Medical device development from ideation to regulation and technology transfer in low- and middle-income countries

@#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.

Analysis and comparison of major plant databases in China and ASEAN countries / 国际中医中药杂志

At present, countries around the world are paying greater attention to the protection of medicinal plants and traditional medicinal knowledge resources, and are looking for various ways to protect medicinal plants. Many countries have established their own databases to save the medicinal plant information resources. This paper focuses on the introduction of medicinal plant databases in six countries including Malaysia, Philippines, and Singapore, and compares their basic information. It is difficult to achieve integration and sharing among these databases. It brings certain difficulties to the use of researchers in related fields. It is suggested that the construction of a multinational common medicinal plant database should be included in the "Belt and Road Initiative" to systematically organize massive information, enhance exchanges between countries on traditional medicinal plants, and achieve medicinal plant information sharing, and the establishment of a shared database will reduce optimization and maintenance to a certain extent or renewal work, laying the foundation for the protection, development and sustainable use of traditional medicinal plant resources.

Analysis on the cooperative intentions and needs of Chinese and Association of Southeast Asian Nations medical universities/colleges in research / 中华医学科研管理杂志

Objective:The study aims to gain information on medical research status and cooperative needs of medical universities/colleges from China and Association of Southeast Asian Nations (ASEAN) and provide evidence to guide the regional cooperation and development in medical reserach.Methods:A self-constructed questionnaire survey was adopted to collect information on the cooperative intentions, expertise and challenges of the 43 member institutions of China-ASEAN University Consortium on Medicine and Health in medical research.Results:In total, 20 Chinese members and 10 ASEAN members completed the survey. The study found that both Chinese and ASEAN medical universities/colleges were particularly interested in cooperation in academic conferences, multi-center clinical trials and joint research projects /flagship projects, followed by large cohort studies and medical journal/publication. In terms of research priority, both Chinese and ASEAN institutions were very interested in big data, followed by cancer precision medicine; while ASEAN members were more interested in natural drugs and dengue than Chinese ones.Conclusions:Both Chinese and ASEAN medical universities/colleges had strong interest in international cooperation in medical research. They should further explore the advantages and characteristics of both sides in medical research based on the interests of two sides, adopt appropriate scientific research cooperation methods, and establish sound scientific research cooperation mechanism so as to deepen cooperation in medical research, promote the development and improve the outcome of regional medical research, and facilitate the building of a community of common health for mankind.

Traditional medicinal plants for arthropod-borne diseases of five countries in Lancang-Mekong region:a review / 中国中药杂志

Arthropod-borne diseases, such as malaria and dengue fever, have frequently beset five countries(Cambodia, Vietnam, Laos, Myanmar, and Thailand) in the tropical rainy Lancang-Mekong region, which pose a huge threat to social production and daily life. As a resort to such diseases, chemical drugs risk the resistance in plasmodium, non-availability for dengue virus, and pollution to the environment. Traditional medicinal plants have the multi-component, multi-target, and multi-pathway characteristics, which are of great potential in drug development. Exploring potential medicinals for arthropod-borne diseases from traditional medicinal plants has become a hot spot. This study summarized the epidemiological background of arthropod-borne diseases in the Lancang-Mekong region and screened effective herbs from the 350 medicinal plants recorded in CHINA-ASEAN Traditional Medicine. Based on CNKI, VIP, and PubMed, the plants for malaria and dengue fever and those for killing and repelling mosquitoes were respectively sorted out. Their pharmacological effects and mechanisms were reviewed and the material basis was analyzed. The result is expected to serve as a reference for efficient utilization of medicinal resources, development of effective and safe drugs for malaria and dengue fever, and the further cooperation between China and the other five countries in the Lancang-Mekong region.

Path selection of internationalization of traditional Chinese Medicine based on Belt and Road Initiative strategy / 中草药

With the continuous promotion of "Belt and Road Initiative" strategy, it has brought unprecedented opportunities for the development of traditional Chinese medicine (TCM) industry in China. Although TCM culture has a long history and TCM industry is huge, the data analysis with the ASEAN countries from 2009 to 2018 shows that there is still much room for development in the aspects of technological progress efficiency, scale efficiency, and technological innovation efficiency of TCM industry in China. The internationalization of TCM industry in the process of "Belt and Road Initiative" strategy from three aspects: setting up "Belt and Road Initiative"TCM technology industry fund, building authentic medicine cluster brand, and promoting the breakthrough of TCM biotechnology by equipment innovation are put forwardin this paper.

The COVID-19 pandemic in the ASEAN: A preliminary report on the spread, burden and medical capacities

Objective: To provide preliminary descriptions of the spread, burden and related medical capacity characteristics of the ASEAN countries. Methods: We utilized the data from four main official databases, including WHO reports, the Statistics and Research of the Coronavirus Disease, and the Southeast Asia Program of the Center for Strategic and International Study. The spread of the COVID- 19 pandemic, current burden and the COVID-19 medical response capacities were extracted before April 11, 2020. Results: As of April 13, 2020, the ASEAN countries reported 19 547 COVID-19 positive cases with 817 deaths (case-facility rate of 4.2%). Thailand was the first country in the region that reported having the COVID-19 cases, while Laos was the last to report confirmed COVID-19 cases. Durations for the number of deaths to double were between 8-12 days. For the testing and treatment capacities, the number of PCR tests provided to the populations was the highest in Vietnam, followed by Singapore, Malaysia, and Thailand. Meanwhile, the percentage of the population being tested was the highest in Brunei (2.31%), followed by Singapore (1.30%). Conclusions: A wide range of interventions were taken into practice in response to the outbreak with an effort of curbing the rise of this pandemic. However, special care should not be overlooked as the pandemic is placing a huge impact on the population and becomes increasingly unpredictable. To tackle the spread of the pandemic in the region, the ASEAN countries should work together as one community to provide better responses to future pandemics and other transboundary public health challenges.

The COVID-19 pandemic in the ASEAN: A preliminary report on the spread, burden and medical capacities

Objective: To provide preliminary descriptions of the spread, burden and related medical capacity characteristics of the ASEAN countries. Methods: We utilized the data from four main official databases, including WHO reports, the Statistics and Research of the Coronavirus Disease, and the Southeast Asia Program of the Center for Strategic and International Study. The spread of the COVID- 19 pandemic, current burden and the COVID-19 medical response capacities were extracted before April 11, 2020. Results: As of April 13, 2020, the ASEAN countries reported 19 547 COVID-19 positive cases with 817 deaths (case-facility rate of 4.2%). Thailand was the first country in the region that reported having the COVID-19 cases, while Laos was the last to report confirmed COVID-19 cases. Durations for the number of deaths to double were between 8-12 days. For the testing and treatment capacities, the number of PCR tests provided to the populations was the highest in Vietnam, followed by Singapore, Malaysia, and Thailand. Meanwhile, the percentage of the population being tested was the highest in Brunei (2.31%), followed by Singapore (1.30%). Conclusions: A wide range of interventions were taken into practice in response to the outbreak with an effort of curbing the rise of this pandemic. However, special care should not be overlooked as the pandemic is placing a huge impact on the population and becomes increasingly unpredictable. To tackle the spread of the pandemic in the region, the ASEAN countries should work together as one community to provide better responses to future pandemics and other transboundary public health challenges.

Discussion on Japanese Nursing Contributions for Quality Improvement of Nursing in the ASEAN Region: Meeting Report / 国際保健医療

  One of the characteristics of nursing in Southeast Asia is the ASEAN Mutual Recognition Arrangements on Nursing Services, which strengthens professional capabilities through four objectives include facilitating mobility of nursing professionals within ASEAN.  The Japanese government supports human resources for health in the ASEAN region, as a member country of ASEAN+3. A meeting was held at the Annual Meeting of the Japan Association for International Health 2017. The meeting objectives were as follows: (1) to share three nursing research findings regarding nursing migration, regulatory framework, and in-service training that may affect quality of nursing and (2) to discuss Japan’s role in improving the quality of nursing in the ASEAN region. This report aims to summarize the presentations and points of that meeting.   The academic level of nursing education and nursing regulations have improved in ASEAN member countries. All member countries have university nursing education, and some have master’s and doctoral degree nursing programs. In lower middle income ASEAN countries, such as Cambodia, Laos, and Vietnam, the nursing education system is in the process of transition, from the technical to professional level of nursing. The next step for these countries is to strengthen the capabilities of nursing teachers who are responsible for professional nursing education at universities. The ASEAN University Network and universities in neighboring Thailand could also contribute to this end. In-service training is also needed because the guidance of more experienced nurses is crucial in nursing service as well as nursing practicums. Japan’s experience of developing an in-service training system could be useful for some ASEAN countries.   The objective of mobility among nursing professionals within the ASEAN has yet to be accomplished. However, there are pull and push factors of nurse migration due to economic conditions within the ASEAN. It is predicted that nurse migration will occur with mixed-skill caregivers to high income countries out of the ASEAN countries, because of the lack of caregivers for the aging population. In order to ensure quality nursing in the ASEAN region, it is not only necessary to share country-level experiences to improve nursing education and regulations but also crucial to develop systems that promote the circulation of nursing professionals through wide regional cooperation.

‘Houdini’s Pituitary:’ A case report of regression of pituitary mass to Empty Sella in a 58-year-old man with autoimmune Hypophysitis / Journal of the ASEAN Federation of Endocrine Societies

@#A 58-year-old male presented with persistent severe headache, lethargy, decline libido and no neurological deficits. Besides quadruple anterior pituitary hormonal deficiencies, magnetic resonance imaging (MRI) demonstrated an enlarged ring-enhanced non-homogenous pituitary. Following hormonal replacement, these symptoms improved but empty sella evolved. The challenges of diagnosis and management were discussed. Awareness of the unclear etiologyand uncertain clinical course of autoimmune hypophysitis in a man in this age group is essential for prompt and appropriate management.

Research on differentiated marketing strategy of ASEAN market for development of Chinese patent medicine based on principal component analysis and hierarchical clustering method / 中草药

With high-tech, high added-value, and independent intellectual property rights, Chinese patent medicine (CPM) is one of the most important exporting categories in Chinese materia medica (CMM), and its overseas development has become an important symbol of international recognition for CMM. With the implementation of the Belt and Road Initiative and the acceleration of bilateral economic integration, CMM trade between China and Association of Southeast Asian Nations (ASEAN) is facing with great potential and opportunities. ASEAN market is bound to be a vital breakthrough in the globalization of CPM and has strategic significance for its transnational operation. Since ten member countries of ASEAN have obvious differences in their economic development, market size, and medical and health levels, this paper aims to establish evaluation index system, further subdivide the ASEAN market by means of principal component analysis and hierarchical clustering method, and put forward different marketing strategies for each segmented markets including developed market, emerging market, potential market, and secondary market, hoping to provide useful advice and reference for the globalization of CPM in ASEAN or even in European and American main market.

Medical team arrangement and practice during fourth ASEAN regional forum disaster relief exercise / 医疗卫生装备

Objective To summarize the practices of national emergency medical rescue team in the fourth ASEAN regional forum disaster relief exercise.Methods The establishing principle and training mode of national emergency medical rescue team were introduced,and the advantages and disadvantages of the team were described in the preparation for exercise and rescue practice.Results The experience in Malaysia improved the team in emergency support.Conclusion The medical preparedness and rescue practice in transnational disaster relief are of great value for rapid response of national emergency medical rescue team.

For effective training program on nursing education system in Southeast Asia: Lessons learnt from the training evaluation / 国際保健医療

<p><b>Purpose</b></p><p>  The training for “Strengthening Human Resource Development for Nursing and Midwifery in Southeast Asia” was implemented in order to strengthen the nursing education system in Cambodia, Laos, Myanmar and Vietnam. The purpose of this study was to evaluate the training using the training evaluation guide suggested by WHO; and to explore factors for training program to be effective, issues, and lessons.</p><p><b>Methods</b></p><p>  The WHO training evaluation guide which has five evaluation levels was modified as a tool to evaluate the training. Data were collected from training evaluations questionnaire, meeting records during training, and records of interviews conducted during follow-up visits. The factors for training to be effective, issues, and lessons were inductively identified by methodological triangulation from the results of training evaluations, the summary of training feedback from participants and the results of action plan progress. </p><p><b>Results and Discussion</b></p><p>  The training was evaluated as effective that not only achieved “Level 1: Reaction and Satisfaction” and “Level 2: Learning”, but also “Level 3: Behavior”. The factors for training to be effective were (1) practical content through sharing experiences amongmulti-country participants in neighboring countries, (2) selection of suitable trainees by setting the training language as the native language of each participating country, (3)lecture documents in native language facilitated sharing of the learning with relevant people in one’s own country, (4) maintain trainees’ motivation to implement action plans following an agreement with trainees during the training to confirm action plan progress through follow-up visits, and (5) pre-visitingeach participating country to explain the training outline makes relevant people’s much understanding of the training and interest in the action plan. Lessons learned were the importance of the definitions of technical terminology in each country’s native language and the efficacy of follow-up visits. Future issues are: “Level 4: Results”, support for each participant’s needs and “Level 5: Impact”, the development of mechanisms for continued sharing of experiences.</p><p><b>Conclusions</b></p><p>  Our evaluation confirmed the effective factors　for training, issues, and lessons. These are needed to be considered for the future training.</p>

Indonesian strategy in reducing Aedes aegypty diseases in ASEAN economic community era.

Indonesia is one of the countries that has a very strategic role in the ASEAN region. The state of readiness of Indonesia in ASEAN Economic Community (AEC) 2015 will involve all elements of the society due to very large population. Economically, Indonesia should be able to compete with ASEAN countries, and human resources should also be prepared. On the other hand, shifts and movements of the people between countries will be increased, this could be a threat for the country. However, those who are ready with the human resources, it might be a positive value, otherwise, it might be a weakness for unprepared countries. AEC era is not only economic power that should be concerned, but also health problems that should be a priority. Nowadays, the Aedes aegypti cases are still high in Indonesia. This paper aims to describe the strategies to reduce the disease, which also be a focus of government.

ASEAN mutual recognition arrangement for Indonesian nurses: is it a promise.

Nurse surplus, nurse shortage, nurse migration, unequal distribution, and multiple backgrounds of nurses are challenges being faced by Indonesian government and nurse leaders. ASEAN mutual recognition arrangement is expected to address these challenges by facilitating nurses‟ mobility, exchanging knowledge and best practice, and providing a scheme to develop nurse competency in Indonesia. However, there are some concerns need to consider related to the policy and the context of Indonesian nurses, and the objectives and requirements of MRA.

A systematic review of the burden of neonatal mortality and morbidity in the ASEAN Region.

Neonatal morbidity and mortality are major global public health challenges representing an increasing proportion of overall under-5 child mortality, with the vast majority of neonatal deaths occurring in resource-limited settings. In the Association of Southeast Asian Nations (ASEAN) region, it is estimated that approximately 200 000 neonatal deaths occur annually with reported estimates of the neonatal mortality rate ranging from 1 to over 30 per 1000 live-births, depending on the setting. The aim of this study is to conduct a systematic review of published data on neonatal morbidity and mortality from the ASEAN region over the last 10 years. Very few published studies reporting neonatal morbidity and mortality in this region were found. Importantly, data are available from just a few countries, with an underrepresentation of the most resource-limited settings. The majority of the studies describing mortality and morbidity were retrospective surveys or focussed on a specific cause of neonatal morbidity. Studies included findings from a range of settings, from neonatal intensive care to community settings utilizing verbal autopsy. Therefore, comprehensive and prospective data are needed to inform priorities and potential interventions to improve neonatal care and reduce neonatal mortality in this region.

Resources and organization of Neurology care in South East Asia

ASEAN Neurology Association (ASNA) consists of 9 member countries, Brunei, Indonesia, Lao, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Among them 2 countries are considered lower middle income, 4 as upper middle income, and 3 as high income by World Bank criteria. The life expectancy is above 75 years in Brunei and Singapore, below 60 years in Lao and Myanmar. There are a total of 1,871 neurologists in ASNA member countries which has a total of 540 million populations. This constitutes 2.2% of the world neurologists, although ASNA member countries accounts for 8.3% of the world population. Myanmar and Lao in particular, has lowest ratio of neurologist, with one neurologist serving 5 million populations in Myanmar, and 2 million populations in Lao.