Examinando por Materia "Medical Devices"
Mostrando 1 - 4 de 4
Resultados por página
Opciones de ordenación
Ítem Design of medical devices for pressure ulcer prevention(DESIGN SOC, 2015-01-01) Velasquez, Alejandro; Almonacid, Ana Maria; Jaramillo, Lisa Maria; Aramburo, Mauricio; Velasquez, David; Iza, Camilo; Zapata, Luis MiguelThis paper presents a stage-gate design methodology implemented during the design of two mechatronic medical devices for the prevention of ulcers in skin. Each product required the integration of different disciplines such as mechanics, electronics and software, and went through three stages on which technical tests were performed on each stage. Afterwards a feedback was introduced into the next stage and improvements were implemented on the design. At the end both products were tested by health-care staff members, and patent applications were issued for.Ítem Guía de integración de la gestión de la calidad y la normativa legal colombiana para el diseño, desarrollo, fabricación, comercialización y exportación de dispositivos médicos clase I y IIa(Universidad EAFIT, 2023) Mantilla Caballero, Fredy Alonso; Giraldo Hernández, Gina María; Velásquez Cuartas, Jhon OrlandoA guide is presented for the integration of the quality management system of class I and IIA medical devices and the regulatory aspects in the Colombian framework, applicable in the design, development, manufacture, commercialization and export of Medical Devices. An investigation of the current normogram was carried out in the databases of Invima and the Ministry of Health and Social Protection, the NTC-ISO 13485:2016 standard was reviewed; Inquiries were made in articles in electronic databases, technical consultations with Invima regarding the interpretation of the regulation and experts in the sector. This study and the application guide made it possible to identify methodologies and practical recommendations for the sector, by granting recommendations based on comments from experts in it, also leading to strengthening knowledge as a guide to medical device manufacturing companies in Colombia.Ítem In vitro mechanical evaluation of mandibular bone transport devices(ASME, 2014-06-01) Zapata, Uriel; Watanabe, Ikuya; Opperman, Lynne A.; Dechow, Paul C.; Mulone, Timothy; Elsalanty, Mohammed E.; Zapata, Uriel; Watanabe, Ikuya; Opperman, Lynne A.; Dechow, Paul C.; Mulone, Timothy; Elsalanty, Mohammed E.; Universidad EAFIT. Departamento de Ingeniería de Producción; Materiales de IngenieríaBone transport distraction osteogenesis (BTDO) is a surgical procedure that has been used over the last 30 years for the correction of segmental defects produced mainly by trauma and oncological resections. Application of BTDO has several clinical advantages over traditional surgical techniques. Over the past few years, several BTDO devices have been introduced to reconstruct mandibular bone defects. Based on the location and outline of the defect, each device requires a uniquely shaped reconstruction plate. To date, no biomechanical evaluations of mandibular BTDO devices have been reported in the literature. The present study evaluated the mechanical behavior of three different shaped prototypes of a novel mandibular bone transport reconstruction plate and its transport unit for the reconstruction of segmental bone defects of the mandible by using numerical models complemented with mechanical laboratory tests to characterize strength, fatigue, and stability. The strength test evaluated device failures under extreme loads and was complemented with optimization procedures to improve the biomechanical behavior of the devices. The responses of the prototypes were characterized to improve their design and identify weak and strong regions in order to avoid posterior device failure in clinical applications. Combinations of the numerical and mechanical laboratory results were used to compare and validate the models. In addition, the results remark the importance of reducing the number of animals used in experimental tests by increasing computational and in vitro trials. © VC 2014 by ASME.Ítem In vitro mechanical evaluation of mandibular bone transport devices(ASME, 2014-06-01) Zapata, Uriel; Watanabe, Ikuya; Opperman, Lynne A.; Dechow, Paul C.; Mulone, Timothy; Elsalanty, Mohammed E.; Universidad EAFIT. Departamento de Ingeniería Mecánica; Bioingeniería GIB (CES – EAFIT)Bone transport distraction osteogenesis (BTDO) is a surgical procedure that has been used over the last 30 years for the correction of segmental defects produced mainly by trauma and oncological resections. Application of BTDO has several clinical advantages over traditional surgical techniques. Over the past few years, several BTDO devices have been introduced to reconstruct mandibular bone defects. Based on the location and outline of the defect, each device requires a uniquely shaped reconstruction plate. To date, no biomechanical evaluations of mandibular BTDO devices have been reported in the literature. The present study evaluated the mechanical behavior of three different shaped prototypes of a novel mandibular bone transport reconstruction plate and its transport unit for the reconstruction of segmental bone defects of the mandible by using numerical models complemented with mechanical laboratory tests to characterize strength, fatigue, and stability. The strength test evaluated device failures under extreme loads and was complemented with optimization procedures to improve the biomechanical behavior of the devices. The responses of the prototypes were characterized to improve their design and identify weak and strong regions in order to avoid posterior device failure in clinical applications. Combinations of the numerical and mechanical laboratory results were used to compare and validate the models. In addition, the results remark the importance of reducing the number of animals used in experimental tests by increasing computational and in vitro trials. © VC 2014 by ASME.