Product Lifecycle Management Research Articles

Strategic Innovation Management: A Framework for Digital Product Portfolio Optimization

Abstract—This research introduces a framework for managing digital product portfolios in rapidly evolving markets. By examining the intersection of strategic management and digital innovation, we present a structured approach to portfolio optimization that enhances value creation while minimizing technology risk. The study draws on real-world implementations across multiple industries, demonstrating how organizations can effectively balance innovation initiatives with resource constraints. Our findings reveal that organizations implementing this framework achieved a 40% improvement in portfolio performance and significantly reduced technology risk. The paper provides practical guidelines for executives and product leaders to evaluate, prioritize, and optimize digital product portfolios while maintaining strategic alignment with enterprise objectives. Keywords— Digital Product Portfolio, Strategic Innovation Management, Portfolio Optimization, Technology Risk Management, Digital Transformation, Innovation Strategy, Resource Allocation, Product Lifecycle Management, Multigeneration product planning

Evaluation of product lifecycle management and digital twin integration in aviation field

In today's world, digital transformation is becoming increasingly crucial in industry. The Digital Twins and simulations become much more important with growing complexity of products, the need to accelerate product development processes while reducing costs. The increasing value of Digital Twins is prompting organizations in the aviation industry to actively utilize them in research and development efforts. However, due the idea of difficulties of using Digital Twins in the industries, product developers don’t have a clear idea where to begin. This article provides readers with a general overview of the current situation by offering an examination of the aviation sector. Initially, the concept of Digital Twin, its evolution, and relevant studies are explored, followed by an examination of the impact of creating Digital Twins for companies operating in aviation on the product development process. In this study, unlike other published works, the concept of Digital Twin is explained under three subheadings. These include the Design Digital Twin for design steps, the Production Digital Twin for manufacturing processes, and the Performance Digital Twin for post-delivery work related to the product. The final section of the study evaluates the contribution of Product Lifecycle Management (PLM) systems to the process of creating Digital Twins and the advantages they provide to companies in product development processes. The present research work does not contain any studies performed on animals/humans subjects by any of the authors.

Product lifecycle management as a sustainable approach within the Moroccan social and solidarity economy sector

Product Lifecycle Management (PLM) is a crucial strategy that presents a range of benefits at both technical and organizational levels. It involves the integration of collaborative methods that facilitate the sharing, centralization, and harmonization of product information, while also streamlining the processes of information exchange. This study serves as an initial endeavor to introduce PLM within the cottage industry by examining the integration of PLM and the resulting organizational transformations. The research follows a structured three-step methodology. Initially, a comprehensive literature review was conducted to explore the concept under investigation. Subsequently, a survey is carried out within the Moroccan social economy sector to identify prevalent challenges. The survey sample comprises 500 workshops from diverse regions and sectors. An analysis of the results using SPSS and Excel software reveals that organizational and management issues constitute the primary obstacles faced by the sector, representing 40% of the total challenges. Notably, production-related challenges emerge as the most significant, accounting for 68.89% of the total challenges in the sector. In the final step, the ceramics sector is chosen as the focal industry, and a VBA Excel-based tool is developed to address the identified issues. This tool incorporates four essential functionalities -user management, order management, complaints management, and cost management- that are currently lacking in the sector, facilitating organizational change management. The proposed functionalities are subsequently implemented by two pilot ceramics companies. The outcomes of this implementation reveal various barriers that could hinder collaborative efforts post-implementation.

NFT-Based Life Cycle Management for Batteries of e-Cars

AbstractThe classical pathway of mass production followed a linear model with trashed products and wasted remaining materials at the final stage of their life cycle. Smart approaches of manufacturing and product life cycle management aim for Circular Economy (CE) models to implement sustainable business models to overcome imbalances between resource supply and demand of goods. Non-Fungible Token (NFT) solutions together with smart contracts seem to have the potential to realise such new sustainable business models in the context of CE. The study demonstrates how NFT technology can become an integral part of smart product life cycle management for batteries of e-cars. The research highlights how circular business models can be developed and implemented in the e-car sector around the life cycle management of batteries as well as how NFT technology can contribute to sustainable conceptualisation for battery recycling.

Automating the Recycling Process in PLM: A Case Study from the Automotive Sector

The world is in the grip of a very hard challenge these last few years: the conservation of the environment. To reduce waste, we are initiating actions and recycling methods. Our study will focus on the automotive sector, which generates different types of waste, recyclable and non-recyclable. The article explores the innovative integration of product lifecycle management (PLM) from the beginning of life (BOL) to the end of life (EOL) stages, with the goal of creating a comprehensive recycling process. The automotive sector serves as a compelling case study to showcase the practical application of this holistic approach. The study illustrates how aligning BOLandEOLinPLMcanlead to sustainable practices in the automotive industry. The results reveal a remarkable synergy between designing eco-friendly products, efficient manufacturing, and responsible disposal. The article emphasizes the significant environmental and economic benefits of optimizing the entire product lifecycle by connecting these stages. The article presents an automated model embedded within the PLM tool as a notable outcome, reflecting the combined process. The automated model embodies a futuristic vision that seamlessly integrates sustainable practices into product development and management, highlighting the immense potential for industries to contribute to a greener and more sustainable future.

Optimization of architectural design and construction with integrated BIM and PLM methodologies.

Digital transformation in the architecture industry encounters challenges such as data silos within design stages, between design and construction, and across the entire industry chain, including BIM and project management. This study introduces a pioneering approach for seamlessly integrating building information modeling (BIM) and product lifecycle management (PLM) within the management framework and collaborative workflows of architectural design and construction. The proposed methodology was implemented in two major projects, namely, the Wuhan Next-Generation Weather Radar Construction Project and the Hubei Center for Disease Control and Prevention Comprehensive Capacity Enhancement Project (Phase I), with the former being China's first end-to-end digitally integrated construction project. Compared with traditional projects, these implementations achieved improvements of 24.39% and 38.04%, respectively, in objective function values. The findings highlight the unique advantages of BIM-PLM integration in optimizing lifecycle management, enhancing cross-disciplinary, cross-enterprise, and cross-regional collaboration, improving project design efficiency and quality, and reducing costs and waste. This integration provides valuable insights into the digital advancement of the construction industry.

Technique of functional simulation as a tool for providing the required quality of fortified bakery products

Relevance. The problem of irrational and unbalanced nutrition is relevant for almost all regions of Russia. There is a need to enrich everyday products with micronutrients that are of particular importance in the diet. Fortified bread and bakery products with specified consumer properties in the diet can be one of such valuable products.Methods. The methodology of structural analysis and design of systems (Structured Analysis and Design Technique, SADT) is often used in life cycle management of complex high-tech products and has not found wide application in the food industry. The authors substantiate the need to introduce tools for functional and graphical modeling of business processes that implement the SADT methodology in life cycle management to ensure the quality of finished bakery products.Results. An original generalized functional and logical model of the process “To produce enriched bread (bakery products) with regionally significant micronutrients” has been developed. The analysis of the technology of enriched bakery products, carried out at various levels of decomposition of the process, revealed that the quality of the finished product is significantly influenced by the choice of the technological stage of applying the components of the mixture proposed for the enriching composition. It has been established that preference should be given to organic forms of additives — components of the enriching composition. To preserve the nutritional properties of bakery products, an enriching composition is proposed to be applied to the surface of the finished product. The proposed method has been tested in experimental production conditions. Its manufacturability and controllability of the proposed technical solutions are proved. The approach to functional and graphical modeling of food technologies developed by the authors on the example of bakery products opens up prospects for improving the quality of finished products and can be widely used in food engineering.

Blockchain and Digital Twins in Smart Industry 4.0: The Use Case of Supply Chain-A Review of Integration Techniques and Applications

The Fourth Industrial Revolution has transformed industries and supply chains by integrating advanced operations, tools, and logistics services. Despite these advancements, challenges persist, particularly in ensuring data dependability, security, and operational efficiency. Digital twins (DTs), which replicate real-world components and processes, have emerged as essential tools for enhancing predictive analytics, simulation, and product lifecycle management in Industry 4.0. However, traditional DT development relies on centralized systems, which are vulnerable to data tampering and security breaches, especially in the management of transaction logs and historical data. To address these challenges, this review provides a comprehensive analysis of the current state of integrating blockchain with DTs. Using a qualitative research methodology, including desk research, case studies, and interviews with industry experts, we analyze various blockchain-based DT applications across industries and specifically in supply chain management. The findings reveal that blockchain-enhanced DTs can significantly improve data integrity, traceability, and security, thus boosting operational efficiency and quality control in supply chains. Additionally, this study identifies key integration techniques and the role of blockchain in automating processes through smart contracts. This review provides insights into the practical implications of blockchain-based DTs, highlighting their potential to enhance the reliability and scalability of Industry 4.0 operations.

Interior Profile Accuracy Assessment Method of Deep-Hole Parts Based on Servo Drive System.

Dimensional and profile measurements of deep-hole parts are key processes both in manufacturing and product lifecycle management. Due to the particularity of the space conditions of deep-hole parts, the existing measurement instruments and methods exhibit some limitations. Based on the multi-axis, highly precise servo drive system, a novel measuring device is developed. The laser displacement sensors are fed by the flux-switching permanent magnet linear motor, and the part is rotated by the servo motor. On this basis, the assessment methods of roundness, straightness, and cylindricity are proposed by employing the least square method (LSM). Additionally, considering the axial center deviation between the sensors and the part, the rotating center coordinate is optimized by the gradient descent algorithm (GDM). Then, the measurement system is constructed and the experiment study is conducted. The results indicate favorable evaluation error of the LSM fitting and GDM iteration. Compared with the coordinate measuring machine (CMM), the measured results show good consistency. In the error analysis, the angle positioning error of measured point is less than 0.01°, and the axial positioning error is less than 0.05 mm. The proposed system and assessment method are regarded as a feasible and promising solution for deep-hole part measurements.

The role of digital technologies in the circular transition of the textile sector

In recent years, the Circular Economy has gained significant traction, driven by increased awareness among governments, companies, and consumers about the imperative to optimize resource consumption. The textile industry, acknowledged as one of the most resource-intensive sectors, is now actively adopting circular practices to supersede traditional linear strategies. These circular practices may cover all the aspects of the product lifecycle from the design and production usage to the end of life, aiming to value as much as possible the resources used. In parallel, the fourth industrial revolution reshapes manufacturing companies by integrating vital enabling technologies on the shop floor, enhancing operational efficiency alongside existing information systems. Nevertheless, exploring how these technologies may facilitate the circular transition of the textile industry has been performed in a scattered manner by some authors, and a comprehensive picture covering the entire product lifecycle opportunities still needs to be included. To address this gap, the authors analyzed 20 academic articles published till November 2023, retrieved from the Scopus database. The findings from the literature provided the use of digital technologies to implement the transition of a circular economy within the textile industry. The framework is developed to integrate existing studies, assisting textile industries in leveraging digital transformation for a circular transition across product lifecycle management. Finally, this study highlights future research directions that could offer valuable insights to practitioners and researchers.

The Moroccan leather sector between modernity and authenticity: what problems? What solutions?

The leather sector remains one of the sectors that encounters a multitude of problems on an international scale, particularly in Morocco. Therefore, we carried out a literature review through which we were able to identify the major problems found within the leather sector. After that, we conducted a case study on the Chouara tannery in the Fes Meknes region where we studied the problems found within the sector by using the 5M and SWOT methods as well as the proposal of certain improvement actions with a view to revitalizing the sector. The novelty of our work lies in the proposal of certain functionalities that could play the role of product lifecycle management (PLM) within the sector, such as life management, complaint management and cost management since the notion of PLM is absent within traditional tanneries. In addition, we propose integrating ecological PLM to limit the amount of garbage generated during the execution of tasks.

Product Lifecycle Management using AI

This paper also discussed into AI built into your (PLM) Product lifecycle Management processes. Transform your PLM with AI-driven insights, recommendations, and automation integrated into supply chain solutions from.

Quality risk management and data integrity in R&D laboratories supporting CMC lifecycle of biological products

The development of pharmaceutical products is the critical bridge that moves a potential new medicine from academic discovery to applied treatment of patients. It translates an idea for a new drug to bench-level research on how it can be manufactured, formulated, characterized and controlled for use in non-clinical and early clinical trials.From pre-clinical R&D discovery work through the commercial launch, substantial R&D CMC data is generated to develop and optimize cGMP manufacturing and testing operations, while also supporting product comparability, elucidating product / impurity structures, assessing critical quality attributes, developing the drug delivery mode, and developing the product formulation for long-term stability. Significant R&D CMC work continues post-approval to support continuous improvement and market expansion of the commercial product. These activities are crucial elements of Product Lifecycle Management, and taken together, they comprise Pharmaceutical Quality or Chemistry, Manufacturing and Controls (CMC). The objective of this paper is to mitigate the regulatory ambiguity of R&D quality systems with practical, risk-based examples and recommendations when conducting supportive CMC studies for biological products.Making sound strategic CMC decisions under any circumstances assumes data from R&D studies are reliable, traceable, and complete. While there are specific regulatory guidelines on phase-appropriate cGMP activities, none exist for quality practices in R&D CMC laboratories conducting non-cGMP studies. Hindsight is not the time to discover that R&D studies lack key elements that would otherwise have allowed the data to be directly presented to regulators, if needed. There is a strong prospective business interest in protecting considerable investments made for CMC R&D studies. Therefore, establishment of a robust and stage-appropriate R&D laboratory quality system is essential for companies seeking to capitalize on prior knowledge, protect investments, and be prepared for accelerated approval pathways.

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Post-approval changes in Labelling regulations in the United States, European Union and Canada

The review “Post-approval changes in Labelling Regulations in the United States, Europe and Canada” goes into the details and consequences of post-approval changes in labeling regulations for pharmaceutical products. It covers the concept of post-approval changes and outlines the key areas of changes, such as various elements of product lifecycle management, market access, innovation, risk control, and legal compliance for manufacturers in the United States, Europe, and Canada. Apart from that, the abstract discusses the similarities and differences in labeling regulations across the regions in authority, structure, and the affected changes. In summary, the abstract outlines the complexities and effects of post-approval-related changes in labeling regulations concerning the pharmaceutical industry in multiple jurisdictions and the challenges encountered in implementing them. More specifically, the issues include differing regulatory frameworks and varying interpretations; operator compliance, safety evaluation and management; consolidation approaches; and the influence of digitalization and automation as a pivotal and minor player.

Virtual Engineering: Hands‐on Integration of Product Lifecycle Management, Computer‐Aided Design, eXtended Reality, and Artificial Intelligence in Engineering Education

AbstractEngineering education at the Institute for Information Management in Engineering integrates product lifecycle management (PLM), computer‐aided design (CAD), eXtended reality (XR), and artificial intelligence (AI) to enhance learning and prepare students for modern challenges. Our interdisciplinary approach, emphasizing digital twins and virtual twins, fosters immersive, hands‐on experiences. This paper reviews our strategies, comparing them with global initiatives, highlighting the transformative impact of our curriculum on preparing future engineers for complex industrial environments.

A Global Industry Survey on Post-Approval Change Management and Use of Reliance.

Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken and critical to enable both innovation and secure sustained supply. In a world of global supply chains, the existence of divergent national PAC requirements (with additional countries introducing new requirements with potential differences) and other factors including document preparation and response timelines, can lead to long delays in approval (of up to 3-5years) increasing the risk of disruption and shortages.We undertook an Industry survey in 2023 to assess implementation of ICH Q12, PAC procedures (change categorisation and review timelines) and use of reliance mechanisms across different countries (9 selected ICH Members and 19 Observers). Although this survey revealed limited implementation of Q12 in ICH Member countries, when comparing the data collected with those of a previous survey performed in 2020, we observed a broader adoption of risk-based approaches to variation categorisation (in all countries). This, however, was not reflected in improved timelines for approval.With regards to ICH Q12 adoption, the uptake of Post-Approval Change Management Protocols (PACMPs) was unchanged (with only one country reporting in-use) and implementation gaps were evident for Established Conditions (EC) and the Product Life Cycle Management document (PLCM). The survey found greater awareness of ICH Q12 and its tools compared to 2020, potentially illustrating the positive impact of training efforts. This illustrates the challenges being faced to broaden its implementation and use globally.In the same Industry survey, we also assessed PAC processes across different international countries. Long unpredictable timelines were the major concern across the countries surveyed together with limited capacity of the regulators. Four different CMC changes were selected and categorized by the respondents according to current knowledge of national classifications and timelines in the selected countries and compared with a reference classification and timeline from the European Medicines Agency and the World Health Organisation. This highlighted the lack of harmonisation of many countries with EU/WHO requirements, especially within the ICH Observer group.Last, this survey showed that some use of unilateral forms of reliance to Reference Authorities for PACs is starting. This is a mechanism all countries can employ, regardless of convergence of requirements and expertise, to enhance capacity building and reduce duplication of reviews, streamline variations approval, whilst accelerating patient access to innovation and securing supply.

A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management.

The pursuit of harnessing data for knowledge creation has been an enduring quest, with the advent of machine learning and artificial intelligence (AI) marking significant milestones in this journey. Machine Learning (ML), a subset of AI, emerged as the practice of employing mathematical models to enable computers to learn and improve autonomously based on their experiences. In the pharmaceutical and biopharmaceutical sectors, a significant portion of manufacturing data remains untapped or insufficient for practical use. Recognizing the potential advantages of leveraging available data for process design and optimization, manufacturers face the daunting challenge of data utilization. Diverse proprietary data formats and parallel data generation systems compound the complexity. The transition to Pharma 4.0 necessitates a paradigm shift in data capture for manufacturing and process operations. This paper highlights the pivotal role of artificial intelligence in converting process data into actionable knowledge to support critical functions throughout the whole process life cycle. Furthermore, it underscores the importance of maintaining compliance with data integrity guidelines, as mandated by regulatory bodies globally. Embracing AI-driven transformations is a crucial step toward shaping the future of the pharmaceutical industry, ensuring its competitiveness and resilience in an evolving landscape.

Towards the DTT configuration management platform architecture

Effective project management methods, tools and working practices shall be applied to facilitate the communication and collaboration among the different institutions involved in the Divertor Tokamak Test (DTT) project. This paper deals with the definition of the configuration management platform architecture enabling technical integration of the DTT system. The first step consists in the identification of main requirements the platform should satisfy, considering the multidisciplinary domains and the geographically dispersed working teams characterizing the nuclear fusion sector and the maturity level of the specific project. Main characteristics of the most advanced Product Lifecycle Management (PLM) tools are identified, their limits and benefits are evaluated, and the suitable PLM platform is selected, satisfying the DTT project needs. The definition of the architecture of the configuration management platform for the DTT project aims at implementing the DTT assembly model in a unique environment able to exchange models and data even developed outside the platform ensuring the congruence of the design, the traceability of design changes and the adoption of a proper Systems Engineering approach.

Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities

Post-approval changes (PACs) to marketed products are routinely introduced to continuously enhance the product lifecycle management. However, bringing a chemistry, manufacturing and control (CMC) change through the global health authorities can be a complex and lengthy process taking up to several years, therefore negatively impacting supply continuity. In order to accelerate the review and approval of regulatory submissions and ensure continuous supply to patients, the World Health Organization (WHO) is strongly supporting the implementation of reliance among National Regulatory Authorities (NRAs). While some promising developments have been made with the use of reliance pathways for initial marketing authorizations, reliance is still not widely used for PACs. With the support of the European Medicines Agency (EMA) and WHO, Roche launched a reliance pilot based on EMA approval to file a supply critical variation for a monoclonal antibody. The variation constitutes major changes to the approved manufacturing process. Sameness of the product is ensured by submitting to all participants the same variation package as in the EU. The objectives of the pilot are to ensure continuous supply of this critical medicine by targeting global approval in 6.5 months, to promote regulatory convergence by waiving country specific requirements, and enhance greater transparency by sharing EMA Committee for Medicinal Products for Human Use (CHMP) final assessment report and Q&As to participating NRAs. Globally 48 NRAs have agreed to join the pilot. This article outlines the process of establishing the pilot project, including a planning phase and an engagement phase with the EMA, WHO and the participating NRAs.