Business Management Development Model in Medical Devices Manufacturing Industry

Abstract

This research aimed 1) to study the guideline of business administration and management in medical device manufacturing industry that for 2) developing a model and 3) evaluating the management handbook of the medical device manufacturing industry. Studied participants in this study were the management persons (n=89) in the medical device manufacturing industries, which obtained the ISO13485 and CE Mark. Quantitative and qualitative research were used in this studied which tools consisted of an in-depth interview form and a questionnaire survey. Descriptive statistics were utilized including percentage, mean, and standard deviation. Analysis and synthesis initiated a Model which confirmed by key specialists. The results showed that the management persons indicated 24 items of the important management issue as greater than a high level of the scores, and can be summarized as followed. The financial issue consisted 4 main items: 1) short term cash flow, 2) long term fund, 3) risk management during research and development period, and 4) inquire for board of investment support. The human resource issue consisted of 5 main items: 1) skill labor training and development, 2) motivation for the gorgeous person, 3) network building with academic institute, 4) offering the stock to be the stakeholder, and 5) coeducation with academic institute. The research and development issue consisted of 3 main items: 1) research and develop the new innovation products, 2) registering for patent or copyright, and 3) certified ISO13485 and CE Mark standard. The operation and production issue consisted of 4 main items: 1) self-production, 2) technology based machine, 3) product design, and 4) quality control under ISO13485. The marketing issues consisted of 8 main items: 1) packaging, 2) branding, 3) clinical and evidence support, 4) domestic public relation, 5) market expanding to Asian countries, 6) market expanding to European countries, 7) memorandum of understanding with key user agency, and 8) memorandum of understanding with government agency for Thailand innovation lists. In conclusion, the model and operational handbook guideline practice seems to be appropriate and potential for developing sustainable business of medical device manufacturing industries.