Necessity motivates innovators in low- to middle-income countries (LMICs) to develop medical devices that solve unmet local health needs. At the start of each process, multidisciplinary teams incubate ideas. Design planning and validation require funding, infrastructure, procurement, and testing. Ultimately, the regulatory and technology transfer processes usher the technology to market. These stages are standard procedures in developed nations; in an LMIC, these present a new set of hurdles to overcome. To assist innovators, this paper describes the hurdles from ideation to regulation and technology transfer and delineates mechanisms to address them.
medical device ; health technology ; technology transfer

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.
China ; Computer-Aided Design ; Imaging, Three-Dimensional ; Technology Transfer

OBJECTIVES: This paper introduces a telemedicine innovation network and reports its implementation in Tehran University of Medical Sciences. The required conditions for the development of future projects in the field of telemedicine are also discussed; such projects should be based on the common needs and opportunities in the areas of healthcare, education, and technology. METHODS: The development of the telemedicine innovation network in Tehran University of Medical Sciences was carried out in two phases: identifying the beneficiaries of telemedicine, and codification of the innovation network memorandum; and brainstorming of three workgroup members, and completion and clustering ideas. The present study employed a qualitative survey by using brain storming method. Thus, the ideas of the innovation network members were gathered, and by using Freeplane software, all of them were clustered and innovation projects were defined. RESULTS: In the services workgroup, 87 and 25 ideas were confirmed in phase 1 and phase 2, respectively. In the education workgroup, 8 new programs in the areas of telemedicine, tele-education and teleconsultation were codified. In the technology workgroup, 101 and 11 ideas were registered in phase 1 and phase 2, respectively. CONCLUSIONS: Today, innovation is considered a major infrastructural element of any change or progress. Thus, the successful implementation of a telemedicine project not only needs funding, human resources, and full equipment. It also requires the use of innovation models to cover several different aspects of change and progress. The results of the study can provide a basis for the implementation of future telemedicine projects using new participatory, creative, and innovative models.
Brain ; Delivery of Health Care ; Education ; Financial Management ; Humans ; Remote Consultation ; Technology Transfer ; Telemedicine*

With more and more attention and investment on acupuncture scientific researches, considerable outcomes and achievements has been acquired, but the shortcoming of low transformation rate of acupuncture research achievements is gradually exposed. Nowadays there is no related report on this problem, so based on achievement translational research in other areas and practical situation of acupuncture, the existing problems and solutions are analyzed. As a result, the existing problems include (1) the research content is mainly basic research and clinical research but less acupuncture device research, leading to limited transformation efficiency; (2) the evaluation system and transformation pattern are still needed to be perfect. The solutions are (1) to properly evaluate the research achievements of acupuncture, (2) to advocate the concept and method of translational medicine, (3) to reform the policy and system, and (4) to establish valid platforms covering research, outcomes and transformation.
Acupuncture ; economics ; legislation & jurisprudence ; manpower ; Biomedical Research ; Biotechnology ; economics ; legislation & jurisprudence ; manpower ; China ; Humans ; Technology Transfer

To set up a new pattern of quality control and evaluation for Chinese medicine. By investigating the limitation of quality control pattern for Chinese medicine, the differences and similarities in the chemical substantial style as well as quality control patterns among Chinese medicine, chemical synthetic drugs and Biologicals, combining with the author's experience on the research of geo-authentic medicinal material and theory of Chinese medicinal nature, a new pattern of quality control for Chinese medicine has been explored and designed. A more rational pattern of quality control for Chinese medicine should be referred to Biologicals instead of chemical synthetic drugs, there are more similarity in chemical substantial style and quality control pattern for Chinese medicine between Chinese medicine and Biologicals than that between Chinese medicine and chemical synthetic drugs. Based on geo-authentic medicinal material and bioassay or biopotency detection, a new pattern of quality control for Chinese medicine could be built and applied.
Biological Assay ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; standards ; Energy Transfer ; Evaluation Studies as Topic ; Medicine, Chinese Traditional ; standards ; Pattern Recognition, Automated ; Plants, Medicinal ; chemistry ; Quality Control ; Technology, Pharmaceutical ; methods