This thesis aims to explore the challenges of Medical Devices sector in their innovative activities with the use of qualitative and quantitative methods. The specific subject of analysis is the Turkish Medical Device industry. Throughout the thesis the convergence of Medical Devices with pharmacy and its role in healthcare is mentioned in addition to the institutional regulations of the sector due to their effect on the firms innovative activities. The main focus of this thesis is the innovation in medical devices as vital components of healthcare supply with an important share in health expenditures. Even though Medical Devices are considered to be heterogeneous and classified in many other sectors such as chemicals, textiles and electronics, they have common features sufficient to be considered as a special product group and being an important part of the healthcare system, they are subject to common regulations. Sectoral Systems of Innovation approach is used to investigate Medical Devices Sector in Turkey. Medical devices sector also suffer from regulations that put cost on innovative activities, reimbursement policies that aim at cost containment, lower degrees of consumer support (in terms of user-producer relationship), high marketing costs due to the specific market they act in, in addition to the general obstacles such as scarce finance and human resources. Nonetheless, the ambiguity in entrance and allowance to reimbursement lists is also found to be a blocking factor on innovation.The studies on this aspect of the medical devices sector are limited and this thesis aims to fulfil the gap in this respect.

[pt] Nas últimas décadas, vem ocorrendo uma importante revolução na área da tecnologia médica, em particular nos equipamentos de diagnóstico por imagem. O propósito central da presente tese concentra-se na análise e compreensão das estratégias e sistemas produtivos empregados na produção desses equipamentos, com enfoque específico na produção de equipamentos de Ressonância Magnética, pela importância de se dispor de dados e informações principalmente em países como o Brasil que, apesar de ainda não apresentarem produção nacional, fazem uso de toda essa tecnologia e necessitam preparar recursos humanos não só para a sua própria utilização, mas também para o desenvolvimento e produção de componentes e periféricos específicos. Um grande motivador para esta pesquisa foi o Projeto ToRM, desenvolvido pela Universidade de São Paulo. O projeto constava do desenvolvimento local de um equipamento de ressonância para que fosse possível a formação de mão-de-obra especializada e a realização de estudos para acessórios e componentes. A metodologia empregada neste estudo, o qual é de caráter exploratório, envolve uma pesquisa bibliográfica e dois estudos de casos realizados em empresas produtoras de equipamentos de diagnóstico por imagem - Philips Medical Systems e Siemens Medical. Assim, com a compreensão dos sistemas produtivos aplicados, objetiva-se subsidiar as empresas e universidades com informações atualizadas referentes a essa indústria, principalmente pela falta de material acadêmico sobre o assunto. / [en] In the last decades, an important revolution has taken place in the medical technology field, particularly in image diagnosis equipment. The central purpose of the present thesis is to analyze and understand the strategies and productive systems used in the production of such equipment, with specific focus on the production of Magnetic Resonance equipment. It is important to make data and information available especially in countries like Brazil, which, despite still not having a national production, make use of this technology and need to prepare human resources not only for its own use but also for the development and production of specific components. A great motivation to this research was the ToRM Project, developed by the University of São Paulo. This project consisted in the local development of a resonance machine, which would allow for the preparation of specialized professionals and the development of studies about accessories and components. The methodology used in the present study, which is exploratory in character, involves a literature review and case studies performed in two major manufacturers of image diagnosis equipment - Philips Medical Systems and Siemens Medical. Thus, by understanding the productive systems applied, our goal is to provide companies and universities with updated information about this industry, especially considering the lack of academic material on this subject.

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.

Com o aumento da capacidade de processamento de dados dentro das empresas de todos os portes e da disponibilidade de informações cada vez maior nos tempos atuais, o uso de indicadores e ferramentas de análise quantitativa tornam-se cada vez mais comuns nas mais diversas áreas, buscando-se eficiência, uma correta alocação de recursos e na geração de expectativas mais realistas de vendas e resultados. Enquanto muitos mercados apresentam uma variedade de dados e de estudos para serem usados como bases de referência, existem outros que ainda são carentes de informações básicas para planejamento e análise. O mercado de materiais cirúrgicos é um destes, onde não estão disponíveis as demandas dos clientes, as projeções de mercado ou as estimativas de market share. Este estudo busca, através da análise das vendas em 43 territórios de empresas de dispositivos médicos com atuação no Brasil nas áreas de ortopedia traumatologia, neurocirurgia e buco-maxilo-facial, aplicar a técnica de Análise Envoltória de Dados (DEA, do inglês “Data Envelopment Analysis”) como um modelo de análise comparativa de eficiência que possa auxiliar nos processos de tomada de decisão, mesmo com uma base restrita e limitada de informações. A aplicação da técnica de DEA apresenta resultados que permitem [1] destacar os pontos de melhoria para os territórios ineficientes buscando [2] homogeneizar a eficiência de atendimento por meio do [3] benchmarking entre as regiões buscando [4] uma maior competitividade neste mercado. / With the increased capacity of data processing within companies of all sizes and the currently availability of all sort of informations, the use of indicators and tools for quantitative analysis become increasingly common in many areas, allowing companies to achieve better efficiency, proper resources allocation, and the settle of more realistic performance expectations. While many markets feature a variety of data and studies, others are deprived of basic information for planning and analysis. Among these, the medical devices market have almost unavailable informations of customers demands, markets forecasts or estimated market share at a regional level. Through the analysis of 43 sales territories of medical devices companies in Brazil, this study uses the technique of data envelopment analysis (DEA) as a model for comparative efficiency analysis that can assist the processes of decision making, even with a restricted and limited database. The application of DEA technique provide results that [1] highlight the points of improvement for inefficient territories [2] in order to homogenize the efficiency of regions through [3] benchmarking between them, [4] to improve overall competitive level.

Com o aumento da capacidade de processamento de dados dentro das empresas de todos os portes e da disponibilidade de informações cada vez maior nos tempos atuais, o uso de indicadores e ferramentas de análise quantitativa tornam-se cada vez mais comuns nas mais diversas áreas, buscando-se eficiência, uma correta alocação de recursos e na geração de expectativas mais realistas de vendas e resultados. Enquanto muitos mercados apresentam uma variedade de dados e de estudos para serem usados como bases de referência, existem outros que ainda são carentes de informações básicas para planejamento e análise. O mercado de materiais cirúrgicos é um destes, onde não estão disponíveis as demandas dos clientes, as projeções de mercado ou as estimativas de market share. Este estudo busca, através da análise das vendas em 43 territórios de empresas de dispositivos médicos com atuação no Brasil nas áreas de ortopedia traumatologia, neurocirurgia e buco-maxilo-facial, aplicar a técnica de Análise Envoltória de Dados (DEA, do inglês “Data Envelopment Analysis”) como um modelo de análise comparativa de eficiência que possa auxiliar nos processos de tomada de decisão, mesmo com uma base restrita e limitada de informações. A aplicação da técnica de DEA apresenta resultados que permitem [1] destacar os pontos de melhoria para os territórios ineficientes buscando [2] homogeneizar a eficiência de atendimento por meio do [3] benchmarking entre as regiões buscando [4] uma maior competitividade neste mercado. / With the increased capacity of data processing within companies of all sizes and the currently availability of all sort of informations, the use of indicators and tools for quantitative analysis become increasingly common in many areas, allowing companies to achieve better efficiency, proper resources allocation, and the settle of more realistic performance expectations. While many markets feature a variety of data and studies, others are deprived of basic information for planning and analysis. Among these, the medical devices market have almost unavailable informations of customers demands, markets forecasts or estimated market share at a regional level. Through the analysis of 43 sales territories of medical devices companies in Brazil, this study uses the technique of data envelopment analysis (DEA) as a model for comparative efficiency analysis that can assist the processes of decision making, even with a restricted and limited database. The application of DEA technique provide results that [1] highlight the points of improvement for inefficient territories [2] in order to homogenize the efficiency of regions through [3] benchmarking between them, [4] to improve overall competitive level.

Com o aumento da capacidade de processamento de dados dentro das empresas de todos os portes e da disponibilidade de informações cada vez maior nos tempos atuais, o uso de indicadores e ferramentas de análise quantitativa tornam-se cada vez mais comuns nas mais diversas áreas, buscando-se eficiência, uma correta alocação de recursos e na geração de expectativas mais realistas de vendas e resultados. Enquanto muitos mercados apresentam uma variedade de dados e de estudos para serem usados como bases de referência, existem outros que ainda são carentes de informações básicas para planejamento e análise. O mercado de materiais cirúrgicos é um destes, onde não estão disponíveis as demandas dos clientes, as projeções de mercado ou as estimativas de market share. Este estudo busca, através da análise das vendas em 43 territórios de empresas de dispositivos médicos com atuação no Brasil nas áreas de ortopedia traumatologia, neurocirurgia e buco-maxilo-facial, aplicar a técnica de Análise Envoltória de Dados (DEA, do inglês “Data Envelopment Analysis”) como um modelo de análise comparativa de eficiência que possa auxiliar nos processos de tomada de decisão, mesmo com uma base restrita e limitada de informações. A aplicação da técnica de DEA apresenta resultados que permitem [1] destacar os pontos de melhoria para os territórios ineficientes buscando [2] homogeneizar a eficiência de atendimento por meio do [3] benchmarking entre as regiões buscando [4] uma maior competitividade neste mercado. / With the increased capacity of data processing within companies of all sizes and the currently availability of all sort of informations, the use of indicators and tools for quantitative analysis become increasingly common in many areas, allowing companies to achieve better efficiency, proper resources allocation, and the settle of more realistic performance expectations. While many markets feature a variety of data and studies, others are deprived of basic information for planning and analysis. Among these, the medical devices market have almost unavailable informations of customers demands, markets forecasts or estimated market share at a regional level. Through the analysis of 43 sales territories of medical devices companies in Brazil, this study uses the technique of data envelopment analysis (DEA) as a model for comparative efficiency analysis that can assist the processes of decision making, even with a restricted and limited database. The application of DEA technique provide results that [1] highlight the points of improvement for inefficient territories [2] in order to homogenize the efficiency of regions through [3] benchmarking between them, [4] to improve overall competitive level.