• Title/Summary/Keyword: Post-marketing

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New Medical Device Regulations (MDR) in Europe (유럽의 새로운 의료기기 규제제도 MDR)

  • Jeong, Hyun-Woo;Yeom, Hojun;Park, Sangsoo
    • The Journal of the Convergence on Culture Technology
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    • v.8 no.5
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    • pp.29-37
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    • 2022
  • MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

Effects of dietary supplementation of Pediococcus pentosaceus strains from kimchi in weaned piglet challenged with Escherichia coli and Salmonella enterica

  • Dongcheol Song;Jihwan Lee;Kangheung Kim;Hanjin Oh;Jaewoo An;Seyeon Chang;Hyunah Cho;Sehyun Park;Kyeongho Jeon;Yohan Yoon;Yoonjeong Yoo;Younghyun Cho;Jinho Cho
    • Journal of Animal Science and Technology
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    • v.65 no.3
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    • pp.611-626
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    • 2023
  • Escherichia coli (E. coli) and Salmonella enterica (SE) infections in pigs are major source associated with enteric disease such as post weaning diarrhea. The aim of this study was to investigate the effects of Pediococcus pentosaceus in weaned piglets challenged with pathogen bacteria. In Experiment.1 90 weaned piglets with initial body weights of 8.53 ± 0.34 kg were assigned to 15 treatments for 2 weeks. The experiments were conducted two trials in a 2 × 5 factorial arrangement of treatments consisting of two levels of challenge (challenge and non-challenge) with E. coli and SE, respectively and five levels of probiotics (Control, Lactobacillus plantarum [LA], Pediococcus pentosaceus SMFM2016-WK1 [38W], Pediococcus acidilactici K [PK], Lactobacillus reuteri PF30 [PF30]). In Experiment.2 a total of 30 weaned pigs (initial body weight of 9.84 ± 0.85 kg) were used in 4 weeks experiment. Pigs were allocated to 5 groups in a randomized complete way with 2 pens per group and 3 pigs per pen. Supplementation of LA and 38W improved (p < 0.05) growth performance, intestinal pathogen bacteria count, fecal noxious odor and diarrhea incidence. In conclusion, supplementation of 38W strains isolated from white kimchi can act as probiotics by inhibiting E. coli and SE.

A Study on the Use of Salted Cabbage and the Purchasing Promotion in School Foodservice (학교급식에서의 절임배추 이용 실태 및 구매 촉진에 관한 연구)

  • Cha, Sung-Mi;Han, Gwi-Jung;Lee, Sae-Rom;Park, Young-Hee
    • Journal of the Korean Society of Food Culture
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    • v.25 no.2
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    • pp.198-206
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    • 2010
  • In recent years consumers have become used to products geared toward a more convenient lifestyle, thus, the demand for salted-cabbage, for use in preparing Kimchi is increasing. This study aims to investigate purchasing factors, the satisfaction and demands of salted-cabbage, and to ascertain a marketing strategy for expanding the use of salted cabbage in food-service departments of schools. Self-administered questionnaires were collected from 131 buying agents who manage food materials for schools, and statistical data analysis was completed using the SPSS V.14.0 program. 46.9% of the participating respondents were from elementary schools, 27.7% from middle schools, and 25.4% were from high schools.. Most of the subjects (67.9%) recognized the salted cabbage retailed for foodservice, but 62.3% of these had not purchased them, due to both their lack of trust in the sanitation and raw material handling of the food product, and the high price. Respondents considered different factors when deciding whether or not to purchase: the origin (local or imported) of the cabbage, hygiene, and taste, as well as characteristics such as the cabbage weight, package weight, and package materials. The score of post-behavior intentions as well as overall satisfaction was rather high. Also, they perceived the need of strategic promotion for enlarging the market portion of salted-cabbage. These results will done the guidelines for diversifying the salted-cabbage market and for creating an added value of agricultural products in rural areas.

Exploratory Study on the Success Factors of Rehabilitation Medical Device Cluster

  • Kim, Sung-Jin;Kim, Gyu-Bae
    • The Journal of Economics, Marketing and Management
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    • v.6 no.4
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    • pp.17-27
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    • 2018
  • Purpose - As Korea is reaching a post-aged society, the number of chronic illness is increasing, and the demand for rehabilitation medical device is growing. Although there is high potential for the growth in rehabilitation industry, because most of the related companies in Korea are relatively small, lacking capital or R&D resource, it is difficult for them to create an innovative product, and currently most of the high-tech equipments are imported. Therefore a medical device cluster, where business, research, medical institutes and universities may work cooperatively to enhance research development and solve issues is necessary for future development. Research design, data, methodology - In this method we have done a literature review of the rehabilitation industry and industrial cluster. Based on the studies, we have conducted an exploratory factor analysis by studying examples of foreign and domestic medical clusters and drawing success factors in forming a medical cluster. Next based on the studies we have conducted a survey to domestic medical device companies to find their difficulties and needs to form a successful medical device cluster. Results - This paper provides both theoretic review on success factors of forming a medical device cluster and practical analysis using case study and survey. Conclusion - The significance of this paper is that based on the literature review, we have compared actual examples of domestic/foreign medical clusters and drawn difference and coincidence between literature and actual cluster success factor. We were also able to conduct a survey on actual medical device companies and through the results we were able to search difficulties and necessities of medical device companies.

Diabetes Detection and Forecasting using Machine Learning Approaches: Current State-of-the-art

  • Alwalid Alhashem;Aiman Abdulbaset ;Faisal Almudarra ;Hazzaa Alshareef ;Mshari Alqasoumi ;Atta-ur Rahman ;Maqsood Mahmud
    • International Journal of Computer Science & Network Security
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    • v.23 no.10
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    • pp.199-208
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    • 2023
  • The emergence of COVID-19 virus has shaken almost every aspect of human life including but not limited to social, financial, and economic changes. One of the most significant impacts was obviously healthcare. Now though the pandemic has been over, its aftereffects are still there. Among them, a prominent one is people lifestyle. Work from home, enhanced screen time, limited mobility and walking habits, junk food, lack of sleep etc. are several factors that have still been affecting human health. Consequently, diseases like diabetes, high blood pressure, anxiety etc. have been emerging at a speed never witnessed before and it mainly includes the people at young age. The situation demands an early prediction, detection, and warning system to alert the people at risk. AI and Machine learning has been investigated tremendously for solving the problems in almost every aspect of human life, especially healthcare and results are promising. This study focuses on reviewing the machine learning based approaches conducted in detection and prediction of diabetes especially during and post pandemic era. That will help find a research gap and significance of the study especially for the researchers and scholars in the same field.

Effect of essential oils and linalool on berry quality during simulated marketing of 'Shine Muscat' grapes

  • Yu-Rim Kim;Hyeong-Seok Lee;Young-Jik Ahn;Jinwook Lee;Jong-Pil Chun
    • Korean Journal of Agricultural Science
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    • v.49 no.4
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    • pp.1025-1033
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    • 2022
  • 'Shine Muscat' (Vitis labruscana Bailey x Vitis vinifera L.) grapes recently have been greatly favored in Korea, and as of 2022, account for 38.6% of the total grape market in Korea. However, there is a lack of research on post-harvest quality control appropriate to the unique characteristics of 'Shine Muscat'. In order to continuously increase domestic demand and exports in the future, it is essential to establish proper postharvest techniques. Essential oils have remarkable potential as biologically active and environmentally friendly antiseptics for the fruit industry. The objective of this study is to evaluate the effects of essential oils and aroma constituent treatment on fruit quality attributes of 'Shine Muscat' grapes in order to extend fruit quality during a simulated export period. A cluster of 'Shine Muscat' grapes was placed in a newly developed paper box container, and treated with rosemary essential oil, thyme essential oil, and linalool, along with an untreated control. The results showed no significant effect on fruit quality indices, such as cluster weight loss, berry firmness, soluble solids content, titratable acidity, sugar acid ratio, and color change, but showed a positive effect on the alleviation of berry shatter compared to the untreated control. In addition, rosemary oil treatment reduced the proportion of unhealthy berries. Therefore, the results indicated that the newly developed packaging container along with certain essential oil treatment could be applied as a promising packaging material for table grape export.

Self-Regulatory Mode Effects on Emotion and Customer's Response in Failed Services - Focusing on the moderate effect of attribution processing - (고객의 자기조절성향이 서비스 실패에 따른 부정적 감정과 고객반응에 미치는 영향 - 귀인과정에 따른 조정적 역할을 중심으로 -)

  • Sung, Hyung-Suk;Han, Sang-Lin
    • Asia Marketing Journal
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    • v.12 no.2
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    • pp.83-110
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    • 2010
  • Dissatisfied customers may express their dissatisfaction behaviorally. These behavioral responses may impact the firms' profitability. How do we model the impact of self regulatory orientation on emotions and subsequent customer behaviors? Obviously, the positive and negative emotions experienced in these situations will influence the overall degree of satisfaction or dissatisfaction with the service(Zeelenberg and Pieters 1999). Most likely, these specific emotions will also partly determine the subsequent behavior in relation to the service and service provider, such as the likelihood of complaining, the degree to which customers will switch or repurchase, and the extent of word of mouth communication they will engage in(Zeelenberg and Pieters 2004). This study investigates the antecedents, consequences of negative consumption emotion and the moderate effect of attribution processing in an integrated model(self regulatory mode → specific emotions → behavioral responses). We focused on the fact that regret and disappointment have effects on consumer behavior. Especially, There are essentially two approaches in this research: the valence based approach and the specific emotions approach. The authors indicate theoretically and show empirically that it matters to distinguish these approaches in services research. and The present studies examined the influence of two regulatory mode concerns(Locomotion orientation and Assessment orientation) with making comparisons on experiencing post decisional regret and disappointment(Pierro, Kruglanski, and Higgins 2006; Pierro et al. 2008). When contemplating a decision with a negative outcome, it was predicted that high (vs low) locomotion would induce more disappointment than regret, whereas high (vs low) assessment would induce more regret than disappointment. The validity of the measurement scales was also confirmed by evaluations provided by the participating respondents and an independent advisory panel; samples provided recommendations throughout the primary, exploratory phases of the study. The resulting goodness of fit statistics were RMR or RMSEA of 0.05, GFI and AGFI greater than 0.9, and a chi-square with a 175.11. The indicators of the each constructs were very good measures of variables and had high convergent validity as evidenced by the reliability with a more than 0.9. Some items were deleted leaving those that reflected the cognitive dimension of importance rather than the dimension. The indicators were very good measures and had convergent validity as evidenced by the reliability of 0.9. These results for all constructs indicate the measurement fits the sample data well and is adequate for use. The scale for each factor was set by fixing the factor loading to one of its indicator variables and then applying the maximum likelihood estimation method. The results of the analysis showed that directions of the effects in the model are ultimately supported by the theory underpinning the causal linkages of the model. This research proposed 6 hypotheses on 6 latent variables and tested through structural equation modeling. 6 alternative measurements were compared through statistical significance test of the paths of research model and the overall fitting level of structural equation model and the result was successful. Also, Locomotion orientation more positively influences disappointment when internal attribution is high than low and Assessment orientation more positively influences regret when external attribution is high than low. In sum, The results of our studies suggest that assessment and locomotion concerns, both as chronic individual predispositions and as situationally induced states, influence the amount of people's experienced regret and disappointment. These findings contribute to our understanding of regulatory mode, regret, and disappointment. In previous studies of regulatory mode, relatively little attention has been paid to the post actional evaluative phase of self regulation. The present findings indicate that assessment concerns and locomotion concerns are clearly distinct in this phase, with individuals higher in assessment delving more into possible alternatives to past actions and individuals higher in locomotion engaging less in such reflective thought. What this suggests is that, separate from decreasing the amount of counterfactual thinking per se, individuals with locomotion concerns want to move on, to get on with it. Regret is about the past and not the future. Thus, individuals with locomotion concerns are less likely to experience regret. The results supported our predictions. We discuss the implications of these findings for the nature of regret and disappointment from the perspective of their relation to regulatory mode. Also, self regulatory mode and the specific emotions(disappointment and regret) were assessed and their influence on customers' behavioral responses(inaction, word of mouth) was examined, using a sample of 275 customers. It was found that emotions have a direct impact on behavior over and above the effects of negative emotions and customer behavior. Hence, We argue against incorporating emotions such as regret and disappointment into a specific response measure and in favor of a specific emotions approach on self regulation. Implications for services marketing practice and theory are discussed.

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The Structural Relationships between Control Types over Salespeople, Their Responses, and Job Satisfaction - Mediating Roles of Role Clarity and Self-Efficacy - (영업사원에 대한 통제유형, 반응, 그리고 직무만족 간의 구조적 관계 - 역할명확성과 자기효능감의 매개효과 -)

  • Yoo, Dong-Keun;Lim, Jong-Koo;Lim, Ji-Hoon
    • Journal of Global Scholars of Marketing Science
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    • v.17 no.4
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    • pp.23-49
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    • 2007
  • Salespeople act at the point of MOT with customers and deliver the enterprise's message to the customers. They build up relationships with customers as well as deliver the customer's message to the enterprise. The salespeople's activity at the point of MOT with the customers and the degree of satisfaction of the customers' needs will affect the customers' attitude toward the enterprise, brand loyalty, and retention intention. Ultimately, it will influence the enterprise's financial performance. The control of salespe1ople is one of the most interesting topics of marketing. This research investigates the relationships of the control types over salespeople(positive/negative outcome control, positive/negative behavior control) and job satisfaction and their mediating variables. The mediating variables in the relationships have been identified as outcome/behavior-related role clarity and self-efficacy. The purpose of this study is more specifically as follows: First, it investigate how the perception of salespeople control types affect role-clarity. Second, it examines how the perception of salespeople control types influence self-efficacy. Third, it investigate the mediating role of role-clarity between the perception of salespeople control types and self-efficacy. Fourth, it investigates how role-clarity affect self-efficacy and job satisfaction. Finally, it will investigates how self-efficacy influences job satisfaction. Data were collected from the pharmaceutical industry salespeople and analyzed by SPSS 12.0 and AMOS 6.0. The data were collected by 400 respondents and 377 valid questionnaires were analyzed. The results are summarized as follows: First, positive/negative outcome controls had a positive relationship with outcome-related role clarity. Also positive behavior control had a positive effect on behavior-related role clarity, but negative behavior control didn't influence behavior-related role clarity. Second, positive outcome control influenced self-efficacy positively, but positive behavior control didn't have a positive effect on self-efficacy. In addition negative outcome control and negative behavior control had a positive effect on self-efficacy due to the mediating role of outcome-related and behavior-related role clarity. Third, outcome-related role clarity and behavior-related role clarity influenced self-efficacy positively. Behavior-related role clarity had a positive effect on job satisfaction, but outcome-related role clarity didn't influence job satisfaction. Finally, self-efficacy didn't have any effect on job satisfaction. The contributions of this study are as follows: First, existing studies have investigated the direct causal relationship between salespeoples' control type and performance, but this study investigates the structural causality between salespeoples' control types, responses, and performances. Second, this study found the mediating role of outcome-related/behavior-related role-clarity between outcome/behavior control and self-efficacy. Finally, the findings of this study further insight to existing studies on the relationship between job satisfaction and self-efficacy. The confidence of salespeoples' task influenced job satisfaction positively in existing articles,field studies, but the relationship between these two variables was not significant in this study. This means that there can be a different relationship between confidence and job satisfaction according to salespeoples' business. That is, the business environment may not be satisfying, even if the salespeople say that they have ability and confidence about their business. This means that able salespeople who have ability and confidence about their business are not satisfied with their job advancement in the company. Therefore, enterprise need to provide training that can establish a business environment that can satisfy the salespeole's expectation level which will secure good salespeople. This study may have limitation when applied to future studies. First,in this study as with existing studies it investigates the control level that salespeople feel is being measured. Actuality, the control level that a manager enforces and the control level that salespeople perceive when one is late can be different. There is need to measure lateness from both the perspective of the manager and salespeople should be done to supplement this study in the future Second, this study used variables that were connected with action result but salespeople's job satisfaction is due to the result of control. But, focusing on result of control can provide a more important financial result than sales performance. This study is also limited in that it did not consider financial result by result of control. Further studies on this will need to be done in the future. Third, this study may have a further limitation,because the investigation was restricted to pharmaceutical salespeople selling to hospitals. It is necessary to execute investigations in various industries to increase the generalization of the study findings Fourth, in this study, role clarity and self-efficacy by response variable for control and considered job satisfaction by outcome variable of control was considered. But, can other variables be considered beside response variable and result variable for control? For example, can financial affairs and change of post by outcome variable along with business stress by response variable for control be considered? Therefore, future studies need to consider various control variables. Finally, there is limited supporting research in the field of marketing which restricts the generalization of the study finding along with collecting material through random sampling of a limited size. This research summarizes the research in this area, the difference from the previous research, and provides a discussion of its limitations and the need and direction for further future research.

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Simultaneous Effect between eWOM and Revenues: Korea Movie Industry (온라인 구전과 영화 매출 간 상호영향에 관한 연구: 한국 영화 산업을 중심으로)

  • Bae, Jungho;Shim, Bum Jun;Kim, Byung-Do
    • Asia Marketing Journal
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    • v.12 no.2
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    • pp.1-25
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    • 2010
  • Motion pictures are so typical experience goods that consumers tend to look for more credible information. Hence, movie audiences consider movie viewers' reviews more important than the information provided by the film distributor. Recently many portal sites allow consumers to post their reviews and opinions so that other people check the number of consumer reviews and scores before going to the theater. There are a few previous researches studying the electronic word of mouth(eWOM) effect in the movie industry. They found that the volume of eWOM influenced the revenue of the movie significantly but the valence of eWOM did not affect it much (Liu 2006). The goal of our research is also to investigate the eWOM effects in general. But our research is different from the previous studies in several aspects. First, we study the eWOM effect in Korean movie industry. In other words, we would like to check whether we can generalize the results of the previous research across countries. The similar econometric models are applied to Korean movie data that include 746,282 consumer reviews on 439 movies. Our results show that both the valence(RATING) and the volume(LNMSG) of the eWOM influence weekly movie revenues. This result is different from the previous research findings that the volume only influences the revenue. We conjectured that the difference of self construal between Asian and American culture may explain this difference (Kitayama 1991). Asians including Koreans have more interdependent self construal than American, so that they are easily affected by other people's thought and suggestion. Hence, the valence of the eWOM affects Koreans' choice of the movie. Second, we find the critical defect of the previous eWOM models and, hence, attempt to correct it. The previous eWOM model assumes that the volume of eWOM (LNMSG) is an independent variable affecting the movie revenue (LNREV). However, the revenue can influence the volume of the eWOM. We think that treating the volume of eWOM as an independent variable a priori is too restrictive. In order to remedy this problem, we employed a simultaneous equation in which the movie revenue and the volume of the eWOM can affect each other. That is, our eWOM model assumes that the revenue (LNREV) and the volume of eWOM (LNMSG) have endogenous relationship where they influence each other. The results from this simultaneous equation model showed that the movie revenue and the eWOM volume interact each other. The movie revenue influences the eWOM volume for the entire 8 weeks. The reverse effect is more complex. Both the volume and the valence of eWOM affect the revenue in the first week, but only the volume affect the revenue for the rest of the weeks. In the first week, consumers may be curious about the movie and look for various kinds of information they can trust, so that they use the both the quantity and quality of consumer reviews. But from the second week, the quality of the eWOM only affects the movie revenue, implying that the review ratings are more important than the number of reviews. Third, our results show that the ratings by professional critics (CRATING) had negative effect to the weekly movie revenue (LNREV). Professional critics often give low ratings to the blockbuster movies that do not have much cinematic quality. Experienced audiences who watch the movie for fun do not trust the professionals' ratings and, hence, tend to go for the low-rated movies by them. In summary, applied to the Korean movie ratings data and employing a simultaneous model, our results are different from the previous eWOM studies: 1) Koreans (or Asians) care about the others' evaluation quality more than quantity, 2) The volume of eWOM is not the cause but the result of the revenue, 3) Professional reviews can give the negative effect to the movie revenue.

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The Best Practices of Performance Management & Application from Public Research Institutes in Korea (국내 공공연구기관의 성과관리.활용에 관한 우수 사례 연구)

  • Back, Seunghee;Chung, Do-Bum
    • Journal of Korea Technology Innovation Society
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    • v.16 no.4
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    • pp.1032-1054
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    • 2013
  • An increase of national R&D has brought the growth of research performance such as paper and patent quantitatively. However, the results of technology transfer and commercialization still leave much to be desired in Korea. Therefore, it has to be drawn up a plan for effective management & application of research performance created by public research institutes. We select four leading institutes (two universities, two government-funded research institutes) that performed efficient performance management & application. Then, we analyze the best practices and suggest contributions. The results show that four institutes build up a framework of performance management & application from research planning to technology transfer and commercialization. At an early planning phase, institutes set up definite needs-oriented goals, and prior review as well as prior art search is executed through experts. Besides, they systematically promote strategic patent management, technology marketing, post management, and so forth. For such a performance management & application process, capabilities have to be supported with regard to specialized organization, system, routine. This study can give an hint to improve performance management & application from public research institutes in Korea.

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