Product Development Risk Research Articles

A customer-driven quality function deployment approach for intelligent product design: A case of automatic-dishwasher

Quality Function Deployment (QFD) is one of the very effective customer-driven product development tools. With automatic dishwashers entering the Chinese market, manufacturers can use QFD to develop products that meet the unique Chinese customer requirements and explore the Chinese market. To help manufacturers maximize profits by developing automatic dishwashers to China’s market situation and competitive environment, this paper proposes an improved QFD model considering competitive learning and cost analysis based on market information analysis with Product Life Cycle (PLC) theory. On the one hand, the improved QFD model determines the life cycle stage of the product by analyzing the characteristics of the market. The improvement rate of customer requirements (CRs) determined by competitive learning in different stages has different influence on the importance weights of CRs, so that the new products developed based on design requirements (DRs) converted from CRs can better adapt to the current market environment. On the other hand, the cost strategy will also change according to different PLC stages. In cost analysis, different cost criteria weights will be determined in different life cycle stages to deal with product development risks in different market environments and help enterprises achieve better sustainable development. Finally, we take Chinese HE company’s automatic-dishwasher design as an example to show the specific application of the proposed model. The proposed model identifies the important DRs and their relative importance ranking for the product development. Comparison with existing QFD models shows the ranking obtained through the model is better integrated with market information, enabling the development of products that are better suited to the market, and helping companies to achieve sustainable development.

Research on Evaluation and Prediction Methods of Cognitive Intentions for Product Morphological Features

The morphological characteristics of a product serve as essential carriers for conveying design intentions. These characteristics directly affect users’ comprehension of the product’s functions and proper usage, which are critical to the safety of product utilization and the overall comfort of the user experience. Incorporating prior experience to predict users’ cognitive intentions regarding product form characteristics can provide valuable evaluation and decision-making references for design. This approach effectively reduces product development risks and contributes to enhancing user acceptance and experience. The study established intention discrimination indicators for form characteristics, covering six dimensions: functional orientation, behavioral intention, recognizability, cognitive load, attention distribution, and experiential feeling. Combining multidimensional scaling (MDS) and systematic clustering, samples were screened, and the morphological decomposition method was used to categorize and extract form characteristic categories and feature factors. The entropy weight method was applied to assign weights to the feature categories, and a feedforward neural network (FNN) was employed to construct a prediction model for cognitive intentions regarding product form characteristics. The model was tested using leave-one-out cross-validation, yielding a mean squared error (MSE) of 0.0089 and an R correlation coefficient of 0.9998, indicating high reliability. Finally, the feasibility and effectiveness of this method were validated through a case study on earthquake science experience facilities.

Perancangan Startup Aqibers Platform Penyedia Jasa Aqiqah Metode Lean Startup

Startup Aqibers is a platform providing aqiqah services that uses the Lean Startup method in its design. This method is used to optimize innovation, efficiency and resource management. In the design phase, Startup Aqibers focuses on identifying market needs through in-depth research. StratupAqibers aims to simplify the aqiqah process by providing an online platform that makes it easier for users to choose an aqiqah package, confirm orders and make payments. Through the use of Lean Startup methods, Aqibers was able to identify the key features most desired by customers, improve user experience, and reduce product development risk. By leveraging continuous customer feedback, Aqibers was able to quickly iterate on its platform, ensuring that the solution they created offer in line with changing market needs. In this way, Aqibers is expected to achieve sustainable growth and provide significant added value for consumers who are looking for practical and reliable aqiqah services.

Development of New Products for Climate Change Resilience in South Africa—The Catastrophe Resilience Bond Introduction

Climate change has brought several natural disasters to South Africa in the form of floods, heat waves, and droughts. Neighbouring countries are also experiencing tropical cyclones, almost on a yearly basis. The insurance sector is faced with an increased level of climate change risk with individuals, corporates, and even the government approaching it for financial cover. However, with an increased level of competition in the insurance sector, (re)insurers must engage in massive product research and development. Therefore, this paper looks at the possibility of the insurance industry developing new products in the form of catastrophe resilience bonds (CAT R Bonds). A qualitative approach is used following content analysis of (re)insurers’ product development policies, marketing documents, company reports, and risk management reports as well as the Conference of Parties 27 and 28 resolution papers. The findings reveal that (re)insurers’ underwriting capacity, reinsurance protection, and innovative and creative product development increase because of CAT R Bonds. CAT R Bonds enhance the interaction between the capital market and money market, thereby giving speculative investors another investment option. Increased investment into new product development such as CAT R Bonds must continue in South Africa in pursuit of climate change resilience goals.

IBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products.

In this article, we specify for the first time a quantitative biopharmaceutics classification system for orally inhaled drugs. To date, orally inhaled drug product developers have lacked a biopharmaceutics classification system like the one developed to navigate the development of immediate release of oral medicines. Guideposts for respiratory drug discovery chemists and inhalation product formulators have been elusive and difficult to identify due to the complexity of pulmonary physiology, the intricacies of drug deposition and disposition in the lungs, and the influence of the inhalation delivery device used to deliver the drug as a respirable aerosol. The development of an inhalation biopharmaceutics classification system (iBCS) was an initiative supported by the Product Quality Research Institute (PQRI). The goal of the PQRI iBCS working group was to generate a qualitative biopharmaceutics classification system that can be utilized by inhalation scientists as a "rule of thumb" to identify desirable molecular properties and recognize and manage CMC product development risks based on physicochemical properties of the drug and the deposited lung dose. Herein, we define the iBCS classes quantitatively according to the dose number and permeability. The proposed iBCS was evaluated for its ability to categorize marketed inhaled drugs using data from the literature. The appropriateness of the classification of each drug was assessed based on published development, clinical and nonclinical data, and mechanistic physiologically based biopharmaceutics modeling. The inhaled drug product development challenges for each iBCS classification are discussed and illustrated for different classes of marketed inhaled drugs. Finally, it is recognized that discriminatory laboratory methods to characterize regional lung deposition, dissolution, and permeability will be key to fully realizing the benefits of an iBCS to streamline and derisk inhaled drug development.

Developing Flexible Risk Management Systems for Resilience in a Post-pandemic World: Can Lessons from a Makerspace Case Study Support Pacific Island Communities?

Pacific Island communities are facing disruptions to supply chains from natural disasters and a changing global environment, which have become more acute following the COVID-19 pandemic. Further, it has been demonstrated how flexible systems can enhance resilience in low-resource environments, such as adapting to changing consumer needs and minimizing supply chain disruptions. This paper considers how the development of a flexible system for conducting a risk assessment on a product that was developed and manufactured in a Makerspace environment would have application in Pacific Island communities to improve resilience. Using a participative action research (PAR) approach, a traditional product risk assessment is refined through iterative PAR cycles to reconceptualize it into a structured simplified risk process. The resulting product development risk assessment process (PDRAP) demonstrates that it is possible to adapt a detailed systematic risk assessment process, such as hazard and operability analysis (HAZOP), to be more suitable and effective for low-resource situations requiring flexible solutions. The improved process provides greater system flexibility to empower people to develop products which may improve their resilience in an ever changing and complex world. The PDRAP process can improve product design and adaptability which assists safeguarding supply chains from system wide disruptions. With the emergence of Makerspaces in developing countries for supply chain recovery from natural disasters and a changing national strategy, the PDRAP provides communities with a low-resource approach for risk assessment to ensure the safe use of products fabricated using emerging low-volume, rapid prototyping, and manufacturing technology.

In silico model to assess thrombosis risk of TAVR with hemodynamic predictors using fluid structure interaction

Abstract The promising results of transcatheter aortic valve replacement (TAVR) over the past two decades indicate an expansion of the patient cohort toward patients with intermediate or low surgical risk. Since some complications of TAVR have already been minimized, subclinical leaflet thrombosis (SLT) has gained importance in recent years. SLT is manifested by a thrombotic layer on the prosthetic leaflets that gradually reduces leaflet motion. The resulting decrease in functionality of the TAVR causes a need for re-intervention. The origin of SLT and approaches to prevent SLT are still unexplored. For this reason, we have developed an in silicomodel that can be used during the design development process of TAVR devices to estimate the thrombosis risk of the implant. Based on passive scalar transport, hemodynamic metrics are used to quantify platelet activation and aggregation which are associated with the formation of thrombosis. In conjunction with a numerical simulation model considering the fluid-structure interaction between the blood mimicking fluid and the TAVR implanted in an aortic root, the thrombosis risk can be modeled. The simulation model can be used to calculate the three-dimensional flow structures within the native sinus and neo-sinus and also provides the ability to derive metrics to assess the risk of thrombosis. We demonstrated that this in silicomodel is a time-effective tool to assess thrombosis risk in TAVR product development.

Automated High-Throughput Matrix Assisted Laser Desorption Ionization Mass Spectrometry Methodology for Formulation Assessment of Polyethylene-Glycol-Conjugated Cytokine Proteins

Biological therapeutics are major contributors to the pharmaceutical pipeline and continue to grow in sales and scope. Additionally, the field's understanding of cancer biology has advanced such that biopharmaceuticals can harness the power of the immune system for oncology treatments. Several of these novel therapeutics are engineered versions of naturally occurring proteins designed to improve therapeutic properties including potency, target engagement and half-life extension. Cytokines, such as interferons and interleukins, are a broad class of signaling proteins which modulate the body's immune response; engineered cytokines have entered the clinic as promising new immuno-oncology therapies. While these therapies hold great promise, their additional structural complexity introduces analytical challenges, and traditional analytical platforms may be ill-suited to effectively assess product development risks. Further, the pharmaceutical industry relies on streamlining approaches for high-throughput experimentation to achieve speed and efficiency for the discovery and development of new modalities. These demands necessitate the use of state-of-the-art techniques to rapidly characterize these new modalities and guide process development and optimization. Matrix Assisted Laser Desorption Ionization Mass Spectrometry (MALDI-MS) is a rapid, sensitive and automatable technique amenable for high-throughput analysis of proteins. In this work, we have developed an automated MALDI-MS platform to prepare, acquire and analyze molecular degradation in engineered PEGylated cytokines formulation samples. This orthogonal technique integrated seamlessly with current developability risk assessment workflows, ultimately enabling selection of a final formulation strategy for clinical development.

Grey-Markov model of user demands prediction based on online reviews

Users have higher demands on product with the developing e-commerce and the increasing online shopping. Enterprises must design products that meet user demands accurately and quickly to improve user satisfaction and increase product competitiveness. In the face of ever-changing user demands, enterprises need to predict the changing trend of user demands, so as to design products more in line with user demands and reduce the market risk of new product development. Therefore, this paper proposes a Grey-Markov model of user demands prediction based on online reviews for enterprises to predict the monthly changing trend of user demands in advance. Firstly, LDA topic model and sentiment analysis are used to get user attention values and user satisfaction values. Secondly, The Grey-Markov model of user demands prediction was established. According to two dimensions of the attention and satisfaction of user demands, the values of user demands are predicted, and the division of user demand improvement sequence is used to balance the scheme of product optimisation. Finally, taking the demand prediction and optimisation design of smartphones and automobiles for examples to illustrate the effectiveness of the proposed method and to provide a reference for manufacturing enterprises to optimise product design.

Agricultural Insurance in the Philippines: Innovative Product Development and Scale-Up Amid Climate Risks and Other Hazards

The Philippines, an archipelago situated in the Pacific Ring of Fire and the typhoon belt, is highly vulnerable to natural disasters. The continued global warming experienced in the country in the past years shows a trend of climate changes that have caused casualties and losses in agriculture and properties. One of the solutions to address the negative effects of climate change is agricultural insurance. The Philippine Crop Insurance Corporation (PCIC) is a government institution that has served as the country’s sole provider of traditional crop insurance since 1981. However, because of PCIC’s limited resources, the private sector’s participation in the agricultural insurance business is necessary to increase the number of farmers, fisherfolk, and other stakeholders protected with insurance. The issuance of rules and regulations for private agricultural insurance operations and the formation of a Public-Private Partnership composed of the PCIC and private insurance companies are vital strategies to scale-up agricultural insurance business in the country. Further, to improve the agricultural insurance program, innovative/index-based agricultural insurance products, such as Weather Index-Based Insurance (WIBI) and Area-Based Yield Index Insurance (ARBY), have been developed and piloted with funding from donor agencies. New products such as the Yield Insurance Products for High-Value Crops (a hybrid of traditional, ARBY, and WIBI schemes), initially for coconut, coffee, and cacao crops could enable the PCIC and private insurers to provide insurance services at lesser loss adjustment cost and with a faster settlement of claims. Challenges to a successful and sustainable implementation of the new products need to be met, namely the (1) development of the required data infrastructure; (2) acquisition of advanced weather equipment and technologies for crop modeling and experimentation; and (3) collaboration with government research institutions and state colleges and universities to undertake science-based modeling and experimentation for the development of various weather indices/parametric for crops, fisheries/aquaculture, and livestock. Further measures to strengthen the existing agricultural insurance program include (1) integrating plans for agricultural insurance in the development and implementation plans of all concerned government institutions involved in agriculture, fisheries, and forestry sectors and (2) organizing small farmers and fisherfolk to undertake collective farming and business activities as they cannot cope with rapid changes in climate on their own that affect their livelihood.

On the Nature of Over Featuring in the New Product Development Process

The tendency to develop new products and services beyond what is required by market, users, plans, and the resources in the organization ranks at top 10 of risks of new product development (NPD) failures. However, scholars and practitioners devoted limited attention to it. Many terms are used to outline the excesses in product development, such as Feature Creep, Feature Fatigue, Overdesign, Overspecification, Over-requirement, Scope Creep, and Gold-Plating, among the others. Excessive development configures in various forms that can be grouped inside the name of “Over Featuring” (OVF). Nevertheless, a terminological and conceptual confusion exist inside the realm of OVF together with a lack of theoretical development, and a limited investigation of the causes, the drivers, and the performance effects of BPs. The present paper presents an overview of OVF phenomenon, the evolution of the concept over time, together with an integrative review of findings emerged from the available empirical studies about OVF on the NPD projects. In doing so, a theoretical and conceptual development of OVF is proposed to clarify and advance such a multifaced phenomenon. OVF is also explored inside the most common NPD frameworks, namely Stage-Gate and Agile.

Risk Management of New Cosmetic Product Development Based on Data Management of Visualization in Scientific Computing

With the continuous development of the social economy, people pay more and more attention to their own protection and maintenance, especially the quality of commodities in terms of usage of the commodity. As commonly used commodities, the quality of their new products in cosmetics is extremely important. In the rapidly developing cosmetics industry, in view of these needs and limitations, the data management method of visualization in scientific computing is introduced in this paper. Multiple risk factors in cosmetics development are established and sorted from the three perspectives of cosmetics development, production, and sales, by combining the new cosmetic product development process. The biggest risks are clarified, the corresponding cosmetic product risk assessment model is constructed, and the new cosmetic product development risk strategy and related management are realized. The simulation experiment results show that the data management method of visualization in scientific computing is effective and can support the risk management of new cosmetic product development.

Related and unrelated product diversification and collaboration strategies: Comparison between the pharmaceutical and biopharmaceutical industries

AbstractIn pharmaceutical and biopharmaceutical industries, developing and commercializing products require great investments and intensive clinical trials. With regard to managing the risk and uncertainty of such product development, especially given the low success rates, product diversification and collaboration strategies can be instrumental for firms. Especially, the differences in product development complexity and market condition among industries require more case‐specific implications due to the absence of a universally applicable strategy, even in these two similar industries. To date, little is known or discussed regarding whether product diversification and collaboration strategies work differently by industry and to what extent their impact differs across industries. Accordingly, this study examines the impact of product diversification on firm performance and compares the diversification effects between the pharmaceutical and biopharmaceutical industries. Related product diversification (RPD), which involves diversifying existing product functions, and unrelated product diversification (UPD), which involves diversifying the selling market, are considered here, and their linear and curvilinear effects are examined for each industry. Furthermore, the mediating role of product diversification in the relationship between collaboration and performance is examined to explore diversification through collaboration and the effect of collaboration on firm performance. For empirical analysis, an integrated firm‐level dataset combining a full set of commercialized product information, collaboration, and statistics from Medtrack and Compustat are used. The results indicate that RPD enhances pharmaceutical firms' performance, while RPD and UPD contribute to biopharmaceutical firms' performance. In both cases, mediating effect of product diversification is found; however, collaboration is found to play different roles, thereby showing that collaboration enhances product diversification for pharmaceutical firms, while for biopharmaceutical firms it negatively affects product diversification, but positively affects performance. This study contributes to the literature by providing empirical evidence on how diversification should be treated differently across industries by considering product development complexity and market maturity.

Improvement of Risk Management Process in Space Product Development Through its Continuous Integration

Relevance. Nowadays, enterprises not only have to constantly introduce new products, but also to reduce development time, reduce costs, and improve the variety and quality of their products. In the product development process, risk management is too often underutilized and relegated to the background compared to product development planning and monitoring tools. Moreover, the measurement of process performance of risk management within product development is not defined and does not allow for comparison with peers or support continuous process improvement.The purpose of the study is to provide a framework for improving the risk management process performance in space product development. So that risk managers have the proper tools to monitor and understand where resources and efforts should be directed to improve the process.Results. This article identifies how to represent risk in product development and how to measure its impact on the performance of the risk management process in product development. Through a survey of key players in the Russian space industry, the study identifies different practices and needs in risk management, product development and performance measurement of these processes.Methods. Theoretical research methods: analysis, synthesis, classification, comparison, abstraction, generalization, modeling. Empirical method — survey: questionnaire survey. The key contribution of this study (to limit the usual delays and cost overruns in the space industry) is to establish specific characteristics and methods that can serve as a reference practice and basis for the future development of a tool that will assist in the evaluation of space development projects.

Globalised Adoption of Knowledge Management in New Product Development: A Conceptual Framework from Project Management Perspective

The growth in new knowledge and technology has substantially increased the complexity of the projects that is strongly influencing the time, cost, and quality of the project management. Due to the volatility of the current market, the effectiveness of knowledge management (KM) could reduce the project uncertainties, project life cycle costs, and risks of new product development (NPD). Since NPD is regarded as the key to innovation due to its strong connection between the knowledge and core competence, the ways how the knowledge will be captured, created, and shared among the project teams is important to remain competitive in today's business and market competition. Hence, the modes of how they are created and shared between the project team members as well as the impact of KM towards NPD will be discussed in this paper. KM are normally created and transferred through the conversion between explicit and tacit knowledge, which can be further applied into the project management. Furthermore, the existing knowledge of the organisation can be evaluated by the actions of decision makers, hence, it is undoubted that a better knowledge can lead to measurable efficiencies in production and product development. The key success factors of KM that have been implemented will be discussed in this paper as well, which help to increase the probability of project success. Keywords: New Product Development; Project Management; Knowledge Management; Globalisation

Globalized Adoption of Knowledge Management in New Product Development: A Conceptual Framework

Objective - The article presents the concept between the relationship of knowledge management adoption in global new product development. The growth in new knowledge and technology has substantially increased the complexity of the projects that is strongly influencing the time, cost, and quality of the project management. Due to the volatility of the current market, the effectiveness of knowledge management could reduce the project uncertainties, project life cycle costs, and risks of new product development. Since new product development is regarded as the key to innovation due to its strong connection between the knowledge and core competence, the ways how the knowledge will be captured, created, and shared among the project teams is important to remain competitive in today's business and market competition. Hence, the modes of how they are created and shared between the project team members as well as the impact of knowledge management towards new product development will be discussed in this paper. knowledge management are normally created and transferred through the conversion between explicit and tacit knowledge, which can be further applied into the project management. Methodology/Technique - The paper embarks a conceptual review of present literatures which specifically address the perspectives of project management, and simultaneously explains the relationship between the knowledge management (namely knowledge creation, knowledge sharing, knowledge utilization and key success factor) and new product development. Finding - This research ascertains the conceptual framework that relate to knowledge management and new product development that contribute to increase the probability of project success in project management. Novelty - Present study aims to shed light on the existing knowledge of the organization can be evaluated by the actions of decision makers and introduce a conceptual framework that a better knowledge can lead to measurable efficiencies in production and product development. Type of Paper - Review Keywords: New product development; project management; knowledge management; globalization; competitiveness. JEL Classification: M11, O32

Systems Engineering and DevSecOps: Reviewing the Principles

ABSTRACTAs software engineering adopts a more continuous delivery mode for embedded and complex systems, systems engineering must adapt and influence DevSecOps and related practices. In this article, I revisit agile, lean, and DevSecOps principles and comment on their interactions, focusing on those that may increase product and system development, deployment, and evolution risk, and those that increase improvement opportunities through productive engagement across the two disciplines. This material is also available as a Software Engineering Institute Blog Post from 15 March 2021 [https://insights.sei.cmu.edu/blog/comparing-devsec-ops-and-systems-engineering-principles/.]

Towards understanding dynamic design change propagation in complex product development via complex network approach

Design change propagation is a primary source of risk and innovation in complex product (CP) development. Soundly predicting and managing the design change propagation have become critical issues. Dynamicity is the non-negligible nature of design change propagation. However, existing specific case studies and static predicting methods are inadequate to analyze the dynamicity quantitatively. Here, a general model based on complex network is developed to depict the dynamic design change propagation. Numerical simulations are conducted to explore the general law of the propagation and investigate the influences of design change tolerance capacity distribution (), attack strategies, and recovery capacity (). The results show that the model can well portray the real design change propagations. The dynamic design change propagation can be controlled by adjusting the parameter , , and . A new indicator is proposed to represent the robustness of the CP network, which is negatively related to β and positively related to γ. The influences of attack strategies and recovery capacity decrease with the increase of β. The cost-effective trade-off criteria to conclude the design change propagation within limited time are provided. This paper provides a basic framework to understand the dynamic design change propagation in CP development.

A case study on FMEA-based improvement for managing new product development risk

PurposeThe purpose of this paper is to explore the applicability of the failure mode and effects analysis (FMEA) as an effective tool for decreasing failure risk in the early phase of the new product development (NPD), which adds to existing literature on the application of FMEA in NPD.Design/methodology/approachThrough the application of action research (AR) methodology, it was possible to develop a case study examining the use of FMEA to decrease NPD risk in an early phase of NPD execution.FindingsThe importance and immediate gains of identifying NPD failures support FMEA's usefulness for NPD risk decrease. Moreover, its user-friendliness, timeliness and cost advantages facilitate the introduction of FMEA in the early phase of NPD execution.Originality/valueFMEA is a well-known method used in manufacturing companies to identify and correct failures in products, processes and systems. This article explores the lack of practice-oriented evidence on the use of FMEA in the early phase of NPD execution and provides support to its applicability and effectiveness.

USING CROWDFUNDING AS PART OF THE PRODUCT DEVELOPMENT PROCESS

AbstractCrowdfunding is the process of taking a project in need of investment and asking a large group of people to supply the investment. It allows organisations to sell their product before production, reducing the risk of new product development. Organisations such as Tesla and General Electric have used crowdfunding successfully but crowdfunding is yet to be explored as part of a formalised product development framework. This paper includes the business case for commercialising new products with crowdfunding and presents crowdfunding as part of a product development and commercialisation framework.