Les infections nosocomiales liées aux dispositifs médicaux, et plus particulièrement ceux de la perfusion, sont un problème majeur dans le milieu hospitalier. Ces infections sont liées à la présence de biofilm. Pour lutter contre le biofilm, les mesures préventives en hygiène ne sont pas suffisantes. Les recherches se dirigent vers la modification des surfaces des matériaux des dispositifs médicaux: ajout de substances biocides, développement de surfaces antiadhésives par voie chimique ou topographique. L’objectif de cette thèse est de créer des polymères nanostructurés pouvant entrer dans la composition de dispositifs médicaux de la perfusion et de tester leur impact sur l’adhésion bactérienne et le développement du biofilm. Dans un premier temps, la technique de nanostructuration choisie repose sur la réplication d’un moule nanostructuré en alumine nanoporeuse qui se caractérise par des nanopores auto-organisés en nid d’abeille. Après avoir mis en place une station d’anodisation permettant la nanostructuration de ce moule, la reproductibilité du procédé de fabrication a été validée (diamètre des pores : 51 ± 6 nm, profondeur: 97 ± 9 nm, espace interpores: 102 ± 6 nm). Ensuite, les travaux de réplication ont été effectués avec le polymère ABS (acrylonitrile-butadiène-styrène). Plusieurs méthodes de réplication ont été testées à partir de dépôt de solutions de polymères ou de fonte du matériau sur le moule d’alumine. La méthode sélectionnée sur des critères de reproductibilité et de facilité de transposition industrielle donne des nanostructures de type nanopicots (diamètres des picots : 56 ± 7 nm, distances interpicots : 101 ± 16 nm, longueurs : 73 ± 33 nm). Les surfaces développées sont ensuite caractérisées (MEB, DSC analyse calorimétrique différentielle, spectrométrie Infra Rouge, angle de contact). La fabrication des nanostructures ne semble pas dégrader le matériau ABS et la modification topographique rend la surface plus hydrophile. Une étude de stabilité montre que les nanostructures résistent à plusieurs modes de stérilisation (oxyde d’éthylène, plasma H2O2 et rayon Beta) et sont conservés dans le temps, ce qui les rend applicables à la surface d’un dispositif médical. La seconde étape du travail consiste à évaluer l’adhésion bactérienne sur les surfaces témoins et nanostructurées. Différents tests de culture de biofilm ont été réalisés avec S. epidermidis en conditions statique ou dynamique. Après un temps de 3 à 48h, les bactéries sont décrochées de la surface puis dénombrées sur gélose. Il n’y a pas de différence significative d’adhésion bactérienne entre les deux types de surface. L’observation en microscopie électronique à balayage et confocale à 24h semble confirmer ce résultat. Des tests réalisés avec d’autres souches bactériennes (S. aureus, K. pneumoniae, P. aeruginosa) en condition statique montrent également que l’adhésion est également identique sur les deux surfaces. Par conséquent, nous pouvons conclure que nos surfaces ABS développées avec ces nanopicots spécifiques n’ont pas un effet anti-adhésion sur les bactéries testées. Des recherches récentes mettent en évidence que l’espacement entre les nanopciots est un facteur critique sur l’adhésion bactérienne. L’étape suivante de notre travail consiste à tester de nouvelles nanostructures réalisées avec un moule AAO ayant une distance interpore plus grande. / Medical device-related infections are a public health concern and an economic burden. The role of biofilms in medical device-related infections is clearly established. Preventive hygiene measures are not often sufficient to prevent biofilms formation. One promising way of preventing device-related infections is the development of medical devices with surfaces or materials that reduce either microbial viability using biocidal substances or microbial adhesion with topographical modifications.Developing nanostructured polymeric surfaces, which could have applications in medical devices, and testing their impact on bacterial adhesion and biofilm development were the main goals of this thesis. First of all, the polymer was replicated on an aluminum anodized oxide nanostructured mold (AAO), characterized by highly ordered nanopores. An anodization station was made in order to create molds. Then, the reproducibility of the process fabrication was validated (pore diameter: 51 ± 6 nm, deepness 97 ± 9 nm, interpore espace: 102 ± 6 nm). Several replication techniques with ABS were tested including polymers solutions and melted polymers. The selected method was the one with the most reproducible results pillar diameter: 56 ± 7 nm, interpillar distance: 101 ± 16 nm, length: 73 ± 33 nm) and the most representative of industrial injection processes. The created surfaces were then characterized (MEB, DSC, ATR-FTIR, wettability). The fabrication process does not seem to degrade the ABS material and the topographical change increases the hydrophilicity of the surface. A stability study showed that the nanopillars were resistant to several sterilization processes (ethylene oxide, H2O2 plasma, Beta irradiation) and were maintained through time, which is an important element for applications in medical-devices.The second step of our work consisted of assessing bacterial adhesion on control and nanostructured ABS samples. Several biofilm tests were made with S. epidermis in static and dynamic conditions. Between 3 and 48 hours of culture, bacteria were removed from the surfaces and then viable plate counting was performed. No significant differences were observed between the samples. Microscopic observations (MEB, CSLM) seemed to confirm this result. Other bacteria with different morphologies were tested (S. aureus, K. pneumoniae, P. aeruginosa): bacterial adhesion was similar for the two surfaces. Therefore, we can conclude that our developed ABS surfaces with these specific nanopillars do not have an anti-adhesion effect on the tested bacteria. Recent researches showed that spacing between nanopillars is a critical factor on bacterial adhesion. The following step of our work would be to test new nanostructures using AAO molds with bigger interpore distance.

En raison de leur haute spécificité d’interaction, les protéines thérapeutiques sont de plus en plus utilisées et représentent une part majoritaire du marché pharmaceutique. Néanmoins, ces molécules sont fragiles et leur stabilité est une problématique majeure pour l'industrie pharmaceutique. La dégradation des protéines thérapeutiques peut survenir à chaque étape de leur cycle de vie : production, stockage, transport et administration au patient. Les modifications chimiques, l'exposition à des forces de cisaillement (fort débit fluidique), la température, le pH et les interactions avec les matériaux et/ou les interfaces gazeuses sont autant de facteurs qui peuvent nuire à la stabilité de ces protéines. De plus, l'utilisation croissante de dispositifs médicaux automatisés pour la manipulation et l'injection de protéines thérapeutiques augmente drastiquement le risque de dégradation. Dans cette thèse, nous étudions l’effet et le rôle de la triple interface solide/liquide/air sur l'agrégation des protéines. Ce phénomène se produit fréquemment dans les procédés de manipulation d’une solution de protéines thérapeutiques (cavitation, agitation…). Lors d’un mouillage intermittent, les interfaces air/liquide et liquide/solide se confondent en une seule et même interface appelée triple interface ou ligne triple. La ligne triple est une zone favorisant fortement l'agrégation des protéines. Notre étude, basée sur l’insuline, montre que la ligne triple cause une accumulation progressive de protéines qui déclenche, après une période de nucléation, leur agrégation, précisément à l’endroit de cette ligne triple. Nos résultats démontrent aussi que les forces de cisaillement, seules, n’entrainent pas l’agrégation de l’insuline. De plus, nous observons que la diminution de la tension superficielle (induite par l’ajout de polysorbates) d'une solution de protéines réduit le risque de formation d’agrégats. En conclusion de ce travail, nous proposons des recommandations pour la conception des dispositifs médicaux de préparation et d’administration de protéines thérapeutiques. / Due to the high specificity of their interactions, proteins are increasingly used in therapy and represent a vast majority of the global pharmaceutical market. Nevertheless, these molecules are fragile and therapeutic protein stability is a major concern in pharmaceutical industry. Protein degradation and aggregation can occur at every step during production, storage, transport and delivery. In this thesis, we interrogate the possible role of intermittent wetting in protein aggregation. Intermittent wetting frequently occurs in protocols involving pumping (cavitation), agitation, and liquid handling. During intermittent wetting, the air/liquid and liquid/solid interfaces meet at a triple line or triple interface, which is a local trigger for protein aggregation because it concentrates the mechanical action of the recessing fluid on the surface adsorbed proteins. We study the effect of surface intermittent wetting on insulin aggregation. Our results demonstrate that the triple interface line, where an air/water interface meets a hydrophobic surface, allows progressive protein accumulation, and finally triggers local insulin aggregation. We also show that shear stress, alone, is not detrimental for protein stability. Additionally, Additives such as polysorbates were tested, showing that the modification of the surface tension of a protein solution impacts its ability to form aggregates. Based on this work, we propose recommendations for the design of drug delivery and preparation devices in order to limit the risk of protein aggregation at the triple interface.

With the inevitable adoption of information technology into all areas of human pursuit, the potential benefits for health care should not be overlooked. In Australia, details of most health care encounters are currently recorded for administrative purposes. This results in an impressive electronic data-bank that could provide a national resource for health service evaluation. ¶ Evaluation of health services has become increasingly important to provide indicators of the benefits, risks and cost-effectiveness of treatments. However, if administrative data are to be used for this purpose, several questions must first be addressed: Are the current data collections accessible? What outcome measures can be derived from these data? Can privacy issues be managed? Could the quality of the data be improved? Is the existing infrastructure adequate to supply data for evaluation purposes? Could the existing system provide a basis for the development of an integrated health information system? ¶ The aims of the project were: · To examine the potential for using administrative data to generate outcome measures and surveillance indicators. · To investigate the logistics of gaining access to these data for the purpose of research. This to be achieved within the current ethical, political and financial framework. · To compare the Australian health-service data system with the current international state-of-the-art. · To develop suggestions for expansion of the present system as part of an integrated health record and information system. This system to manage patient records and provide data for quality management, treatment surveillance and cost-effectiveness evaluation as a routine activity. ¶ The thesis is presented in two parts. In the first part, a historical cohort study is described that involved patients with implantable medical devices. The potential to evaluate outcomes was investigated using all national health-service information currently available in electronic form. Record linkage techniques were used to combine and augment the existing data collections. Australia’s national health databases are to varying degrees, amenable to such linkage and cover doctor visits, pharmaceuticals, hospital admissions and deaths. The study focused on medical devices as an illustrative case but the results are applicable to the routine assessment of all medical and surgical interventions. ¶ For the Australian ‘Medical Devices study’, the records of 5,316 patients who had medical device implants in 1993-94 were selected from the archives of a major private health insurer. Five groups of medical implants were studied: heart valves, pacemakers, hips, vascular grafts and intra-optic lenses. Outcomes for these patients, including death, re-operation and health service utilisation, were compared and analysed. ¶ A comparison study was performed using data from the Manitoba Health database in Winnipeg, Canada. Manitoba provides a very similar demographic group to that found in Australia and is an example of a prototype integrated-health-information system. One of the principal advantages for research is that personally identified data about medical and hospital services are collected for all patients. Selection bias is eliminated because individual consent is not required for this type of research and all selected patients could be included in the study. ¶ The two studies revealed many barriers to the use of administrative data for health outcomes research. Service event data for the Australian cohort could be collected but only after long delays and hospital morbidity data were not available for the entire cohort. In contrast to the situation in Australia, the Manitoba data were both accessible and complete, but were lacking in detail in some areas. ¶ Analysis of the collected data demonstrated that without the addition of clinical data only general indications of trends could be deduced. However, with minimal supplementary clinical data, it was possible to examine differences in performance between brands of medical devices thus indicating one of the uses for this type of data collection. ¶ In the second part of the thesis, conclusions are presented about the potential uses and limitations of the existing system and its use as a basis for the development of a national Integrated Health Record and Information System (IHRIS). The need for the establishment of a systemic quality management system for health care is discussed. ¶ The study shows that linked administrative data can provide information about health outcomes which is not readily available from other sources. If expanded and integrated, the system that is currently used to collect and manage administrative data, could provide the basis for a national health information system. This system would provide many benefits for health care. Benefits would include the monitoring, surveillance and cost-effectiveness analysis of new and existing treatments involving medical devices, drugs and surgical procedures. An integrated health information system could thus provide for both clinical and administrative needs, while in addition providing data for research. ¶ Unfortunately, in Australia, the use of administrative data for this purpose is not currently feasible. The principal barrier is the existence of a culture within the Australian health care system which is not supportive of research and is deficient in quality and safety measures. ¶ Recent initiatives by both the Commonwealth and state governments have supported the introduction of measures to improve quality and safety in health care. It is argued here that an Integrated Health Record and Information System (IHRIS) would provide an essential component of any such scheme. The results of this study have important policy implications for health care management in both the administrative and clinical domains.

The delivery of quality healthcare to all citizens at reasonable costs is an important challenge. With the increase in the aging population, the costs of managing chronic diseases increase. Today, healthcare services tend to shift from recovery to prevention. Remote healthcare monitoring is crucial for prevention and monitoring of chronic diseases since they require continuous and long-term monitoring. The advances in networking, mobile communications and medical device technologies offer a great potential to realize remote healthcare monitoring. However, seamless integration of multi-modal medical devices to the existing healthcare information systems is necessary for the automated use of medical device observations in related applications. The thesis addresses the automatic acquisition and use of multi-modal medical device observations in healthcare information systems. The interoperability of medical devices with healthcare information systems requires both physical connectivity and application level interoperability. Therefore, the thesis concentrates on both the medical device domain and the interoperability efforts on the existing healthcare information systems. It provides an interoperability solution based on ISO/IEEE 11073 and HL7 standards. This work is also realized the automatic acquisition and use of multi-modal medical device observations in an intelligent healthcare monitoring and decision support system which is developed as a part of the IST-027074 SAPHIRE project funded by the European Commission.

The public relations field is rapidly adopting two-way symmetrical communications as a way to achieve excellence and win-win solutions for multiple publics. This paper focuses on activism and industry public relations approaches involving a group of expert physicians in Houston and the medical devices industry. After exploring two-way symmetrical communications and the Excellence Theory of Public Relations, the paper explores these physicians’ viewpoints and provides an overview of the medical device industry. The discussion then provides public relations suggestions for the physicians to symmetrically approach the industry to create change. Next, the paper recommends how the medical device industry can respond to work with the physicians and to prevent possible public relations damage and crisis. The paper concludes by expressing the importance of applying symmetrical communications methods to solve challenges and create win-win solutions. / text

The present day world has been experiencing rapid technological advancement on the one hand and increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, taking an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialled before its launch to ensure safety and efficacy. Of late, India has emerged as one of the preferred destinations to carry out clinical studies due to numerous advantages, primarily its diverse human gene pool and cost-competitiveness. However, there is very little understanding on the landscape of medical devices clinically trialled in India. It is to throw light on this critical issue with respect to the selection of participants in the clinical trial process, selection of locations and determination of trial duration that the present study has been carried out. In addition, the role of patents associated with the introduction of new medical devices in relation to the key challenges is examined. Furthermore, we studied the characteristics of clinical trials by industry and non-industry sponsors and between cardiovascular and other disease related trials. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008-2014. At the outset, the pattern of trials related to the most prominent diseases such as cardiology and cardiovascular diseases and those which are invasive and non-invasive are examined. Our findings indicate that almost 50% of the trials are related to diseases of cardiology, cardiovascular diseases and those which are invasive in nature. For studying the patenting aspect, we proposed a conceptual grouping of sponsors as Incumbent, Potential Entrant and Supporter, based on their patent holdings in the domestic market and in PCT (Patent Cooperation Treaty) filings. Patents owned by Primary Sponsor (PS) showed significant variations in their clinical trial characteristics particularly the invasiveness of device, disease type, locations and participants. Three quantitative models are developed to identify the factors that influence the selection of number of participants, locations and time taken to execute medical device clinical trials using multivariate statistical techniques. The results of the three conceptual models on number of participants, locations and trial duration showed invasiveness of device and disease type playing significant roles in all the three models. The number of PCTs owned by PS was found to be influential in selecting the number of locations and participants but not the patents owned in IPO (Indian Patent Office). We also observed significant differences between industry and non-industry sponsors in terms of their clinical trial characteristics. The findings of the study formed the basis to understand the medical device clinical trial landscape and other pertinent issues in the Indian context, which enabled us to derive appropriate inferences and policy implications.

A economia da saúde, composta pela demanda social de bens e serviços, pela formação de profissionais, por indústrias de alta tecnologia e por produção e consumo de insumos e medicamentos, pode ser entendida por meio dos conceitos de circuito espacial produtivo e círculos de cooperação no espaço, assim como pelo de complexo industrial da saúde. Essa economia desenvolveu-se na relação entre serviços públicos e privados, tendo o Estado como mediador, para corrigir as assimetrias das estratégias de mercado. Estudando suas principais periodizações e o processo brasileiro de industrialização, esta pesquisa sistematiza informações que explicitam a vertente espacial da produção de equipamentos para radiologia e diagnóstico por imagem, que se caracteriza pela profunda interação entre ciência e técnica sob a égide do sistema capitalista de produção e que logram tornar-se globais, e discute a tipologia e a topologia dos equipamentos avaliados, refletindo sobre sua distribuição desigual no território, o que acaba reforçando as contradições socioeconômicas já existentes. Assim, esse período técnico-científico-informacional assiste à permanente introdução de novos objetos técnicos, conformando uma tecnosfera e uma psicosfera que orientam a racionalidade, a irracionalidade e a contrarracionalidade no território e nas práticas médicas contemporâneas. / Health economics, formed by the social demand for goods and services, specific professional education, high technology industries, the production and consumption of medicines and intermediary goods, can be understood through the concepts of productive spatial circuits, circles of cooperation in space and the health industry complex. It has been developed through the relations between public and private services, having the State as mediator to rebalance the asymmetric market strategies. Stressing its most important periods and to the brazilian industrialization process, this research intents to undertake: systematically address data regarding the spatial perspective on the production of radiology and diagnostic imaging devices for medical uses, which is deeply involved with the interaction between science and technique under the auspices of the capitalist system of production, thanks to whom it became global; the characteristics and the topology of the devices studied, reflecting the uneven distribution of these devices in the use the brazilian territory, which end up to reinforce the existing socioeconomic contradictions. This period, technical, scientific and informational, thus, witness the constant addition of technical objects, creating a tecnosphere and a psychosphere that conducts the rationality, counter-rationality in brazilian territory and the contemporary medical practice.

Notre équipe a optimisé la formulation de dispositifs médicaux implantables pour l’ingénierie tissulaire osseuse et cartilagineuse. A ces fins, nous nous sommes basés sur des implants nanostructurés d’origine naturelle ou synthétique conçus au sein du laboratoire par la méthode d’électrospinning, pour imiter la matrice extracellulaire du compartiment osseux, et un hydrogel composé d’alginate et d’acide hyaluronique imitant la composition du compartiment cartilagineux. Dans une première partie de mon travail, pour la régénération osseuse, nous avons optimisé la formulation d’un implant nanostructuré à base de chitosane pour une accélération de cette régénération. Ceci a été possible en rendant actif ce dispositif médical implantable par incorporation de nanoparticules de silice, conférant à la construction nanocomposite des propriétés mécaniques accrues, et une excellente biocompatibilité avec le tissu hôte. Une autre étude pour la même visée a permis d’élaborer une nouvelle stratégie d’ensemencement de dispositif implantable synthétique et nanostructuré par des microtissus cellulaires, remplaçant un ensemencement de cellules isolées et permettant des performances de minéralisation accrues à l’intérieur de l’implant. Dans un deuxième temps, pour la régénération de l’unité ostéoarticulaire, nous avons proposé deux implants bi-compartimentés et hybrides comportant des microtissus de cellules souches mésenchymateuses. Ces implants sont composés d’un hydrogel contenant les cellules souches permettant la régénération du cartilage, et d’une membrane collagénique naturelle (Bio-Gide®) ou synthétique (membrane de polycaprolactone), dotée de nanoréservoirs (technologie brevetée par le laboratoire) de facteur de croissance ostéogénique (BMP-7) pour une régénération du socle osseux (os sous-chondral) de l’unité os-cartilage. La troisième partie de mon travail a concerné la vascularisation des implants osseux et particulièrement l’accélération du recrutement vasculaire. Dans ce cadre plus vasculaire, nous avons proposé une stratégie qui vise à doter un implant synthétique nanostructuré de facteur de croissance angiogénique (VEGF), puis à lui appliquer un ensemencement séquentiel de cellules mésenchymateuses adultes « ostéoblastes humains» et de cellules endothéliales humaines (HUVECs). Cette stratégie a permis un recrutement et une hiérarchisation accrue des cellules endothéliales dans l’implant. En conclusion, l’optimisation des implants développés au laboratoire permettra sans nul doute de proposer dans un futur proche de nouveaux dispositifs médicaux implantables (DMI) thérapeutique combinés de type DMI-MTI (Médicaments de Thérapie Innovante) pour l’ingénierie tissulaire osseuse et cartilagineuse en particulier en médecine régénérative ostéo-articulaire. / Our team optimized the formulation of implantable medical devices for bone and cartilage tissue engineering. To that end, we based our work on nanostructured implants, either natural or synthetic, made in the laboratory by electrospinning process, to mimic bone extracellular matrix, and hydrogel of alginate/hyaluronic acid to mimic cartilage extracellular matrix. First, concerning bone regeneration, we optimized the formulation of a nanostructured scaffold composed of natural chitosan to enhance bone regeneration. This was made possible by doping this implantable medical device with silica nanoparticles, offering this nanocomposite better mechanical properties, and excellent biocompatibility with host tissue. Another study with the same aim allowed elaborating a new cell seeding strategy, to seed these implantable medical devices with cell microtissues instead of single cells, offering higher mineralisation efficiencies within the implant. Consequently, for the regeneration of the osteochondral unit, we proposed two compartmented and hybrid implants comprising mesenchymal stem cells microtissues. Those implants are made of a hydrogel containing the stem cells, allowing the regeneration of cartilage, and a membrane, either natural (collagenic Bio-Gide®) or synthetic (electrospun polycaprolactone) equipped with nanoreservoirs (technology patented by the laboratory) of osteogenic growth factor (BMP-7) for the regeneration of osseous stand (the subchondral bone) of the bone-cartilage unit. Finally, to study the improvement in vascular recruitment, we proposed a new strategy combining the modification of an implantable device with angiogenic growth factor (VEGF), prior to its sequential seeding with mesenchymal cells “human osteoblasts” and human endothelial cells (HUVECs). This strategy allowed higher recruitment and structuration of endothelial cells within the implant. To conclude, the implant optimisation strategies developed in the laboratory will certainly allow proposing in the near future new combined Advanced Therapy Medicinal Products (ATMPs) and Implantable Medical Device for bone and cartilage regeneration, in particular in the field of osteoarticular regenerative nanomedicine.

The healthcare environment is a complex one, saturated by wireless medical devices and sensitive patient data flowing through the network traffic. With the increased popularity of wireless medical devices in the healthcare domain together with the announcement of the new wireless security standard WPA3 comes a need to prepare for a new generation shift in wireless security. The goal of this study is therefore to investigate what challenges the healthcare sector can encounter when faced with the inevitable transition to WPA3. By performing a literature review on the security state of WPA3 compared to its predecessor and performing qualitative interviews with network technicians working in the healthcare sector, three major challenges were identified. IT professionals in the healthcare domain struggle with integrating legacy software systems, keeping middleware software solutions secure, and with handling hardware medical devices that come with outdated wireless standards. By analysing existing literature, several mitigating actions to battle these challenges were presented in this study.

La presente investigación busca identificar y analizar los factores que incrementaron las importaciones Chinas de Dispositivos Médicos, en la categoría desechables en el periodo, 2016-2019, las cuales tuvieron un crecimiento del 58% del valor CIF. En el Perú el 98% de Dispositivos Médicos son importados lo cual indica una gran necesidad para abastecer al mercado nacional. Por lo cual estudiaremos las categorías como: Requisitos y costos de importación, TLC Perú-China y el avance tecnológico. Se estableció el marco teórico, se detalló la metodología de la investigación y se utilizó un enfoque cualitativo, para recopilar la información se realizaron encuestas a la muestra conformada por 09 entrevistados, los cuales son importadores de Dispositivos Médicos Chinos, posterior a esto la información será analizada a través del programa Atlas Ti. Finalmente, se presentaron las conclusiones y recomendaciones de la investigación donde se logró validar la hipótesis general. De este modo se validó las categorías, sub categorías. y dos nuevos hallazgos. Además, se recomendó para futuros estudios realizar una investigación cuantitativa para tener otra perspectiva del sector. / This research seeks to identify and analyze the factors that increased Chinese imports of medical devices, in the disposable category in the period, 2016-2019, which had a growth of 58% of the CIF value. In Peru, 98% of Medical Devices are imported which indicates a great need to supply the national market. Therefore, we will study categories such as: Import requirements and costs, Peru-China FTA and technological advance. The theoretical framework was established, the research methodology was detailed and a qualitative approach was used, to collect the information, surveys were conducted on the sample made up of 09 interviewees, who are importers of Chinese Medical Devices, after this the information will analyzed through the Atlas Ti program. Finally, the conclusions and recommendations of the research were presented where the general hypothesis was validated. In this way, the categories and sub categories were validated. and two new finds. In addition, it was recommended for future studies to carry out a quantitative investigation to have another perspective of the sector. / Tesis