properties for 3D tissue engineering. The high control and tunability of spacer fabric properties makes it a promising candidate for the regeneration of different tissues in patient-specific applications.Publication Actuation-mediated compression of a mechanoresponsive hydrogel by soft robotics to control release of therapeutic proteins(Wiley, 2024-12-18) Wallace, Eimear J.; O'Dwyer, Joanne; Dolan, Eimear B.; Burke, Liam P.; Wylie, Robert; Bellavia, Gabriella; Straino, Stefania; Cianfarani, Francesca; Ciotti, Gabriella; Serini, Simona; Calviello, Gabriella; Roche, Ellen T.; Mitra,Tapas; Duffy, Garry P.; Irish Research Council; EU Horizon 2020Therapeutic proteins, the fastest growing class of pharmaceuticals, are subject to rapid proteolytic degradation in vivo, rendering them inactive. Sophisticated drug delivery systems that maintain protein stability, prolong therapeutic effects, and reduce administration frequency are urgently required. Herein, a mechanoresponsive hydrogel is developed contained within a soft robotic drug delivery (SRDD) device. In a step-change from previously reported systems, pneumatic actuation of this system releases the cationic therapeutic protein Vascular Endothelial Growth Factor (VEGF) in a bioactive form which is required for therapeutic angiogenesis, the growth of new blood vessels, in numerous clinical conditions. The ability of the SRDD device to release bioactive VEGF in a spatiotemporal manner from the hydrogel is tested in diabetic rats – a model in which angiogenesis is difficult to stimulate. Daily actuation of the SRDD device in the diabetic rat model significantly increased cluster of differentiation 31+ (CD31+) blood vessel number (p = 0.0335) and the diameter of alpha-smooth muscle actin+ (α-SMA+) blood vessels (p = 0.0025) compared to passive release of VEGF from non-actuated devices. The SRDD device combined with the mechanoresponsive hydrogel offers the potential to deliver an array of bioactive therapeutics in a spatiotemporal manner to mimic their natural release in vivo.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, LuísDue 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, TaraThe 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 Implementing a customised Lean Six Sigma methodology at a compound animal feed manufacturer in Ireland(Emerald, 2023-01-27) Trubetskaya, Anna; McDermott, Olivia; Brophy, PadraigThis 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, ManjeetThe 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 supportPublication 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 WesleyPurpose 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, OliviaThe 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, RajaThis 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 Designing online delivery of lean education during COVID-19(Emerald, 2023-08-23) McDermott, OliviaThis 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, MichaelThis 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, KathrynSerialization 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 EuropeThis 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 Application of design for Lean Six Sigma to strategic space management(Emerald, 2023-02-28) Trubetskaya, Anna; McDermott, Olivia; Ryan, AnthonyThis 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, AngeloThis 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, JijuThis 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.