Abstract: With the rising concept of Industry 5.0, the worker’s needs and well-being are placed at the center of the production process. The use of extended reality can be exploited to provide the operator with interactive training, allowing independent, step-by-step learning in the real environment, with instructional digital contents, superimposed over the machinery in the workplace. This kind of training promotes the operator’s skills, and consequently empowers the industrial competitiveness. The aim of this paper is to assess and compare the effectiveness of two different marker-less mixed reality (MR) applications to train the operator in the wire harness activities over a tractor’s drivetrain. An application based on Azure Spatial Anchors by Microsoft and another one based on the CAD model of the tractor’s drivetrain have been developed and tested through the comparison with the traditional paper-based instructions. On-field trials have been accomplished with 10 end-users. User experience, usability, perceived workload, and training effectiveness have been assessed through specific questionnaires and by analyzing user performances. Even if the Anchors-based app showed better outcomes in terms of effectiveness and acceptability, both MR applications resulted in good usability. Operators’ willingness of using this technology as a standard tool for training and support emerged.

Keywords: HoloLens | human centred manufacturing | Industry 5.0 | mixed reality | spatial anchors | training

Abstract: The orbital walls and floor are common sites of facial bone fracture and may cause severe functional impairment. The complex geometry of the bony orbit makes anatomical reconstruction extremely challenging, with main issues related to the implant’s correct shaping, positioning, and orientation inside the orbital cavity. This study proposes an innovative medical device to place patient-specific implants in fractured eye sockets properly. The device must be used with the developed improved version of a tailored implant shaping mould. The design of the orbital implant positioner followed specific clinical and technical requirements and specifications investigated through the Quality Function Deployment method. The device has been conceived to be simple, economical, capable of managing deantigenated bones or titanium meshes for orbital floor and wall, and reusable multiple times. The positioner consists of two handles hinged together and adequately coupled by a spring to allow the grasping and placing of the implant. Positioner and mould have been manufactured in polyamide using the Selective Laser Sintering technique. The system accuracy assessment resulted in promising outcomes. The mould can precisely shape the implant with a lower than 0.1 mm deviation. The implant positioner can place the implant with a rotation angle around the orbital rim of barely 7.1° and 1.2 mm deviation in the mediolateral direction (no deviations in the anteroposterior and superior-inferior directions occur)

Keywords: Computer-aided design | Craniomaxillofacial surgery | Implant design | Medical devices | Rapid prototyping

Abstract: Extended Reality (XR) technologies can be a valid tool for supporting operators with assembly instructions in real-time, directly superimposed on the product. A strategy to face dynamic effects, such as sudden environmental changes and objects in movement, still needs to be defined to implement effective XR applications in moving production lines. The physical environment must be tracked and recognized to determine the position and the orientation of digital content in space. This paper aims to address these open issues by proposing a Mixed Reality (MR) application to support workers in the wire harness process for the tractor’s drivelines production, which requires the product to be in motion. For this aim, the Microsoft Azure Spatial Anchors with Microsoft HoloLens 2 were adopted. The designed and developed MR application allows the operator to display, step-by-step, consecutive work instructions provided through textual indications, pictures, videos, and animations. Through the Azure Spatial Anchors, the digital content can be anchored over the driveline parts. By knowing the speed of the production line and the duration of each wiring task, a time-controlled application has been developed, to assure the visualization of the instruction in correspondence of the relative driveline elements, in the right time. The application has been tested on-field with expert operators. Despite the presence of some drawbacks related both to the driveline motion and technology, the operators’ feedback pointed out satisfactory and promising results since the application allowed them to reduce errors and forgetfulness.

Keywords: Azure Spatial Anchor | In-motion tracking | Industry 4.0 | Mixed Reality | Wire harness process

Abstract: Background: Simulation has been recognized as a shift in healthcare education that can improve skills and patient safety and outcomes. High-fidelity simulation of critical medical situations can be a source of stress among participants that can interfere with students' abilities leading to unexpected emotional responses. The aim of this study is to determine if two simulation methods, high-fidelity (HF) and procedural simulation (PS), may be associated with stress responses at a self-perceived and biological level (salivary cortisol variations), and to compare stress levels of the two different simulation method. We also wanted to find independent variables associated with cortisol total hormonal output. Methods: A quasi-experimental before-after study was used including the administration of questionnaires, and biomarkers evaluation by salivary cortisol samples before and after simulation. A total of 148 students were eligible and agreed to participate in the study. We used paired T-test for mean comparison regarding State-trait anxiety for both HF and PT simulations. For NASA-TLX we performed a T-test mean comparison between groups. We used paired T-test mean comparison for cortisol analysis. Multivariable linear regression has been used to assess variables associated with AUCg values and perceived stress. Results: values of STAI-Y scores were relatively higher at the end of the HF and PS sessions. NASA-TLX was significantly higher at baseline for the HF simulations, with respect to the PS simulation. Cortisol fold increase was significantly different in the two groups. Linear regression showed that cortisol AUCg was related to the STAI-Y score in both groups. Conclusion: Participating students developed a stress response both after in the HF and PS training, testified by psychological and biological outputs. According to our results, stress levels were increased for simply being in a simulation scenario than to the intrinsic complexity of the task required. More studies are needed to confirm this trend and to clarify the role of simulated stress response in a long-term learning scenario.

Keywords: Anxiety | Cortisol | High-fidelity | Medical training | Simulation | Stress

Abstract: In response to rapid population ageing, digital technology represents the greatest resource in supporting the implementation of active and healthy ageing principles at clinical and service levels. However, digital information platforms that deliver coordinated health and social care services for older people to cover their needs comprehensively and adequately are still not widespread. The present work is part of a project that focuses on creating a new personalised healthcare and social assistance model to enhance older people’s quality of life. This model aims to prevent acute events to favour the elderly staying healthy in their own home while reducing hospitalisations. In this context, the prompt identification of criticalities and vulnerabilities through ICT devices and services is crucial. According to the human-centred care vision, this paper proposes a decision-support algorithm for the automatic and patient-specific assignment of tailored sets of devices and local services based on adults’ health and social needs. This decision-support tool, which uses a tree-like model, contains conditional control statements. Using sequences of binary divisions drives the assignation of products and services to each user. Based on many predictive factors of frailty, the algorithm aims to be efficient and time-effective. This goal is achieved by adequately combining specific features, thresholds, and constraints related to the ICT devices and patients’ characteristics. The validation was carried out on 50 participants. To test the algorithm, its output was compared to clinicians’ decisions during the multidimensional evaluation. The algorithm reported a high sensitivity (96% for fall monitoring and 93% for cardiac tracking) and a lower specificity (60% for fall monitoring and 27% for cardiac monitoring). Results highlight the preventive and protective behaviour of the algorithm.

Keywords: decision-support algorithm | digital health | elderly | healthy ageing | personalised care | wearable sensors

Abstract: The importance of training for operators in industrial contexts is widely highlighted in literature. Virtual Reality (VR) is considered an efficient solution for training, since it provides immersive, realistic, and interactive simulations environments promoting a learn-by-doing approach, far from the risks of the real field. Its efficacy has been demonstrated by several studies, but a proper assessment of the operator’s cognitive response in terms of stress and cognitive load during the use of such technology is still lacking. This paper proposes an integrated methodology for the analysis of user’s cognitive states, suitable for each kind of training in the industrial sector and beyond, fostering the human-centred design and manufacturing perspective. The methodology has been assessed using an industrial case study where virtual training is used for assembly of agricultural vehicles. Experimental results highlighted that, with VR additional supportive information, while operators’ errors drastically decrease, the stress increases for complex tasks, due to the greater amount of information to manage. The proposed protocol allows understanding the operators’ cognitive conditions in order to optimize the VR training application, avoiding operators’ stress, mental overload, and improving performance.

Keywords: cognitive ergonomics | mental workload | stress | virtual assembly | Virtual reality | virtual training

Abstract: Among the main features of Industry 4.0, digitization and the evolution of the human-machine interaction occupy a central role. These concepts are transferring even in the health domain, moving toward Healthcare 4.0. The new concept of Industry 5.0 further promotes the human-centric perspective focusing on the consideration of human factors. In this context, training for workers, both in the industry and in the healthcare sectors, needs to be strongly human-centred to be efficient and effective. This paper refers to simulation-based training and aims to provide a transdisciplinary framework for the simulation assessment from the learners’ perspective. The final scope is to outline a set of data-driven guidelines for the simulation optimization and redesign, throughout a human-centred approach, aiming to improve the workers’ performance and the overall learning process, considering the physical, cognitive, and emotional conditions. The proposed method is suitable for each kind of training (both traditional and with the use of virtual reality/augmented reality systems) and relevant for every sector. Two different use cases are presented, respectively referring to the healthcare and industry fields, proposing a unique assessment protocol. The healthcare use case considered the low-fidelity simulation of lumbar puncture, while the industrial use case referred to the replacement of the engine oil filter on tractors. Although the great differences between the content of the use cases, the results obtained about performance as well as cognitive and emotional states are close enough to define a common set of guidelines to redesign and optimize the simulation-based training.

Keywords: Design optimization | Ergonomics | Healthcare 4.0 | Human Factors | Industry 4.0 | Simulation-based training

Abstract: The population aging phenomenon has been increasing in the last years and will become prevailing in the future ones. In the era of Healthcare 4.0, the application of information and communication technologies (ICT) is the main enabler for the health and social care sectors, advancing user-centered care and preventing or delaying frailty conditions. This work focuses on a preliminary usability and user experience (UX) assessment regarding a self-monitoring device, smartphone, and tablet, with a 5-users sample. The user interface layout and content of smartphone and tablet have been previously simplified according to the human-computer interaction principles, to hinder the digital divide inherent to the Silver Generation. Structured and semi-structured interviews have been conducted to evaluate users' expectations, familiarity, and acceptance of ICT devices. A specific assessment protocol has been designed to evaluate the usability of devices. Preliminary results show that all participants were able to complete the test with few committed errors. However, even if a good inclination toward the use of smart technologies emerged, the need for digital mediation and individual training sessions is undisputed.

Keywords: Elderly | healthy ageing | self-monitoring | telemedicine | usability | user experience

Abstract: Approximately 10% of hospitalized patients develops decubitus ulcers that quickly degenerates into chronic illness that reduces the quality of life and requires expensive clinical management. The use of an anti-decubitus active mattress, that automatically redistributes the pressure loads, reduces the occurrence of new lesions and promotes the healing of the pre-existing ones. The aim of this work is to design and develop two tools to support the design of an anti-decubitus active mattress. Almost all the systems found in literature are based on the classification of pressure maps through machine learning and are difficultly usable in the design context. This work proposes a pressure map Classifier and an Interactive Simulator of the mattress, based on a simpler logic, by integrating image processing techniques and functioning simulations. The Classifier can recognize the patient's pressure maps and classify them according to six reference sleep postures. The Interactive Simulator allows to understand the operating mechanisms of the mattress and to test the controller and the various control logics in the absence of a physical prototype.

Keywords: Active Anti-decubitus Mattress | Images Classifier | New product development | Simulation | User centred design

Abstract: Craniomaxillofacial surgeries are performed using custom-made physical cutting guides and resin dental splints that present several drawbacks (e.g. time and cost required for their design and production). The literature commonly provides augmented/mixed reality (AR/MR) solutions for assisting maxillofacial osteotomies and repositioning without any interactive guide. This work proposes a new MR application, useful for osteotomy and repositioning, providing interactive, fast, and intuitive feedback to the surgeon, who is then supported in performing the bone fragment resection and replacement frame by frame. The proposed application speeds up the surgery and reduces under/overshooting errors. Moreover, the idea of integrating osteotomy and repositioning assistance in the same MR application is rarely found in the literature. It is an entirely novel approach to craniomaxillofacial surgery. The MR application has been designed with a three-button menu. The “App Start” calibrates the app, the “Osteotomy Mode” visualises the holograms of the cutting lines and drilling points, and the “Repositioning Mode” visualises the step-by-step real-time feedback to precisely support the surgeon placing the osteotomised bone fragment towards the final pre-planned position. The MR app has been developed in Unity and deployed on Microsoft HoloLens V2. A laboratory test bench was realised to validate the accuracy of the proposed MR-based approach. The validation protocol consists of two tasks to test the osteotomy and repositioning modes using a 3D-printed skull phantom. For osteotomy, the accuracy is 0.89 mm (genioplasty), 1.24 mm (maxillary osteotomy), 1.33 mm (orthognathic surgery), and 2.89 mm (mandibular angle osteotomy). For repositioning, the accuracy is 0.6 mm (anteroposterior deviation), 0.7 mm (mediolateral deviation), and 0.6° (angular deviation).

Keywords: Augmented reality | Hololens | Maxillofacial surgery | Mixed reality | Surgical guide

Abstract: Worldwide, life expectancy has steadily increased over the years. However, the integrity and the functionality of physiological systems reduce over time making older people more vulnerable to adverse events such as falls. Consequences of falls can include physical injuries (hip fractures), psychological issues (fear of falling) and social isolation (need for assistance) increasing the demand for healthcare services (hospitalization, rehabilitation, institutionalization). Despite many studies investigated the most predisposing factors to a fall risk, this study aimed at identifying those factors through a multidimensional health assessment of elderly people crossing over multiple health domains such as nutritional, clinical, psychological, social, and functional. The acquired variables were processed in terms of data cleaning and coding, to make them ready for subsequent statistical evaluation. Correlation and regression analyses were performed to find out the relevance of the variables with respect to the fall event. The most significant variables were accounted for the development of the predictive index. Each predictor was associated with a score according to specific weights so that the sum of the answers to each question of the index gave the final fall risk index. Its validation was assessed over the sample of the study by comparing the index output to that of the multidimensional evaluation and the one of a common fall risk test. Clinicians will benefit from this tool for a fast and easy screening of fall risk among community-dwelling seniors to act promptly on those subjects at increased risk, and preventively on low-risk subjects. This way, it is possible to optimize time, costs, and resources for sustainable and effective management of patient care.

Keywords: Data-driven approach | Fall-risk detection | Older adults | Predictive algorithm | Risk assessment | Risk prediction

Abstract: The European Commission defined the new concept of Industry 5.0 meaning a more human-centric, resilient, and sustainable approach for the design of industrial systems and operations. A deep understanding of the work environment and organization is important to start analysing the working conditions and the resulting User eXperience (UX) of the operators. Also, the knowledge about users’ needs and ergonomics is fundamental to optimize the workers’ wellbeing, working conditions, and industrial results. In this context, the paper presents a strategy to effectively assess the UX of workers to promote human-centric vision of manufacturing sites, enhancing the overall sustainability of the modern factories. A set of non-invasive wearable devices is used to monitor human activities and collect physiological parameters, as well as questionnaires to gather subjective self-assessment. This set-up was applied to virtual reality (VR) simulation, replicating heavy duty work sequence tasks that took place in an oil and gas pipes manufacturing site. This approach allowed the identification of possible stressful conditions for the operator, from physical and mental perspectives, which may compromise the performance. This research was funded by the European Community's HORIZON 2020 programme under grant agreement No. 958303 (PENELOPE).

Keywords: Cognitive ergonomics | Human-centred design | Industry 5.0 | User experience | Virtual reality

Abstract: In hip arthroplasty, preoperative planning is fundamental to reaching a successful surgery. Nowadays, several software tools for computed tomography (CT) image processing are available. However, research studies comparing segmentation tools for hip surgery planning for patients affected by osteoarthritic diseases or osteoporotic fractures are still lacking. The present work compares three different software from the geometric, dimensional, and usability perspectives to identify the best three-dimensional (3D) modelling tool for the reconstruction of pathological femoral heads. Syngo.via Frontier (by Siemens Healthcare) is a medical image reading and post-processing software that allows low-skilled operators to produce prototypes. Materialise (by Mimics) is a commercial medical modelling software. 3D Slicer (by slicer.org) is an open-source development platform used in medical and biomedical fields. The 3D models reconstructed starting from the in vivo CT images of the pathological femoral head are compared with the geometries obtained from the laser scan of the in vitro bony specimens. The results show that Mimics and 3D Slicer are better for dimensional and geometric accuracy in the 3D reconstruction, while syngo.via Frontier is the easiest to use in the hospital setting.

Keywords: bio-imaging | CT image segmentation | hip surgery | orthopaedics | reverse engineering | software comparison | surgical planning

Abstract: In the era of the fourth industrial revolution, human has still a central role. Manufacturing industries have to deal with human sustainability in order to guarantee workers’ health and well-being. Several studies have proved the importance of ergonomics in workplace design and the benefits related to the adoption of the human-centered approach. The enabling technologies of Industry 4.0 are changing the role of the operator and can support him from a physical and cognitive point of view. On the other hand, companies are increasingly implementing lean philosophies, such as World Class Manufacturing, to maintain their competitiveness by reducing wastes and costs. However, the need arises for a comprehensive methodology to support the design of manufacturing equipment considering human factors by integrating Industry 4.0 technologies and World Class Manufacturing elements. It aims at improving both ergonomic and efficiency aspects of the workstation. The proposed methodology allows identifying and in-depth analyzing the problem, thus finding and implementing a solution that complies with all the requirements and constraints defined. Each step of the methodology can be strengthened by Industry 4.0 technologies. The methodology has been experimented in a real case study with a global company of agriculture and industrial vehicles, leading to the design and implementation of a new equipment. Relevant benefits in terms of ergonomics, efficiency, and process standardization have been achieved.

Keywords: Equipment design | Ergonomics | Human-centered manufacturing | Industry 4.0 | Workplace organization pillar | World class manufacturing

Abstract: The scientific literature highlights how Mixed Reality (MR) simulations allow obtaining several benefits in healthcare education. Simulation-based training, boosted by MR, offers an exciting and immersive learning experience that helps health professionals to acquire knowledge and skills, without exposing patients to unnecessary risks. High engagement, informational overload, and unfamiliarity with virtual elements could expose students to cognitive overload and acute stress. The implementation of effective simulation design strategies able to preserve the psychological safety of learners and the investigation of the impacts and effects of simulations are two open challenges to be faced. In this context, the present study proposes a method to design a medical simulation and evaluate its effectiveness, with the final aim to achieve the learning outcomes and do not compromise the students' psychological safety. The method has been applied in the design and development of an MR application to simulate the rachicentesis procedure for diagnostic purposes in adults. The MR application has been tested by involving twenty students of the 6th year of Medicine and Surgery of Università Politecnica delle Marche. Multiple measurement techniques such as self-report, physiological indices, and observer ratings of performance, cognitive and emotional states of learners have been implemented to improve the rigour of the study. Also, a user-experience analysis has been accomplished to discriminate between two different devices: Vox Gear Plus® and Microsoft Hololens®. To compare the results with a reference, students performed the simulation also without using the MR application. The use of MR resulted in increased stress measured by physiological parameters without a high increase in perceived workload. It satisfies the objective to enhance the realism of the simulation without generating cognitive overload, which favours productive learning. The user experience (UX) has found greater benefits in involvement, immersion, and realism; however, it has emphasized the technological limitations of devices such as obstruction, loss of depth (Vox Gear Plus), and narrow FOV (Microsoft Hololens).

Keywords: Augmented reality | Cognitive load | Medical education | Mixed reality | Simulation | Stress

Abstract: Purpose To evaluate the accuracy of 3-D printed models of the femoral head based on preoperative computed tomography (CT) images. Other goals were to compare the cartilage thickness of bony specimen to the printed models and calculate the standard deviation between 3-D printed models based on CT images and laser scan models. Methods This retrospective study analyzed 10 patients who underwent preoperative CT imaging and hip replacement. Preoperative femoral head 3-D printed models were produced from CT images. Bony specimens were collected from surgical operations and scanned using CT and 3-D laser scanning, and cartilage thickness subsequently was measured by histological analysis. Comparisons of printed models based on CT images and printed models based on 3-D laser scanning were performed by overlapping their external surfaces using dedicated software and the standard deviation was calculated. Results The average standard deviation between the bony specimen 3-D models and preoperative 3-D printed CT femoral head models was 0.651 mm. The cartilage was approximately 1.487 mm thick. Discussion The comparison between preoperative CT image-based 3-D models and the postoperative bony specimenbased models permitted evaluation of the accuracy of preoperative CT image-based 3-D printed models. Cartilage thickness was estimated indirectly by comparing models obtained by CT and laser scanning, and it was related to the calculated standard deviation to overcome the cartilage detection limit of CT. This study shows how each step can generate accuracy errors on the final 3-D printed model. A repeatable and sustainable workflow for creating accurate and reproducible 3-D printed models could overcome this issue. Moreover, orthopedic surgeons should be aware of 3-D printed model precision in clinical practice. Conclusions This study provides encouraging results on the accuracy of 3-D printed models for surgical planning.

Keywords: 3-D printing | accuracy assessment | bone segmentation | femoral head model | hip replacement surgical procedure

Abstract: Since custom-made 3D printed surgical guides for maxillofacial surgery are usually expensive, Augmented Reality (AR) can be efficiently employed to overcome the high costs. The proposed work aims to develop and test an AR application for different maxillofacial surgeries. The application consists in overlaying the cutting lines on the patient’s mandible to guide the clinician during the procedure. It has been realized in Unity and preliminary tested with HoloLens 2 and a 3D printed mandible. Seven participants performed two consecutive trials. The mandible with the obtained surgical lines has been scanned after each test to digitally reconstruct the traced lines and compare them with the surgical lines previously designed. The results allowed the preliminary analysis of the developed AR system’s accuracy and precision. Mean distances from the designed surgical guides showed good accuracy for the genioplasty (deviation error around 1.03 mm) and orthognathic surgery (deviation error around 1.27 mm), suggesting the applicability of HoloLens 2 for these kinds of surgery. On the contrary, the application was not suitable for the mandibular angle osteotomy (deviation error over 2.50 mm).

Keywords: Augmented reality | HoloLens 2 | Maxillofacial surgery | Surgical guides

Abstract: In the industrial context, the wire harness represents a process with a high degree of manual work and significant customizability of final products. To reduce the workers’ mental demand, the augmented reality (AR) can be an effective tool. The existing industrial applications mainly focus on manual assembly assistance, but few solutions have been developed for the wire harness. This paper tries to enhance such a process by supporting operators with an AR application that shows the work instructions and allows reducing their cognitive workload. The main goals are to propose a user-friendly and versatile tool and carry out a structured and complete evaluation of the user experience. Two experimental sessions were conducted in the laboratory by simulating the wire harness assembly and quality inspection. The use of the AR application is efficient and effective especially when instructions far from the workstation are considered as a reference.

Keywords: Augmented reality | Hololens 2 | Human-centered manufacturing | Industry 4.0 | Wire harness assembly

Abstract: The Obstructive Sleep Apnea Syndrome (OSA) concerns episodes of complete or partial obstruction of the upper airway. Mandibular Advancement Device (MAD) is one of the most used systems for treating this syndrome. Clinicians frequently observe a combination of OSA and periodontitis. There is no research aiming to evaluate how periodontitis staging affects the overall mandibular and maxillary dental arches in the literature. Furthermore, no one has studied the combination between OSA and periodontitis and the effects of MADs on the patients in this condition. This paper aims to develop a numerical simulation approach based on FEM and evaluate the consequences (displacement and stress fields) of the periodontitis staging on PDL and teeth of patients suffering from OSA and treated with MADs. Simulations have been performed for evaluating Stage I of periodontitis. Results highlight a correlation between bone resorption and teeth displacement and periodontal ligaments stress (the higher the bone resorption, the higher the stress and displacement).

Keywords: Finite Element Analysis | Mandibular Advancement Device | Numerical simulation | Obstructive Sleep Apnea | Periodontitis

Abstract: Disability conditions characterized by hand dysfunction are particularly relevant for the use of touchscreen technology. This work investigates the effects of hand impairment produced by systemic sclerosis (SSc) on touchscreen interaction. It aims to fulfil a dual objective: to provide guidelines to design inclusive interfaces and interaction modalities for SSc patients and to design a hand physio-rehabilitation based on a touchscreen application. Eighty patients participated in the observational study and, accordingly, eighty subjects without impairments were recruited as a control cohort. A specific touchscreen application has been designed and developed including three gestures: tap, drag and drop, and pinch-to-zoom. The work allowed identifying the interface features that significantly influence the performance and, consequently, the design rules for the physio-rehabilitation application.

Keywords: Hand impairment | Human-computer interaction | Inclusive design | Interface design | Systemic sclerosis | User-centred design

Abstract: Several implant materials are used in cranial surgery. Still, each one has its drawbacks, such as the risk of infections, low mechanical strength, or low osseointegration. Implants with a porous surface are considered more effective than a smooth and rough coating. The porosity density and structure also influence the mechanical properties of the final implant. Moreover, the implant properties depend on the manufacturing method. This study aims to present a custom-made cranial scaffold composed of two distinct layers. A compact inner one guarantees adequate structural properties to the scaffold. In contrast, a porous outer one lightens the scaffold structure and assures the correct osseointegration. The customized scaffold has been designed through a 3D free-form modeling system. It can be manufactured by 3D printing techniques such as direct metal laser sintering in titanium or via selective laser sintering using PEEK. The advantages and limitations of the multi-layered custom-made scaffold and the related design process are qualitatively described.

Keywords: Additive manufacturing | Craniofacial reconstruction | Customized scaffolds | Multi-layered scaffolds | Porous scaffolds

Abstract: Fractures to the orbital walls and floor must be appropriately managed to avoid severe conditions. This results in particularly challenging anatomical reconstructions. The main issues are the implant’s proper shaping, placement, and orientation onto the eye socket. A new, customized implant-shaping mould has already been developed to shape patient-specific implants. However, it still does not address the implant positioning in the fractured orbital cavity. This present research aims to design, develop, and assess an innovative implant positioner to be used with the optimized version of the aforementioned implant-shaping mould. The new medical device was designed to be used with titanium meshes and deantigenated bone implants. It is easy to use, has a low cost, and is reusable several times. It is composed of (1) two coupled and hinged handles that allow the grasping of the implant, and (2) the positioner itself that permits proper implant placement and orientation. Selective laser sintering was used to print the mould and the new device in polyamide. Promising results for implant shaping, positioning, and orientation accuracy were obtained. An accuracy of 0.1 mm and 1.3 mm was, respectively, achieved for the implant shape and its placement in the mediolateral direction. The mean malrotation angle around the orbital rim was about 6°.

Abstract: Operator 4.0 has to deal with a vast amount of product variants and production data especially within the mass customization paradigm, high mental demanding tasks, and smart production systems. Technologies capable of supporting his training and his work become fundamental, such as the extended reality (XR). Its increasing use in industrial applications, however, opens up new challenges related to interface and interaction design, which can determine the success of both the use and development experience. The lack of guidelines for designing interfaces for mixed reality (MR) applications is what this paper aims to address. Design requirements for MR interfaces are presented and applied in the context of operator training in wire harness activities. Different interaction modes and user interfaces have been developed to evaluate the most suitable and user-friendly one for the operator. A pilot test was conducted to assess the applications' usability and potentialities with satisfactory results.

Keywords: Augmented Reality | Human-Computer Interaction | Industry 4.0 | Mixed Reality | Operator training | User Interface | Wire harness

Abstract: The human‐centered design (HCD) approach places humans at the center of design in order to improve both products and processes, and to give users an effective, efficient and satisfy-ing interactive experience. In industrial design and engineering, HCD is very useful in helping to achieve the novel Industry 5.0 concept, based on improving workers’ wellbeing by providing prosperity beyond jobs and growth, while respecting the production limits of the planet as recently promoted by the European Commission. In this context, the paper proposes an ergonomic assessment method based on the analysis of the workers’ workload to support the design of industrial products and processes. This allows the simultaneous analysis of the physical and cognitive workload of operators while performing their tasks during their shift. The method uses a minimum set of non‐invasive wearable devices to monitor human activity and physiological parameters, in addition to questionnaires for subjective self‐assessment. The method has been preliminarily tested on a real industrial case in order to demonstrate how it can help companies to support the design of optimized products and processes promoting the workers’ wellbeing.

Keywords: Design for ergonomics | Human factors | Human‐centered design | Product design | Workload assessment

Abstract: Simulation in healthcare is rapidly replacing more traditional educational methods, becoming a fundamental step in the medical training path. Medical simulations have a remarkable impact not only on learners' competencies and skills but also on their attitudes, behaviors, and emotions such as anxiety, stress, mental effort, and frustration. All these aspects are transferred to the real practice and reflected on patients' safety and outcomes. The design of medical simulations passes through a careful analysis of learning objectives, technology to be used, instructor's and learners' roles, performance assessment, and so on. However, an overall methodology for the simulation assessment and consequent optimization is still lacking. The present work proposes a transdisciplinary framework for the analysis of simulation effectiveness in terms of learners' performance, ergonomics conditions, and emotional states. It involves collaboration among different professional figures such as engineers, clinicians, specialized trainers, and human factors specialists. The aim is to define specific guidelines for the simulation optimization, to obtain enhanced learners' performance, improved ergonomics, and consequently positively affect the patient treatment, leading to cost savings for the healthcare system. The proposed framework has been tested on a low-fidelity simulation for the training of rachicentesis and has allowed the definition of general rules for its enhancement.

Keywords: Design optimization | Human Factors | Simulation-based training | Transdisciplinary design | User experience

Abstract: Even in the era of the fourth industrial revolution, companies should necessarily deal with human sustainability, with the aim of improving workers’ health and safety and enhancing their skills. Several studies have faced this issue by proposing approaches or framework to boost the consideration of human factors in the workstation design and support ergonomic evaluations. However, the need arises for a methodology that collects and systematizes existing methods and tools in order to create workplaces that fit to human needs. For this aim, this paper proposes a structured methodology that supports the design and engineering of manufacturing equipment in order to improve workstations in terms of ergonomics and efficiency. It allows identifying a problem, solving it and carrying out a complete and objective evaluation from different perspectives. The methodology has been experimented in a real case study in collaboration with a global manufacturer of agriculture and industrial vehicles. Significant benefits in terms of productivity, process standardization and human factors have been achieved.

Keywords: Equipment design | Ergonomics | Human-centered manufacturing | Workplace organization pillar | World class manufacturing

Abstract: The importance of training for operators in industrial contexts is widely highlighted in literature. Virtual Reality (VR) technology is considered an efficient solution for training, since it provides immersive, realistic, and interactive simulations environments where the operator can learn-by-doing, far from the risks of the real field. Its efficacy has been demonstrated by several studies, but a proper assessment of the operator's cognitive response in terms of stress and cognitive load, during the use of such technology, is still lacking. This paper proposes a comprehensive methodology for the analysis of user's cognitive states, suitable for each kind of training in the industrial sector and beyond. Preliminary feasibility analysis refers to virtual training for assembly of agricultural vehicles. The proposed protocol analysis allowed understanding the operators' loads to optimize the VR training application, considering the mental demand during the training, and thus avoiding stress, mental overload, improving the user performance.

Keywords: Cognitive ergonomics | Industrial ergonomics | Training Assessment | Virtual assembly | Virtual Reality

Abstract: In the medical education field, the use of highly sophisticated simulators and extended reality (XR) simulations allow training complex procedures and acquiring new knowledge and attitudes. XR is considered useful for the enhancement of healthcare education; however, several issues need further research. The main aim of this study is to define a comprehensive method to design and optimize every kind of simulator and simulation, integrating all the relevant elements concerning the scenario design and prototype development. A complete framework for the design of any kind of advanced clinical simulation is proposed and it has been applied to realize a mixed reality (MR) prototype for the simulation of the rachicentesis. The purpose of the MR application is to immerse the trainee in a more realistic environment and to put him/her under pressure during the simulation, as in real practice. The application was tested with two different devices: the headset Vox Gear Plus for smartphone and the Microsoft Hololens. Eighteen students of the 6th year of Medicine and Surgery Course were enrolled in the study. Results show the comparison of user experience related to the two different devices and simulation performance using the Hololens.

Keywords: Design methodology | Education | Medical Simulation | Mixed Reality | Training

Abstract: A mixed reality (MR) system, by providing visual, auditory, and haptic feedback to the learner, can offer a high level of immersion and realism, especially in the healthcare context. In medical training through MR simulations, it is particularly important to avoid mental overload, discomfort, fatigue, and stress, to guarantee productive learning. The present work proposes a systematic assessment of stress, cognitive load, and performance (through subjective and objective measures) of students during an MR simulation for the rachicentesis procedure. A specific application has been developed to enhance the sense of realism, by showing, over the skill trainer, a digital patient that responds with auditory and visual feedback, based on the learner’s interaction. A sample of 18 students has been enrolled in the pilot study. Preliminary results suggest the effectiveness of the proposed MR application using Hololens: high performances are achieved, and the cognitive conditions are well balanced.

Keywords: Cognitive load | Medical simulation | Mixed reality | Performance | Stress

Abstract: High-fidelity medical simulations refer to the use of computerized mannequins that simulate real-life scenarios. It is important to avoid stress and cognitive overload of students in order to ensure a productive learning. This study concerns the identification and assessment of events related to intrinsic cognitive loads (ICL), extraneous cognitive loads (ECL) and stress episodes through the analysis of physiological parameters. 170 students were enrolled in the study. Analysed heart rate (HR) and electrodermal activity (EDA) were acquired through Empatica E4 wristband. Cognitive load assessment was performed by evaluating peaks in HR, associable with ICL or ECL through video analysis. The stressful events were assessed considering EDA in relation to HR, according to Russell’s circumplex plan. Results show good achievements in students’ performance and an ICL increment and an ECL decrement during simulation repetition. The stressful conditions increase with the increasing difficulty of the simulations.

Keywords: Cognitive load | Human factor | Medical simulation | Stress | Training

Abstract: This paper presents a methodological procedure, based on the anatomical reconstruction and constrained deformation, to design custom-made implants for forehead augmentation in people affected by Apert syndrome, experiencing a frontal bone deficiency. According to the anthropometric theory, a cranial landmarks identification procedure was applied to retrieve, from a repository, a healthy skull, used as reference geometry for implant modelling. Then, using constrained deformation and free-form modelling techniques, it was possible to design a patient-specific implant. At last, the implant was realised using a custom mould, specially designed according to the patient’s needs to provide an accurate fit of the defect site. The design procedure was tested on a patient suffering from Apert syndrome. Three implants were virtually modelled and 3D-printed for pre-surgical evaluation. Their shapes were 3D compared with a reference one (handcrafted by a surgeon) to test the accuracy. Deviations are negligible, and the customised implant fulfilled the surgeon’s requirements.

Keywords: Computer-aided design | Craniomaxillofacial surgery | Implant design | Medical devices | Rapid prototyping

Abstract: In factories of the future, advanced automation systems (e.g., cobots, exoskeletons, cyber physical systems) will reduce the physical effort of workers and compensate their limitations as well as ensure more flexibility, agility, and competitiveness. However, the activities of the operator 4.0 will entail an increased share of complex cognitive tasks. Therefore, monitoring the mental load will be increasingly important to ensure work environments that promote healthy life and wellbeing for all at all ages. For this aim, this paper proposes a framework to analyze heart rate, galvanic skin response and electrooculogram signals in order to extract features able to detect an excessive stress or cognitive load. Two wearable devices are used: Empatica E4 wristband and J!NS MEME electrooculography glasses. The proposed framework has been experimented through a laboratory test focused on LEGO brick-based simulations of manufacturing activities.

Keywords: Electrodermal activity | Electrooculogram | Heart rate | Physiological measurements | Stress monitoring | Wearable sensors

Abstract: Impaired hand function is a major contributor to overall disability and reduced health-related quality of life in scleroderma patients. A relevant issue concerns interaction of scleroderma subjects with touchscreen interfaces. This study aims at investigating this problem assessing scleroderma patients’ performance with a novel, aptly designed, touchscreen application in order to identify critical items of touchscreen technology which may impair or facilitate the use by scleroderma subjects. Eighty scleroderma patients performed this novel application including three games, each of which tested a different gesture: tapping, dragging/dropping, and pinching-to-zoom. Eighty healthy subjects without hand impairments were recruited as controls. Scleroderma patients performed worse than healthy users in each game, and statistically significant negatively impacting items were identified. In the second phase of the study, the 10 worst touchscreen performers within the scleroderma cohort were recruited for a physio-rehabilitation trial based on the daily use at home of a modified version of the software application downloaded into the personal devices of patients. The results of this study allow introduction of guidelines to design accessible touchscreen interfaces for subjects with scleroderma and suggest that touchscreen technology may be included in self-administered physio-rehabilitation programs for scleroderma hand.

Keywords: hand | hand disability | hand rehabilitation | Scleroderma | SSc | systemic sclerosis | touchscreen | touchscreen application | touchscreen device | touchscreen interface

Abstract: The transition toward smaller lot sizes in production requires the design of highly flexible processes where person and automation systems work together in a synergistic, safe and efficient manner. The new role of the operator requires researchers to study methods and tools able to evaluate the workers performance in order to maximize the comfort and quality of work. The virtual prototyping and simulation systems become fundamental to be able to design adequate production solutions, but before the tools it is necessary to study methods able to represent and consider the characteristics of the operators in the Industry 4.0-oriented factory environment appropriately. In this context, this paper proposes a method to assess the well-being of operators from different perspectives and, consequently, design operator-centered workstations. The first objective is preparatory in order to be able to fine-tune the second one, in a continuous improvement perspective. The approach has been successfully tested in collaboration with a food company.

Keywords: Ergonomics | Human-Centered Manufacturing | Operator 4.0

Abstract: Eco-design strategies aim to integrate environmental considerations into product design and development. Several regulations, directives and standards have been issued on this topic during last years. In particular, European Directive (2009/125/EC) establishes the eco-design requirements related to domestic and commercial kitchen appliances (e.g. cookers, hobs, grills). The present paper focuses on the virtual product eco-design of domestic induction heating cookers, which are becoming one of the leading cooking systems due to their advantages, e.g. energy efficiency, rapid heating, cleanliness, and user safety. The adoption of numerical analysis tools for the simulation of cooktops use phase, based on thermodynamic modelling, allows to provide useful information regarding the performance of cooking system at each phase of cooking. The paper provides a progress beyond the state-of-art on thermodynamic models for induction hob simulation considering interaction between the cooktop and the pot in the work environment. The goal of the paper is therefore to propose a methodology able to support designers in evaluating heating performances of induction cooking appliances, early in the design phases, through a virtual and multi-physical product model. Thermodynamic performances are determined by measuring several parameters and reproducing the energy consumption test by the mean of a virtual prototyping tool. Results highlight how the proposed model is adherent with the real tests following a specific standard in this sector with a maximum deviation of 3.2% considering the different cooking pot sizes.

Keywords: Design methodology | Eco-design strategies | Virtual Prototyping

Abstract: Although performance measures are strongly used in the field of medical education to evaluate skills of trainees and medical students, the assessment of their cognitive state is relatively “uncommon”. This fact is disadvantageous if we consider the introduction of technologies as physical medical simulators and augmented/virtual reality devices, which may represent an improvement in the students’ immersion in the simulated scenario or, conversely, a potential risk of a serious information overload. Therefore, a precise assessment of the cognitive conditions is an essential element of the design process of a medical training session. This study aims to provide the current state in literature on the assessment of cognitive state during medical simulation training sessions. It provides critical insights on the validity and reliability of current metrics and helps in the selection of measurements tools when applied in simulation-based training contexts.

Keywords: Cognitive conditions | Human factors – stress and workload | Medical simulation | Training

Abstract: An adequate medical education is the key driver of healthcare quality improvement. Technological innovations have led to consistent improvement in learning outcomes but the systematic measurement of students performance and cognitive workload need further research. The aim of this paper is to propose an innovative method for the Design and Development of new advanced learning models, to be used in the training of medical students, which includes also the analysis of students performance and cognitive ergonomics. A web-based survey, on team simulation training and technology role, has been administered to 180 medical students. On the basis of this analysis, a list of guidelines for the design of medical education training has been proposed.

Keywords: Advanced learning technologies - cognitive ergonomics | Augmented reality | Instructional design | Medical simulations | Mental workload | Training

Abstract: Everyday life is increasingly rich in man-machine interactions and new challenges in user interface design arise. In particular, it emerges the need of adaptable solutions that learn from the user's behavior to improve their experience. In this context, the paper aims to redesign an existing UI to make it an Adaptive System. The introduction of an adaptive module allows finding the optimal interface features combination based on the user profile and previously interactions. The experimentation results demonstrate the adaptability and versatility of the proposed application by evaluating the user satisfaction and the perceived adaptability with respect to the native application.

Keywords: adaptive interfaces | household appliances | usability | user-centered

Abstract: Purpose: Orbital fractures are the most commonly encountered midfacial fractures, and usually, the fracture involves the floor and/or the medial wall of the orbit. This paper aims to present an innovative approach for primary and secondary reconstructions of fractured orbital walls through the use of computer-assisted techniques and additive manufacturing. Design/methodology/approach: First, through the 3D anatomical modelling, the geometry of the implant is shaped to fill the orbital defect and recover the facial symmetry. Subsequently, starting from the modelled implant, a customised mould is designed taking into account medical and technological requirements. Findings: The selective laser sintered mould is able to model and form several kind of prosthetic materials (e.g. titanium meshes and demineralised bone tissue), resulting in customised implants and allowing accurate orbital cavity reconstructions. The case study proved that this procedure, at the same time, reduces the morbidity on the patients, the duration of surgery and the related costs. Originality/value: This innovative approach has great potential, as it is an easy and in-office procedure, and it offers several advantages over other existing methods.

Keywords: Customized implant | Orbital cavity reconstruction | Reverse engineering | Selective laser sintering | Surgery | Surgical guide

Abstract: This study defines a methodological procedure for the design and manufacturing of a prosthetic implant for the reconstruction of a midsagittal bony-deficiency of the skull due to the Apert congenital disorder. Conventional techniques for craniofacial defects reconstruction rely on the mirrored-image technique. When the cranial lesion extends over the midline or in case of bilateral defects, other approaches based on thin plate spline interpolation or constrained anatomical deformation are applied. The proposed method uses the anthropometric theory of cranial landmarks identification for the retrieval of a template healthy skull, useful as a guide in the successive implant design. Then, anatomical deformation of the region of interest and free-form modelling allow to get the customized shape of the implant. A full bulk and a porous implant have been provided according to the surgeon advises. The models have been 3D printed for a pre-surgical analysis and further treatment plan. They fulfilled the expectancies of the surgeon thus positive results are predictable. This methodology results to be reproducible to any other craniofacial defect spanning over the entire skull.

Keywords: Additive Manufacturing | Apert Syndrome | Biomedical design | Design process | Implant design

Abstract: In manufacturing context, social dimension is often neglected. With Industry 4.0, companies focus more on technologies and data. However, human continues to play a key role in cyber-physical systems and company growth. This work proposes a method to help the company to evaluate workers’ experience and identify the optimal solution to improve workers’ well-being and company performance. It starts from personalized social analysis within a production plant to identify ergonomics problems and intelligently suggest effective corrective actions. The latter are selected achieving the best trade-off between social, economic and productive aspects. Three case studies are proposed to validate the method.

Keywords: Human factors | Industry 4.0 | Manufacturing systems | Social sustainability

Abstract: OBJECTIVE The aim of this study is the evaluation of the temporomandibular joint stress distribution during the use of a Mandibular Advancement Device. MATERIALS AND METHODS This study is made using Finite Element Method (FEM). Dental casts, advancement bite, CBCT and MRI were taken in a 27-year-old woman. A Somnodent device was scanned and associated with a three-dimensional cranium. FEM analysis was made using ANSYS software with 1 and 2 mm of advancement. RESULTS The articular disc showed values range between 0.099-6.39 and 0.5-2.02 MPa for an advancement of 1 and 2 mm respectively. The condyle load distribution showed values range between 0.0037-7.50 and 0.0020-10.0 MPa for an advancement of 1 and 2 mm respectively. CONCLUSIONS Values obtained are significantly lower than limit values of the condyle and articular disc. Slight mandibular advancement can be consider a safe procedure even for the long period and should not cause permanent side effects.

Keywords: CBCT | Finite Element Method | Mandibular advancement device | OSAS | Temporomandibular joint

Abstract: The paper aims to evaluate the effects caused by a Mandibular Advancement Device (MAD) for Obstructive Sleep Apnoea Syndrome (OSAS) treatment. This study is based on Finite Element Method (FEM) for evaluating the load distribution on temporomandibular joint, especially on the mandibular condyle and disc, and on periodontal ligaments. The stress values on condyle and periodontal ligaments lead authors to consider MAD a safe procedure even for a long period. The obtained results also show the relationship between MAD material and load distribution at the periodontal ligaments. The paper is a step toward future analyses for studying and comparing the effects of MAD features, such as material, shape and dimensions, in order to allow the clinician prescribing the most fitting device.

Keywords: Finite element method | mandibular advancement device | obstruction sleep apnea syndrome | periodontal ligament | temporomandibular joint

Abstract: This paper presents a knowledge-based method and relative multi-user web platform to prescribe Custom Made Insoles (CMI) involving the various stakeholders (patients/customers, practitioners, manufacturers and controllers) in an integrated approach that covers the entire process. The CMI prescription and design are carried out by using configuration rules, which combine foot parameters with insoles features. The platform also offers functionalities to collect and monitor the patients feedbacks, to control the clinician work and to obtain an electronic insole order used by manufactures.

Keywords: Co-design | Custom-made insole | Design knowledge | Healthcare design | Knowledge-based process

Abstract: Many foot pathologies are prevented or treated with Custom Made Insoles (CMIs). Although a strong computerization has characterized the shoe development process during the last decade, the CMI sector still lacks a software platform integrating the design and diagnosis tools used by the stakeholders of this area. Moreover, the prescription of CMIs is only based on the experience of skilled podiatrists rather than on a common and shared knowledge (e.g. guidelines, best practices, rules, etc.). This paper presents a multi-users and knowledge-based platform, called Smart Prescription Platform (SPP), covering the whole CMI development phases, from foot diagnosis to the production, involving clinicians, patients, manufacturers and controllers. The web-based platform is fully integrated with the technologies available in the orthopaedic sector, which are 3D/4D scanners, baropodometric platforms, footwear virtual catalogues, plantar pressure simulators, Augmented Reality devices and 3D CAD systems. The use of standard file formats (e.g.stl,.bmp,.xml) allows an electronic dataflow among the tools. The main module of the platform, called Prescription System (PS), is used for prescribing custom-made insoles for patients with different health conditions, satisfying the needs of all actors and optimizing the data exchange. PS is a knowledge-based prescription system integrating the best practices related to the prescription of CMIs. The PS output is a XML file representing the electronic order, used to exchange data with the other tools of the SPP. The proposed platform has been tested with a twofold aim: to validate the usability of the Prescription System and the inter-operability of the platform tools. The positive results gathered during the validation, led the experts to start using the web platform for their daily work.

Keywords: Collaborative platform | Custom Made Insole | Insole prescription | Knowledge-based platform | Web-based platform

Abstract: Diagnosis and treatment of orbital wall fractures are based on both physical examination and computed tomography scan of the orbital cavity. The present paper reports on the secondary reconstruction of the skeletal orbit following untreated orbital floor fracture in a patient wearing an ocular prosthesis because of an orbital trauma. A computer-assisted approach, based on anatomical modelling and custom-made mould fabrication via selective laser sintering, is proposed for manufacturing a preformed orbital implant. Such a procedure offers precise and predictable results for orbital reconstructions. This protocol proved an effective reduction of operating time, patient morbidity and a fast and low-cost preoperative planning procedure. Such an approach can be used for immediate and in-office manufacturing of custom implants in trauma and reconstructive patients.

Keywords: computer aided surgery | ocular prosthesis | Orbital wall reconstruction | surgical tools

Abstract: The custom-made insole is largely recognized as the most important orthotics for decreasing the foot plantar pressure, using additions or cutouts, which modify the geometry of the insole. This paper proposes a procedure for supporting the clinicians in prescribing innovative custom made insoles for offloading the plantar pressure by using specific combinations of materials for the foot peak-pressure areas, without modifying the geometry of the insole. The process starts with the acquisition of the plantar pressure map of the customer and ends with the definition of the customised insole. The aim of the procedure is choosing the best combination of materials for each foot anatomical area for reducing the plantar pressure peaks below a maximum admissible pressure value decided by the physician. The positions and dimensions of the inserts are defined through analyzing the customer plantar pressure while the inserts materials are defined using FEM simulations of the insole-foot interaction. The case study showed a plantar pressure reduction congruent with the FEM simulations results. This procedure is applicable both for subtractive and additive manufacture techniques.

Keywords: Biomedical design | Custom made insole | Design process | Pressure offloading | Simulation