Product Development Challenges Research Articles

Towards a method for human-centred analysis of external variety

AbstractAddressing VUCA challenges in product development, the Human-Centred Analysis of External Variety (HAV) method is introduced. Focusing on the early stages of new product development, HAV provides a structured approach, reducing uncertainty through quick market analysis, customer engagement, and goal setting. HAV is illustrated using a cargo bike product family case study and emphasizes its role in aligning human-centred methods with project goals. The first steps of the HAV method are presented, but also the need for further action towards a validated and elaborated method is discussed.

A patent text-based product conceptual design decision-making approach considering the fusion of incomplete evaluation semantic and scheme beliefs

Conceptual design evaluation is a significant challenge in product development to select suitable conceptual schemes (CS). Relying on decision makers' (DMs) personal experience for design information may result in incomplete and ambiguous evaluation semantics, creating an incomplete decision matrix. Previous approaches use attributes based on candidate schemes to complete the missing information, but neglect the mining of associated design information from external resources such as patents, reducing the beliefs objectivity after missing semantic completion. Besides, non-compensatory nature between DMs’ interactivity and criteria have not been well considered. To fill these issues, a patent text-based CS decision approach considering the fusion of incomplete semantics and scheme beliefs is proposed. First, using the beneficial effects text from patents as historical design data, constructing general evaluation criteria using the Latent Dirichlet Allocation topic model, and introducing the Apriori model to extract strong association rules between criteria to complete the incomplete semantics. Second, a fuzzy measure model for DMs is constructed based on intuitionistic fuzzy cross-entropy and Shapley value method, supporting the allocation of DMs' interactive weights. Then, the fuzzy Dempster-Shafer evidence theory is used to transform the multi-criteria decision model into a belief fusion problem of CS that avoids aggregating the evaluation semantics of non-compensatory criteria and outputting the optimal CS with interval credibility. A practical case study of an in-pipe inspection robot will be employed to validate the proposed approach, sensitivity analysis and comparison results confirmed that the complement data have the reliability to avoid continuous investment in the evaluation process.

Challenges experienced by pediatric nurses in the process of developing innovative products: A qualitative study

ObjectiveAs essential healthcare providers, nurses are key to contributing innovations to improve the quality of care. This study aimed to explore the challenges pediatric nurses face in developing and patenting innovative products. MethodA qualitative descriptive design has been used in this study. The study sample consists of pediatric nurses who had developed innovative products and successfully obtained product registrations. Purposive sampling was used to select 17 pediatric nurses who met the inclusion criteria. Data were collected through semi-structured, individual, in-depth interviews. ResultsTwo main themes and two related subthemes were identified. The first main theme is ‘product development and management challenges.’ The subthemes of this theme are ‘unknown ecosystem’ and ‘burnout.’ The second theme is ‘protecting ideas and innovation.’ The subthemes of this theme are ‘fear of idea theft’ and ‘dead patents.’ ConclusionNurses face challenges, such as taking part in an unfamiliar innovation ecosystem, burnout due to long processes, and fear of idea theft. At the same time, commercialization of these innovations and market demand emerge as additional challenges. Practice implicationsIdentifying the challenges experienced by pediatric nurses during the innovation process can help to develop strategies to overcome difficulties, create an innovation culture, and increase the quality of pediatric patient care.

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.

BIOAVAILABILITY AND POLYMORPHIC STABILITY CHALLENGES AFFECTING DRUG PRODUCT’S POTENTIAL: A CRITICAL EVALUATION AND PERTINENT SOLUTION

Clinical failure remains an ongoing challenge in pharmaceutical drug product development. Solubility and permeability therefore play a very critical role in achieving desired bioavailability and pharmacological response, which in turns affects clinical safety and efficacy significantly. The situation becomes more critical when the drug candidate exhibits polymorphism and undergoes polymorphic transformation due to its meta-stable nature. This review article outlines the available technologies, pertinent regulations, the concepts involved in the enhancement of bioavailability and polymorphic stability to overcome the clinical failures. Various available technologies for bioavailability enhancement such as salification, micronization, complexation, microemulsification, nano emulsification, cocrystal formation, and amorphous solid dispersion with their advantage and disadvantage in formulating a stable drug product containing a polymorphic and meta-stable drug substance. Thermodynamic and kinetic aspects of polymorphic transformation are discussed to understand different excipient and process-induced transformation during manufacturing and shelf life of the drug product. Selecting the right instrument from the analytical toolbox is equally important to understand the diverse nature of polymorphic transformation. This review provides state-of-the-art information available on advanced analytical tools along with their capabilities, advantages, and disadvantage with respect to physical/structural analysis of polymorphs and polymorphic transformation.

Examining Seasonality in Tourism with Special Reference to the Recent Effects of Covid-19 – The Case of the Sopron-Fertő Tourism Destination (Hungary)

Abstract Seasonality, meaning that the vast majority of tourist locations do not distribute arrivals evenly throughout the year, in tourism, it is widely regarded as one of the most crucial problems for the majority of the world’s destinations, particularly in terms of sustainability. Nevertheless, despite its importance and that this unbalanced nature has become one of tourism’s most distinguishing characteristics, we can say that no globally comparable international measurement of seasonality is currently available. Based on the abovementioned phenomena, the main objective of the present study and research is to detect and analyse the tourism seasonality of a case study area, the Sopron-Fertő destination (Hungary), using multiple methodologies such as the Gini index, a representative consumer questionnaire and expert interviews. The analysis demonstrates seasonality in tourism demand between 2008–2021, based on which implications on product development and new directions and challenges, influenced by the most recent impacts of the COVID-19 pandemic, are revealed and suggested.

The effect of the COVID-19 pandemic on US Food and Drug Administration-funded clinical trials and natural history studies for rare diseases

BackgroundSince 1983, the Orphan Product Grants Program, administered by the US Food and Drug Administration, provides funding for clinical trials and natural history studies in rare diseases. The COVID-19 pandemic created new challenges in rare disease product development. This study sought to determine the effects of the pandemic on rare disease studies using data from grantees of this program, and determine lessons learned that can potentially be applied to future trials in rare diseases. MethodsAll grants that were being funded by the Orphan Products Grants Program between March 2020 and March 2021 were included in the study. Data was gathered from grantees and described the effects of the pandemic on multiple aspects of the studies including enrollment, patient follow-up, protocol, and budget. ResultsThere were 62 grants active during the study period, and of these 54 (87%) were clinical trials and 8 (13%) were natural history studies. 94% of the grantees reported their studies being affected by the COVID-19 pandemic, and the addition of virtual capabilities was reported by 34 (55%) of grantees. ConclusionsThis study suggested two important lessons learned. First, virtual capabilities, when appropriate, can be an important component of trials because they decrease the travel burden on participants and reduce in-person risks, which should increase patient recruitment and retention. Second, building in flexibility in clinical trials is critical in the post-COVID era and could include increasing the use of multi-site trials, clinical networks, and innovative designs and collaborations to speed up trials without compromising study data.

Digital Transformation Through Service Design and Programme Management

Service design initiatives face challenges in digital product development as they navigate cross-functional teams and rigid processes. Drawing inspiration from programme management techniques used in the successful 2012 London Summer Olympics, the article below will showcase tools and methods which offer potential solutions to a service designer’s operational challenges.

A new journal dedicated to the science of sustainable food proteins

Harjinder Singh, Editor-in-Chief In the next decade, we will see a dramatic dietary shift toward more plant-based and alternative proteins. Global population growth and the dietary changes associated with rising standards of living are placing tremendous pressure on the systems that provide our proteins. How will we reconcile the creation of new protein foods that are not only sustainable but also affordable and highly nutritious? Sustainable Food Proteins (SFP) is a new international, open access, peer-reviewed journal focused on the research attempting to answer this question. The journal publishes high-quality original research articles, reviews, and opinion pieces on all aspects of the science dedicated to the advancement of sustainably derived protein foods. It covers the entire spectrum from protein sourcing to food formulations, to analytical characterization, to digestion and nutrition, and the nuanced research in between. The food industry is clamoring for knowledge on novel protein sources, structures, and functionality to inform formulations, as well as sensory information that may drive consumer perceptions. We are interested in manuscripts on these topics, as well as on novel techniques used to characterize and enhance these functionalities. For example, we are accepting papers on processing and extraction technologies, especially for edible proteins that are not sourced from traditionally farmed livestock. We welcome submissions on recombinant technologies for protein production (in bacteria, yeast, or plants) and cell culture-based production of animal protein. We also seek papers on addressing scientific challenges in food product formulations and product development using alternative protein ingredients. We welcome research on the digestibility, nutritional quality, and health impacts of alternative proteins and protein-based foods. There is currently a significant focus on protein science and innovation to transform our food system to become more environmentally sustainable. The academic community and scientists in the food industry now have a dedicated forum to showcase their important work. The editorial board of SFP is eager to share those findings in our journal and our goal is for SFP to be the leading journal where anyone interested in this burgeoning field can find cutting-edge protein research.

Opportunities and Challenges in Mechanochemical Cocrystallization toward Scaled-Up Pharmaceutical Manufacturing

Recently, pharmaceutical cocrystals have gained immense interest because of their potential to tune mechanical, pharmacokinetic, and physicochemical properties of active pharmaceutical ingredients (APIs) while keeping their therapeutic action intact. In this review, cocrystallization is raised as a viable strategy toward commercialized pharmaceutical manufacturing, where attention has been paid to solid-state cocrystal preparation methods and their opportunities and challenges in overall product and process development. A comparative study of cocrystallization in the form of mechanical energy is demonstrated with the aid of SELECT criteria to qualitatively evaluate the synthetic route selection of scalable mechanochemical cocrystallization methods. Remedies and alternatives for the challenges that arise in mechanochemical synthesis of cocrystals are presented in this review, highlighting the commercial perspectives of sustainable, eco-friendly, and less toxic mechanochemical methods.

Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.

Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.

Influence of Agility on the Innovation Capability of Organizations – A Systematic Review of Influencing Factors

The increasing dynamization of markets, changing customer requirements and unpredictable occurrences pose new challenges for product development and design. Agile methods and processes can serve as a solution to secure the innovation capability of organizations in this environment. Since the areas of agility and innovation capability of organizations have mostly been treated separately in research, this research effort is focusing at hollistically collecting success factors for agility and success factors for the innovation capability of organizations and analyzing them in detail - including collecting indicators and directional characteristics. The analyzed factors are specifically focused on the development of mechatronic products and are intended to serve as a type of library that enables organizations and researchers to understand their own situation as best as possible, select appropriate recommendations for action in a targeted manner, and track their implementation / operationalization on the basis of the corresponding indicators and characteristics. This research work thus makes a contribution to sustainably increasing innovation capability and agility of industrial organizations.

Sustainable Systemic Lightweight Design (S2LWD) - Guidance for the heuristic application of lightweight design within an integrated product development process

Apart from costs, product development is increasingly driven by environmental constraints. Particularly regarding products with moving masses, lightweight design can be an effective instrument to reduce the environmental impact of products during their use phase since it often allows for higher energy consumption in manufacturing and disposal processes. However, a serious challenge in product development is to find an optimal trade-off between the benefits for sustainability through lightweight design strategies and further sustainability principles regarding the entire life cycle, while keeping development costs and times as low as possible.Thus, this contribution introduces guidance for sustainable lightweight design that enables the efficient and effective application of methods of lightweight design while considering sustainability aspects based on product and company-specific characteristics. By asking focused questions, diverse lightweight and sustainable design methods can be effectively integrated into product development along conventional and established product development processes and paradigms (e.g., systems engineering). This leads to a minor supplemental development effort compared to the well-established processes, which however ultimately lowers the barrier to introduce lightweight and sustainable design principles by increasing knowledge transfer so that products and product generations can be systematically and successfully improved.

Analyzing current Challenges on Scaled Agile Development of Physical Products

Agile development has successfully established itself for coping with VUCA conditions on a team level. Furthermore, in developing cyber-physical systems or mechatronic products, the collaboration of multiple teams is often necessary. This necessity to scale contrasts with the paradigm of agile development from which additional challenges arise. The study examines the current challenges in scaling agile product development, characterized by scale-related challenges and physical constraints. This paper provides an empirical investigation to address these challenges. This publication shows that product development's top challenges are synchronization, coordination, resource allocation, and dependencies between different organizational units. It is determined that the challenges in the non-scaled environment also apply to scaling; however, substantial differences in their dependencies exist. Furthermore, an attempt to explain differences in scaled agile software development using comparative analysis is given. It becomes apparent that challenges such as production setup or physical limitations are non-existent.

Residential mobility boosts new product adoption

AbstractA major challenge in new product development is how to increase consumers' adoption of new offerings. Using the socio‐ecological perspective, we reveal a largely ignored but important social factor that alters consumers' new product adoption. Specifically, we propose that residential mobility—the frequency with which individuals change their residence—acts as an antecedent of new product adoption. Six studies—using different operationalizations of residential mobility—provide convergent evidence that residential mobility (vs. stability) augments new product adoption in both laboratory settings and real business settings. This effect is driven by openness to new experiences and moderated by the voluntariness of moving. Our findings add to the literature on new product adoption and residential mobility. Moreover, marketers should take residential mobility into full consideration when designing marketing strategies for new products and presenting contextual cues to activate consumers' residential mobility mindset to enhance their acceptance of new products.

Daging organik: kualitas, persepsi konsumen, dan aplikasi di Indonesia

Organic food products are currently or have even become a trend for public consumption. This paper was compiled to summarize the differences in the characteristics of organic and non-organic meat for some livestock commodities, how consumers perceive and accept organic meat products, as well as examples of applications and how to get organic certification in Indonesia. Based on the literature study that has been carried out, it is known that the character of organic meat has a meat taste that is savorier with a more chewy meat texture. Organic livestock has better quality than non-organic, especially its nutritional content which is healthy because of the essential fat content produced in meat. Consumer food choices have a huge impact on the environment. The environmental impact of organic meat is high because consumers have beliefs about environmental friendliness although it is not significant. Consumers perceive organic meat as meat that is healthy, safe, natural, delicious, expensive, environmentally friendly, and of good quality. The reason people do not consume organic meat is the low supply and high price, as well as the lack of assurance that the meat is truly organic. Several farms that have applied organic systems in Indonesia are CV Rahayu in Sigi, Central Sulawesi, TML Farm in Bogor, West Java, Bina Sarana Bakti Foundation in Bogor, West Java, PT. Wahyu Utama Group in Tuban, East Java, etc. The guarantee of organic products has been facilitated by the presence of a certification body. Several certification bodies that handle organic farming include PT Sucofindo, PT Mutuagung Lestari, INOFICE, LeSOS, BIOCert Indonesia, PT Icert Agritama Internasional, etc. Thus, producers gain market trust and consumers get product quality assurance. In the future, the organic industry has the challenges of product development and the possibility of wider market interest.

Predictive cost comparison of manufacturing technologies through analyzing generic features in part screening

The selection and interaction of different manufacturing technologies are major challenges in product development and production processes. Costs are one criterion for selecting the most suitable manufacturing technology for a component. Therefore, they must be considered for an automated technology selection in part screening approaches. These costs arise during the component manufacture, during the transport of the components to the production site, and within the factory’s assembly line. However, holistic cost data is not available at an early stage during product development. Hence, these information gaps must be filled to ensure the correct selection of a component’s manufacturing technology. This paper first analyzes the cost data of past product developments regarding potential differences between manufacturing technologies. Abstracted geometric part information and production-related aspects are derived and predicted to serve as input features for the subsequent cost prediction. These AI-based cost prediction models are trained for relevant cost types along the part’s lifecycle. The most capable prediction models are combined into a manufacturing technology-dependent cost analysis of the components. Based on that, the forecasted costs of different manufacturing scenarios represent one input for the overarching part screening methodology to select the most suitable manufacturing technology for each component.

A Study on the Influence of Natural Agents on the Absorption Properties of Cotton Fabrics – Part Two

Abstract Increased worldwide competition in textiles has given opportunities to researchers and industries to work toward new challenges in product development. This research work aims to investigate how the herbal extract-treated cotton fabrics were made with a focus on the absorption properties. The treated fabric samples were analyzed for their static absorption (%), immersion time (s), surface water absorption (mL), and vertical wicking height (cm). The mangosteen dyed cotton fabrics with specifications of 140 g/m2 and the plain weave with 40 % dyed concentration and untreated cotton fabrics had static water absorptions of 320 % and 328 %, immersion times of 1.68 s and 1.65 sec, surface water absorptions of 17 ml and 18.1 ml, and vertical wicking heights of 4 cm and 4.9 cm, respectively. Water repellency properties had slight changes for treated terry fabrics say 220 and 240 GSM with rating ‘50’ in adjacent to the untreated fabric sample with rating ‘0’. Water repellency results indicated that there was no characteristic change in the water response property (i.e., water absorption) of herbal extract-treated samples. Mangosteen and orange extracts-treated cotton fabrics of 140 and 240 g/m2 with a 30 % dye concentration showed better water absorption properties in comparison to the other herbal extract dyed samples.

Fundamental Aspects of Lipid-Based Excipients in Lipid-Based Product Development.

Poor aqueous solubility of drugs is still a foremost challenge in pharmaceutical product development. The use of lipids in designing formulations provides an opportunity to enhance the aqueous solubility and consequently bioavailability of drugs. Pre-dissolution of drugs in lipids, surfactants, or mixtures of lipid excipients and surfactants eliminate the dissolution/dissolving step, which is likely to be the rate-limiting factor for oral absorption of poorly water-soluble drugs. In this review, we exhaustively summarize the lipids excipients in relation to their classification, absorption mechanisms, and lipid-based product development. Methodologies utilized for the preparation of solid and semi-solid lipid formulations, applications, phase behaviour, and regulatory perspective of lipid excipients are discussed.

A Contribution to Sustainable Product Development Using the Example of Battery Electric Vehicles

Currently, a consensus in the scientific community can be observed that it is necessary to reduce the carbon footprint and the use of fossil resources in order to ensure the ongoing well-being of humanity and our planet. Battery electric vehicles (BEVs) can contribute to this reduction, as they can use energy from sustainable sources as well as store it in order to enable individual mobility. Still, as long as sustainable energy is not available in abundance and a share of our energy still is generated using fossil sources, it is important to consider the energy consumption of these BEVs in greater detail. BEVs may actually consume more energy than necessary due to an architecture borrowed from non-BEVs, due to their drive-train topology, due to many individual product development issues and last but not least because they are not operated at their highest efficiency. This paper addresses the evaluation of a specific sustainable product development process for BEVs. The study is based on detailed energy consumption simulations of smaller BEVs with different drive train technologies. A general consideration of sustainability and utility based on the design choices, as well as of societal consequences, leads to requirements and challenges for sustainable product development. A digital product development process is described, which addresses these challenges.