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

To promote the clinical treatment technical training and popularization of traumatic shock and cardiac arrest, Health Emergency Committee of Chinese Research Hospital Association, Cardiopulmonary Resuscitation Specialized Committee of Chinese Research Hospital Association, Cardiopulmonary Resuscitation Specialized Committee of Henan Hospital Association jointly established "Chinese expert consensus on the clinical application of innovative first-aid resuscitation technology for traumatic shock in 2019". This consensus has solved the problem of volume resuscitated gel mix and ratio in the emergency situation of pre-hospital transfusion and blood products unable to be used in traumatic shock. Hypertonic gel compound liquid can treat traumatic shock with small dosage and good effect of stabilizing blood pressure, which can replace whole blood and other blood products, improve the safety of transport to hospital, and provide an opportunity for life-saving surgery. At the same time, abdominal lifting and compression cardiopulmonary resuscitation (CPR) has solved the difficulty of treating patients with post-traumatic cardiac arrest who cannot perform traditional chest compressive CPR, and greatly improved the success rate of pre-hospital treatment for patients with traumatic shock. In view of the actual demand of emergency medical treatment in China and the contraband of chest CPR for chest trauma, the combination of "administration, production, study, research and application" was adopted, and the abdominal lifting and compression CPR was successfully developed and popularized. This expert consensus summarized the scientific evidence on traumatic shock and traumatic cardiac arrest published at home and abroad so far, and put forward the expert consensus on the clinical application of innovative first-aid resuscitation technology for traumatic shock based on Chinese national conditions. This consensus incorporated the wisdom and philosophy of Chinese and foreign scholars in the training of traumatic shock and CPR, and would certainly make the training of traumatic shock and cardiac arrest in China entering a new stage with strong pertinence, quick onset, few side effects and high treatment rate.
Cardiopulmonary Resuscitation/methods* ; China ; Consensus ; Diffusion of Innovation ; First Aid/methods* ; Heart Arrest/therapy* ; Humans ; Shock, Traumatic/therapy*

PURPOSE: We examined the effects of a community outreach program for maternal health in Tigray, Ethiopia, on women's knowledge about pregnancy, childbirth, postpartum care, and family planning, and assessed their participation in antenatal care, postpartum checkups, institutional childbirth, and contraceptive use. METHODS: We recruited Ethiopian women of reproductive age (15 to 49 years) in Tigray, Ethiopia. Two villages in Tigray, Kihen and Mesanu, which have similar population sizes and living environments, were chosen as the intervention and comparison groups, respectively. A two-group pretest-posttest design with cluster sampling was employed. We conducted self-report questionnaire surveys using face-to-face interviews. The 2.5-year community outreach program was developed based on Rogers' diffusion of innovation theory. It consisted of mass media use and health education for lay women in the community, along with training of health care providers, including nurses, midwives, and health extension workers, in maternal health care. RESULTS: The intervention group showed significant increases in knowledge and behaviors regarding maternal health and family planning compared to the comparison group (p < .001). In particular, there was a dramatic increase from 10.8% to 93.5% in the institutional birth rate in the intervention group. CONCLUSION: The community outreach program and health care professional training effectively improved knowledge and behaviors regarding maternal health in Ethiopian women. Mass media and interpersonal communication channels for health education may be useful health interventions in developing countries.
Birth Rate ; Community-Institutional Relations* ; Delivery of Health Care ; Developing Countries ; Diffusion of Innovation ; Ethiopia* ; Family Planning Services* ; Female ; Health Education ; Health Personnel ; Humans ; Mass Media ; Maternal Health* ; Midwifery ; Parturition ; Population Density ; Postnatal Care ; Pregnancy

OBJECTIVES: We assessed the public acceptance of a health information exchange (HIE) and examined factors that influenced the acceptance and associations among constructs of the Technology Acceptance Model (TAM). METHODS: We collected data from a survey of 1,000 individuals in Korea, which was administered through a structured questionnaire. We assessed the validity and reliability of the survey instrument with exploratory factor analysis and Cronbach's alpha coefficients. We computed descriptive statistics to assess the acceptance and performed regression analyses with a structural equation model to estimate the magnitude and significance of influences among constructs of TAM. RESULTS: Eighty-seven percent of the respondents were willing to use the technology, and the average level of agreement with the need for the technology was 4.16 on a 5-point Likert scale. The perception of ease of use of the technology significantly influenced perceptions of usefulness and attitudes about the need for HIE. Perceptions of usefulness influenced attitude and behavioral intention to use HIE, and attitude influenced intention. Age showed a wide range of influences throughout the model, and experience with offline-based information exchange and health status also showed noteworthy influences. CONCLUSIONS: The public acceptance of HIE was high, and influences posited by TAM were mostly confirmed by the study results. The study findings indicated a need for an education and communication strategy tailored by population age, health status, and prior experience with offline-based exchange to gain public buy-in for a successful introduction of the technology.
Diffusion of Innovation ; Education ; Health Information Exchange* ; Intention ; Korea* ; Public Opinion ; Reproducibility of Results ; Surveys and Questionnaires

PURPOSE: The purpose of this study is to explore factors which influence adoption, implementation and continued use of tele-healthcare systems. METHODS: Qualitative research was conducted by in-depth interviews with 17 professionals from various fields of organizations involved in developing and implementing tele-healthcare systems. Data were analysed thematically, using a conceptual model of diffusion of innovations. RESULTS: The system users were reacted positively to the 3 attributes out of 9 which decided the adoption of innovation. In addition, it is required to redesign the tele-health care system simpler and easier so that the system users can access to the system much more easily regardless of space and time limitations. From the design stage on an individual level, it is necessary to conduct detailed needs analysis and listen to users who are at the center of innovation diffusion. On an organizational level, it is necessary to actively prepare for possible problems during system implementation, educate the users and build communication channels continuously. CONCLUSION: This study has identified the factors affecting the innovation of tele-health care systems and contributed to the understanding of the operation of tele-health care systems by the diffusion of innovation theory in community health posts.
Delivery of Health Care ; Diffusion of Innovation* ; Diffusion* ; Qualitative Research ; Telemedicine

Chronic Disease ; Delivery of Health Care ; organization & administration ; trends ; Diffusion of Innovation ; Education, Medical, Continuing ; Forecasting ; Health Services Research ; Humans ; Public Health ; trends ; Singapore ; Societies, Medical

Rheumatoid arthritis (RA) is expected to increase in Africa and South Africa. Due to the low numbers of rheumatologists in South Africa, specialist physicians also have to care for patients with RA. Furthermore several new developments have taken place in recent years which improved the management and outcome of RA. Classification criteria were updated, assessment follow-up tools were refined and above all, several new biological disease-modifying anti-rheumatic drugs were developed. Therefore it is imperative for specialist physicians to update themselves with the newest developments in the management of RA. This article provides an overview of the newest developments in the management of RA in the South African context. This approach may well apply to countries with similar specialist to patient ratios and disease profiles.
Antirheumatic Agents/adverse effects/*therapeutic use ; Arthritis, Rheumatoid/diagnosis/*drug therapy/epidemiology ; Diffusion of Innovation ; Humans ; Practice Guidelines as Topic ; Practice Patterns, Physicians' ; Prevalence ; *Rheumatologists/standards ; Risk Factors ; Severity of Illness Index ; South Africa/epidemiology ; *Specialization ; Treatment Outcome

OBJECTIVES: Electronic detailing (e-detailing), the use of electronic devices to facilitate sales presentations to physicians, has been adopted and expanded in the pharmaceutical industry. To maximize the potential outcome of e-detailing, it is important to understand medical representatives (MRs)' behavior and attitude to e-detailing. This study investigates how information technology devices such as laptop computers and tablet PCs are utilized in pharmaceutical marketing, and it analyzes the factors influencing MRs' intention to use devices. METHODS: This study has adopted and modified the theory of Roger's diffusion of innovation model and the technology acceptance model. To test the model empirically, a questionnaire survey was conducted with 221 MRs who were working in three multinational or eleven domestic pharmaceutical companies in Korea. RESULTS: Overall, 28% and 35% of MRs experienced using laptop computers and tablet PCs in pharmaceutical marketing, respectively. However, the rates were different across different groups of MRs, categorized by age, education level, position, and career. The results showed that MRs' intention to use information technology devices was significantly influenced by perceived usefulness in general. Perceived ease of use, organizational and individual innovativeness, and several MR characteristics were also found to have significant impacts. CONCLUSIONS: This study provides timely information about e-detailing devices to marketing managers and policy makers in the pharmaceutical industry for successful marketing strategy development by understanding the needs of MRs' intention to use information technology. Further in-depth study should be conducted to understand obstacles and limitations and to improve the strategies for better marketing tools.
Administrative Personnel ; Commerce ; Diffusion of Innovation ; Drug Industry ; Education ; Humans ; Intention* ; Korea ; Marketing*

BACKGROUND: Innovation has molded the current landscape of plastic surgery. However, documentation of this process only exists scattered throughout the literature as individual articles. The few attempts made to profile innovation in plastic surgery have been narrative, and therefore qualitative and inherently biased. Through the implementation of a novel innovation metric, this work aims to identify and characterise the most prevalent innovations in plastic surgery over the last 50 years. METHODS: Patents and publications related to plastic surgery (1960 to 2010) were retrieved from patent and MEDLINE databases, respectively. The most active patent codes were identified and grouped into technology areas, which were subsequently plotted graphically against publication data. Expert-derived technologies outside of the top performing patents areas were additionally explored. RESULTS: Between 1960 and 2010, 4,651 patents and 43,118 publications related to plastic surgery were identified. The most active patent codes were grouped under reconstructive prostheses, implants, instruments, non-invasive techniques, and tissue engineering. Of these areas and other expert-derived technologies, those currently undergoing growth include surgical instruments, implants, non-invasive practices, transplantation and breast surgery. Innovations related to microvascular surgery, liposuction, tissue engineering, lasers and prostheses have all plateaued. CONCLUSIONS: The application of a novel metric for evaluating innovation quantitatively outlines the natural history of technologies fundamental to the evolution of plastic surgery. Analysis of current innovation trends provides some insight into which technology domains are the most active.
Bias (Epidemiology) ; Breast ; Diffusion of Innovation ; Fungi ; Lipectomy ; Natural History ; Plastics* ; Prostheses and Implants ; Publications ; Surgery, Plastic* ; Surgical Instruments ; Tissue Engineering