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Background: 3D printing is one of the fastest-growing technologies in medicine, but it is essential to have a system for 3D printing documentation that is accessible for not only clinical engineers and surgeons, but also quality managers and data-privacy officers in hospitals. Dedicated software such as product lifecycle management (PLM) software could enable comprehensive management and traceability of all data relevant to 3D printing tasks in a hospital and would highly beneficial. Therefore, customizable software called 3Diamond was developed for 3D printing in medicine. Methods: The software development process involved several stages, including setting specifications based on end-user requirements, design, implementation, and testing. In order to ensure the software's long-term success and smooth operation, critical phases were also considered, such as deployment and maintenance. Results: The developed software provides immediate and complete traceability of all preparations and controls, as well as management of reports, orders, stock, and post-operative follow-up of tasks related to 3D printing in a hospital. Based on user requirements, software testing is provided automatically with each release. The software was implemented in a natural clinical environment with a developed 3D printing center. Conclusion: Although 3D printing has potential for innovation in the medical profession, it is nevertheless subject to regulations. Even though there are exemptions for patient-specific products, the effects of their local legal implementations related to 3D printing cannot be fully overseen. To this end, 3Diamond provides a robust system for 3D printing documentation that is accessible to different personnel in hospitals.

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ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case studies are presented in this manuscript to demonstrate how science- and risk-based stability strategies were used to support drug substance and product CMC PAC and lifecycle management activities. The accumulated stability knowledge held by original manufacturers of marketed products is substantial, and different elements of this knowledge base were used to assess the risks and impact of the proposed changes for confident change management. This paper provides ways to leverage science- and risk-based stability strategies as part of the post-approval change-management risk-mitigation strategy, which may enable a reduced stability data commitment and/or a reduced reporting category for change implementation.

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Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

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The Internet of things (IoT) is expected to have an impact on business and the world at large in a way comparable to the Internet itself. An IoT product is a physical product with an associated virtual counterpart connected to the internet with computational as well as communication capabilities. The possibility to collect information from internet-connected products and sensors gives unprecedented possibilities to improve and optimize product use and maintenance. Virtual counterpart and digital twin (DT) concepts have been proposed as a solution for providing the necessary information management throughout the whole product lifecycle, which we here call product lifecycle information management (PLIM). Security in these systems is imperative due to the multiple ways in which opponents can attack the system during the whole lifecycle of an IoT product. To address this need, the current study proposes a security architecture for the IoT, taking into particular consideration the requirements of PLIM. The security architecture has been designed for the Open Messaging Interface (O-MI) and Open Data Format (O-DF) standards for the IoT and product lifecycle management (PLM) but it is also applicable to other IoT and PLIM architectures. The proposed security architecture is capable of hindering unauthorized access to information and restricts access levels based on user roles and permissions. Based on our findings, the proposed security architecture is the first security model for PLIM to integrate and coordinate the IoT ecosystem, by dividing the security approaches into two domains: user client and product domain. The security architecture has been deployed in smart city use cases in three different European cities, Helsinki, Lyon, and Brussels, to validate the security metrics in the proposed approach. Our analysis shows that the proposed security architecture can easily integrate the security requirements of both clients and products providing solutions for them as demonstrated in the implemented use cases.

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Electronic waste (e-waste) is a growing waste stream. In Europe, e-waste is regulated by the Waste Electrical and Electronic Equipment (WEEE) Directive. Each manufacturer or importer is responsible for the end-of-life (EoL) treatment of the equipment it handles, although this task is usually outsourced to producer responsibility organizations (PROs) that collect and treat the e-waste. The WEEE regime has been criticized for focusing on waste handling according to the traditional linear economy, while, in a circular economy, the goal is to eliminate waste. Information sharing helps improve circularity, and digital technology is seen as enabling information transparency and visibility in the supply chain. However, there is need for empirical studies demonstrating the use of information in supply chains to improve circularity. We conducted a case study of a manufacturer, including its subsidiaries and PROs in eight European countries, in which we investigated the product lifecycle information flow related to e-waste. Our findings indicate that product lifecycle information is available, but that it is provided for purposes other than e-waste handling. Actors are willing to share this information, but it is not regarded as useful for EoL treatment since the actors involved in EoL handling believe that using this information could lead to delays and poorer performance in e-waste handling. Our findings contradict the optimistic view of digital technology as improving circularity in circular supply chain management. The findings further give reason to question the implementation of digital technology to improve the product lifecycle information flow as long as the involved actors do not request this information.

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Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

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OBJECTIVES: This study aimed to understand the importance of criteria describing methods (eg, duration, costs, validity, and outcomes) according to decision makers for each decision point in the medical product lifecycle (MPLC) and to determine the suitability of a discrete choice experiment, swing weighting, probabilistic threshold technique, and best-worst scale cases 1 and 2 at each decision point in the MPLC. METHODS: Applying multicriteria decision analysis, an online survey was sent to MPLC decision makers (ie, industry, regulatory, and health technology assessment representatives). They ranked and weighted 19 methods criteria from an existing performance matrix about their respective decisions across the MPLC. All criteria were given a relative weight based on the ranking and rating in the survey after which an overall suitability score was calculated for each preference elicitation method per decision point. Sensitivity analyses were conducted to reflect uncertainty in the performance matrix. RESULTS: Fifty-nine industry, 29 regulatory, and 5 health technology assessment representatives completed the surveys. Overall, "estimating trade-offs between treatment characteristics" and "estimating weights for treatment characteristics" were highly important criteria throughout all MPLC decision points, whereas other criteria were most important only for specific MPLC stages. Swing weighting and probabilistic threshold technique received significantly higher suitability scores across decision points than other methods. Sensitivity analyses showed substantial impact of uncertainty in the performance matrix. CONCLUSION: Although discrete choice experiment is the most applied preference elicitation method, other methods should also be considered to address the needs of decision makers. Development of evidence-based guidance documents for designing, conducting, and analyzing such methods could enhance their use.

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OBJECTIVES: Cost-effectiveness analyses (CEAs) generally assume constant drug prices throughout the model time horizon, yet it is known that prices are not constant, often with price decreases near loss of exclusivity (LOE). This study explores the impact of using dynamic drug-specific prices on the incremental cost-effectiveness ratio (ICER) using selected reproduced case studies. METHODS: Case studies were selected following explicit criteria to reflect a variety of drug characteristics. For each drug, a published CEA model was identified, replicated, and modified with dynamic real-world pricing data, to compare ICERs based on constant drug prices with estimates obtained when including drug life cycle pricing. The impact of dynamic real-world pricing-inclusive LOE-was analyzed using a single patient cohort and multiple cohorts over time. RESULTS: Fluvastatin, alendronic acid + colecalciferol combination therapy, letrozole and clopidogrel were selected as case studies. Inclusion of real-world pricing data compared with applying constant prices reduced the ICER in a single-cohort setting up to 43%. In the multicohort analyses, further reductions of the ICERs were observed of up to 113%. The ICERs were sensitive to the period of drug usage relative to the models' time horizons, the relative proportions of drug costs in the overall treatment costs, and timing of LOE compared with the cost year of the original analysis. CONCLUSIONS: Assuming dynamic drug prices may lead to more representative ICER estimates. Future CEAs for drugs could account for predicted and disaggregated life cycle price developments based on retrospective data.

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In this study, we analyzed Korean and foreign systems, focusing on high-risk medical devices that urgently need to be managed, and we present an life cycle calculation method for determining replacement time. A literature review was conducted to confirm the regulations of the medical device management system and life cycle by country, and a case analysis was performed to verify the replacement evaluation criteria of actual medical institutions. In addition, durability data from the Public Procurement Service, American Hospital Association, and Samsung Medical Center were used to calculate the life cycle of high-risk medical devices. The analysis showed that in the case of Korean and foreign medical device regulatory agencies, there were no specific life cycle regulations for high-risk medical devices. In addition, the important items in the medical device replacement evaluation were found to be the year of introduction, repair cost, component discontinuation, and several failures. On calculating the life cycle of high-risk medical devices revealed that the replacement time is 13 years for anesthesia machines, 14 years for defibrillators, 16 years for heart-lung machines, and 13 years for ventilators. To introduce a uniform medical device replacement standard and life cycle calculation method, the government will need to reorganize the medical device replacement laws and systems. In addition, in the case of medical institutions, it is necessary to secure patient safety by using expert groups to prepare specific life cycle standards that consider the characteristics of medical devices.

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Durability has become a valuable design aspect for designers, manufacturers, service providers, and end-of-life actors. Nowadays, developing products for new business models based on renting and servitization practices is of paramount importance. Furthermore, durability enables the application of circularity strategies for product lifespan extension, including reuse, repair, refurbish, and remanufacture. However, despite the growing trend around durability, there is no precise tracing of its evolution, implementation, and potential benefits from the product design stage. Therefore, this article aims to analyze the existing literature about durability and its relationship with the circular economy concept starting from the product design process, uncovering potential research directions, challenges, and trends for its application. A total of 147 articles were selected and analyzed from 40 years of research using two main approaches. First, a keyword-based analysis was used to identify trending topics around the concept of durability. Second, a content-based analysis was used, encompassing four main aspects: objectives and methodology; actors involved and lifecycle phases; circular economy strategies; and design phase, design attributes, and type of products involved. The analysis identified how the concept has evolved during the last four decades, indicating that future trends envisage methodologies, assessment tools, and guidelines to support product life extension.

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This study examines two pharmaceutical supply chains (PSCs) under the product life cycle and marketing strategies for the first time. Nash equilibrium between PSCs is based on marketing mix factors (i.e., price, the value provided by the value chain, availability, and promotion) at different periods of product life (i.e., introduction, growth, and maturity). Considering the previous step's outputs, environmental protection, and sustainable development, this study provides a multi-objective mixed-integer nonlinear programming model (MOMINLP) for the design of PSCs to minimize environmental pollution and maximize profit, consumer health level, and brand equity. At this stage of the network design, disruption issues in the manufacturer, distributor, and retailer are considered. Based on the value from the value chain in different periods of product life, different scenarios are considered. Optimizing the supply chain network design (SCND) under uncertainty through the reliability and Six Sigma concepts is examined. The proposed approach is validated with a real-case study in Iran. The results show that the brand equity, pollution created, and supply chain profits decrease with increasing optimization levels. However, the level of consumer health rises with increasing levels of optimization. Based on the obtained results, the total profit of the two supply chains at the optimization level 3σ is 3.6% more than the profit at the optimization level 6σ. The total environmental pollution of the two supply chains at the optimization level 3σ is 1.9% less than the environmental pollution at the optimization level 1.285σ. The total consumer health level of the two supply chains at the optimization level 3σ is 3.3% more than the consumer health level at the optimization level 1.285σ. The total brand equity of the two supply chains at the optimization level 3σ is 2.5% more than the brand equity at the optimization level 6σ. It seems that the optimization level 3σ for the two pharmaceutical supply chains is more appropriate than the other optimization levels.

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Seed security is vital for food security. Rapid-cycle, climate-adaptive breeding programs and seed systems that deliver new, elite varieties to farmers to replace obsolete ones can greatly improve the productivity of maize-based cropping systems in sub-Saharan Africa (SSA). Despite the importance and benefits of accelerated varietal turnover to climate change adaptation and food security, the rate of maize varietal replacement in SSA is slow. This review outlines the major bottlenecks, drivers, risks, and benefits of active replacement of maize varieties in eastern and southern Africa (ESA) and highlights strategies that are critical to varietal turnover. Although there is an upsurge of new seed companies in ESA and introduction of new varieties with better genetics in the market, some established seed companies continue to sell old (over 15-year-old) varieties. Several recently developed maize hybrids in ESA have shown significant genetic gains under farmers' conditions. Empirical evidence also shows that timely replacement of old products results in better business success as it helps seed companies maintain or improve market share and brand relevance. Therefore, proactive management of product life cycles by seed companies benefits both the farmers and businesses alike, contributing to improved food security and adaptation to the changing climate.

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The expanded availability of adalimumab products continues to widen patient access and reduce costs with substantial benefit to healthcare systems. However, the long-term success of these medicines is highly dependent on maintaining consistency in quality, safety and efficacy while minimizing any risk of divergence during life-cycle management. In recognition of this need and demand from global manufacturers, the World Health Organization (WHO) Expert Committee on Biological standardization established the WHO 1st International standard (IS) for Adalimumab (coded 17/236) in October 2019 with a defined unitage ascribed to each of the individual bioactivities evaluated in the study namely, TNF-α binding, TNF-α neutralization, complement dependent cytotoxicity and antibody-dependent cellular cytotoxicity. For development of the IS, two candidate standards were manufactured as per WHO recommendations. Analysis of extensive datasets generated by testing of a common set of samples including the candidate standards by multiple stakeholders including regulatory agencies using their own qualified assays in a large international collaborative study showed comparable biological activity for the tested candidates for the different activities. Use of a common standard significantly decreased the variability of bioassays and improved agreement in potency estimates. Data from this study clearly supports the utility of the IS as an important tool for assuring analytical assay performance, for bioassay calibration and validation, for identifying and controlling changes in bioactivity during life-cycle management and for global harmonization of adalimumab products. In addition, in a separate multi-center study which included involvement of hospital and clinical diagnostic laboratories, the suitability of the adalimumab IS for therapeutic drug monitoring assays was examined by analysis of data from testing of a common blind coded panel of adalimumab spiked serum samples representative of the clinical scenario along with the IS and in-house standards in diverse immunoassays/platforms. Both commercially available and in-house assays that are routinely used for assessing adalimumab trough levels were included. Excellent agreement in estimates for adalimumab content in the spiked samples was observed regardless of the standard or the method with inter-laboratory variability also similar regardless of the standard employed. This data, for the first time, provides support for the extended applicability of the IS in assays in use for therapeutic drug monitoring based on the mass content of the IS. The adalimumab IS, in fulfilling clinical demand, can help toward standardizing and harmonizing clinical monitoring assays for informed clinical decisions and/or personalized treatment strategies for better patient outcomes. Collectively, a significant role for the adalimumab IS in assuring the quality, safety and efficacy of adalimumab products globally is envisaged.

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European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well as there is a lot of Academia research on the matter. Despite that, the word innovation is often associated to such tools and there is a still slow implementation at industry. The paper is the outcome of the Associazione Farmaceutici dell'Industria (AFI) Study Group on Process Innovation and Product Lifecycle; the aim is to describe some case studies referring to practical approaches in pharmaceutical industry, in order to depict challenges and opportunities for the implementation of spectroscopic techniques. Case studies include: feasibility and pre-screening evaluations, chemometric model development approaches, way for the method maintenance during commercial manufacturing, challenges for implementation on existing equipment and on sterile processes. Case studies refer to oral solid products, liquid products and sterile Active Pharmaceutical Ingradient (API) manufacturing. There are already successful and robust spectroscopic applications in pharmaceutical industry and the technology is mature: this is the outcome of a strong applied research performed at pharmaceutical production departments. It is necessary to acknowledge efforts done by industry as Research for strengthening the cooperation with Academia, so that advantage of process innovation might reach the patients in a fastest way.

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Real-world evidence (RWE) is derived from real-world data (RWD) sources including electronic health records, claims data, registries (disease, product) and pragmatic clinical trials. The importance of RWE derived from RWD has been once again demonstrated during the coronavirus disease 2019 (COVID-19) pandemic, as it can improve patient care by complementing information obtained from traditional clinical trial programs. Additionally, RWE can generate insights into disease mechanisms, epidemiology, patient flows in and out of healthcare systems, and drivers and barriers to optimal clinical care in real-world settings. Identifying unmet medical needs is crucial as it often can inform which investigational new drugs enter clinical trial testing, and RWE studies from hospital settings have contributed substantial progress here. RWE can also optimize the design of clinical studies, inform benefit risk assessments and use networks of pragmatic studies to help with clinical trial feasibilities and eventual trial initiation. The challenges of RWD include data quality, reproducibility and accuracy which may affect validity. RWD and RWE must be fit for purpose and one must be cognizant of inherent biases.

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OBJECTIVES: There is an increased interest in patient preferences informing the development and authorisation of medical products. A requirement for robust and meaningful results of such studies is that patients adequately understand the risks and benefits associated with treatments for which their preferences are elicited. This study aims to determine the influence of an educational tool, compared with traditional written information on patient preferences elicited in a discrete choice experiment (DCE). METHODS: Treatment preferences of Swedish patients with rheumatoid arthritis (RA) were assessed using a DCE. Patients were recruited via clinics, a research panel, and the Swedish Rheumatism Association. Respondents received training materials either as plain written text or as an online educational tool. The educational tool was designed to enhance understanding of the written text by using graphics, pictograms, icon arrays, spoken text, and click-on functions. Data were analysed using random parameter logit models. RESULTS: 675 patients with RA were included in the analysis. The patients received either a written information (n = 358) or information via an educational tool (n = 317). Respondents receiving the educational tool placed relatively more importance on all included side effects in their decision making, compared to respondents receiving the written text, who placed greater importance on treatment effectiveness and administration methods. CONCLUSION: Compared to the respondents receiving the written text, the decisions of respondents receiving the educational tool were more influenced by medication side effects. Further research is needed to provide guidance on how and when to use educational tools to inform and elicit patients' preferences. PRACTICE IMPLICATIONS: The ways in which attributes are presented to patients significantly impacts preferences measured in a DCE.

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During the COVID-19 pandemic, global health services have faced unprecedented demands. Many key workers in health and social care have experienced crippling shortages of personal protective equipment, and clinical engineers in hospitals have been severely stretched due to insufficient supplies of medical devices and equipment. Many engineers who normally work in other sectors have been redeployed to address the crisis, and they have rapidly improvised solutions to some of the challenges that emerged, using a combination of low-tech and cutting-edge methods. Much publicity has been given to efforts to design new ventilator systems and the production of 3D-printed face shields, but many other devices and systems have been developed or explored. This paper presents a description of efforts to reverse engineer or redesign critical parts, specifically a manifold for an anaesthesia station, a leak port, plasticware for COVID-19 testing, and a syringe pump lock box. The insights obtained from these projects were used to develop a product lifecycle management system based on Aras Innovator, which could with further work be deployed to facilitate future rapid response manufacturing of bespoke hardware for healthcare. The lessons learned could inform plans to exploit distributed manufacturing to secure back-up supply chains for future emergency situations. If applied generally, the concept of distributed manufacturing could give rise to "21st century cottage industries" or "nanofactories," where high-tech goods are produced locally in small batches.

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BACKGROUND: Incorporating patient preference (PP) information into decision-making has become increasingly important to many stakeholders. However, there is little guidance on which patient preference assessment methods, including preference exploration (qualitative) and elicitation (quantitative) methods, are most suitable for decision-making at different stages in the medical product lifecycle (MPLC). This study aimed to use an empirical approach to assess which attributes of PP assessment methods are most important, and to identify which methods are most suitable, for decision-makers' needs during different stages in the MPLC. METHODS: A four-step cumulative approach was taken: 1) Identify important criteria to appraise methods through a Q-methodology exercise, 2) Determine numerical weights to ascertain the relative importance of each criterion through an analytical hierarchy process, 3) Assess the performance of 33 PP methods by applying these weights, consulting international health preference research experts and review of literature, and 4) Compare and rank the methods within taxonomy groups reflecting their similar techniques to identify the most promising methods. RESULTS: The Q-methodology exercise was completed by 54 stakeholders with PP study experience, and the analytical hierarchy process was completed by 85 stakeholders with PP study experience. Additionally, 17 health preference research experts were consulted to assess the performance of the PP methods. Thirteen promising preference exploration and elicitation methods were identified as likely to meet decision-makers' needs. Additionally, eight other methods that decision-makers might consider were identified, although they appeared appropriate only for some stages of the MPLC. CONCLUSIONS: This transparent, weighted approach to the comparison of methods supports decision-makers and researchers in selecting PP methods most appropriate for a given application.

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This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.

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This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.

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