scholarly journals Pharmaceutical Product Modularization as a Mass Customization Strategy to Increase Patient Benefit Cost-Efficiently

Systems ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 59
Author(s):  
Maria Siiskonen ◽  
Johan Malmqvist ◽  
Staffan Folestad

Customized pharmaceutical products aim to comply with the individual needs of a patient to enhance the treatment outcome. The current pharmaceutical production paradigm is, however, dominated by mass production, where the pharmaceutical products embrace a one-size-fits-all design with a low possibility of treatment optimization to patient needs. This production paradigm is not designed or intended for customized pharmaceutical products and operating this production context for customized pharmaceutical products is argued to be cost-inefficient. To address this challenge of inefficient production of customized pharmaceutical products, this study proposes an approach to modular pharmaceutical product design. As a mass customization strategy, product modularization enables serving customers with customized products cost-efficiently. The proposed modular pharmaceutical products integrate three product design requirements originating from patient needs: a scalable dose strength, a flexible target release profile, and a scalable treatment size. An approach to assess the value of these product designs is presented, by means of proposing three benefit metrics complying with respective design requirements and a cost metric assessing the cost of producing these modular pharmaceutical product designs. Results suggest that pharmaceutical product modularization can, by keeping the number of produced components low, substantially increase the external product variety and, hence, enhance the treatment outcome of patients. Furthermore, results indicate that the achieved benefit for the patient through product modularization increases beyond additional costs arising during production. However, a careful modularization must be performed to optimize the tradeoff between the increased benefit and cost.

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 771
Author(s):  
Rydvikha Govender ◽  
Susanna Abrahmsén-Alami ◽  
Anette Larsson ◽  
Anders Borde ◽  
Alexander Liljeblad ◽  
...  

Independent individualization of multiple product attributes, such as dose and drug release, is a crucial overarching requirement of pharmaceutical products for individualized therapy as is the unified integration of individualized product design with the processes and production that drive patient access to such therapy. Individualization intrinsically demands a marked increase in the number of product variants to suit smaller, more stratified patient populations. One established design strategy to provide enhanced product variety is product modularization. Despite existing customized and/or modular product design concepts, multifunctional individualization in an integrated manner is still strikingly absent in pharma. Consequently, this study aims to demonstrate multifunctional individualization through a modular product design capable of providing an increased variety of release profiles independent of dose and dosage form size. To further exhibit that increased product variety is attainable even with a low degree of product modularity, the modular design was based upon a fixed target dosage form size of approximately 200 mm3 comprising two modules, approximately 100 mm3 each. Each module contained a melt-extruded and molded formulation of 40% w/w metoprolol succinate in a PEG1500 and Kollidon® VA64 erodible hydrophilic matrix surrounded by polylactic acid and/or polyvinyl acetate as additional release rate-controlling polymers. Drug release testing confirmed the generation of predictable, combined drug release kinetics for dosage forms, independent of dose, based on a product’s constituent modules and enhanced product variety through a minimum of six dosage form release profiles from only three module variants. Based on these initial results, the potential of the reconfigurable modular product design concept is discussed for unified integration into a pharmaceutical mass customization/mass personalization context.


Author(s):  
XUAN F. ZHA ◽  
RAM D. SRIRAM ◽  
WEN F. LU

Mass customization has been identified as a competitive strategy by an increasing number of companies. Family-based product design is an efficient and effective means to realize sufficient product variety, while satisfying a range of customer demands in support for mass customization. This paper presents a knowledge decision support approach to product family design evaluation and selection for mass customization process. Here, product family design is viewed as a selection problem with the following stages: product family (design alternatives) generation, product family design evaluation, and selection for customization. The fundamental issues underlying product family design for mass customization are discussed. Then, a knowledge support framework and its relevant technologies are developed for module-based product family design for mass customization. A systematic fuzzy clustering and ranking model is proposed and discussed in detail. This model supports the imprecision inherent in decision making with fuzzy customers' preference relations and uses fuzzy analysis techniques for evaluation and selection. A neural network technique is also adopted to adjust the membership function to enhance the model. The focus of this paper is on the development of a knowledge-intensive support scheme and a comprehensive systematic fuzzy clustering and ranking methodology for product family design evaluation and selection. A case study and the scenario of knowledge support for power supply family evaluation, selection, and customization are provided for illustration.


Author(s):  
Zahed Siddique ◽  
David W. Rosen ◽  
Nanxin Wang

Abstract The issue of moving from a mass production operating mode to mass customization, or even limited customization, has many companies struggling to reorganize their product architectures. Enabling the production of several related products for different market segments, from a common base, is the focus of the product variety design research area. In this paper, the applicability of product variety design concepts to the design of automotive platforms is explored. Many automotive companies are reducing the number of platforms they utilize across their entire range of cars and trucks in an attempt to reduce development times and costs. To what extent can research on product variety design apply to the problem of platform commonization? This question is explored by comparing product variety design concepts (standardization, modularity, mutability, etc.) to platform structures and requirements. After assessing the applicability of these concepts, a platform representation and methods for measuring platform commonality are proposed that incorporate key characteristics of these concepts. An application to two platforms is included. Although preliminary, this work has led to insight as to why automotive platform commonization is difficult and how product design variety research can potentially aid commonization. The findings are potentially applicable to product platforms in general.


2018 ◽  
Vol 57 (18) ◽  
pp. 5660-5684 ◽  
Author(s):  
Xinjun Lai ◽  
Qixiang Zhang ◽  
Qingxin Chen ◽  
Yunbao Huang ◽  
Ning Mao ◽  
...  

Author(s):  
Rushikesh Aher ◽  
Pratik Aher ◽  
Tejas Ahire ◽  
Hitesh V. Shahare ◽  
Charulata T. Nemade

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.


2019 ◽  
Vol 70 (7) ◽  
pp. 2471-2476
Author(s):  
Camelia Liana Buhas ◽  
Bogdan Adrian Buhas ◽  
Lucia Georgeta Daina ◽  
Bianca Hanganu ◽  
Irina Smaranda Manoilescu ◽  
...  

Ingestion of cheap para-pharmaceuticals (such as disinfectants, deodorizing solutions, etc.) which are designed only for external use is an unfortunate habit encountered in the recent decades in the economically disadvantaged areas of Romania inhabited by poor, uninformed, and sanitary uneducated population. These para-pharmaceutical products are based on different concentrations of ethanol. Occasionally, the manufacturer modifies the product formula, or worse omits on the label that the ethanol was replaced with methanol, resulting in mass poisoning with a large number of casualties. The authors present a case of mass poisoning by methanol that occurred during one month and resulted in 40 cases of methanol intoxication. Only 5 out of the 40 victims survived the intoxication. All the dead victims underwent medico-legal autopsy which revealed only general features, liable to poisoning. The toxicological examination result was positive for methanol in all the cases. All the intoxicated victims were homeless; they were heavy ethanol consumers, especially of the product rubbing alcohol. The male: female ratio was 31:4 and the age range was between 25 and 70 years old, with an average of 50 years. All the victims were hospitalized in deep coma, showing obvious pathological changes specific to chronic ethanol consumption. Conclusions: some alcoholic para-pharmaceutical products manufactured for external use are ingested by chronic ethanol drinkers. When these products contain methanol, they can cause severe intoxication followed by an impressively large number of deaths.


2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Ming Li

The selection of a design for the given product is a critical problem in product design development. Focuses of the designers and customers on the design are not identical. In order to bridge the gap and provide a more relaxing way to select the design, a new method based on quality function deployment (QFD) is proposed. In such a method, customers are required to give their linguistic preferences on the design with respect to the customer requirements (CRs). In the rating of the weight of CRs, they are allowed to provide incomplete linguistic weight information and the objective optimization model is proposed to derive the exact linguistic weight information. Designers are required to rate the correlation between design requirements (DRs) and the relationship between the CRs and DRs to construct the house of quality. Opinions given by the customers are translated into the opinions with respect to the DRs based on the QFD. Afterwards, the priorities of the designs and design requirements are determined. The assessment results not only show the contribution of each design requirement to the customer satisfaction but also show the advantages and disadvantages of each design from the designers’ perspective clearly and directly. An example is provided to validate the applicability of the proposed method.


2020 ◽  
Vol 124 (1276) ◽  
pp. 917-939 ◽  
Author(s):  
S.W. Paek ◽  
S. Kim ◽  
L. Kronig ◽  
O. de Weck

ABSTRACTThe development of oceanography and meteorology has greatly benefited from satellite-based data of Earth’s atmosphere and ocean. Traditional Earth observation missions have utilised Sun-synchronous orbits with repeat ground tracks due to their advantages in visible and infrared wavelengths. However, diversification of observation wavelengths and massive deployment of miniaturised satellites are both enabling and necessitating new kinds of space missions. This paper proposes several unconventional satellite orbits intended for use in, but not limited to, Earth observation. This ‘toolbox’ of orbits and taxonomy thereof will thus support the definition of design requirements for the individual satellites in nano-satellite constellations developed by national space agencies, industries and academia.


2013 ◽  
Vol 311 ◽  
pp. 398-403
Author(s):  
Jui Che Tu ◽  
Yu Chen Huang ◽  
Chuan Ying Hsu ◽  
Tung Che Wu

With the threat of global warming nowadays in the 21st century, the European Union has set the standard “Eco-Design Requirements for Energy-using Product(EuP)” for controlling the development of consumptive electronic machinery and products. Therefore, the trend of green design sees the instruction of EuP as the main direction for energy-saving. Considering the factors, undergoing the comprehensive evaluation and development process, the industry needs to draw up the corresponding design strategy in response to the new situation. Therefore, to optimize the green design strategy, the designers can replace hardware with the intelligent system to develop more optimal energy-saving products. Following the ecological instructions of energy-saving of EuP as direction, this study combined the advantage of the intelligent system and green design in order to optimize strategy of green design on intelligent energy-saving product under eco-design requirements for energy-using product (EuP). The evaluation factors were included in the strategies of intelligent energy-saving product design by analyzing the product users’ cognition, needs, habit and etc. Furthermore, through the Fuzzy Analytic Hierarchy Process (FAHP), the priority and the important factors of green design were analyzed. By examining the green design strategy on energy-using product, industry needs to think the energy-saving conditions and the key factors on deciding process. Eventually, the efficiency of product design for environment can be fulfilled successfully.


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