Journal of Taiwan Occupational Therapy Research and Practice
在設計各種智慧型高齡者照護用醫療器材時，其最終目的都希望能達到“病得輕，老得慢”的目的，如此才能提升高齡者的生活品質及反映照護用醫療器材的價值。因此，針對開發完成之智慧型高齡者照護用醫療器材，進行臨床試驗與功能測試實有其必要性。希望能從臨床試驗執行的經驗中，依據高齡者之使用型態發展出最適合的智慧型高齡者照護用醫療器材。 然而，在進行臨床試驗前，需先經過繁瑣的審查過程後，取得IRB (institutional reviewboard)認證後，方可對人體進行試驗。再者，過去醫療器材產業與醫療院所缺少溝通合作管道，廠商無法瞭解使用者需求，院方瞭解病人的需求卻無建議之管道，造成開發出的醫療器材，無法切合使用者的需求。 因此，本研究主要的目的在於開發智慧型醫療器材臨床測試專案管理系統，使設計開發出的創新高齡者照護用智慧型醫療器材，能夠有效而且快速取得IRB認證，符合臨床上的要求，進而滿足使用者的需求。並提供試驗主持人與廠商共同參與臨床測試會議之機制，以會議系統及視訊會議系統工具輔助溝通。藉試驗主持人及臨床專業人員之參與IRB認證及臨床試驗，開發符合高齡者健康需求之使用者導向智慧型醫材產品，達成健康促進之目的。
In the design of a variety of intelligent medical devices for the elderly, the main purpose is to achieve that the developed devices are able to help the user with physical problems getting recovery and health, to enhance the quality of life of the elderly and to reflect the value of medical devices used by the elderly. Therefore, it is essential to have clinical trials and functional validation for the developed devices. Based on the data of clinical trials and the behaviour of the elderly, it could help to develop the most appropriate medical devices for the elderly. However, it needs to obtain IRB (institutional review board) certification before conducting clinical trials. Moreover, the medical devices and equipment manufacturers are lack of appropriate channels to communicate and cooperate with medical doctors and hospitals and resulting in that the manufactures are difficult to understand and find out users' needs. In the other side, the medical doctors and hospitals understand the needs of the patients but without appropriate channels to contribute their knowledge and to cause the development of inappropriate medical devices to meet the needs of the users. Therefore, the research aims to develop a clinical trial management system and expects that the developed system could be useful for assisting the development of intelligent medical devices and equipment, effective and speedy access to IRB certification, and easy manage clinical trials. The developed system provides the mechanism to assist communication and cooperation between trial investigator and manufacturers through a meeting system and online conference system. Hence, trail investigator and clinical professionals could use the developed system to obtain IRB certification and implement clinical trials, to develop good intelligent medical devices and equipment to meet elderly users' needs.