Early Product Development Research Articles

A Virtual Reality Assembly Assessment Benchmark for Measuring VR Performance & Limitations

With an increasing product complexity in manufacturing industry, virtual reality (VR) offers the possibility to immersively assess assembly processes already in early product development stages. Within production validation phases, engineers visually assess product part assembly and interactively validate corresponding production processes. Nevertheless, by now research does not give answers on how VR assembly system’s performance can be measured with respect to its technical limitations. The proposed Virtual Reality Assembly Assessment (VR2A) benchmark is an open, standardized experiment design for evaluating the overall VR assembly assessment performance in terms of sizes and clearances instead of measuring single technical impact factors within the interaction cycle, such as tracking, rendering and visualization limitations. VR2A benchmark focusses on the overall production engineer’s assessment objective generating quantifiable metrics. Using VR2A, users gain practical insights on their overall VR assessment system’s performance and limitations. An in-depth evaluation with production engineers (N=32) revealed, that negative clearances can be detected more easily than positive ones, part sizes directly correlate with the assessment performance. Additionally, the evaluation showed that VR2A is easy to use, universally usable and generates objective insights on the applied VR system.

The Development of Authentic Assessment Instrument to Measure Science Process Skill and Achievement based on Students' Performance

This study aims to develop an authentic assessment instrument based on students' performance. It can build the science process skill and measure the cognitive aspects of student’s achievement. The procedure of research & development method is adapted from Borg and Gall’s model, consisting collecting information, planning, early product development, preliminary field testing, first product revision, field testing, second product revision, and dissemination. The initial field testing was executed to 15 participants, and the field testing to 31 participants in MAN III Yogyakarta use the One – Shot Case Study model. The results of the study as follows: (1) instruments according to the experts' judgment, physics teachers and peers, in general, was valid, (2) instruments at the preliminary field test and main field test was reliable, and (3) instruments could build skills and measure cognitive achievement’s aspect of the scientific process skills of the senior high-school students for heat and temperature topic.

Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model

Topical ophthalmic drugs are the most commonly used dosage form to treat diseases of the anterior segment of the eye. Although this dosage form has the advantages of ease of application, small volume dose, and rapid action and is largely devoid of systemic adverse effects, the bioavailability is low due to pre-corneal anatomical barriers and the nature of the drug formulation itself. Some complex generic formulations (suspensions, ointments, gels) for topical ophthalmic products face impediments to rapid regulatory approval because of the complex nature of the formulations and difficulties in determining bioequivalence with the innovator product. Clinical endpoint bioequivalence studies of ophthalmic products in humans are challenging due to inaccessibility of internal compartments of eye, large inter-subject variability that reduces study sensitivity, patient safety issues, and the prohibitively high costs of these types of clinical studies. Because of its ocular anatomical similarity to human eye, rabbits are frequently used as a model in early product development. Generating appropriate animal model data can inform physiological-based pharmacokinetic (PBPK) model building that might eventually replace the need for extensive, expensive preclinical and clinical testing. Little detail was found in the existing literature on sampling and bioanalytical protocols for determining drug concentration in different compartments of fresh eye tissues. This study describes in detail a sampling protocol for evaluating dexamethasone concentration in different tissues of freshly harvested eyes using TobraDex ST topical ophthalmic drug product in a rabbit model.

HIV Antiretroviral Pre-Exposure Prophylaxis: Development Challenges and Pipeline Promise.

The US Food and Drug Administration (FDA) approved oral daily tenofovir/emtricitabine (Truvada) for pre-exposure prophylaxis of human immunodeficiency virus (HIV) infection in 2012 on the basis of two randomized controlled trials (RCTs), one in men who have sex with men (MSM) and another in HIV serodiscordant heterosexual couples. Subsequently, even greater efficacy has been demonstrated in MSM with rapid population-level incidence reductions in some locations. In contrast, studies of antiretroviral pre-exposure prophylaxis (PrEP) in heterosexual women showed only modest or no efficacy, largely attributed to low adherence. The mixed results of antiretroviral-based PrEP bear witness to unique drug development challenges at this complicated intersection of sexual behavior, public health, and drug development. Multiple innovative methods and formulation strategies followed to address unmet medical needs of persons struggling with daily oral PrEP adherence or preference for nonsystemic PrEP options. Clinical pharmacology plays essential roles throughout this PrEP development process, especially in early product development and through pharmacologically informed enhancement and interpretation of clinical trials.

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME).

This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line monitoring system. A sequential design of experiments (DoE) (screening, optimisation and verification) was used to gain process understanding for the manufacture of piroxicam (PRX)/Kollidon® VA64 amorphous solid dispersions. The influence of die temperature, screw speed, solid feed rate and PRX concentration on the critical quality attributes (CQAs) absorbance and lightness of color (L*) of the extrudates was investigated using multivariate tools. Statistical analysis results show interaction effects between concentration and temperature on absorbance and L* values. Solid feed rate has a significant effect on absorbance only and screw speed showed least impact on both responses for the screening design. The optimum HME process conditions were confirmed by 4 independent studies to be 20% w/w of PRX, temperature 140 °C, screw speed 200 rpm and feed rate 6 g/min. The in-line UV-Vis system was used to assess the solubility of PRX in Kollidon® VA64 by measuring absorbance and L* values from 230 to 700 nm. Oversaturation was observed for PRX concentrations higher than 20% w/w. Oversaturation can be readily identified as it causes scattering in the visible range. This is observed by a shift of the baseline in the visible part of the spectrum. Extrudate samples were analyzed for degradation using off-line High-Performance Liquid Chromatography (HPLC) standard methods. Results from off-line experiments using differential scanning calorimetry (DSC), and X-ray diffraction (XRD) are also presented.

A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes

In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100 raw material descriptors related to particle size and shape distribution, specific surface area, bulk, tapped and true density, compressibility, electrostatic charge, moisture content, hygroscopicity, permeability, flowability and wall friction. Principal component analysis (PCA) was applied to reveal similarities and dissimilarities between materials and to identify overarching properties. The developed PCA model allows to rationalize the number of critical characterization techniques in routine characterization and to identify surrogates for use during early drug product development stages when limited amounts of active pharmaceutical ingredients are available. Additionally, the developed database will be the basis to build predictive models for in silico process and formulation development based on (a selection of) property descriptors.

Impact of blend properties on die filling during tableting

Based on characterization of a wide range of fillers and APIs, thirty divergent blends were composed and subsequently compressed on a rotary tablet press, varying paddle speed and turret speed. The tablet weight variability was determined of 20 grab samples consisting of each 20 tablets. Additionally, the bulk residence time, ejection force, pre-compression displacement, main compression force, die fill fraction and feed frame fill fraction were determined during each run. Multivariate data analysis was applied to investigate the relation between the process parameters, blend characteristics, product and process responses. Blends with metoprolol tartrate as API showed high ejection forces. This behavior could be linked to the high wall friction value of metoprolol tartrate. The main responses related to the die filling could be predicted via a PLS model based on blend characteristics. Tablet weight variability was highly correlated with the variability on pre-compression displacement and main compression force. A good predictive model for tablet weight variability was obtained taking the porosity, wall friction angle, flowability, density, compressibility and permeability into account. Additionally, turret speed and paddle speed were included in the calibration of the model. The applied approach can save resources (material, time) during early drug product development.

Perspectives of South African youth in the development of an implant for HIV prevention.

IntroductionImplants are a new dosage form in development for HIV pre‐exposure prophylaxis (PrEP) with potential for high adherence given that they are provider‐administered and are intended for long‐acting protection. Integrating end‐user preference into early stage product development may further overcome challenges with future product uptake and adherence. Hence, we sought to optimize the design of a PrEP implant in early‐stage development by gathering opinions about implant attributes from potential end‐users in South Africa.MethodsWe conducted 14 focus group discussions (FGDs) with young women and men aged 18 to 24 in Cape Town and Soshanguve, South Africa, inviting participants into discussion as co‐designers. FGDs were homogenous by gender and previous implant experience. During FGDs, we showed prototype devices and followed a semi‐structured guide with questions on history of contraceptive implant use, preferences for physical characteristics of an implant, implant biodegradability, insertion process, participant‐driven ideas for implant design, and social adoption considerations. FGDs were facilitated in English, isiXhosa, Tswana, isiZulu, or Tsonga, audio‐recorded, transcribed into English, and qualitatively coded and analysed.ResultsIn this qualitative sample of 105 youth (68 women and 37 men), 58 participants were from Soshanguve and 47 from Cape Town, and 23% had previously used contraceptive implants. Participants expressed preferences for several implant design features; specifically, longer duration (≥6 months) was more important to most participants than the size or number of devices implanted. A majority preferred a flexible versus stiff implant to minimize palpability, thereby increasing discreetness and comfort. Nearly all participants favoured a biodegradable implant to avoid removal and thus reduce clinic visits. Concerns about the implant centred on its possible side effects and the “plastic” look of the prototype displayed for demonstration.ConclusionsThis study offers preliminary insights into an implant for HIV prevention that provides long‐lasting protection may be well received among young South Africans. Additionally, flexibility, discreetness, and biodegradability may increase acceptability of the implant. Such end–user feedback is being incorporated into current implant designs in the hope of creating an effective long‐acting PrEP product that is likely to achieve high uptake and adherence in target populations.

Development Of Ultrasonic Testing Based On Delphi Program As A Learning Media In The Welding Material Study Of Detection And Welding Disables In The Environment Of Vocational Education

The development of science and technology has a direct impact on the preparation of qualified workers, including the preparation of vocational high school graduates. Law Number 20 the Year 2003 on National Education System explains that the purpose of vocational education is to prepare learners to be ready to work in certain fields. One of the learning materials in Vocational High School is welding and detecting welding defects. Introduction of welding and detecting welding defects, one way that can be done is by ultrasonic testing will be very difficult if only capitalize the book only. Therefore this study aims to adopt ultrasonic testing in a computer system. This system is called Delphi Program-based Ultrasonic Testing Expert System. This system is used to determine the classification and type of welding defects of the welded defect indicator knew. In addition to the system, there is a brief explanation of the notion of ultrasonic testing, calibration procedures and inspection procedures ultrasonic testing. In this system, ultrasonic input data testing that shows defects entered into the computer manually. This system is built using Delphi 7 software and Into Set Up Compiler as an installer. The method used in this research is Research and Development (R & D), with the following stages: (1) preliminary research; (2) manufacture of software design; (3) materials collection; (4) early product development; (5) validation of instructional media experts; (6) product analysis and revision; (8) media trials in learning; And (9) result of end product of instructional media. The result of the research shows that: (1) the result of feasibility test according to ultrasonic material testing expert that the system is feasible to be used as instructional media in welding material subject and welding defect detection in vocational education environment, because it contains an explanation about detection method of welding defect using method Ultrasonic testing in detail; (2) feasibility test results according to media experts, that this system has a very attractive visual, user friendly, compatible with windows and Linux and media size that is not too large; And (3) result of test by using data of indication of welding defect in PT PAL Surabaya, obtained classification data of welding defect in accordance with calculation of welding defect classification.

Combined development and test of product-service systems in early product development stages for customized, availability-oriented business models in the capital goods industry

Availability-Oriented Product-Service Systems (AOPSS) give manufacturers of capital goods the opportunity to expand their offerings while fulfilling the customers’ needs for product availability. In turn, they generate special requirements for the early product development phase. Condition monitoring has to be taken into account, which results in a contradiction since learning-based condition monitoring approaches require large amounts of data which isn’t available in that particular stage. Techniques from model-based systems engineering allow solving problems newly arising when developing parts or products in AOPSS. The approach proposed in the paper is being illustrated based on a use case from the agricultural industry.

New animal-free concepts and test methods for developmental toxicity and peripheral neurotoxicity.

The complex toxicological fields of repeat dose organ toxicity (RDT) and developmental and reproductive toxicity (DART) still require new concepts and approaches to achieve a fully animal-free safety assessment of chemicals. One novel approach is the generation of relevant human cell types from pluripotent stem cells, and the use of such cells for the establishment of phenotypic test methods. Due to their broad endpoints, such tests capture multiple types of toxicants, i.e. they are a readout for the activation of many adverse outcome pathways (AOPs). The 2016 Lush Science Prize was awarded for the development of one such assay, the PeriTox test, which uses human peripheral neurons generated from stem cells. The assay endpoints measure various cell functions, and these give information on the potential neurotoxicity and developmental neurotoxicity hazard of test compounds. The PeriTox test method has a high predictivity and sensitivity for peripheral neurotoxicants, and thus addresses the inherent challenges in pesticide testing and drug development. Data from the test can be obtained quickly and at a relatively high-throughput, and thus, the assay has the potential to replace animal-based safety assessment during early product development or for screening potential environmental toxicants.

Product development based on design attributes

PurposeThe purpose of this paper is to demonstrate an approach to include the influence of design attributes (DA) into an early product development step. In general, the development of new products with market success is of high relevance for companies. Because of a relatively high-quality level in general, not the product quality itself but rather new issues as attributes with aesthetical values are becoming more and more important. However, the right consideration of these attributes is still one of the challenges.Design/methodology/approachThe underlying investigation is based on an empirical data set resulting from a survey with motorcycles as research object. Motorcycles are a good example for a good with a certain relevance of DA for the buying decision of customers. The data collection and analysis will focus on a recommended presentation alternative of measuring perceptions and influences through customer evaluations, separating customer segments and identifying differences. Therefore, data analysis methods such as cluster analysis will be applied.FindingsThe findings are new for researchers from a theoretical and from a practical point of view. The results verify the use of pictorial stimulus presentation and emphasize the necessary integration of DA within the product development process.Originality/valueWithin the paper the usefulness of the consideration of design elements in case of gathering customer meanings is highlighted. Therefore, existing approaches of measuring design attribute influences and using pictorial instead of verbal descriptions of stimuli are adopted and enhanced through the use of additional information of the respondents.

Environmental Impact Evaluations on Product Design Alternatives Using the Combined Evidential Reasoning with Fuzzy Set

Owing to the rise of societal awareness and hence governmental quest for environmental conservation worldwide, environmental friendliness in products has become a critical design consideration for all manufacturers during new product development. Life Cycle Assessment (LCA) is a comprehensive method to quantitatively assess the environmental burdens of products or services. However, such studies are difficult to carry out at the early product development process because of uncertain or limited product information. Also, LCA is a time and resource-consuming methodology. This paper proposes a shortcut approach to support product designers to carry out the environmental impact evaluations especially in the initial product development stage. This paper discusses the key challenges of implementing environmental impact evaluation in new product development. The combined Evidential Reasoning (ER) and Fuzzy Set Theory (FST) approach is applied to handle the uncertain information of the environmental data and deficiency of LCA. The result demonstrates the superiority of the combined ER and FST for evaluating several design alternatives while the uncertain information has been considered.

Increasing the efficiency of designing hemming processes by using an element-based metamodel approach

In the automotive industry, the manufacturing of automotive outer panels requires hemming processes in which two sheet metal parts are joined together by bending the flange of the outer part over the inner part. Because of decreasing development times and the steadily growing number of vehicle derivatives, an efficient digital product and process validation is necessary. Commonly used simulations, which are based on the finite element method, demand significant modelling effort, which results in disadvantages especially in the early product development phase. To increase the efficiency of designing hemming processes this paper presents a hemming-specific metamodel approach. The approach includes a part analysis in which the outline of the automotive outer panels is initially split into individual segments. By doing a para-metrization of each of the segments and assigning basic geometric shapes, the outline of the part is approximated. Based on this, the hemming parameters such as flange length, roll-in, wrinkling and plastic strains are calculated for each of the geometric basic shapes by performing a meta-model-based segmental product validation. The metamodel is based on an element similar formulation that includes a reference dataset of various geometric basic shapes. A random automotive outer panel can now be analysed and optimized based on the hemming-specific database. By implementing this approach into a planning system, an efficient optimization of designing hemming processes will be enabled. Furthermore, valuable time and cost benefits can be realized in a vehicle’s development process.

Critical success factors in early new product development: a review and a conceptual model

The literature on the front end in the New Product Development (NPD) literature is fragmented with respect to the identification and analysis of the factors that are critical to successful product development. The article has a two-fold purpose. First, it describes, analyses, and synthesizes those factors through a literature review of the research on the front end in NPD. Second, it conceptualizes a framework that features two types of success factors: foundational success factors (common to all the firm’s projects) and project-specific success factors (appropriate for the firm’s individual projects). The article makes recommendations for the management of this important phase of product development, discusses limitations of relevant previous research, and offers suggestions for future research. The article makes a theoretical contribution with its analysis and synthesis of the reasons for success in front-end activities and a practical contribution with its conceptual framework that can be used as an analytical tool by firms and their product managers.

Pengembangan Komik Akidah Akhlak Untuk Meningkatkan Minat Baca dan Prestasi Belajar Siswa di Sekolah Dasar

Learning of aqeedah morals at the elementary school is part of the learning of Islam that directs and delivers students have a noble character. Teaching and learning in school during this time, many still rely on textbooks in the form of textbooks, although there have been several variations of the addition of illustrations but neither has a significant influence on the increase reading interest and student learning achievement. From this, appear the idea of researchers to combine an attractive performance of the comic, the plot coherent and easy to understand with textbooks tend textbook. This study aims to produce a attractive aqeedah morals comic, feasible and effective use design research and development include the steps of the research and data collection, planning, early product development, limited testing, and revision of the final product. Techniques validation performed by materials experts, media experts, and conducted limited trials to the students. The final product has different characteristics from other comics, they are : delivery of content aqeedah morals with simple language, the colors clear with animated images and material and matter comic emphasizes the cartoons.

Assessment of manual assembly complexity: a theoretical and empirical comparison of two methods

There are several theoretical methods for assessment of assembly complexity but there are few practically applicable methods. One of the methods, CompleXity Index (CXI), aims at assessing operators’ perception of manual assembly complexity in running production. Another recently developed method, Basic Assembly Complexity (CXB) is intended for predictive assessment of basic manual assembly complexity in early product and production development. Both CXI and CXB aim to improve assembly conditions for operators, reduce assembly-related errors and the costs for corrective measures as well as increase assembly quality although in different ways and at different organisational levels and life cycle stages. The purpose of this study was to compare the two methods to obtain feedback and learn from operators experience in order to develop better predictive assessment criteria. The method comparison showed that about 50% of the CXB assessment approaches were similar to CXI but other covered different aspects. In comparison of the complexity values of the methods no significant results were obtained. However, some CXI issues that were not taken into account in CXB should be considered. CXB and CXI could be used in conjunction but further assessment criteria are probably needed.

Material criticality assessment in early phases of sustainable product development

Improving structural performance of products is often realized by introducing increasingly advanced and complex materials as well as material combinations. What material to use in products is decided in the early product development phases and has a decisive impact for manufacturing, maintenance and end-of-life. A particular challenge is that the decisions need to be made upfront, where information of the forthcoming product is limited. This paper presents an early product development method to assess the criticality of alloy materials from a resource availability- and sustainability perspective. The method distinguishes itself from previous studies that focus on element criticality on a country level. The method is used to characterize and analyze the criticality of alloys in a three-step process that aims to support product design teams selecting what material alloy to use in early phases of design. It provides a proactive and systematic approach related to critical materials to avoid potential future problems on a long-term basis. The method presented has been developed in an action research-based approach in an aerospace company where a product design team validated and evaluated the material criticality method. The generic nature of the method is likely to be applicable not only to aerospace companies but also to other industries using advanced alloys. An important finding from applying the method in the company case was the clear link between long term business impact and sustainability performance.

Establishment of a Molding Procedure to Facilitate Formulation Development for Co-extrudates.

Co-extrusion offers a number of advantages over conventional manufacturing techniques. However, the setup of a co-extrusion line is cost- and time-intense and formulation development is challenging. This work introduces a novel procedure to test the applicability of a co-extruded reservoir-type system at an early product development stage. We propose vacuum compression molding (VCM), a fast procedure that requires only small material amounts, for the manufacturing of cylindrical reservoir-type system. To this end, the commercially available co-extruded product NuvaRing® and variations thereof were used as test systems. All VCM systems showed a homogeneous skin thickness that adhered well to the core, thereby providing a precise core/skin interface. As drug release is a key criterion for pharmaceutical products, a modified in vitro dissolution method was set up to test the VCM systems. The drug release from the VCM systems was in the same order of magnitude as the corresponding co-extruded strands and followed the same release kinetics. Moreover, the VCM systems were capable of indicating the relative effect of formulation-related modifications on drug release. Overall, this shows that this system is a powerful tool that facilitates formulation tailoring and co-extrusion process setup at the earliest stage.

Development and evaluation of the LittlEARS® Early Speech Production Questionnaire – LEESPQ

ObjectiveUniversal Newborn Hearing Screening programs, now instituted throughout the German-speaking countries, allow hearing loss to be detected and treated much earlier than ever before. With this earlier detection, arises the need for tools fit for assessing the very early speech and language production development of today's younger (0–18 month old) children. We have created the LittlEARS® Early Speech Production Questionnaire, with the aim of meeting this need. Methods600 questionnaires of the pilot version of the LittlEARS® Early Speech Production Questionnaire were distributed to parents via pediatricians' practices, day care centers, and personal contact. The completed questionnaires were statistically analyzed to determine their reliability, predictive accuracy, internal consistency, and to what extent gender or unilingualism influenced a child's score. Further, a norm curve was generated to plot the children's increased expected speech production ability with age. ResultsAnalysis of the data from the 352/600 returned questionnaires revealed that scores on LittlEARS® Early Speech Production Questionnaire correlate positively with a child's age, with older children scoring higher than do younger children. Further, the questionnaire has a high measuring reliability, high predictability, high unidemensionality of scale, and is not significantly gender or uni-/multilingually biased. A norm curve for expected development with age was created. ConclusionsThe LittlEARS® Early Speech Production Questionnaire (LEESPQ) is a valid tool for assessing the most important milestones in very early development of speech and language production of German language children with normal hearing aged 0–18 months old. The questionnaire is a potentially useful tool for long-term infant screening and follow-up testing and for children with normal hearing and those who would benefit from or use hearing devices.