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This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Customer Support Knowledge of Customer Support Organization is one of the important assets of enterprises and “Customer Support Knowledge Management” is also the critical aspect of Business Knowledge Management; however, the attributes of Customer Support Knowledge are complicated, diverse, renewed rapidly and difficult to be managed. Thus, in order to design a successful Customer Support Knowledge Management System, apart from the consideration of “human” and “information technology” aspects, the concerns of attributes and Customer Support Knowledge and industry characteristics should be involved for meeting the requirements of Customer Support Organization and allowing the organization to acquire the competitive advantage of “Differentiation Service”. This research used the “Customer Support Knowledge Management System” in a high‐tech industry as an example and treated the end users of medical instruments in different types of hospitals in Taiwan which have received the support service of our company in recent six months as the population. The end users were mostly the nursing executives or ultrasonic wave technical personnel in intensive care unit and they had similar educational background and incomes and adopted the medical instruments such as physical supervision system, ultrasonic wave system, heart start or ECG machine produced by our company; the research method was to randomly treat the investigation results of the telephone customers’ satisfaction from respective 30 end users in the population three months before and after this system execution as the samples and use hypotheses to validate if the end users’ customer satisfaction significantly improved in terms of “Remote Support,” “On‐site Support,” “Service Turn Around time,” “Technical Competence” and “Service Manner” in order to understand the influence and managerial significance of execution of “Customer Support Knowledge Management System” on Customer Support Organization.

The purpose of this paper is to explore how different country-specific institutional healthcare settings affect an international new venture’s (INV’s) selling strategies and internationalization process when commercializing a medical technology innovation.

The study is based on a longitudinal in-depth case study approach with a comparative healthcare analysis in Sweden, UK, Germany and the USA.

An institutional framework helps elucidate the regulative, normative and cultural-cognitive dimensions in different healthcare settings. National markets differ when operating in a healthcare setting and thus affect both sales patterns and the internationalization process. In this study, three different sales patterns emerged from the countries’ and even regions’ distinctive institutional differences. Although the actual internationalization process starts from the INV’s inception, the subsequent internationalization process was both slow and focused due to institutional diversity and complexity.

Every nation has its own unique healthcare structure, indicating the importance of choosing markets that facilitate a swift uptake of a specific medical technology innovation. Commercializing a medical technology innovation in different country-specific healthcare settings is a lengthy, complex and costly process, especially if new behaviors and routines need to be created.

The paper contributes to the international entrepreneurship-marketing interface by developing an analytical framework for understanding country differences in relation to regulative, normative and culture-cognitive dimensions and by advancing six propositions related to the role of institutional healthcare settings and their impact on INVs’ sales patterns and internationalization processes.

Ineffective management inventory of medical products such as blood and vaccines can create severe repercussions for hospitals, clinics or medical enterprises, such as surgery delays and postponements. Inventory sharing is a form of horizontal collaboration that can provide solutions to key actors of the healthcare supply chain (HSC), yet no prior study reviewed this topic.

This study conducts a systematic literature review of thirty-nine inventory-sharing studies in the context of HSCs published from 2012 until early 2022. The descriptive and thematic analyses include chronological distribution, geographical location, comparison between developed/developing regions, stakeholder and incident analysis.

Thematic analysis classified inventory sharing among five product supply chains (blood, medical supplies, medicines, vaccines and generic medical products). Benefits include shortage reduction, cost minimisation, and wastage mitigation. Barriers include (1) IT infrastructure, (2) social systems, (3) cost and (4) supply chain operations. Perishable inventory policies include Fresher-First (FF), Last-Expire-First-Out (LEFO), First-In-First-Out (FIFO) and First-Expire-First-Out (FEFO). The analysis also showed differences between developed and developing countries. The study identifies several future research opportunities that include (1) product utilisation rate, (2) cost reductions, (3) shortage mitigation and (4) waste reduction.

No prior study has systematically reviewed inventory sharing in HSCs to reveal benefits, barriers, patterns and gaps in the current literature. It makes five propositions and develops a research model to guide future research. The study concludes with theoretical and managerial implications.

This study contends that customers’ perceived value can drive medical tourism. To demonstrate this, the purpose of this paper is to propose and test a research model capturing elements of perceived benefits and sacrifice that, by affecting the perceived value of medical tourism products, influence the buying intention of potential customers.

Potential medical tourists from China are tapped due to their cultural similarity to Taiwan, and the absence of a language barrier. Data from 301 usable questionnaires were tested against the research model using the structural equation modeling approach.

The results indicated that perceived value was a key predictor of customer intentions. As for benefits, perceived medical quality, service quality and enjoyment were critical components that significantly influenced the perception of value. Regarding sacrifice, the effects of perceived risk on perceived value were significant.

This study targeted potential medical tourists. Therefore, a validation using another large sample gathered elsewhere is required to generalize the findings.

The findings can assist governments in developing policies that promote medical destination and provide insights into research on how destination countries can make medical tourism a win/win option for themselves and international patients.

The proposed model is original; unlike most prior papers which take a conceptual approach to medical tourism, this study contributes to an understanding of the factors that influence the travel intentions of medical tourists through its empirical investigation, and especially in its targeting of customers’ value perception.

The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000 quality management systems.

Literature research and comparative analysis between ISO 13485:2003 and ISO 9001:2000 standard and requirements. A reference model is developed to assist the Malaysian SMEs towards ISO 13485:2003 accreditation.

Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efficacy of medical devices that are being produced. For this reason risk management is an essential process that needs to be adopted into the ISO 13485:2003 quality management system. Moreover, to demonstrate the effectiveness of the ISO 13485:2003 implementation, this standard has placed great emphasis on documentation requirements which are more prescriptive in insisting on the use of formal procedures.

The paper provides guidelines to ISO 13485:2003 implementations as well as risk management approaches for small and medium‐sized businesses of Malaysian medical device manufacturers, which at the same time maintains its ISO 9001:2000 certification.

This chapter analyzes the tourism industry from national and regional perspectives, in order to understand the past and current trends in Costa Rica’s positioning and branding attributes and strategies for tourism development. The intent here is not to provide an exhaustive comprehensive literature review of academic research on country branding; and so it is by all means a case study as it describes the evolution of the tourism industry in Costa Rica – including the transformative stages the country went through since the 1980s – as planned tourism national management programs evolved toward reaching the target of creating a nature-based tourism brand. The medical industry and then medical tourism industries are analyzed in a global basis and the US market is examined in detail because of its potential to develop a new complementary niche for Costa Rica’s tourism industry. The chapter intends to asses Costa Rica’s potential to become a country brand in medical tourism, leveraged on its natural tourism destination branding status quo.

The purpose of this paper is to investigate physicians' attitudes toward smart fabric medical innovation and more specifically to examine how perceived ease of use and perceived usefulness affect physicians' attitudes and intention to use smart fabric technology.

Data for this study were collected using a web‐based survey instrument delivered via email to a randomly selected group of physicians (n=207) responses with no missing data). Physicians were chosen because physicians' acceptance is key to social acceptance of smart medical innovations, whether as an instrument to further their efforts to monitor patients through telemedicine or to expand their diagnostic capabilities.

Significant effects were found for the direct relationships between attitude and intention to use and between perceived ease of use and perceived usefulness. However, the relationships between attitude on intention to use, perceived usefulness on intention to use and perceived ease of use on perceived usefulness were not statistically significant.

Smart fabric technology is a recent development that has received widespread attention in textile industry publications as well as consumer market publications, but relatively little in medical journals. Even though many of the applications are still limited to military situations, the diffusion of these “smart” innovations into mainstream markets has the potential to significantly impact numerous lives. This is especially true for smart fabrics that have been developed for medical markets because these innovations have the potential to save lives, alter the way physicians practice and impact significantly the quality of care provided to patients.

The medical tourism industry has become one of the most profitable industries around the world wherein most of the countries exploit every effort to attract medical tourists to take advantage of its medical care benefits. The purpose of this study is to explore the determinants of medical tourists’ perceived services and their satisfaction for medical care in hospitals.

The quantitative method was conducted to examine the three groups of foreign travellers such as medical tourists, expats and normative medial tourists’ perceived medical services quality and satisfaction. Data from a survey of 266 respondents were analyzed using the structural equation modelling technique.

The findings of this study provide evidence that hospital accessibility and interpersonal behaviour are the most critical constructs that influence medical tourists’ attributes. Additionally, medical costs and health-care technicality have a significant relationship with the perceived services of medical tourists. The study also demonstrated that medical tourists’ satisfaction highly attributed to their perceived services towards the quality of medical care they received and experienced in the hospitals.

The results have important implications for managerial considerations at hospitals. Hospital accessibility is a crucial dimension to be measured at hospitals when measuring service quality. Service providers need to be mindful that all aspects of medical services are essential and need to be delivered satisfactorily to ensure customer satisfaction. Patients’ perceived services and their satisfaction is a crucial bridge in determining the likelihood of future return among patients to the hospitals.

This study has managed to convincingly secure findings to provide useful information and understanding of the hospital accessibility and interpersonal manner of health-care professionals at hospitals in Malaysia. Particularly, when any hospital offers quality services, they must consider the reasonable medical expenses that can be affordable by the average people and update their medical equipment that are necessary for technical and diagnostic purposes. By ensuring these, they can attract the medical tourists.

Emerging interest in medical tourism products offers a lucrative market and opens doors for Malaysia in positioning itself as a Muslim-preferred halal medical care center point. In spite of the tremendous capability of this industry, the Muslim-friendly medical tourism practice is rationally new idea, with endeavors to clarify such tourism product is inadequate. This paper aims to investigate the promoting Muslim-friendly medical tourism market mechanism and its prospects and challenges.

As the purpose of this study is to investigate the perceptions of the Muslim patient’s inspiration towards Muslim-friendly medical tourism market mechanism in Malaysia. This study uses structural equation modeling (SEM) technique for data analysis. The target population for this research comprised Muslim medical tourists coming to Malaysia seeking Muslim-friendly medical tourism. A total sample size of 231 is gathered through non-probability sampling method during the period between July and December 2015.

The outcome confirms that Muslim tourist’s perceptions play a critical part in travel intention to Malaysia for Muslim-friendly medication. Along these lines, Malaysia needs to promote the success of such medical tourism endeavors with proper practice and services they offer to pull in more outside patients.

Malaysia is a country that has long been a stronghold for Muslim leisure visitors. Differences in general and spiritual values raise challenges to Muslim-friendly medical care services. A comprehensive research is required on the best way to advance and set up emerging Muslim-friendly medical tourism market mechanism.

Muslim-friendly medical tourism is a rising advertising discipline. It is confident that the findings could expand information on Muslim-friendly medical tourism service sector and improve providers’ capacity to take advantage of the developing business sector, offering quality medical care services and opportunities that suit the Muslim patients’ needs. In addition, it is essential to understand the most ideal approach to outline Muslim-friendly medical tourism market to make it more useful to various spiritual and religious accept.