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KMID : 1142220170120010059
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.59 ~ p.74
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Road Map in Increased Efficiency from Medical Device Product Planning to Technology Commercialization
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Byun Jae-Youn
Kim Sung-Min
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Abstract
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Even if medical device company have a good technology and medical device business has different characteristics, the success rate of commercialization is low. This study was presumed the root cause was that medical device company has not been set up the risk management strategy nor prepared from the business planning stage to commercializing stage in advance. This study divided medical device commercialization stages to 9 stages as like 1. Product Planning 2. Research and Development 3. Design Validations as like Clinical Trial 4. Government Approval 5. Promotion and Marketing 6. Insurance Registration 7. Sales and Distribution Network Set up 8. Mass Production 9. Sales, and surveyed medical device manufacturing company employees 59 people for each step's weight & risk & considerations of key elements for strategy set-up for successful commercialization. The result was that all of 9 stages weight for commercialization were recorded more than 3.6 score out of 5. Especially 1. Product Planning 4. Government Approval 7. Sales and Distribution Network Set up 8. Mass Production stages were recorded more than 4.0 score which surveyed as a highly weighted stages. This study suggested a road map including key elements for strategy set-up risk and consideration. Lastly, as a result of effectiveness opinion survey analysis for medical device technology commercialization road map's effectiveness,
49 (98%) of all respondents (out of 50) are answered that road map is helpful for medical device commercialization. If government supports as balanced for each commercialization steps, and inexperienced medical device company also applies the road map and the stage of commercialization planning, then medical device commercialization success ratio will be increased.
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KEYWORD
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Medial Device, Technology Commercialization, Risk Management, Strategy Set Up
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Listed journal information
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