Early Stages Of Product Development Research Articles

Production-oriented design of electric traction drives with hairpin winding

In recent years, the manufacturing of stators by hairpin technology has proven its ability to fulfill the requirements on quality, productivity and robustness of traction drive applications in automotive industry. However, the uncertainty and necessity of rapid product development despite fuzzy target systems still cause that processes, machines and equipment – as well as the electric design – are often in an imperfect prototype stage at the start of production ramp-up. Due to the complex interdependencies between the stator components in combination with a high sensitivity of the overall process reliability to minor adjustments of stator design features, possible production-related weaknesses in design are often recognized first in the prototype stage of the production system. In order to reduce the economic risk resulting from these volatile technological conditions, production-oriented design based on numerical simulation methods can be applied from the beginning of product development. Therefore, several techniques for numerical process modeling are presented in this paper as possibilities to consider manufacturing constraints in an early stage of product development. For this purpose, the influence of wire dimensions on the forming process of hairpin coils is investigated using the example of rotary bending as well as the twisting process of a full stator by finite element simulations. Furthermore, a numerical approach to investigate the influence of heat input during laser welding of hairpin coils on the required stripping length is introduced.

Usage of Visual Representations for Innovation Decision Making by Organizational Leadership at Early Innovation Stage of New Product Development

Usage of Visual Representations for Innovation Decision Making by Organizational Leadership at Early Innovation Stage of New Product Development

Life Cycle Assessment of a Point-Absorber Wave Energy Array

Wave energy has a large global resource and thus a great potential to contribute to low-carbon energy systems. This study quantifies the environmental impacts of a 10MW array of 28 point-absorber wave energy converters, by means of a process-based life cycle assessment (LCA). Midpoint and Cumulative Energy Demand LCA results are presented over 19 impact categories, representing impacts encompassing human health, ecosystems and resource availability. Three scenarios are undertaken to represent the use phase of the array, identified as a particularly uncertain input, with very little long-term operation of wave energy arrays available to validate assumptions. The resultant global warming potential of the array ranges from 25.1- 46.0 gCO2e/kWh over a 95% confidence interval, 23-43 times lower than conventional fossil fuel electricity generation. The Energy Payback Time of the array ranges between 2.6-5.2 years. LCA results are found to be particularly sensitive to annual energy production across all impact categories, and to assumptions associated with the frequency of marine operations over a number of categories quantifying the production of greenhouse gases. This LCA has been undertaken at an early stage in the WEC product development and will inform innovative research focused on further reducing the environmental impacts of electricity generation.

Anticipated cell lines selection in bioprocess scale-up through machine learning on metabolomics dynamics

The development of biopharmaceutical therapeutics, such as monoclonal antibodies, requires the testing of several cell lines at different development scales and the selection of the high performing cell lines which allow meeting the desired quality attributes of the product. In this context, data analytics, which is extremely useful for a better process understanding and a faster scale-up, can be used to understand the relation between biological information, such as cell metabolism, and process productivity. This study shows that monoclonal antibodies end-point titer can be estimated in the early stages of the industrial product development for cell line selection using information on cell metabolism dynamics. This allows the anticipated identification of the high-performing cell lines, and a better understanding of the relationships between the time evolution of both the metabolic information and the product titer.

A Method to Support Design for Serviceability in the Early Stages of New Product Development

ABSTRACT In the New Product Development (NPD) process, in addition to the customer’s requirements, it is necessary to consider the other actors that will intervene throughout the product’s life cycle, including the performance of maintenance services. Designing a product with characteristics that facilitate the intervention of services requires that the designer takes into consideration knowledge often scattered in physical materials, or implicitly in the experience of professionals allocated in several sectors. Thereby, after bibliographic research, the existence of a gap in the performance of Design for Serviceability (DFS) techniques at the beginning of the NDP was observed. The Design Science Research (DSR) methodological approach was adopted. The solution consists of a method of surveying the requirements for feeding a database, creating SysML diagrams, and monitoring within the CAD system through developed additional tools. These tools offer the possibility of consulting SysML diagrams, as well as query and insertion of requirements in the database and the creation of an access envelope to preserve the space needed to use the tools required for the service. In the end, the method was satisfactorily evaluated by professionals. Therefore, the method may be an alternative for the designers to guide their projects to serviceability.

Comparative Safety Assessment of Automated Driving Strategies at Highway Merges in Mixed Traffic

We present a simulation-based approach to assess the safety impacts of vehicles equipped with Automated Driving Systems (ADS) in mixed traffic with Human-driven Vehicles (HV). Specifically, we compare two generic longitudinal strategies of ADS to handle a cut-in: Reactive ADS acting only when the cut-in vehicle crosses the target lane boundary, and Predictive ADS acting at the onset of the cut-in manoeuvre. We identify their distinctive effects on the traffic safety under cut-in maneuvers of adjacent human-driven vehicles at highway merges. We employ a microscopic traffic flow simulator that describes the lane changing process with high detail, accounting for the vehicle interaction and consequent trajectory updates. These high-resolution trajectories are post-processed to estimate a set of relevant surrogate measures of safety. By analyzing these measures, we find that the predictive ADS significantly outperforms the reactive ADS in aspects such as temporal proximity to crash, expected crash severity and the driving risk (combining the two aspects), and the number of aborted lane changes by HV. The negative safety impact of reactive ADS becomes prominent at penetration rate >10%. The major difference between the two ADS approaches appears in the dynamics of risk during the lane changing. When a vehicle cuts in ahead of Reactive ADS, the risk peaks approximately halfway through the maneuver; whereas with Predictive ADS the risk remains marginal throughout. This work demonstrates the potential of simulation-based safety assessment to differentiate the safety impacts of automation functionalities at an early stage of product development.

Users’ Needs in Designing a Mobile Dialysis Device. Insights from an Interview in a Mixed Methods Study

The goal of this study is to identify ways to increase the usability of a mobile dialysis device through semi-structured interviews during the early stage of product development. We analyzed interview data using a mixed method of rank order and open-ended questions. The results from the open-ended questions showed that patients and care partners prefer the device being carried on patients’ backs, followed by the waist and the shoulder. We also identified 13 key categories of ideal features that the mobile dialysis device must hold. The results from the rank order question showed that the participants significantly preferred the Vest over the Backpack, Shoulder bag, and Distributed model. Accuracy of the device is more important compared to Safety, Ease of attachment, Comfort, Size, Operational simplicity, and Invisibility. The prioritized needs from patients and care partners provide designers and clinicians with better target solutions for designing a mobile dialysis device.

Computer-aided gear product realization using enhanced decision-making in material selection and reliability assessment

Unmatched in its diversity of applications, gears continue to be one of the most successful components used to transfer energy throughout a mechanical system. Certain project settings can require gears to meet more than one criterion to achieve optimal performance. In this paper, we proposed the simulation-based design synthesis using virtual simulations and material selection charts. For this, a computer-generated two gear mechanism is made to create a gear material selection chart, similar to an Ashby chart, that compares the desired conditions of angular velocity and torque. By utilizing computer software to personalize specifications, a gear design material selection chart can be constructed to expedite the material selection process for project environments and needs. Using this approach, gear designers and manufactures can promote design efficiency in the early stage of product development by flexibly determining possible material choices for their gear design based on the desired performance specifications.

Effect of strain rate on powder flow behaviour using ball indentation method

There are a number of techniques available for characterising powder flow behaviour, most of which are carried out under quasi-static conditions. Quasi-static methods are commonly used to define the conditions for the flow initiation, but they are inadequate for characterising the shear strain rate sensitivity of powder flow. The number of devices available to capture powder behaviour under dynamic conditions is indeed very limited. The very few commercially available instruments all require a large sample, which is not desirable for early stages of product development. We have recently proposed the use of ball indentation for characterising flow resistance of cohesive powders. The technique can be applied at very low consolidation stress levels (much less than 1 kPa) and requires only a small sample quantity, typically a few mm3. Previous work showed a good correlation of flowability with established methods under quasi-static conditions. Therefore, an attempt is made to extend the method to dynamic conditions and investigate the sensitivity of the stresses on the shear strain rate for a range of powders, including glass ballotini, α-lactose monohydrate, calcium carbonate (Durcal) and limestone. The results show the existence of a threshold boundary above which the flow resistance experienced by the penetrating ball becomes dependent on the shear strain rate. This is in line with the trends reported in the literature. Therefore, the ball indentation technique has the potential to be used to assess powder flowability at high strain rates.

Towards predicting the product quality in hot-melt extrusion: Small scale extrusion

In product development, it is crucial to choose the appropriate drug manufacturing route accurately and timely and to ensure that the technique selected is suitable for achieving the desired product quality. Guided by the QbD principles, the pharmaceutical industry is currently transitioning from batch to continuous manufacturing. In this context, process understanding and prediction are becoming even more important. With regard to hot melt extrusion, the process setup, optimization and scale-up in early stages of product development are particularly challenging due to poor process understanding, complex product-process relationship and a small amount of premix available for extensive experimental studies. Hence, automated, quick and reliable process setup and scale-up requires simulation tools that are accurate enough to capture the process and determine the product-process relationships. To this end, the effect of process settings on the degradation of the active pharmaceutical ingredient (API) in a lab-scale Leistritz ZSE12 extruder was investigated. As part of the presented study, the limitations of traditional process analysis using integral process values were investigated, together with the potential that simulations may have in predicting the process performance and the product quality. The results of our investigation indicate that the average melt temperatures and the exposure times in specific zones along the screw configuration correlate well with the API degradation values and can be used as potent process design criteria to simplify the process development.

A Model for Managing Packaging in the Product Life Cycle in the Automotive Industry

Due to its many benefits, the automotive industry is increasingly focused on the use of returnable packaging, but the benefits of using it can only be fully realized if the system is properly managed. This study therefore aims to build a model that enables a comparison between different sustainable packaging systems: non-returnable packaging, returnable packaging, and returnable foldable packaging. The applicability of the model was verified in a multinational manufacturing company that is a development supplier in the international automotive industry. The results highlight the main advantages of the model: enabling the comparison between the use of different sustainable packaging systems; when simulating different scenarios, it takes into account several different cost components and ensures a systematic selection of the packaging system in the early phase of product development. The high degree of practicality and usability of the model was also validated by the sensitivity analysis, as the longer the transport distance, the more acceptable the use of non-returnable packaging. In addition, higher demand for the product was correlated with a reduction in the total cost of all three aspects of packaging choice. The model upgrades existing studies and represents a practical decision-making tool for manufacturing companies and the logistics industry. It will contribute to the systematic construction of a packaging management system at an early stage of product development, which will reduce costs in the long run, improve the quality of logistics processes, and ensure an effective sustainable packaging management system.

Circularity Evaluation of Alternative Concepts During Early Product Design and Development

Product design and development are essential for a circular transition. Circularity decisions, such as those concerning the type of material, assembly method, and expected lifespan, made during the early design stages will significantly influence a product’s quality, cost, esthetics, sustainability, and circularity performance over the product lifecycle. However, circularity is not often considered in the early stages of product design and development. This paper presents the development of the concept circularity evaluation tool (CCET), which aims to support the evaluation of alternative product concepts in terms of their circularity potential in the early stages of product design and development. The CCET was iteratively developed based on an extensive literature review of the success criteria for tool development, guidelines, and existing tools for circular product design and development and strong collaboration with manufacturing companies. The tool was tested and verified at four manufacturing companies in Nordic countries. The tool has been proven useful for evaluating the circularity of products and supportive in the decision-making process in the early stages of product design and development.

Founder need to belong, tertius iungens orientation and new venture performance

SummaryIn this study, we examine the role of founders' need to belong and tertius iungens orientation (i.e., the tendency of bringing people together and coordinating among others) in the context of new ventures. We propose and document evidence that a founder's tendency to engage in tertius iungens oriented networking is positively associated with new venture performance. We also reveal that a founder's need to belong is a significant motivational antecedent of the founder's tertius iungens orientation. Further, the need to belong–networking orientation linkage is stronger for founders in new ventures at the early product development stage than those at the late product development stage. We tested our hypotheses using survey data collected with a two‐wave sample of new ventures in China. We discuss the theoretical significance of studying the need to belong and tertius iungens orientation for social networks and entrepreneurship literatures, as well as the practical implications for managing a successful new venture.

An Adaptive Bayesian Melding Method for Reliability Evaluation Via Limited Failure Data: An Application to the Servo Turret

In the early stage of product development, reliability evaluation is an indispensable step before launching a product onto the market. It is not realistic to evaluate the reliability of a new product by a host of reliability tests due to the limiting factors of time and test costs. Evaluating the reliability of products in a short time is a challenging problem. In this paper, an approach is proposed that combines a group of experts’ judgments and limited failure data. Novel features of this approach are that it can reflect various kinds of information without considering the individual weight and reduces aggregation error in the uncertainty quantification of multiple inconsistent pieces of information. First, an expert system is established by the Bayesian best–worst method and fuzzy logic inference, which collects and aggregates a group of expert opinions to estimate the reliability improvement factor. Then, an adaptive Bayesian melding method is investigated to generate a posterior by inaccurate prior knowledge and limited test data; this method is made more computationally efficient by implementing an improved sampling importance resampling algorithm. Finally, an application for the reliability evaluation of a subsystem of a CNC lathe is discussed to illustrate the framework, which is shown to validate the reasonability and robustness of our proposal.

Investigation into powder tribo-charging of pharmaceuticals. Part I: Process-induced charge via twin-screw feeding.

Powder feeding is a crucial unit operation in continuous manufacturing (CM) of pharmaceutical products. Twin-screw feeders are typically employed to ensure the accurate mass flow of pharmaceutical materials throughout the production process. Here, contact and separation of particles can give rise to electrostatic charges, affecting feeder performance and final product quality. The knowledge of the material charging tendency would therefore be beneficial for both formulation and process design. At the early stage of product development, only a limited amount of material is available and the propensity of the powders to charge needs to be assessed on lab test equipment, which not necessarily represent the material state during processing. In this study, the tribo-charging behaviour of a set of common pharmaceutical materials (i.e., microcrystalline cellulose, D-mannitol, paracetamol and magnesium stearate) was experimentally evaluated. To this end, powder materials were let to flow over the stainless-steel pipes of the GranuCharge™ instrument. The resulting charge was compared to the one acquired during twin-screw feeding. In both cases, paracetamol exhibited the highest charging tendency followed by D-mannitol and microcrystalline cellulose and last by magnesium stearate. A good correlation was found for charge values obtained for both methods, despite the different tribo-charging mechanisms involved in the two set-ups. However, these differences in experimental set-ups led to diverse magnitudes and, in one case, polarity of charge. Additionally, an extensive material characterization was performed on the selected powders and results were statistically analyzed to identify critical material attributes (CMAs) affecting powder tribo-charging. A strong correlation was obtained between the measured charge and inter-particle friction. This indicated the latter as one of the most influencing material characteristic impacting the powder tribo-charging phenomenon of the selected materials.

Unravelling the Immunotoxicity of Polycaprolactone Nanoparticles-Effects of Polymer Molecular Weight, Hydrolysis, and Blends.

Poly-ε-caprolactone (PCL) is a biodegradable polyester that has FDA and CE approval as a medical device. Nonetheless, the lack of toxicity exhibited by the polymer cannot be extrapolated to its nanomaterial conformation. Despite PCL-based NPs being widely studied in the biomedical field for their advantages as controlled drug delivery systems, little data describe PCL NPs' toxicity, particularly immunotoxicity. This work assessed different PCL-based delivery systems intended for protein delivery regarding their immunotoxicity and hemocompatibility. Two different molecular weight PCL polymers were used, as well as blends with chitosan and glucan. Results showed that the presence of NaOH during the production of PCL2 NPs and PCL2/glucan NPs induced PCL alkali hydrolysis, generating more reactive groups (carboxyl and hydroxyl) that contributed to an increased toxicity of the NPs (higher reduction in peripheral blood mononuclear cell viability and lower hemocompatibility). PCL2/glucan NPs showed an anti-inflammatory activity characterized by the inhibition of LPS stimulated nitric oxide (NO) and TNF-α. In conclusion, generalizations among different PCL NP delivery systems must be avoided, and immunotoxicity assessments should be performed in the early stage of product development to increase the clinical success of the nanomedicine.

Decision modeling and analysis in new product development considering supply chain uncertainties: A multi-functional expert based approach

Successful new product development projects and extant research literature advocate for inclusion of inputs pertaining to the supply chain at early stages of product development to proactively identify risk averse product design concepts. To this end, we devise an analytical framework to converge upon product design concept(s) that would be associated with lesser supply chain risks, usually function of both technical and commercialization considerations. The high-level and constituent lower-level supply chain risks are represented by parent and root nodes respectively within the devised Bayesian network driven research framework. Thereafter, a quantitative measure denoted as SCRI (supply chain risk index) is evolved that yields overall composite risk numbers corresponding to respective design concepts at different risk states. Validation and comparison of the devised method with an extant study illustrates the consistency and reliability of the study. It is found that the risk propensity of a particular design concept is inversely related to the probabilistic utility of that particular concept. The case of a construction power tool of a global firm is used to demonstrate the methodology. Our research addresses an important future research pathway as argued by Hosseini et al. (2020) that extant research literature is devoid of decision-making frameworks focused on measurement and analysis the propagation of risks on complex networks.

Scalable Set-Based Design Optimization and Remanufacturing for Meeting Changing Requirements

AbstractDesign requirements are often uncertain in the early stages of product development. Set-based design is a paradigm for exploring, and keeping under consideration, several alternatives so that commitment to a single design can be delayed until requirements are settled. In addition, requirements may change over the lifetime of a component or a system. Novel manufacturing technologies may enable designs to be remanufactured to meet changed requirements. By considering this capability during the set-based design optimization process, solutions can be scaled to meet evolving requirements and customer specifications even after commitment. Such an ability can also support a circular economy paradigm based on the return of used or discarded components and systems to working condition. We propose a set-based design methodology to obtain scalable optimal solutions that can satisfy changing requirements through remanufacturing. We first use design optimization and surrogate modeling to obtain parametric optimal designs. This set of parametric optimal designs is then reduced to scalable optimal designs by observing a set of transition rules for the manufacturing process used (additive or subtractive). The methodology is demonstrated by means of a structural aeroengine component that is remanufactured by direct energy deposition of a stiffener to meet higher loading requirements.

Formulation and validation of the shift cell technique for acoustic applications of poro-elastic materials described by the Biot theory

The inclusion of vibroacoustic treatments at early stage of product development through the use of poro-elastic media with periodic inclusions, which exhibit proper dynamic filtering effects, is a powerful strategy for the achievement of lightweight sound packages and represents a convenient solution for manufacturing aspects. This can have different applications in transportation (aerospace, automotive, railway), energy and civil engineering fields, where weight, space and vibroacoustic comfort are still critical challenges. This paper develops the shift cell operator approach as a numerical tool to investigate the dispersion characteristics of periodic poro-elastic media. It belongs to the class of the k(ω) (wave number as a function of the angular frequency) methods and leads to a quadratic eigenvalue problem, even when considering frequency-dependent materials, contrarily to the ω(k) approach that would lead to a non-linear eigenvalue problem for frequency-dependent materials.The full formulation is detailed and the approach is successfully validate for a homogeneous poro-elastic material and a more complex periodic system containing periodic perfectly rigid circular inclusions.

Considerations in the Assessment of Clinical Benefit with a Focus on Pain: a Regulatory Perspective.

In the USA, the regulatory standard for demonstration of efficacy of a drug is evidence of clinical benefit from adequate and well-controlled clinical trials. Understanding the natural history of disease and how treatment is expected to alter its course, and gathering input from relevant stakeholders, such as patients, caregivers, and clinicians, is essential to understand the best way to measure clinical benefit in a clinical trial. Though pain intensity has been the primary outcome measure in clinical trials for pain, an array of measures assessing clinical outcomes from multiple perspectives can allow for more comprehensive interpretation of how a treatment affects patients' lives. Careful consideration should be given to how pain affects the feeling and functioning of each distinct patient population and which outcome assessment, or combination of outcome assessments, may be necessary to provide a more comprehensive view of the patient experience. The early stages of medical product development are an important opportunity to engage with regulatory agencies to discuss potential approaches to clinical trial design and outcome measurement strategies.