Objective This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in phase 1, 2, 3 and 4 clinical trials spanning multiple disease areas.

Design The study design involved a retrospective analysis of completed clinical trials.

Setting Select set of seven clinical trials conducted between 2018 and 2023 and sponsored by Johnson & Johnson Innovative Medicine: TMC114FD1HTX1002, 77242113PSO2001, 42756493BLC2002, 54767414MMY3012, VAC18193RSV3006, R092670PSY3016 and 28431754DIA4032

Participants While participants and the public were involved in all seven trials, the life cycle assessments (LCAs) were performed as an independent retrospective analysis after the clinical trials were completed. As a retrospective analysis, we leveraged clinical trial documentation and interviews with the sponsor trial staff and trial site staff. None of the participating trial subjects were involved specifically in the LCA analysis, nor was any personal identifying information from the trial subjects collected or shared.

The underlying clinical trials were performed in accordance with the Declaration of Helsinki and Guidelines for Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full governing board approval for conducting research involving humans. Sponsor approval and continuing review were obtained through the appropriate Institutional Review Board/Ethics Committee (IRB) and Health Authority channels. For academic investigative sites that did not receive authorisation to use the central IRB, full board approval was obtained from their respective governing IRBs, and documentation of approval was submitted to Johnson & Johnson Innovative Medicine, LLC, before the site’s participation and initiation of any trial procedures. All registry participants provided written informed consent and authorisation before participating.

Primary outcome measure Primary outcome measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to Intergovernmental Panel on Climate Change 2021 impact assessment methodology.

Results The TMC114FD1HTX1002 phase 1 trial was the smallest trial both in terms of number of patients (39) and sites (1) and had the smallest emissions at 17 648 kgCO2e. The 54767414MMY3012 phase 3 trial was not the largest trial in terms of number of participating patients (517) but had the largest number of participating sites (129) and had the largest emissions at 3 107 436 kg CO2e. Across all seven trials analysed, the mean emissions per patient were 3260 kg CO2e. When the overall trial footprints are broken down by phase, the phase 2 mean per patient was 5722 kg CO2e and the phase 3 mean per patient emissions were 2499 kg CO2e. The five largest contributors of greenhouse gas (GHG) emissions were drug product (50% mean), patient travel (10% mean), travel for on-site monitoring visits (10% mean), collection and processing of laboratory samples (9% mean) and sponsor staff commuting (6% mean). Patient travel was the only consistent GHG hotspot across all seven trials, as other hotspots appeared intermittently in some trials but not others based on variations in trial design. Across the multisite phase 2, 3 and 4 trials we analysed, a combination of the observed five largest contributors to GHG emissions were responsible for no less than 79% of GHG emissions for any one trial.

Conclusions Based on our LCAs of seven clinical trials spanning all four phases of development and multiple disease areas, there are five activities that drive no less than 79% of the average clinical trial’s GHG footprint. These are drug product manufacture, packaging, and distribution; patient travel; on-site monitoring visit travel; the collection, transport and processing of laboratory samples; and sponsor staff commuting between their homes and the office. Understanding the activities that drive GHG emissions in clinical trials can both guide trial designers in avoiding or minimising reliance on these activities when designing new trials and guide trial sponsors in taking targeted actions to reduce GHG emissions from these activities where their use cannot be avoided.@en

In an era of electronics-driven healthcare, the disposability of many medical devices raises environmental concerns. Transitioning these devices towards a circular economy, involving practices like reuse, remanufacturing, and recycling, holds promise. Our paper explores this transition through desk research, literature review, and expert interviews, examining the current state of circular design in electronic medical devices. We unveil barriers, opportunities, and design recommendations for circularization. First, we highlight the circularity potential of medical devices currently on the market, implementing e.g. refuse, reuse, recycle, etc. Second, we present barriers for circular medical device design, (e.g. (perceived) safety and infection risks, (perceived) regulatory difficulties, financial constraints, and difficulties in collection and separation) and opportunities to overcome these barriers. Finally, we present 29 design-specific recommendations for creating circular medical devices. Our insights into circular healthcare practices urge design engineers to integrate sustainable principles into medical device development without compromising safety, quality, or functionality.

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OBJECTIVE: This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study. DESIGN: Retrospective analysis. DATA SOURCE: Internal data held by Janssen Pharmaceuticals. STUDIES INCLUDED: Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021. MAIN OUTCOME: Measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology. RESULTS: The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions. CONCLUSIONS: Decentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society's transition towards electric vehicles may result in further reductions. TRIAL REGISTRATION NUMBER: NCT04208061.

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Radical technological innovations are emerging in response to environmental, economic and geopolitical pressures. This affects how we design and manufacture new solutions. Additive manufacturing, one of the enabling technologies of the digital transition, can support more-sustainable manufacturing processes if developed through a system-level approach. In this Perspective, we adopt such an approach: we propose to use established sustainable design methods to innovate additive manufacturing systems and to consider how to make additive manufacturing an enabler of sustainable design in combination with conventional manufacturing. We then discuss how to implement our vision to enable additive manufacturing for sustainability.

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Like many health devices, smart pill boxes designed to enhance medication adherence often incorporate electronic components and smart sensors. However, the production and disposal of these rising numbers of electronics contribute significantly to the global e-waste crisis, exacerbating the negative climate impact of the healthcare industry. To minimize the impact of such electronic health devices, redesign based on circular economy principles is crucial. However, currently no clear circular design methodology exists to apply those principles in the healthcare domain. This paper discusses a case study in which we propose conceptual redesigns that aim to mitigate the environmental impact of smart pill boxes and help align them with circular economy principles. We employ a research-through-design approach in which we attempt to apply the well-known “10R strategies” (i.e. refuse, rethink, reduce, reuse, repair, refurbish, remanufacture, repurpose, recycle, and recover) as a design method. While doing this, we assessed their applicability in a design process and added value in making the device circular through reflective journalling, and their estimated effectiveness on minimizing environmental impacts by comparing fast-track LCAs for each design decision. In this way, we were able to provide insights into the intricacies of designing a more sustainable and circular device in this manner, and subsequently formulate recommendations for designing similar devices in the future.@en

Circular economy (CE) is critical to future manufacturing, as it will foster regenerative systems and pave the way for sustainable practices in advanced manufacturing, especially additive manufacturing (AM). Currently, the widespread implementation of CE in the field of AM has been hindered mostly by limitations in materials and technologies. More research efforts need to be dedicated to understanding and evaluating AM's role in facilitating closed-loop resource flow in industrial ecosystems. This article provides a state-of-the-art review of recently published research studies on this topic, ranging from AM recyclable material design and development to AM-assisted repair and remanufacturing. Additionally, current knowledge gaps are identified, and some future research directions are discussed. This review article is expected to serve as a valuable resource for researchers, practitioners, policymakers, and industry professionals who seek to leverage AM technologies in a sustainable manner.

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Using additive manufacturing for spare part production can ensure that spare parts are available for a long time. However, spare parts are currently not designed for additive manufacturing. This study aimed to find how the production of 3D-printed spare parts can be facilitated in the design of plastic parts. We used a literature review and illustrative case to find how the design requirements for standard injection moulded plastic parts relate to the manufacturing capabilities of additive manufacturing for spare parts. The design requirements were defined by assigning corresponding structural and material properties. These requirements were then used to construct and evaluate the capabilities of additive manufacturing compared to injection moulding. It was found that additive manufacturing is especially suitable for requirements like Accuracy, Heat resistance, and Chemical resistance. However, to fully enable 3D-printed spare parts, certain design challenges still need to be tackled. Designers should pay careful attention to the synergies and trade-offs between design requirements and the challenges that might arise from the combination of certain requirements. Also, designers should ensure products are easily reparable before considering 3D-printed spare parts. If we target these challenges in the design phase, we can facilitate 3D-printed spare parts that enable product repairability.@en

This paper introduces the Total Cost of Ownership Score (TCOS) as a comprehensive framework for evaluating and improving product repair, durability, and maintenance all together on a uniform scale. The scoring procedure, implemented through a spreadsheet, calculates a product's total cost of ownership per year based on likelihood of failure modes, repair costs per failure (parts, labor, and other), likelihoods of repair successes, and cost of replacing the product if repairs fail. Because costs and repair times vary substantially based on many factors, and likelihoods of device failures and repair successes are stochastic by nature, the uncertainties are large and must be displayed in final scores. However, preliminary results indicate that even with large uncertainties, the TCOS provides meaningful product comparisons and hotspot identification. The advantages of the TCOS include scoring quantitatively in units that both consumers and businesses understand and value, to drive market behavior; vast reduction of subjective judgments in scoring; measuring durability and repair on the same scale; universal applicability, enabling legislation or policy to scale across products easier; and enabling legislation to allow innovation rather than prescribing designs. The TCOS's two challenges are that the data required is not publicly available for most products, so it requires empirical product testing; and further development / negotiation is required to decide what standard assumptions can be applied as shortcuts to shrink the scope of empirical testing.@en

The Future of Design Education working group on sustainability developed recommendations for integrating sustainability into higher education design curricula. The recommendations provide a foundation for design instruction, using well-established evidence-based tools, methods, and mindsets that apply to professional practice and support designers as advocates for environmental and social responsibility. The document identifies core ideas for sustainable design, organized under a set of topics. These topics include sustainability fundamentals; circular economy; whole systems thinking; sustainable innovation strategies; impact assessment, and laws and standards; and communication, collaboration, and leadership. A summary table captures each idea, along with corresponding discussion and learning outcomes (things students should know and do). Recommendations are tailored to three levels of study: for all design students, students expecting to practice in sustainable design, and students in elective or advanced study. Resources for such study are also included.@en

Spare parts availability is crucial for extending the life of consumer products. However, long-term availability could lead to high stocks of spare parts, which might not be used. Instead, on-demand manufacturing of spare parts with additive manufacturing (AM) is a promising alternative. This paper presents a method to evaluate parts on their eligibility for AM spare parts. The parts evaluation is based on AM technology accessibility as well as part requirements. This method was tested by assessing all parts of the Dyson V11 broom-stick vacuum-cleaner and validated by printing and testing a selection of parts. For this, both plastic and metal spare parts were made through fused deposition modelling (FDM), stereolithography (SLA), binder jetting (BJ), material jetting (MJ), selective laser melting (SLM), selective laser sintering (SLS), and multi jet fusion (MJF), using both desktop FDM printers and off-site service providers. Based on these results, we conclude that currently only a small number of parts can be replaced by additive manufactured parts without considerable redesign efforts. AM parts can compete on price with the current stocked parts, but may be more expensive for other products. We also identified additional functional requirements for evaluating the eligibility of a spare part for AM.@en

The availability and storage of spare parts are the main barriers to product repair. One possibility would be to 3D print spare parts, which would also enable the repair of products not intended to be repaired. Besides manufacturers, 3D printing spare parts is an interesting option for self-repair by consumers. However, the digitisation of spare parts for 3D printing is a challenge. There is little guidance on how to make a 3D-printed version of the original part. This paper establishes a framework through a literature review and experimental study to describe how to use 3D printing to produce spare parts for repair. Additionally, qualitative data coding was used to find the influence of previous experience, process implementation, and part complexity on the overall success of the 3D printing for repair (3DPfR) process. Our study showed that the 3DPfR process can be described as an iterative design for an additive manufacturing process that is integrated into a repair process. Additionally, it was found that the incorrect implementation of process steps was the most important predictor of the repair result. The steps that were performed incorrectly the most were synthesising design concepts (64%) and validating print quality (also 64%).

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The Circular Economy Action Plan adopted by the European Commission aims to keep value in products as long as possible through developing product-specific requirements for durability and repairability. In this context, various scoring systems have been developed for scoring product repairability. This study assessed the objectivity and completeness of six major repair scoring systems, to see what further development may be required to make them policy instruments for testing product repairability. Completeness of the scoring systems was assessed by comparing them to the latest literature on what design features and principles drive product repairability. Objectivity was determined by assessing whether the scoring levels in each criterion were clearly defined with a quantifiable and operator-independent testing method. Results showed that most of the criteria in the scoring systems were acceptably objective and complete. However, improvements are recommended: The health and safety criterion lacked objectivity and has not yet been fully addressed. Further research is required to expand the eDiM database, and to identify whether the additional accuracy provided by eDiM compared to disassembly step compensates for the increased difficulty in testing. Finally, assessment of reassembly and diagnosis should be expanded. Addressing these gaps will lead to the development of a scoring system that could be better used in policymaking, and for assessment by consumer organizations, market surveillance authorities, and other interested stakeholders, to promote the repairability of products.@en

Purpose: The purpose of this study is to quantify the vertical shrinkage rates and the mechanical strength of three-dimensional (3D) printed parts for a variety of wood-based materials for liquid deposition modeling. Design/methodology/approach: The overall hypothesis was that a well-chosen combination of binders, fibers and fillers could reduce shrinkage in the Z dimension and increase compressive and flexural strength (DIN 52185, 52186). To test this assumption, eight sub-hypotheses were formulated. Mixtures of the ingredients were chosen in different ratios to measure the performance of prints. For time efficiency, an iterative heuristic approach was used – not testing all variations of all variables in even increments, but cutting off lines of testing when mixtures were clearly performing poorly. Findings: The results showed that some mixtures had high dimensional accuracy and strength, while others had neither, and others had one but not the other. Shrinkage of 3D printed objects was mainly caused by water release during drying. An increase of the wood as well as the cement, sand, salt and gypsum content led to reduced vertical shrinkage, which varied between 0 and 23%. Compressive and flexural strength showed mixed trends. An increase in wood and salt content worsened both strength properties. The addition of fibers improved flexural, and the addition of cement improved compression strength. The highest strength values of 14 MPa for compressive and 8 MPa for flexural strength were obtained in the test series with gypsum. Originality/value: This paper is an important milestone in the development of environmentally friendly materials for additive manufacturing. The potential of many ingredients to improve physical properties could be demonstrated.

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This guide takes the reader through the 3D Printing for Repair (3DP4R) process. It consists of guidelines and tools to create a 3D printable version of spare parts needed for a product repair. 3D printing a spare part is more than just printing the original part. Instead, it is an iterative process in which the part is analysed, redesigned, manufactured, and tested, in order to come to a final part. This guide will describe these four phases in detail. The guide is meant for anybody who is interested in trying to manufacture spare parts with 3D printing technologies, remakers, tinkerers, volunteer repairers, professional repairers, and everyone who is interested in repair initiatives.@en

The Sharepair project aims to decrease the waste of electronic and electric consumer products and increase their useful life, by supporting repair communities and scaling up citizen repairs through digital tools. One of the focus areas of this project is to support the discovery or manufacturing of spare parts. With a 3D CAD model of a part and a 3D printer, repair communities could manufacture spare parts. This paper discusses the possibilities of identifying repairs, within repair communities, that can be met through 3D printed spare parts. To understand and identify these possibilities, the repair entries expressed in the Open Repair Database (ORD) from the Open Repair Alliance were examined. The analysis aimed to identify documented examples of repairs that have broken or missing parts, and estimate how many may be suitable for replacement by 3D printed versions. The ORD includes 41,874 repair data entries from 229 repair communities (Repair Café, Restart Project, Fixit Clinic, and Anstiftung) in eighteen countries. Repair entries include information such as product category, brand, model, repair status and notes regarding the repair process and result, all in different languages. The analysis identified a list of the most commonly repaired product categories, brands, and models, as well as an estimate that between 7.5% and 29% of products in repair cafes that are not repaired today could be repaired with 3D printed spare parts. The analysis also showed that the data and information about the repairs is inconsistent, open to interpretation and often too limited to precisely pinpoint opportunities for 3D printed spare parts. Specifying the product parts that need repair or replacement and their functional requirements would be key to a successful identification. Thus, the study proposes recommendations to improve the process of capturing repair information that specifies the repair needs that can be met by the use of 3D printing.@en

There is a growing recognition of the need to incorporate sustainability considerations early-on in the product development (PD) process (PDP). As part of a case study at an engineering consultancy firm, this paper identifies considerations that influence the integration of sustainable design practices into real-world PD practices. This is informed by the first author becoming embedded in the firm as an intern, and closely observing the PD workflow across various projects, conducting interviews and group discussions with a wide range of practitioners, and iteratively designing and testing various potential interventions. From the literature and observations, we find that designers and engineers often struggle to identify and apply the right sustainable design methods and tools (SDMTs) to tackle the environmental impacts associated with their products. Through a human-centered design process, we co-created a reusable, modular framework of practices that aids the selection of relevant strategies, based on the environmental hotspots, stage of the PD process, and the client’s sustainability priorities. Our prominent findings highlight the importance of: (a) co-creation in enhancing receptivity and retention, (b) the use of LCA iteratively to inform design decisions throughout PD, and (c) sharing case studies of successful application of the framework to promote sustainable design among employees and clients, alongside several other takeaways. The paper further presents insights related to the framework’s real-world application and impacts in the firm, based on results of longitudinal engagement with the firm.

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Metal additive manufacturing (AM) is revered for the design freedom it brings, but is it environmentally better or worse than conventional manufacturing? Since few direct comparisons are published, this study compared AM data from life-cycle assessment literature to conventional manufacturing data from the Granta EduPack database. The comparison included multiple printing technologies for steel, aluminum, and titanium. Results showed that metal AM had far higher CO2 footprints per kg of material processed than casting, extrusion, rolling, forging, and wire drawing, so it is usually a less sustainable choice than these. However, there were circumstances where it was a more sustainable choice, and there was significant overlap between these circumstances and aerospace industry use of metal AM. Notably, lightweight parts reducing embodied material impacts, and reducing use-phase impacts through fuel efficiency. Finally, one key finding was the irrelevance of comparing machining to AM per kg of material processed, since one is subtractive and the other is additive. Recommendations are given for future studies to use more relevant functional units to provide better comparisons.

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The process of fault diagnosis is an essential first step when repairing a product: it determines the condition of the parts and identifies the origin of failure. We report on how product users go through the process of fault diagnosis in consumer products and the influence of design features on this process. Two groups of 12 participants were asked to determine the fault in a defective product we supplied; the groups differed in their self-reported repair expertise. Four types of products were used for the study: a vacuum cleaner, kitchen blender, radio CD player, and coffee maker. During the experiment, the participants were asked to think aloud to explain their actions and understandings. Afterwards, they were interviewed regarding their experience. The results from the verbal and video analysis provided input for an updated framework of the diagnosis process, describing user actions at each
diagnosis stage. Furthermore, we show that the way a product is designed and constructed (the positioning, accessibility, and visibility of relevant product components) has a significant influence on the success of the fault
diagnosis. An important factor is user experience: product use facilitates signal recognition, while repair expertise facilitates disassembly. However, user experience is still less influential than the product’s design. Based on these findings, we propose a set of design guidelines to facilitate the process of fault diagnosis in consumer products @en

Water lubricated bearings have been named in literature as a sustainable alternative to their oil-based counterparts. In order to clarify when water lubricated bearings are or are not a sustainable alternative, and inform design decisions, an analytical design tool is introduced based on anticipatory Life Cycle Assessment (LCA). This model is based on data from the bearing geometries, materials, and material combinations that have been the subject of research attention in the past 20 years in water lubricated bearing design. The model provides simple equations, fed with data from literature on materials, production and their tribological combination to provide initial insight on the sustainability of these types of bearings and future designs. A case study illustrates that quantifying environmental impacts can help determine when lubricant loss is more important than material choice, or vice-versa. The method aids bearing designers towards more sustainable designs.

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