RESUMO
In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
Assuntos
Estados Unidos , Legislação de Dispositivos Médicos , Reprodutibilidade dos Testes , United States Food and Drug Administration , Tecnologia , Aprovação de EquipamentosRESUMO
A questionnaire-based survey of board-certified rehabilitation physicians was conducted to identify issues in multidisciplinary interprofessional collaboration and to assess the abilities of board-certified rehabilitation physicians needed to develop assistive devices for individuals requiring long-term care. From the 366 responses, it was revealed that they consider “the ability to gain an insight into what patients need from assistive devices” and the “ability to communicate” as essential abilities needed to develop assistive devices. The respondents considered the ability to communicate and convey information important to overcome differences in thought-process between disciplines；the sharing of information, objectives, and knowledge as a requirement for teamwork；and collaboration, including with the patients, to be important. This approach to device development fits well with “design thinking” and “biodesign.” Unfortunately, more than 70％ of the respondents were unfamiliar with these concepts. Therefore, it is necessary to provide opportunities for rehabilitation physicians to learn innovative biodesign approaches.
RESUMO
A questionnaire-based survey of board-certified rehabilitation physicians was conducted to identify issues in multidisciplinary interprofessional collaboration and to assess the abilities of board-certified rehabilitation physicians needed to develop assistive devices for individuals requiring long-term care. From the 366 responses, it was revealed that they consider “the ability to gain an insight into what patients need from assistive devices” and the “ability to communicate” as essential abilities needed to develop assistive devices. The respondents considered the ability to communicate and convey information important to overcome differences in thought-process between disciplines；the sharing of information, objectives, and knowledge as a requirement for teamwork；and collaboration, including with the patients, to be important. This approach to device development fits well with “design thinking” and “biodesign.” Unfortunately, more than 70％ of the respondents were unfamiliar with these concepts. Therefore, it is necessary to provide opportunities for rehabilitation physicians to learn innovative biodesign approaches.
RESUMO
In 2019, cardiovascular disease (CVD) accounted for 46.74% and 44.26% of all deaths in rural and urban areas, respectively. Two out of every five deaths were due to CVD. It is estimated that about 330 million patients suffer from CVD in China. The number of patients suffering from stroke, coronary heart disease, heart failure, pulmonary heart disease, atrial fibrillation, rheumatic heart disease, congenital heart disease, lower extremity artery disease and hypertension are 13.00 million, 11.39 million, 8.90 million, 5.00 million, 4.87 million, 2.50 million, 2.00 million, 45.30 million, and 245.00 million, respectively. Given that China is challenged by the dual pressures of population aging and steady rise in the prevalence of metabolic risk factors, the burden caused by CVD will continue to increase, which has set new requirements for CVD prevention and treatment and the allocation of medical resources in China. It is important to reduce the prevalence through primary prevention, increase the allocation of medical resources for CVD emergency and critical care, and provide rehabilitation services and secondary prevention to reduce the risk of recurrence, re-hospitalization and disability in CVD survivors. The number of people suffering from hypertension, dyslipidemia and diabetes in China has reached hundreds of millions. Since blood pressure, blood lipids, and blood glucose levels rise mostly insidiously, vascular disease or even serious events such as myocardial infarction and stroke often already occured at the time of detection in this population. Hence, more strategies and tasks should be taken to prevent risk factors such as hypertension, dyslipidemia, diabetes, obesity, and smoking, and more efforts should be made in the assessment of cardiovascular health status and the prevention, treatment, and research of early pathological changes.
Assuntos
Humanos , Doenças Cardiovasculares/etiologia , China/epidemiologia , Diabetes Mellitus , Dislipidemias , Hipertensão/epidemiologia , Infarto do Miocárdio , Fatores de Risco , Acidente Vascular Cerebral/epidemiologiaRESUMO
On the base of the principle of penetrating moxibustion and in combination with free adjustment devices such as movable U-shaped moxa stick holder and movable clamp, a new type of moxibustion box exerted on the head is designed, with precise positioning and sufficient heat intensity.