Manufacturing Perspective Research Articles

Explored the Function of Electromagnetic Compatibility (EMC) of Medical Devices from the Perspective of Test

To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval. The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test. Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations. In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.

Electronics manufacturing entrepreneurs in a performance bonsai trap: the case of an emerging economy

PurposeThe study explores the evolution of Indian domestic electronics manufacturing post-economic reforms and also investigates the lack of natural growth stages among Indian start-up/SME electronics manufactures.Design/methodology/approachThe theoretical framework is inspired by Dawar and Frost's survival strategy theory that local companies may follow to overcome competitive threats from MNCs. The study adopts a qualitative methodology, more precisely, a phenomenological approach to walking through policy/regulatory reforms amid market distortions, technological gaps and colonial mindset from the perspective of Indian domestic electronics manufacturers. The study has adopted Gioia method of data analysis to inductively suggest a few research propositions.FindingsThe phenomenological approach revealed eight essential structure (essence) narratives to explore the complex issue that plague the industry: make in India, made in India, preferential market access strategy, equitable market access strategy, blue ocean strategy, competitive positioning strategy, technical capability and importance of policy/regulatory arbitrage.Practical implicationsThe situation of Indian electronics manufacturing units is comparable to the bonsai tree situation, where natural evolution in business stages does not exist; they are born and die as start-ups/MSMEs. The study advocates for equitable market access by removing market distortions. The long-term solution may lie in making available locally manufactured products as a dependable alternative to the imported products or produced locally by MNC OEMs in terms of cost, quality, technology, volume, after-sale service and integrated supply chain.Originality/valueWhile the favorable FDI policies, digital India and make-in India initiatives have strengthened domestic electronics production, it is yet to significantly impact India's position in global trade, including manufacturing and exports.

Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.

Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product. Typically, risk assessment is focused on product performance wherein critical material attributes, formulation variables, and process parameters are evaluated from a manufacturing perspective. Extending ICH Q9 principles to biopharmaceutics risk assessment to identify factors that can impact in vivo performance is an upcoming area. This is evident by recent regulatory trends wherein a new term critical bioavailability attributes (CBA) has been coined to identify such factors. Although significant work has been performed for biopharmaceutics risk assessment for new molecules, there is a need for harmonized biopharmaceutics risk assessment workflow for generic submissions. In this manuscript, we attempted to provide a framework for performing biopharmaceutics risk assessment for generic regulatory submissions. A detailed workflow for performing biopharmaceutics risk assessment includes identification of initial CBA (iCBA), their confirmatory evaluation followed by definition of the control strategy. Tools for biopharmaceutics risk assessment, i.e., bio-discriminatory dissolution method and physiologically based biopharmaceutics modeling (PBBM) were discussed from a practical perspective. Furthermore, a case study for CBA evaluation using PBBM modeling for an extended-release product for regulatory submission has been described using the proposed workflow. Finally, future directions of integrating CBA evaluation, biopharmaceutics risk assessment to the FDA Knowledge Aided Structured Assessment (KASA) initiative, the necessity of risk assessment templates, and knowledge sharing between industry and academia are discussed. Overall, the work described in this manuscript can facilitate and provide guidance for biopharmaceutics risk assessment for generic submissions.

New Perspective of Additive Manufacturing: From Materials to Processes and Algorithms of Continuous Carbon Fiber-Reinforced Composites.

High-strength and lightweight products have always been the dream of human beings, especially today when energy resources are increasingly depleted. Although additive manufacturing provides us with possibilities, for now, most researchers focus on reinforcing existing printing materials, improving printing processes, and updating algorithms to improve product performance. However, in the statistical classification of this work, these are only a small range of one kind of statistics. This work reviews the key factors of additive manufacturing from materials to processes and algorithms from a new perspective, to get rid of the inherent thinking mode and provide unique ideas. With the idea of "everything is printed," this article emulates nature's "make the most of everything." First, anisotropic materials and the solution of the weak interfacial properties are described. Second, the energy point of view through the process, in space (points, lines, planes, etc.), to summarize the classification and time division of series and parallel printing. Finally, the classification of current hierarchical printing algorithms and the expectation of future spatial printing algorithms are indicated. This article takes the key factors of continuous carbon fiber composite 3D printing as the main line, and provides certain reference for the future development of additive manufacturing from a new perspective.

Cooperation strategies with third‐party platform: E‐tailer and manufacturer perspectives

AbstractWith the rapid development of e‐commerce, both e‐tailers and manufacturers have actively cooperated with third‐party platforms to expand distribution channels and enhance competitiveness. There are three typical choices for firms to cooperate with a third‐party platform: (i) non‐cooperation, (ii) agency selling cooperation mode, and (iii) reselling cooperation mode. We consider a three‐tier supply chain and establish a stylized theoretical model to explore whether and how the e‐tailer or the manufacturer cooperates with a third‐party platform. We investigate the optimal channel cooperation choices from both the e‐tailer's and the manufacturer's perspectives under various channel structures and cooperation modes, revealing their different roles in cooperating with third‐party platforms. Our results indicate that large potential market size of the third‐party platform motivates the e‐tailer to cooperate with the third‐party platform. On this basis, agency selling cooperation mode is preferred by the e‐tailer at mild channel competition and reasonable commission rate, while reselling cooperation mode dominates at high channel competition or when the commission rate exceeds a threshold. Interestingly, we find that the manufacturer has generally similar mode preference with the e‐tailer, and they have opposite preferences under the condition of low commission rate and moderate channel competition intensity. More importantly, our results reveal that direct channel cooperation between the manufacturer and third‐party platform harms the e‐tailer's interests, whereas the channel cooperation between the e‐tailer and third‐party platform may increase profits for all supply chain participants. Our study provides valuable insights for e‐tailers, manufacturers and third‐party platforms to make better channel cooperation decisions and achieve successful partnership in online retailing.

Safe High Stiffness Impedance Control for Series Elastic Actuators using Collocated Position Feedback

Physical human-robot interaction applications requiring safety and compliance characteristics usually employ mechanical devices such as series elastic actuators (SEAs). So far, impedance control schemes for SEAs have been investigated to overcome the limited displayable stiffness at the end point, represented by the stiffness of a physical spring, in a passive manner. SEAs usually mount two encoders on both the motor and load sides for position measurements. However, in several applications, the installation of a load-side encoder is not feasible from both cost and manufacturing perspectives. In this scenario, a Kalman Filter based on micro electro mechanical system accelerometers has been proposed for estimating the external force and load side quantities, without the need for load-side encoders. Herein, a novel impedance control scheme leveraging this approach is proposed to effectively overcome the stiffness of the physical spring while maintaining passivity at the end point. Compared with conventional load-side encoder-based impedance control schemes, the proposed control scheme presents comparable performance, as demonstrated by simulation and experimental results.

YOLO-v1 to YOLO-v8, the Rise of YOLO and Its Complementary Nature toward Digital Manufacturing and Industrial Defect Detection

Since its inception in 2015, the YOLO (You Only Look Once) variant of object detectors has rapidly grown, with the latest release of YOLO-v8 in January 2023. YOLO variants are underpinned by the principle of real-time and high-classification performance, based on limited but efficient computational parameters. This principle has been found within the DNA of all YOLO variants with increasing intensity, as the variants evolve addressing the requirements of automated quality inspection within the industrial surface defect detection domain, such as the need for fast detection, high accuracy, and deployment onto constrained edge devices. This paper is the first to provide an in-depth review of the YOLO evolution from the original YOLO to the recent release (YOLO-v8) from the perspective of industrial manufacturing. The review explores the key architectural advancements proposed at each iteration, followed by examples of industrial deployment for surface defect detection endorsing its compatibility with industrial requirements.

Pricing and carbon emission decisions in the assembly supply chain

In the low-carbon environment, firms must make pricing and carbon emission decisions. This study proposes an assembly supply chain model which contains two manufacturers and one assembler to research their pricing and carbon emission decisions. Because of manufacturing core components for final products, manufacturers dominate the assembler in Stackelberg games. Supply chain members' optimal decisions and optimal carbon emission reduction structure are derived based on different cooperative behaviors. Then, this study analyzes how manufacturers' carbon emission reduction cost coefficients affect decision results and finds that the assembly system will produce products with lower carbon emissions and expand market shares if manufacturers enhance carbon emission reduction abilities, but there exist manipulation spaces for supply chain members to raise the market price. Lastly, this study investigates the impacts of cooperative behaviors on decision results and finds that cooperation in the assembly supply chain can consistently achieve a win-win situation as a Pareto improvement. Meanwhile, this study concludes some management insights with practical significance, such as from the manufacturer's perspective, vertical cooperation with the assembler is more effective than horizontal cooperation with another manufacturer, and the assembler should cooperate with the manufacturer with a lower cost coefficient.

Optimization of panel furniture plates rework based on intelligent manufacturing

Panel furniture uses an intelligent management system, combined with the production method of splitting orders by process, to achieve large quantities and large-scale manufacturing, but because of the insufficient and incomplete use of technology, capacity bottlenecks still exist. The problem of rework and replenishment is a long-term problem in furniture production. Under the constraints of existing production rules, the time difference of plates rework forces the original batch of plates to wait, which reduces the efficiency of warehousing. From the perspective of intelligent manufacturing for the optimization of the plates rework process, this study, through on-site observation records and data analysis of the production system, aimed to find short-term solutions and long-term solutions. In the short-term response, the time node for the completion of the replenishment is mainly according to the process regulations, and the plates are packaged into the warehouse after the replenishment is completed in batches. The long-term response strategy is mainly to achieve the interconnection of different production systems to achieve mutual information, and the paperless online operation of the plates rework process increases the subjective initiative of each process to improve the overall efficiency of the plates rework process.

Towards Customer Outcome Management in Smart Manufacturing

The outcome economy is a relatively new economic and business paradigm that promotes focusing on the effects that the use of provided products and services create for customers in their markets, rather than focusing on these products or services themselves from the providers’ perspective. This paradigm has been embraced in various fields of business but has not yet been fully integrated with the concept of smart industry. To fill this gap, in this vision paper we provide a framework that does make this integration, showing the full structure of customer outcome management in smart manufacturing, from both business and digital technology perspectives. In applying this structure, a feedback loop is created that spans the markets of provider and customer and supports data-driven product evolution, manufacturing, and delivery. We propose a business reference framework that can be used as a blueprint for designing practical scenarios. We show how integrated digital support for such a scenario can be realized using a well-structured combination of technologies from the fields of the internet of things, business intelligence and federated learning, blockchain, and business process management. We illustrate all of this with a visionary case study inspired by industrial practice in the automotive domain. In doing so, we provide both an academic basis for the integration of several currently dispersed research fields that need to be integrated to further smart manufacturing towards outcome management and a practical basis for the well-structured design and implementation of customer outcome management business cases in smart manufacturing.

Biomimetic scaffolds using triply periodic minimal surface-based porous structures for biomedical applications.

The design of biomimetic porous scaffolds has been gaining attention in the biomedical sector lately. Shells, marine sponges, shark teeth, cancellous bone, sea urchin spine, and the armadillo armor structure are examples of biological systems that have already been studied to drive the design of innovative, porous, and multifunctional structures. Among these, triply periodic minimal surfaces (TPMSs) have attracted the attention of scientists for the fabrication of biomimetic porous scaffolds. The interest stems from their outstanding properties, which include mathematical controllable geometry features, highly interconnected porous architectures, high surface area to volume ratio, less stress concentration, tunable mechanical properties, and increased permeability. All these distinguishing features enable better cell adhesion, optimal integration to the surrounding tissue avoiding stress shieldings, a good permeability of fluid media and oxygen, and the possibility of vascularization. However, the sophisticated geometry of these TPMS-based structures has proven challenging to fabricate by conventional methods. The emergence of additive manufacturing (AM) and the enhanced manufacturing freedoms and flexibility it guarantees could solve some of the bottlenecks, thus leading to a surge of interest in designing and fabricating such structures in this field. Also, the feasibility of using AM technologies allows for obtaining size programmable TPMS printable in various materials, from polymers to metal alloys. Here, a comprehensive overview of 3D-printed TPMS porous structures is provided from a design for additive manufacturing (DfAM) and application perspective. First, design strategies, geometry design algorithms, and related topological optimization are introduced according to diverse requirements. Based on that, the performance control of TPMS and the pros and cons of the different AM processes for fabricating TPMS scaffolds are summarized. Lastly, practical applications of 3D-printed biomimetic TPMS porous structures for the biomedical field are presented to clarify the advantages and potential of such structures.

Offering custom products using a C2M model: Collaborating with an E-commerce platform

The e-commerce platform-driven Customer-to-Manufacturer (C2M) strategy is an emerging business model in which the e-commerce platform collects customer preference data and shares this information with manufacturers to facilitate product customization. This model has not been explored in the literature. We examine, from both the platform's and the manufacturer's perspectives, how to effectively offer custom products using the C2M approach. We find that offering custom products is not optimal when the consumers' fit sensitivity (to deviations from their ideal product) is low. When fit sensitivity is medium, offering custom products partially is an optimal strategy. When fit sensitivity is high, offering custom products fully is an optimal strategy. We show that consumers covered in the customization scope receive a greater surplus than customers who buy standard products. Surprisingly, the consumer surplus for the former group decreases with C2M while it remains unchanged for the latter group even though the product price increases. To mitigate the inefficiency arising in a decentralized channel compared to a centralized channel, we propose two types of mechanisms: a commission plus cost-sharing contract and bargaining. These mechanisms facilitate collaboration between the e-commerce platform and the manufacturer and achieve coordination in the supply chain. We extend the model in several ways to verify robustness. Our findings offer managerial insights for e-commerce platforms and manufacturers considering the implementation of the innovative C2M model.

The Halal Certification Essence in Manufacturer's Perspective (A Phenomenology Study)

Purpose: The study aims (1) to explore the comprehension and implementation of halal certification essence from the producers perspective of MSMEs, and (2) to make the model to apply the halal certification essence to MSMEs. Design/methodology/approach: This study used qualitative methods with Hussel's phenomenological approach. This research takes a setting in East Java. The data analysis is the Interactive Model Analysis from Miles and Huberman. Findings: The results showed indicate that the comprehension and implementation of halal certification essence from a producer's perspective of MSMEs in East Java is still relatively low. There are many MSMEs do not have certificates even though they understand the importance of halal certificates. The phenomenon at MSME producers showed that theoretically the halal certificates refers to the first basis set by Islam, namely the origin of something created by Allah is halal and permissible. Research limitations/implications: The samples and findings are exclusively to MSMEs that very supportive in determining informants and research clusters based on MSME industry groups Practical implications: Local governments should conduct training or coaching on positive mental strength, financial management, financial management literacy, risk management training, promotion and marketing strategy training and tourism management training. These trainings need to be done in order MSMEs have the competence and the comprehension on halal certification as one of capabilities of a good promotion The strategy and marketing strategy Social Implications: The training pattern should use a mentoring system by involving academics. The training to MSMEs should be done routinely. Training should be maintained properly at intervals, coordination and cooperation between the government and entrepreneurs. Originality/value: The research originality is shown by the MSMEs comprehension and mapping of halal certification as well as models to implement the halal certification essence in form of MUI regulations, MUI supervision, producer aspects and increased awareness of MSMEs in essence halal certification to supports the development of MSMEs.

Effect of calcium phosphate precipitation on ultrafiltration of acid whey

The high calcium content of acid whey can pose challenges to protein concentration using UF membranes due to calcium-induced fouling. This study examined the effect of pH and temperature on calcium precipitation, UF permeation efficiency and the removal of calcium through UF processing of acid whey across a pH range from 4.6 to 7.0 (15 °C) and a temperature range from 10 to 35 °C (pH 6.0). Calcium phosphate precipitation increased with increasing temperature and pH (from pH 5.6 onwards). This correlated with an increased retention of calcium in the UF retentate, indicating these parameters play a key role in determining the calcium content of the final product. While reducing pH can fully resolubilise calcium phosphate, reducing temperature only partially reverses calcium phosphate precipitation. From a manufacturing perspective, pH adjustment immediately prior to UF may be an effective tool for controlling calcium precipitation, process efficiency and product composition.

IPL-Annealed Mixed-Cation Perovskites with Robust Coating Window toward Scalable Manufacturing of Commercial Perovskite Solar Cells

Perovskite solar cells (PSCs) are a promising alternative solar technology, but the technical challenges of (1) stability/durability, (2) efficiency at scale, and (3) manufacturability must be overcome to achieve widespread PSC commercialization. The challenge of balancing solution ink formulation and scalable manufacturing is often overlooked in the literature, where focus is on adopting inks from processes that will not scale. In this study, we apply a classical roll-to-roll manufacturing perspective, utilizing both compositional engineering and intense pulsed light (IPL) annealing, to develop a mixed-cation perovskite ink with a robust coating window that simultaneously solve issues of stability and manufacturability for PSCs. Our method resulted in blade-coated, flexible, mixed-cation PSCs on ITO-PET substrates with a champion power conversion efficiency (PCE) efficiency of 16.7% using IPL annealing of the absorber layer and, to our knowledge, is one of the fastest processing methods for the perovskite layer. This overall reduction in processing time with a stable ink represents an advance toward the scaled production of perovskite solar cells on flexible substrates.

Strategies for Green Shipbuilding Design and Production Practices Focused on Reducing Microplastic Pollution Generated during Installation of Plastic Pipes

In recent years, microplastic pollution has been given increasing attention in marine environments due to the hazard it poses for aquatic organisms. Plastic pipes are now being widely used in shipbuilding, and due to easy processing, they are often installed directly on ships. This includes the cutting and preparation of pipes for welding, which produces plastic debris in the immediate vicinity of the marine environment. Such plastic debris can easily become airborne, and when it is ultimately deposited into the water, it can be a contributor to marine microplastic pollution. This could be reduced if, during the design stage and outfitting stage, engineers would take into consideration ecological aspect of their design, which is currently not the case. Therefore, in this paper, suggestions for green shipbuilding practices, focused on the piping design and production phases, are presented for the possible reduction in operations with plastic pipes, with the main aim of reducing microplastic pollution. Based on these recommendations, additional economic and feasibility investigations are needed to obtain optimal results, which would be beneficial both from a manufacturing and ecological perspective.

Digital Twins and Smart Manufacturing for Wire Bonding

Low cost, excellent flexibility, and high yield rate have long been the drivers of wire bonding technology. In the past decade, advancements in wire bonding technology have significantly improved wire bond reliability and strengthened the adoption of the technology while maintaining its competitive advantage. Digital twins of wire bonding can now simulate and optimize 3D wire loop shapes to facilitate design-for-manufacturing (DFM), increase design flexibility, reduce product development time, and improve overall package yields. In particular, the benefits of digital twins have been realized in system-in-package (SiPs), large stack-die memory applications, and complex high pin count packages with multiple looping tiers. With increasing package complexity and modular package configurations, the need for smarter functionalities is imperative. More recently, technological developments in wire bonding have been targeted toward furthering design, quality, and time-to-market (TTM) from an Industry 4.0 smart manufacturing perspective. In this paper, we will introduce new digital twin simulation techniques to detect potential interference between wire bond capillaries and wire loops, various dies, passive components, and other structures within the package. These advanced capabilities are demonstrated on a real application and shown to help in the detection of design issues early in the product cycle and aid in the selection of capillary, wire, as well as optimization of the package layout. All these factors significantly improve the overall TTM of semiconductor packages. Technologies that provide improvements via autonomous monitoring and optimization are also strongly desired. We will also explore new on-bonder process monitoring capabilities to detect wire sway such that wire shorts and resultant yield losses can be minimized. Additionally, vision-guided enhancements to on-bonder loop height monitoring capabilities will also be discussed. These new advancements significantly improve production quality and yield, paving the way for smarter factories

Tembikar Dapur Masak Tradisional (Tuku) di Kampung Mambong, Kelantan: Sejarah, Tradisi Pembuatan dan Cabaran

Kampung Mambong in Kuala Krai, Kelantan was the only place in Peninsular Malaysia that had been involved in the making of traditional earthenware cooking stove. However, its history and manufacturing perspectives have never been studied in detail in prior studies. The present study was conducted to unravel the history, manufacturing tradition and challenges faced by the potters at Kampung Mambong in preserving the production of earthenware cooking stove. This study was carried out using the qualitative method involving ethnography fieldwork and a library survey. The findings of the study showed that the production of traditional earthenware cooking stove or locally known as Tuku was inherited by Che Bunga and her ancestors at Kampung Mambong since the 1850s. Like other potteries at Kampung Mambong, Tuku is made using traditional methods without incorporating modern techniques. In the 1930s, however, the manufacturing of Tuku began to dwindle, and its entire production halted by the end of the 1940s. The lack of experts and interest among the younger generations to learn and continue the making of Tuku are two main reasons why the production diminished in the 1930s and 1940s. Apart from that, the invasion of the Japanese military in Sungai Galas in the early 1940s had indirectly caused the production to cease. Overall, this study has successfully contributed new insights into the history, manufacturing tradition and factors that caused extinction to the production of Tuku at Kampung Mambong in the late 1940s. Therefore, essential proactive steps need to be taken to revive the manufacturing of Tuku because it is one of the unique heritage crafts of the Malay potters in Sungai Galas, Kelantan.

Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers.

In the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa's regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives-the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)-as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products.

Policy and Strategy Evaluation of Ridesharing Autonomous Vehicle Operation: A London Case Study

To understand the dynamics of an autonomous ridesharing transport mode from the perspectives of different stakeholders, a single model of such a system is essential, because this will enable policymakers and companies involved in the manufacture and operation of shared autonomous vehicles (SAVs) to develop user-centered strategies. The model needs to be based on real data, network, and traffic information and applied to real cities and situations, particularly those with complex public transportation systems. In this paper, we propose a new agent-based model for SAV deployment that enables the parametric assessment of key performance indicators from the perspective of potential SAV users, vehicle manufacturers, operators, and local authorities. This has been applied to a case study of three regions in London: central, inner, and outer. The results show there is no linear correlation between an increased ridesharing acceptance level and average trip duration. Without a fleet rebalancing algorithm, over 80% of SAVs’ energy expenditure is on picking up customers. By reducing pickup distance, SAVs could be a contender for a nonpersonal transportation system based on trip energy comparisons. The results provide a picture of future SAV systems for potential users and offer suggestions as to how operators can devise an optimal transportation strategy beyond the question of fleet size and how policymakers can improve the overall transport network and reduce its environmental impact based on energy consumption. As a result of its flexibility and parametric capability, the model can be utilized to inform any local authority how SAV services could be deployed in any city.