White paper on Promoting Domestic Manufacturing of Medical Devices

India’s medical device market is the fourth largest in India and one of the top 20 worldwide; however import dependence to the tunes of about 80 percent of overall sales is an impediment to achieve self-reliance vis-a-vis domestic manufacturing of medical devices and equipments. This high reliance on imports presents a grand opportunity to domestic manufacturers. An enabled ecosystem that promotes indigenous manufacturing of medical devices is crucial for the growth of the health care sector. The current white paper analyses various scenarios for manufacturing capability of different medical technologies and probable recommendations to augment and strengthen production within each scenario.The four scenarios described in the paper includes (1) those medical devices for which there is a high domestic demand that is fulfilled through imports even if domestic manufacturing capacity exists, implying low production in the country (2) relatively low-end technology medical devices for which there is domestic demand with high reliance on imports (3) high-end technology devices which are imported to satisfy domestic need and for which there is no domestic manufacturing capacity (4) medical devices which are being exported to rest of the World. The paper recommends for a comprehensive regulatory overhauls, review of existing taxation structure, calibrated customs duty, fixed term capital subsidy, extended coverage of PLI scheme, strengthening the research and innovation ecosystem, emphasis on technology transfer and building brand India as some of the measures that can potentially favour promotion of domestic manufacturing of medical devices and allow the India Med-Tech sector to grow into global champions.

Особенности динамики струйного потока, генерируемого при поверхностном кипении жидкости на лазерном нагревателе

It was experimentally found that hot submerged jets appeared at laser induced nucleation boiling near the tip optical fiber placed in water exponentially decrease the velocity with the increasing of laser power (heat flux). This result was obtained for closed cylindrical cuvette where hot jets collided with walls slipped the cuvette boundary and transfer the heat. Obtained result is necessary to take into account at precise laser induced surface cleaning inside the closed volumes, for development of medical technologies of laser therapy of pathologically changed vessels, cysts, and for other applications.

Temporarily Abled: How Exoskeleton Experience Reinvents Bodies in Spinal Cord Injury and Cerebrovascular Accidents

Recent achievements in rehabilitative robotics modify essential parameters of the human body, such as motility. Exoskeletons used for persons with neurological impairments like spinal cord injury and stroke enter this category by rehabilitating and assisting damaged motor patterns, achievements thought impossible until not long ago. Unlike other examples leading to similar dysfunctions, such as diseases or tumors, the experience of an accident causing a spinal cord injury or the occurrence of a cerebrovascular accident is sudden and perceived as a radical event. This often leads to deep consequences for one’s own body capacities. Exoskeletons attempt to alter this condition, contributing to forge a temporary abled body, although this currently happens in the restricted space of a clinic or a lab and under very controlled conditions for the predominance of users. Using qualitative empirical material from an ongoing study in sociology, including expert and narrative interviews as well as ethnographic visits in labs and centers that design and test exoskeletons, this article addresses the challenges and gains that people with stroke and spinal cord injury experience during their training with exoskeletons. The discussed cases contribute to reassess categories from the phenomenological paradigm, disability studies, and the role medical technologies play in contemporary body worlds.

Clinical and laboratory algorithm for diagnosis of metabolic syndrome with use of new medical technologies in liquidators of Chernobyl accident

Based on a long-term dynamic study of the state of health of liquidators of the consequences of the Chernobyl accident, it was found that 75 % of patients have a metabolic syndrome, burdened with concomitant somatic pathology. The article presents literature data on the key role of adipokine levels in the development of the metabolic syndrome of adipose tissue, hormonal indicators, vitamins and other nutrients, which require modern methods of laboratory diagnostics to determine.The aim. To develop a clinical and laboratory algorithm for diagnosing metabolic syndrome in liquidators of the consequences of the Chernobyl accident using new medical technologies.Methods. 122 liquidators of the consequences of the Chernobyl accident with cerebrovascular diseases, diseases of the digestive system and endocrine system pathology were examined. Based on the International recommendations of 2009, two groups were formed: those with the absence (n = 32) and the presence (n = 90) of metabolic syndrome (MS). The control group consisted of 30 people with MS who were examined and treated at the clinic, but did not have contact with radiation. All patients were male, with an average age of 64–66 years. The main biochemical parameters in blood serum were determined. Immunochemiluminescent method was used to determine hormonal parameters. Mass spectrometry was used to determine the indicators of oxidative stress (MDA, fat-soluble vitamins A, E, D, polyunsaturated fatty acids), and trace elements.Results and analysis. A characteristic feature of MS in LPA is a signifcantly (p < 0.05) low level of total testosterone in the blood serum and the calculated ratio of testosterone/estradiol. With increasing number of MS components signifcantly (p < 0.05) increases in serum level of basal insulin and HOMA IR, leptin levels, decreases the concentration of adiponectin. The analysis of the obtained results did not reveal signifcant differences in the content of the main markers of MS in LP and patients of the control group with MS. In 25% of LPA with MS, adiponectin values are determined below the lower limit of the reference range (less than 5.6 μg/ml), and the leptin content is higher than 21.0 ng/ml at the upper limit of the reference range of 5.6 ng/ml. there Is a stable tendency to reduce HDL cholesterol. When comparing the studied indicators for MS in patients with MS at the Chernobyl NPP and the control group, a statistically signifcant increase in the concentration of vitamin E (9.7 [6.8–12.7] and 6.3 [5.3–7.7]; p = 0.001) was found by 54 % and a decrease in the level of linoleic acid (230.9 [184.6–293.0] and 262.3 [214.1–426.3]; p = 0.014) by 12 %. A decrease in selenium, zinc, copper and iodine was detected.Conclusion. The results of the study demonstrated that liquidators of the consequences of the Chernobyl accident with metabolic syndrome may develop various pathogenetic variants of MS, which can be clarifed by the proposed additional criteria of the diagnostic algorithm. Identifying the pathogenetic variant of MS opens up the possibility of a personalized approach to MS therapy and prevention of the development of circulatory diseases and diabetes.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

PP403 New Medical Technology Adoption In Asia Pacific: Focused On South Korea And Japan

IntroductionThis study is the first to analyze and compare the distinctive market access process of new medical technologies focused on technical fee creation in South Korea and Japan. The purpose of this study is to derive implications for each country through analysis and comparison of the market access process and propose improvements of new medical technology adoption program by referring the United States’ incentive program for innovative technology.MethodsIdentification and review the published articles and health polices, and reports related to the medical procedure (medical technologies) coding and payment rule in South Korea, Japan and the United States.ResultsIn Korea, for the rapid introduction of new medical technologies, a One-Stop Service program (aka parallel review process) is operated that simultaneously conducts regulatory approval and new health technology assessment (nHTA) process. In Japan, the Sakigake designation program aims to give patients better access to innovative pharmaceuticals, medical technologies, and regenerative medicines by streamlining the approval and pricing process but it doesn't provide immediate coverage after approval. Medicare Coverage for Innovative Technology (MCIT) is one of the incentive programs for innovative technology which aims to improve patient access to new medical technologies through rapid market access process in the United States. Medical technologies designated a Breakthrough Device receive immediate Medicare Coverage for 4 years by MCIT.ConclusionsIt is recommended for Korea and Japan to actively implement the accelerated patient access process and grant affordable premium prices for the innovative medical technologies. MCIT can be considered as a breakthrough for innovative medical technology adaption.

Explaining the adoption and use of computed tomography and magnetic resonance image technologies in public hospitals

Objective This article examines what the adoption and use of advanced medical technologies – computed tomography (CT) and magnetic resonance imaging (MRI) – by public hospitals depend on and to what extent. Methods From a sample of panel data for all public hospitals in the health service of Galicia (a subregion of the Galicia-North of Portugal Euroregion) for the 2010–2017 period, we grouped explanatory variables into inputs (resources), outputs (activities) and socio-demographic variables. Factor analysis was used to reduce as much as possible the number of analysed variables, discriminant analysis to examine the technologies adoption decision, and multiple regression analysis to investigate their use. Results Factor analysis identified motivators on adoption and use of CT and MRI medical technologies as follows: hospital inputs/outputs (Factor 1); radiology studies and adoption of CT by public hospitals (Factor 2); research/teaching role and big-ticket diagnostic and therapeutic (lithotripsy) technologies (Factor 3); number of transplants (Factor 4); cancer diagnosis/treatment (Factor 5); and catchment area geographical dispersion (Factor 6). Cronbach’s alpha of 0.881 indicated an acceptable degree of reliability of the factor variables. Regarding adoption of these technologies, Factor 1 is the most influential, explaining 37% of the variance and showing adequate global internal consistency, whereas Factor 2 is limited to 13% of the variance. In the discriminant analysis, values for Box’s M test and canonical correlations such as Wilks’s lambda for the two technologies underpin the reliability and predictive capacity of the discriminant equations. Finally, and according to the regression analysis, the factor with the greatest influence on CT and MRI use is Factor 2, followed by Factors 1 and 3 in the case of CT use, and Factors 3 and 5 in the case of MRI use. Conclusion CT and MRI adoption by public hospitals is mainly determined by hospital inputs and outputs. However, the use of both medical technologies is mainly influenced by conventional radiology studies and CT adoption. These results suggest that both choices – adoption and use of advanced medical technology – may be separate decisions as they are taken possibly by different people (the former by managers and policymakers and the latter by physicians).

2011-2021 – Ten more years of development of laser medical equipment and technologies

The article presents a review on laser medical equipment and laser medical technologies developed for this equipment which have appeared for the last ten years.