A Multilevel Framework for Lean Product Development System Design

Abstract:

Organizations today face intense and growing pressure to reduce cost, decrease time to market, and maximize stakeholder value in product development (PD). Many organizations have adopted lean product development (LPD) methods in an attempt to improve their PD systems; however, despite two decades of research, there is still much less understanding of the characteristics of effective LPD systems than of effective lean manufacturing systems. LPD systems are complex systems involving multiple organizational levels; however, most LPD research to date has focused only on a single level. There is currently a lack of understanding of the interactions between levels and effective means for managing these interactions. In this article, we propose a multilevel framework designed to capture key LPD system principles at the functional, project, and portfolio levels; tools and practices for implementing principles at each level; and approaches for managing the interactions between levels. A longitudinal case study is used to expand and refine a conceptual framework developed through literature review. Future research should focus on further validating the framework and applying the framework to improve LPD system design.     

Rapid System Development (RSD) Methodologies: Proposing a Selection Framework

Abstract:

The current global customer trend requires companies across domains to reduce their product development lifecycle. As a result the exploration of methodologies that will support rapid system development has been gaining importance. The primary focus of this article is to provide a framework for comparative analysis of rapid system development methodologies. The purpose of this framework is to help the project managers and systems engineers choose and tailor an appropriate rapid development methodology to suit their development context and environment. Toward this, the framework identifies and defines a set of critical rapid development attributes. The article redefines rapid system development as adopting methodologies, tools, and techniques that can introduce rapidity into the system development processes while optimizing the success factors of development. The success factors are specific to the system under development and they depend on the system, product line, organization, and customers. Some of the common success factors are return-on-investment (ROI), cost of ownership, other performance factors, and customer satisfaction. The article provides a fundamental discussion on the current rapid system development methodologies, metrics, tools, and techniques.     

Improving the NPD Process by Applying Lean Principles: A Case Study

Abstract:

This article extends the new product development (NPD) literature by presenting a case study of a lean product development (LPD) transformation framework implemented at a U.S. based manufacturing firm. In a departure from typical LPD methods, in this article the design structure matrix and the cause and effect matrix are integrated into the lean transformation framework, allowing analysis of the underlying complexity of a product development (PD) system, and thus facilitating determination of the root causes of wasteful reworks. Several strategies to transform the current PD process into a lean process are discussed. Besides the two-phase improvement plan, a new organizational structure roadmap and a human resources plan are also suggested to support the recommended changes in the NPD process. The results of the first phase show a 32% reduction in PD cycle time due to the proposed NPD process. The article concludes with lessons learned and implications for engineering managers based on the case study.     

Fast-Cycle Product Development

ABSTRACT

In today's highly competitive industrial environment, those who are slow in bringing new products to market often lose out to those with a more agile development process. Developing products quickly while maintaining cost and quality demands a distinctive management approach that integrates marketing, engineering, manufacturing, and other activities. This article discusses the importance of development speed relative to the product's cost, performance, and development expense, and it suggests ways in which a company can cut development time. Topics covered include top management involvement; product objectives and complexity, team composition and leadership; communication vehicles, including the product specification; prototyping and testing; and control systems, such as design reviews.     

Post-Certification Engineering Taxonomy and Task Value Optimization in the Aerospace Industry

Abstract:

This article proposes a novel taxonomy of post-certification engineering activities as a first step toward true lean product development (PD). Relying on key notions developed in a novel lean engineering performance model, the authors compare the leanness of post-certification versus pre-certification tasks for the design of aerospace parts. Discrete event simulation and integer linear programming models are developed to help ascertain the influence of factors such as multitasking, concurrency, task size, task value, and post-certification budget decision making on lean engineering PD performance. The models developed provide the foundation for enhanced PD performance and the establishment of optimal PD process parameters.     

Process Uncertainty: A New Dimension for New Product Development

Abstract

Companies pursuing product leadership continually push products into innovative technology areas and new unknown markets. As companies continue to strive for continuous innovation, often leapfrogging even their own technology, new product development (NPD) processes play an increasingly important role in defining the success or failure of many new innovations. In addition, increased competitive rivalry is driving companies to commercialize their new products much more quickly. To meet these pressures, new strategies are being used to supplement the conventional new product development process that consists of strategy formulation, idea generation, screening and evaluation, development, testing, and launch. The primary objective of each of these innovation strategies is to attain sustainable competitive advantage for the company and achieve higher overall performance.

Our research examined product and service innovation strategies of six projects. Half of which were considered successful and the other half failures. Using several emerging innovation strategies including process-driven, speed-to-market, quantitative, market-driven, technology-driven, and learning-driven to classify these projects, we evaluated the innovation strategies employed in an attempt to determine the overall NPD strategy effectiveness. In addition, we also attempted to identify relevant critical success factors and associated activities to construct an ideal innovation strategy model.

In the projects we studied, we found that no one best strategy leads to successful innovation. While evaluating areas of uncertainty that impact project success, we determined that a new dimension, process uncertainty, plays as important a role as market or technical uncertainty previously examined in the emerging scholarship. Furthermore, the insights that were discovered by comparing the different innovation strategies led us to formulate the technical-market-process (TMP) uncertainty mode. The TMP model serves as a predicator for identifying the appropriate innovation strategies that can be brought together to drive project success. We conclude that the combination of identifying the appropriate innovation strategies and proficiently executing these strategies is the key to successful new product development.     

Application of Neural Computing in Pharmaceutical Product Development: Computer Aided Formulation Design

Abstract

Most pharmaceutical products are complex systems designed to meet several compendial or other performance standards simultaneously. Ideal or ‘optimum’ product composition and the manufacturing process variables are generally established after extensive experimentation. Artificial Neural Networks are pattern recognition tools that allow the development of ‘expert’ systems without having to write computer programs. With this technology it may be possible to develop formulation ‘expert’ systems to predict the formulation composition and the manufacturing process conditions necessary to achieve the desired performance standards. This report introduces the concept of a formulation expert system to predict the in vitro drug release profile from hydrophilic matrix tablets. Formulation expert systems or Computer Aided Formulation Design has the potential to reduce the time and cost of the product development process.     

Development of a product design and supply-chain fulfillment system for discontinuous innovation

Given the lengthy product development lifecycle process, high cost, and low success rate, many firms avoid considering discontinuous innovation strategies, in spite of their increase in frequency and importance in many markets. Even with advances in automation and technology, many of the techniques being utilised in product development are relatively unchanged, and the definition of discontinuous innovation itself lacks a structural component. To address this problem, the authors developed a methodology for generative customisation to implement discontinuous innovation. Using the emerging technologies of generative design and agent-based modelling, the authors developed a methodology to create product inventions and measure product innovations using a complex adaptive system (CAS) model. This appears to be the first model that represents a complex adaptive system environment to measure the success of discontinuous innovation in the development of a market equilibrium agent model.     

Information sharing in multiviewpoint injection moulding design and manufacturing

Global competitiveness challenges manufacturing industry to bring to market well designed and manufactured new products at competitive prices in as short a lead-time as possible. To achieve this, inputs are needed from experts in a multitude of disciplines as well as from customers and suppliers. While the use of design teams is achieving success, there is a need for modern software tools that support design and manufacture to be radically improved. Typically, design for manufacture software systems does not support the multiple views of information needed for information systems to be able to support multiple manufacturing perspectives. This paper proposes a linked, multiviewpoint, product model structure as a means of supporting the many views of product information necessary in team-based design and manufacturing systems. To test the ideas developed, an experimental product model has been implemented using an object-oriented database that focuses on views related to the design and manufacture of injection-moulded products. The experimental system explores the relationships between three views: mouldability, cavity design and cavity machining views.     

An Evaluation of Technology Acquisition Via OEM Relationships

ABSTRACT

This article is a summary of technology acquisition experiences based on original equipment manufacture (OEM) arrangements across various AT&;T projects. These experiences show that OEM relationships that use off the shelf products often provide quickest market entry. On the other hand, OEM relationships that do not use off the shelf products characteristically require significant internal development staffing, equivalent or longer development schedules, and higher overall risks. The three key attributes of successful OEM relationships were observed to be the existence of a long term strategic product plan; the productization of off-the-shelf OEM products; and contractual arrangements with vendors having a large commitment to product support, linking the vendor's success to that of the company (Principal) distributing the OEM product.     

Development of rapidly dissolving pellets within the Quality by Design approach

Abstract

The purpose of this study was the development of novel, fast disintegrating, effervescent pellets by employing the direct pelletization technique as a single step process. In line with the Quality by Design (QbD) regulatory framework, statistical experimental design was extensively applied to correlate significant formulation and process variables with the critical quality attributes of the product. Pellets were studied with regards to sphericity, size and size distribution. In contrast to the existing multiparticulate platforms, this development integrated only water-soluble excipients to facilitate the multifunctional use of the final dosage form. The application of a screening fractional factorial design augmented to a full factorial design set the roadmap for the rational selection of the composition and process parameters, revealing in parallel the positive contribution of the powder feeder on the CQAs, when the critical process and formulation factors were properly adjusted. The response surface methodology was exploited for the final process optimization phase, which allowed the construction of appropriate mathematical models connecting the input variables and the CQAs under study. The implementation of the desirability function, lead to the optimum formulation and process settings for the production of pellets with narrow size distribution and geometric mean diameter of approximately 800?μm. In conclusion, using a lean approach supported by design of experiments (DoE) techniques within the QbD framework, a novel multifunctional formulation platform has been developed.     

Development of a Clinical Capsule Formulation Containing a Marginally Water Soluble Drug

Abstract

A good clinical development program maximizes the clinical efficacy of a new drug product and, in addition, requires only minimal formulation changes in the transition from clinical to market image product. This study demonstrates the development design as well as the technology utilized to improve the dissolution characteristics of a marginally water soluble drug to be administered in a capsule dosage form for clinical trials. A satisfactory formulation was achieved by controlling drug particle size, selecting an appropriate diluent and incorporating a surfactant.     

Development Pharmaceutics and process Validation

Abstract

A resume is presented of the guideline on the data required under Part I.A.4. of the Annex to European Directive 75/318/EEC covering the choice of composition of a medicinal product, supported by data on development pharmaceutics. The broad areas of development studies cover the function and compatibility of active ingredients and excipients, the development of liquid, semi-solid and solid dosage forms and the suitability of containers.

The guideline aims also to cover general aspects of process validation. The principles laid down in the Guideline are compared with those of FDA guideline on process validation which are much more detailed, but share the same overall aim.

One of the fundamental aims of the regulatory control of medicinal products is to ensure the correct purity, potency and consistency of manufacture of each product according to the quality appropriate for its intended use. While Good Manufacturing Practice is essential for quality assurance, other factors such as product design and development may also influence quality, and therefore must be studied and controlled. With this in mind, the Regulatory Authorities of the European Community have produced a guideline to the types of studies that should be undertaken in the development of a medicinal product, and which should be presented in support of application for marketing authorisation. A properly presented section on Development Pharmaceutics at the beginning of a dossier is extremely useful, if not essential, in explaining the rationale behind a particular product and giving the reviewer a clearer understanding of the data presented in support of product quality.

Quality Assurance of every product must be demonstrated, and validation is the key to its demonstration, put simply, validation is the act of proving that a process works. Thus the manufacturing methods and controls specified in an application should follow on from the development studies, and be based on valid principles. Demonstration of the validity of the manufacturing process should be provided as should the validation of the analytical methods used to control the process and therefore the product. Thus process validation should be seen as being strongly supported on the one hand by development pharmaceutics, and on the other by analytical validation.     

Development of novel amisulpride-loaded solid self-nanoemulsifying tablets: preparation and pharmacokinetic evaluation in rabbits

Objective: The current investigation is focused on the formulation and in vivo evaluation of optimized solid self-nanoemulsifying drug delivery systems (S-SNEDDS) of amisulpride (AMS) for improving its oral dissolution and bioavailability.

Methods: Liquid SNEDDS (L-SNEDDS) composed of Capryol? 90 (oil), Cremophor^® RH40 (surfactant), and Transcutol^® HP (co-surfactant) were transformed to solid systems via physical adsorption onto magnesium aluminometasilicate (Neusilin US2). Micromeretic studies and solid-state characterization of formulated S-SNEDDS were carried out, followed by tableting, tablet evaluation, and pharmacokinetic studies in rabbits.

Results: Micromeretic properties and solid-state characterization proved satisfactory flow properties with AMS present in a completely amorphous state. Formulated self-nanoemulsifying tablets revealed significant improvement in AMS dissolution compared with either directly compressed or commercial AMS tablets. In vivo pharmacokinetic study in rabbits emphasized significant improvements in t_max, AUC_(0–12), and AUC_(0–∞) at p?<?.05 with 1.26-folds improvement in relative bioavailability from the optimized self-nanoemulsifying tablets compared with the commercial product.

Conclusions: S-SNEDDS can be a very useful approach for providing patient acceptable dosage forms with improved oral dissolution and biovailability.     

A Conceptual Map of the Lean Nomenclature: Comparing Expert Classification to the Lean Literature

Abstract

Although the implementation of lean can yield improvements in organizational performance, the literature suggests that most organizations are unable to effectively sustain the results from lean implementation efforts. The lack of clarity related to lean concepts may be a cause of unsuccessful implementation. In this work, we seek to clarify conceptual ambiguity in the lean nomenclature. Using an extensive literature review, we document lean principles, practices, and performance measures. Results from a survey of lean experts were used to investigate the relationship between lean principles and practices. Findings from the literature and from the expert survey were synthesized to develop a visual representation of the lean nomenclature. This conceptual map is intended to aid practitioners by increasing clarity of important lean concepts and thus, the probability of successful implementation.     

1997 ASEM Conference Information and Registration Form

Abstract

This article describes and explores several innovation strategies and identifies critical success factors from five new product developments (NPDs) within four technology-based companies. The analysis provides suggestions to new product professionals about how and when to use the best strategies for new products. Our recommendations are based on analyzing three successful and two unsuccessful projects. These projects included two services, one successful and one unsuccessful, and three products, two successful and one unsuccessful. For this study, we use the term “product” to refer to both products as well as services. What we found was that one new product strategy does not fit all innovations. A strategy must be tailored to the degree of uncertainty present in the project – both market as well as technical uncertainty.     

Influence of the Adoption and Use of Social Media Tools on Absorptive Capacity in New Product Development

Abstract:

In this article, we discuss how the adoption and use of social media tools influences new product development (NPD). Our aim is specifically to consider how an organization's absorptive capacity is influenced by using social media tools. Based on a two-phase data collection process comparing the situation before and after adoption of social media tools in three organizations, we conclude that the amount of accessible knowledge and the number of ideas increases as an organization's ability to find and access various sources of intra-organizational expertise increases, thus, increasing knowledge acquisition and assimilation. Consequently, we infer that organizational absorptive capacity rises and is linked to improvement in new product development.     

Formulation Development and Stability Studies of Aqueous Metronidazole Benzoate Suspensions Containing Various Suspending Agents

ABSTRACT

Metronidazole is a synthetic antibacterial and antiprotozoan agent. Crystallization occurs in aqueous metronidazole benzoate suspensions caused by an anhydrate to monohydrate conversion. This study aimed to develop an aqueous metronidazole benzoate suspension that does not exhibit this hydration and the accompanying crystal growth. Four suspending agent systems were evaluated. Xanthan gum and Avicel® RC-591 (a combination of microcrystalline cellulose and carboxymethylcellulose sodium) were found to be the suspending agents that resulted in optimal formulation properties. Monohydrate formation did not occur in product containing Avicel® RC-591, indicating that suspending agents may exert a positive effect on metronidazole benzoate suspension stability.     

Characteristics of a Work Organization from a Lean Perspective

Abstract:

Implementation of lean practices results in significant changes in an organization. Current research in lean production primarily focuses on examining relationships between the implementation of lean production (LP) and the performance of the organization; however, there is a need to assess the implications of large-scale changes such as lean production on work design characteristics and employee outcomes. The purpose of this article is to study the impact of lean production on work design characteristics, such as autonomy, task identity and skill variety, and employee outcomes. This article proposes a conceptual framework that indicates key LP practices and their influences on work characteristics and employee outcomes.

Current research in LP identifies transformations in lean models inspired by sociotechnical principles. This article presents a comprehensive literature review of an evaluation of LP based on sociotechnical design principles. This evaluation contributes toward developing an insight for the proposed framework of the work design characteristics in a lean environment. Finally, a causal loop diagram is used to derive theoretical implications of the conceptual framework proposed.     

Lean-Thinking: Implementation and Measurement in Healthcare Settings

Abstract

Despite positive reports about lean approaches to spearhead quality and patient safety improvement efforts, it is still difficult to determine if healthcare employees have transformed into effective lean thinkers. Lean thinking refers to individuals who operate with thoughtful reflection on organizational issues, are committed to continuous improvement efforts, and demonstrate the willingness to lead change. The objective of this theory building research is to contribute a survey instrument and conceptual model to measure individual transformation to lean thinking. Our learnings from the case study suggest that healthcare a professional’s transition to lean thinking via a complex combination of awareness issues at both the unit and individual levels, and both levels should be considered when moving individuals toward readiness and through a personal transformation to lean thinking.