Real options analysis has been recommended to identify and quantify opportunities where managerial flexibility can influence worth. However, real options models in the literature have become increasingly sophisticated, and managers have cited their reluctance to use such models due to their level of complexity and lack of transparency. Presented in this thesis is a real options model that can be easily incorporated into the current project selection methodology of a firm; the model uses managerial cash flow estimates to price real options on tangible investment opportunities in a financially consistent manner. Next, to demonstrate the application of real options analysis in practice, five real options models, including the proposed model, are applied to value a medical device project. The models all price the real option differently, due to the differences in their underlying assumptions, but they all yield the same investment conclusion: the medical device project has value.

Real options analysis has been recommended to identify and quantify opportunities where managerial flexibility can influence worth. However, real options models in the literature have become increasingly sophisticated, and managers have cited their reluctance to use such models due to their level of complexity and lack of transparency. Presented in this thesis is a real options model that can be easily incorporated into the current project selection methodology of a firm; the model uses managerial cash flow estimates to price real options on tangible investment opportunities in a financially consistent manner. Next, to demonstrate the application of real options analysis in practice, five real options models, including the proposed model, are applied to value a medical device project. The models all price the real option differently, due to the differences in their underlying assumptions, but they all yield the same investment conclusion: the medical device project has value.

abstract: Presented below is the design and fabrication of prosthetic components consisting of an attachment, tactile sensing, and actuator systems with Fused Filament Fabrication (FFF) technique. The attachment system is a thermoplastic osseointegrated upper limb prosthesis for average adult trans-humeral amputation with mechanical properties greater than upper limb skeletal bone. The prosthetic designed has: a one-step surgical process, large cavities for bone tissue ingrowth, uses a material that has an elastic modulus less than skeletal bone, and can be fabricated on one system. FFF osseointegration screw is an improvement upon the current two-part osseointegrated prosthetics that are composed of a fixture and abutment. The current prosthetic design requires two invasive surgeries for implantation and are made of titanium, which has an elastic modulus greater than bone. An elastic modulus greater than bone causes stress shielding and overtime can cause loosening of the prosthetic. The tactile sensor is a thermoplastic piezo-resistive sensor for daily activities for a prosthetic’s feedback system. The tactile sensor is manufactured from a low elastic modulus composite comprising of a compressible thermoplastic elastomer and conductive carbon. Carbon is in graphite form and added in high filler ratios. The printed sensors were compared to sensors that were fabricated in a gravity mold to highlight the difference in FFF sensors to molded sensors. The 3D printed tactile sensor has a thickness and feel similar to human skin, has a simple fabrication technique, can detect forces needed for daily activities, and can be manufactured in to user specific geometries. Lastly, a biomimicking skeletal muscle actuator for prosthetics was developed. The actuator developed is manufactured with Fuse Filament Fabrication using a shape memory polymer composite that has non-linear contractile and passive forces, contractile forces and strains comparable to mammalian skeletal muscle, reaction time under one second, low operating temperature, and has a low mass, volume, and material costs. The actuator improves upon current prosthetic actuators that provide rigid, linear force with high weight, cost, and noise. / Dissertation/Thesis / Doctoral Dissertation Biomedical Engineering 2017

Hardware and software developers rely on different tools for document management, product data management (PDM) and software configuration management (SCM). As more and more products include components of both types there is a growing demand for one collaborative system. This becomes even more critical in the medical sector, where a device is under regulatory demands for document management to even be allowed in to the market. Combined systems become more complex and are generally based on PDM-principles rather than SCM. Current development of SCM tends instead towards simpler systems focused on pure version control (VCS) that are easy to use and economically available to small- and medium sized enterprises (SME), which is not the case with generic PDM-systems or combined systems. This study explored the possibility to extend the usage of such a VCS and include hardware documentation as well as software. The aim was to further our understanding of the SME perspective on product documentation for the medical device field. The method was a case study, collaboration with a SME development company. The scope was to explore possible usage of a chosen VCS (GitLab) and to compare it with a generic PDM-system and with existing manual system. The results showed that for several of the hardware document types there are special made Git-solutions to find within the open source community. However, none of the ones tested in the study was deemed good enough with respect to functionality and reliability. Instead the case study used direct storage of the files in their binary format and focused on testing different VCS functions and on how to organize in order to best gain the advantages of using the system. The conclusions showed that hardware documents can be stored in the same iterative manner as software but with limited Git functionality. Compared with a PDM system GitLab can offer the same level of revision control and communication around the specifications but lacks classification of parts and detailed product structures. GitLab offers better iteration history than both a PDMsystem and the existing manual system does. But not being able to use full Git functionality the organization needs a collaboration strategy to handle the decentralized storage. If the collaboration strategy matches the organization development practices, GitLab is a useful alternative for medical device documentation.

Diagnostiquées à partir de douleurs pelviennes, de dysfonctionnements menstruels ou dans le cadre d’un bilan d’infertilité, les adhérences intra-utérines sont des accolements fibreux des faces internes de la cavité utérine, qui peuvent obstruer partiellement ou totalement la cavité utérine. Tout acte traumatique dans la cavité utérine est considéré comme pourvoyeurs d’adhérences post-opératoires. Pour prévenir l’apparition de ces adhérences intra-utérines, nous avons développé un dispositif médical anti-adhérentiel, résorbable et autodéployable. Pour cela, nous avons synthétisé une famille de copolymères innovants constitués de poly (acide lactique) – poly (éthylène oxyde) – poly (acide lactique) avec des propriétés de gonflement adaptés à l’application. L’évaluation biologique in vitro des copolymères a permis de démontrer l’absence de cytotoxicité et le caractère anti-adhérentiel des biomatériaux en contact avec des cellules endométriales humaines. Les études in vivo ont permis de démontrer l’efficacité du copolymère sélectionné comme barrière physique résorbable permettant la non-adhérence de tissus lésés. L’implantation du copolymère n’entraîne pas de réactions biologiques majeures dans les cornes utérines et n’altère pas la fonction de reproduction de l’animal. De plus, l’étude du déploiement du dispositif dans des utérus issus d’hystérectomies chez des patientes nous a permis de confirmer que le dispositif médical développé est adapté à la morphologie utérine. / The symptoms of intrauterine adhesions are pelvic pain, menstrual abnormalities and infertility. Intrauterine adhesions result in the fibrous adherence of opposing uterine walls, which produce partial or complete obliteration in the uterine cavity. Trauma to a gravid uterine cavity is known to be the main cause of adhesions formation. In order to prevent postsurgical adhesion formation, a new anti-adhesive and resorbable medical device was developed to maintain separated uterine walls after surgical trauma. Anti-adhesive barrier was obtained from polylactic acid – polyethylene oxyde – polylactic acid triblock copolymers presenting specific swelling properties. In vitro biocompatibility and anti-adhesive effects of triblock copolymers were demonstrated using human endometrial cells. In vivo adhesion models have allowed us to confirm the anti-adhesive efficiency and the accuracy of the degradation time of a copolymer. This copolymer does not cause major biological responses after implantation in uterine horns and does not alter reproductive functions. A deployment study of the medical device in uterus of patients from hysterectomy has allowed us to demonstrate that our medical device is adapted to the uterine morphology.

This thesis focuses on the research of RTDI policies (research, technology, development and innovation), and the main theme of this thesis is to link the three variables together: RTDI policy-making process, the contents of RTDI policies, the appropriateness of RTDI policies on configuration of the national, the sectoral and the technological innovation systems. We assume the policy-making process of RTDI policies would shape the contents of the RTDI policies. Once the contents of RTDI policies are implemented, the RTDI policies would influence, whether appropriate or inappropriate, on configuration of the three innovation systems. We define the configuration of the three innovation systems as national, sectoral and technological innovation system (NSTIS). We use the Taiwanese biotechnology and related sectoral policies as the empirical examples. Biotechnology in Taiwan configures with three sectors, i.e. pharmaceuticals, agriculture and medical device. Between 2000 and 2008, the Taiwanese government intensively promoted many policies in order to support the development of biotechnology and related sectors. Among the various policies, we choose the National Science and Technology Programs and the regulation policies (in terms of Law of Pharmaceutical Affairs and the Agro-pesticides Management Act) as our two empirical cases and set up the in-depth discussion for the policy-making process of the two policies.On the basis of the empirical cases of Taiwan, we explore the influence of the RTDI policy-making process on the contents of RTDI policies which further shapes the development of the NSTIS.

The thesis deals with the issue of inventories in a company with business activities. The aim of the thesis is at first theoretically to introduce the accounting of inventories and then to demonstrate the accounting activities on a real company. The practical part of the thesis focuses on a company that sells medical devices. Due to the choice of company and its business activities this thesis highlights the general and specific information about business with medical devices and the areas connected to this.

The goal of this diplom thesis is to analyze economic activities of genesis and existence of non-state medical device. The concrete company shows accounting advances of this special line of business in actual legislature in the Czech Republic

L’objet de ce travail est l’étude de la biocompatibilité in vitro des matériaux à base de COC, afin d’évaluer leur potentiel de biomatériaux implantables.Cette évaluation est réalisée par le suivi de plusieurs paramètres : viabilité cellulaire/cytotoxicité, évaluation des phénomènes de stress oxydant, inflammatoires et hémocompatibilité. Une relation entre ces réponses biologiques et les propriétés physico chimiques des matériaux étudiés a été appréhendée.Les résultats montrent une bonne biocompatibilité des films testés avec un impact significatif de la présence des additifs (anti-oxydant et lubrifiant) sur les paramètres biologiques et physico-chimiques évalués.L’effet simulé du vieillissement biologique de ces matériaux sur leur biocompatibilité et leurs caractères physico-chimiques a également été étudié. Des conditions de pH et d’oxydation extrêmes, ainsi que le contact avec des macrophages pendant 1 mois, ont un effet sur la surface et sur l’interaction des films de COC avec l’environnement biologique sans compromettre leur biocompatbilité. La présence d’additifs a également eu un impact sur ces modifications.En suivant une logique de management du risque, la systématisation de l’ensemble des méthodes développées a permis d’obtenir une approche simplifiée et validée au sein du laboratoire, applicable à l’ensemble des matériaux naturels ou synthétiques susceptibles d’être utilisés dans la fabrication des DM implantables / Abstract : The purpose of this work is the study of the in vitro biocompatibility of COC-based materials in order to evaluate their potential as implantable biomaterials.This evaluation is carried out by monitoring several parameters: cell viability / cytotoxicity, evaluation of oxidative stress, inflammatory reactions and hemocompatibility. A relationship between these biological responses and physicochemical properties of the studied materials has been apprehended.Results show a good biocompatibility of the tested films with a significant impact of the presence of additives (anti-oxidant and lubricant) on the evaluated biological and physicochemical parameters.The simulated effect of biological aging of these materials on their biocompatibility and physico-chemical characteristics has also been studied. Extreme pH and oxidation conditions, as well as contact with macrophages during 1 month, affect the surface and interaction of COC films with the biological environment without compromising their biocompatibility. The presence of additives also had an impact on these changes.Following a risk management logic, the systematization of the developed methods within the laboratory made it possible to obtain a simplified and validated approach, applicable to all natural or synthetic materials that could be used for manufacturing implantable medical devices.

The Stage-gate model has long been used in product development. Alternatives to Stage-gate such as Design Thinking and other models have been developed which are flexible and consider users’ needs early on and thus they could be more suitable for medical device development. This research aims to study and map how medical device development is treated in the existing research literature. This master thesis will focus on product development concerning medical devices. This research aims to conduct a narrative literature review. Data collection here is a set of articles which were collected through a database, which will be used for further analysis concerning how different approaches of models are being utilized in product development, with a specific focus on the healthcare sector. The goal of the literature review was to study what models have been utilized in the development has previously been utilized in the development of medical devices. Other possible alternatives besides conducting a narrative literature review are conducting one or several cases with interviews or surveys with companies. Data collection is limited approximately in the last 15 years (2005 – present), the lookup in the database was based on keywords applied in the research area. The database used for this research is Scopus. Articles chosen were selected also from the Scopus database. The ethical implications based on our findings here are identifying types of product development models that have been utilized by medical companies in the healthcare sector. Based on the review, we can identify several different product development models. Stage-gate and Design Thinking are not the most popular models utilized in the product development process. We classify the models based on elements, the element of the models here are divided into 3 categories which are based on requirements, they are; Regulatory Aspect, Process Workflow Aspect, and Collaboration Aspect. The regulatory aspect mainly concerns administrative affairs and how the system as an entity can control the regulation regarding medical device development. The Process Workflow Aspect, this element is based on a direct approach toward medical device development in terms of phases. The Collaboration aspect, this aspect addresses the stakeholders’ role in policy and decision-making regarding the production of medical devices. Stage-gate and Design Thinking are not the main models utilized in medical device development, other than that, various models are implemented in the healthcare sector, this means other models becoming alternatives and have been utilized and developed in the product development process. Other models besides Stage-gate and Design Thinking are alternatives which do not have significant changes and are just modified forms from the existing ones.