<p>Preterm birth is the leading cause of newborn mortality, with 15 million babies born premature worldwide every year. Children that do survive early delivery are more likely to develop cognitive abnormalities, motor deficits, heart disease, cerebral palsy, and more. While little is known about the pathophysiology of preterm birth, several pregnancy-related complications are related to preterm birth, namely cervical insufficiency and preeclampsia. In the former, premature cervical remodeling and softening can result in the shortening of the cervix, increasing a woman’s risk of preterm birth; this condition is called cervical insufficiency (CI), which is the inability of the cervix to remain closed as a result of weakened tissues. CI is currently measured by a one-dimensional sonographic cervical length, where < 25 mm indicates shortening. Preeclampsia is a disorder that can be explained through the Page kidney phenomenon: compression of the left renal vein (LRV) causes renal venous outflow obstruction, leading to elevated intrarenal pressure and hypertension. The supine pressor test (SPT) is a diagnostic tool for preeclampsia where a positive test is defined by an increase of 20 mmHg in diastolic blood pressure (BP) when shifting from the left lateral recumbent to the supine position. Due to the intense risk of morbidity and mortality for both the mother and the fetus, the need to monitor BP changes is critical. Currently, there is an unmet clinical need to characterize the hemodynamic and geometric properties of the female reproductive organs throughout gestation. Utilizing ultrasound imaging can increase our knowledge about the 3D anatomy and systemic changes during pregnancy, unravel risk factors, establish preventative methods, and standardize treatment plans. In this thesis research, we developed a murine model to 1) examine the pathophysiology of renal vein stenosis, and 2) investigate the effects of stenosis on various cervical dimensions. Renal vein stenosis was found to greatly impact blood flow velocities, as well as cervical width (<i>p<0.05</i>). LRV and cervical area and height also trend towards significance, and there is negative damage to the left kidney and placentae within the stenosed cohort. We also conducted a human study that showed reduced change in postural BP in patients with higher body mass index (BMI). Systolic and diastolic BP in the supine position was significantly greater than in the lateral position for all BMIs with a baseline increase in BP of approximately 9-14 mmHg. These findings suggest that therapeutic positioning and close monitoring of BP could mitigate the risk of developing related disorders in pregnancy.</p>

<p>  </p> <p>Printed electronics (PE) is one of the fastest growing technologies in the 21^st century. Recent reports have shown that PE market will reach 4.9 billion by 2032. PE refers to additive deposition of materials to fabricate electrical circuits, interconnects, and devices. </p> <p>The quest for developing nondestructive processes that enables additive manufacturing of low-cost PEs on heat-sensitive substrates with novel functionalities has resulted in several recent developments in the field which includes investigation of selective and optical sintering processes such as photonic sintering and laser sintering, to name a few. Broadly, this dissertation is an effort to study these sintering technologies for additive manufacturing of bimodal (metal/metal, metal/inorganic, and metal/organic) printed material compositions.  </p> <p>In the first section, nondestructive sintering technologies is combined with chemical sintering to develop bimodal metallic conductive pastes for the fabrication of biodegradable and non-biodegradable printed devices for applications in food packaging and wireless smart drug delivery.</p> <p>Next, a process is developed via near-infrared (NIR) technology to enable soldering and mounting electrical components onto printed materials using low-temperature bimodal metal/organic solder pastes. The developed optimized process is used to fabricate a flexible printed hybrid device for remote assessment of the wound exudate absorption in dressings.</p> <p>Lastly, laser processing is used to fabricate an antibacterial bimodal silver containing glass ceramics coating directly on temperature-sensitive polymeric surgical meshes. The integrated bioceramic coating on the mesh exhibits long-lasting antibacterial properties against Gram-positive and Gram-negative strains of bacteria. </p> <p>The results of this dissertation will open a new route of research to fabricate low-cost devices with bimodal materials with applications in medical device, healthcare, and packaging industries. </p> <p><br></p>

The aim of this study is to optimize the storage and shipping processes of Plasma Separation Cards (PSC) by developing a novel prototype designed to reduce manual labore and ensure sample integrity. An experimental design was employed to address current limitations in PSC handling. These limitations include labor-intensive processes and potential sample degradation. In this approach rigorous testing was done to evaluate the prototype's performance in various environments and different materials. The research in this study include lab testing of samples stored in the prototype, assessment of different storage conditions and analysis of shipping processes. The main research question was: “How can a prototype for PSC storage be optimized to reduce manual labor in PSC handling while ensuring sample integrity during storage and shipping?”. To answer this question the prototype was tested for its effectiveness in reducing storage space and facilitating automated handling The findings of this study show that the prototype that was created can significantly reduce the required storage space while still being usable by liquid handling robots. During the study it was noted that minor misalignment issues were present due to the limitations of the type of 3D printers used. These issues could be addressed with more precise printing technologies such as Stereolithography (SLA) or Selective Laser Sintering (SLS). Both materials used in this study, PLA (Polylactic acid) and PETG (Polyethylene Terephthalate Glycol) materials were found suitable for storing PSC samples under most conditions. However, the measurements for the samples with PLA indicated limitations at 65 °C under certain conditions, making PETG a safer choice under higher temperature. The study contributes to the field by providing an innovating solution for PSC sampling that is scalable. This enhances the possibility for remote monitoring end predictive diagnostics. The prototype indicates a promising direction for future research and application and medical diagnostics by improving operational efficiency while aligning with sustainability goals. This study explores the following aspects: sample handling, storage and shipping. The practical implication includes reduced manual labor, minimized human error and increased efficiency for these aspects.

隨著全球人口結構高齡化和醫療技術的日新月異，使得全球醫療器材市場，正以前所未有的速度，快速地蓬勃發展，預估2006年全球醫療器材市場的總值約為1,643.57億美元，相對於2006年我國醫療器材產業的營業額新台幣690億元，我國目前大概只佔全球醫療器材市場總值的1.4%，相較於半導體、以及電子業稱霸國際，全球醫療器材市場，不啻是我國廠商的一片藍海! 2004年全球骨科市場的價值達190億美元，預期未來十年的年平均成長率將高達10~13%，聯合骨科在人工關節的設計與製造，具有亞洲第一的水準，非常具有競爭優勢，然而，由於歐美知名品牌的公司規模及在中國人工關節市場先驅者的地位，聯合骨科如何在激烈的競爭環境中脫穎而出，考驗著聯合骨科經理人的智慧；目前，聯合骨科在台灣及大陸，分別擁有約20% 以及10% 的市場佔有率，並在西安與新竹建立生產基地。 透過實際參與中國人工關節市場操作的台灣及大陸的聯合骨科經理人、競爭廠商經理人、以及學術界的專家的角度，利用策略行銷4C成本理論，分析聯合骨科在中國人工關節市場的發展現況的優缺點與可能的成因之後，本研究建議聯合骨科在運用有限資源的有效性及時效性的考量之下，可以考慮優先解決買者的外顯單位效益成本以及買者的專屬陷入成本，進而取得市場上的優勢，除此之外，如果他們能夠持續地提升技術層面的優勢之外，更進一步的創造行銷與服務方面的效能，必能在中國的人工關節市場上，取得優勢，創造出更亮麗的成績；深耕中國、佈局世界，以期與世界級的品牌大廠，能夠在全球的人工關節市場競爭上，有更卓越的表現！ / Along with global aging population and rapid advancement of medical technology, global medical devices market is increasing at the fastest speed ever and is reaching US$ 164B in 2006. 2006 Taiwan medical devices market is US$ 2.3B which is only 1.4% of overall global medical devices market. Comparing with dominant positions of Taiwan semiconducting and electronic industries, global medical devices market is a great “Blue Ocean” opportunity! Global orthopedic market will reach US$ 19B in 2004 and is expected to grow at 10-13% annually for the coming 10 years. United Orthopedic Corporation （UOC） is very competitive and is in a leading position in orthopedic joint design and manufacturing in Asia. Due to relative large company size and market pioneer position of well-known US & European brands in China, management team of UOC is facing a tremendous challenge to win this game；So far, UOC is holding 20% and 10% of market share in Taiwan and China, respectively. UOC has set-up manufacturing bases in both Xian and Hsin-Chu. After consolidating individual assessment of UOC management team, competitors’ management team as well as experts from academic society who are personally involving in orthopedic joint market in China and applying the strategic marketing analysis of 4C theory, we have concluded the strength/weakness and their possible causes of UOC current market status in China. Based on our findings, we suggest UOC could consider utilize its limited resources effectively and efficiently, as priorities, to build up its competitiveness on Cost/Utility ratio and Asset Specificity. If UOC can create effectiveness on both marketing and service furthermore, it can achieve competitive advantage and better performance in China orthopedic joint market；Establishing a strong foundation in China and structuring its market position in the world. UOC will be able to tackle face-to-face competition with world-class orthopedic companies in global market!

Thèse numérisée par la Division de la gestion de documents et des archives de l'Université de Montréal.

L’assistance ventriculaire constitue une voie thérapeutique prometteuse de l’insuffisance cardiaque terminale. En dépit des progrès, notamment dans le développement des assistances de type shunt ventriculo-aortique, les écueils relatifs à l’encombrement, à l’alimentation et/ou aux interactions avec le sang de ces dispositifs limitent leur application clinique. Récemment, le concept de Compression Cardiaque Directe (DCC) apparaît comme une piste prometteuse en palliant les difficultés sus-citées. Dans ce travail de thèse, nous avons mis l’accent sur la conception et le test de faisabilité d’une solution de Compression Cardiaque Directe de type mécanique et entièrement implantable appelée l’Exosquelette Cardiaque. Notre travail expérimental a porté, dans un premier temps, sur la conception assistée par ordinateur et sur la modélisation numérique permettant ainsi d’optimiser et de prédire (i) les interactions tissus myocardiques/dispositifs et (ii) les pressions ventriculaires générées. Ensuite, un prototype fonctionnel a été réalisé par fabrication additive (titane, polymères) en s’appuyant sur les données issues de la modélisation et en respectant les contraintes énergétiques, mécaniques et architecturales anatomiques. Enfin, nous avons conduit une phase d’évaluation du potentiel de ce dispositif original sur un modèle de cœur ex vivo. Nous avons pu concevoir et valider un modèle numérique fondé sur le principe des éléments finis. Ce modèle à la fois simple et robuste, a permis de simuler (i) l’impact des points de fixation du dispositif sur le tissu cardiaque, (ii) l’efficacité de la compression externe sur la genèse des pressions intraventriculaires et (iii) l’influence de la compression mécanique externe sur le tissu cardiaque. Le prototype issu de ce travail de thèse a pu produire des résultats prometteurs concernant (i) la restauration physiologique de la pression intraventriculaire, (ii) la consommation énergétique suffisamment basse et (iii) le design compatible avec les contraintes anatomiques thoracique. L’ensemble de ces résultats esquissent la possibilité d’une implantation totale de l’Exosquelette Cardiaque chez le patient / Ventricular assistance is a promising therapeutic pathway for terminal chronic heart failure. Notwithstanding the progress made for the development of aorto-ventricular shunt pump among other things, the difficulties relatives to footprint, power supply and/or blood-device interactions are somehow limiting their clinical applications. Recently, direct cardiac compression (DCC) was suggested as a promising lead to overcome the difficulties mentioned above. In this work, we focused on the design and the feasibility of an implantable and mechanical Direct Cardiac Compression device called: The Cardiac Exosqueleton. Our experimental work used Computer Assisted Design (CAD) and numerical modeling to optimize and predict (i) tissue-device interactions and (ii) pressure generation inside ventricular cavities. Then, a functional prototype was realized by additive manufacturing (titanium, polymer) with the help of modeling data and with respect to the anatomical, mechanical and energetical limitations. Finally, we conducted an evaluation of the ability of our device on both in vitro setup and ex vivo heart. We were able to conceive and validate a numerical model based on finite element techniques. This simple yet robust model allowed us to study (i) the impact of suture fixation of a device at the apex of the heart, (ii) the influence of the direct cardiac compression on intracardiac pressures and (iii) overall and local tissue stress in the myocardium. Our prototype showed promising results concerning (i) the restoration of physiological intraventricular pressures, (ii) a low energy consumption and (iii) a shape that is compatible with the thoracic anatomical constraints. All of these results allow us to envision a total implantation of the cardiac exoskeleton into the patient

La directive européenne 2013/35/UE précise les exigences minimales pour la protection des travailleurs exposés aux champs électromagnétiques et définit les porteurs d’implants comme travailleurs à risques particuliers. Concernant les porteurs de défibrillateur automatique implantable (DAI) ou de stimulateur cardiaque (SC), l’exposition au champ électrique ou magnétique d’extrêmement basse fréquence crée des inductions à l'intérieur du corps humain pouvant générer une tension perturbatrice susceptible de causer le dysfonctionnement de l’implant. Le sujet de ce travail de thèse porte sur la compatibilité électromagnétique des implants cardiaques soumis à un champ électrique basses fréquences (50/60 Hz). Des simulations numériques ont été effectuées afin de concevoir un banc expérimental pour l’exposition de fantômes incluant des stimulateurs ou des défibrillateurs implantables. Une étude expérimentale a permis d’établir par provocation les seuils de champ électrique permettant d’éviter tout dysfonctionnement éventuel de l’implant. Dans la partie simulation numérique ; un modèle humain virtuel (fantôme numérique contenant un implant cardiaque) a été placé en position debout sous une exposition verticale à un champ électrique. La méthode des éléments finis a été utilisée pour définir les phénomènes induits au niveau de l’implant cardiaque avec une résolution de 2mm (logiciel CST®). Dans la partie expérimentale, un banc d'essai dimensionné pour permettre de générer un champ électrique pouvant atteindre 100 kV/m aux fréquences 50-60 Hz a été conçu, optimisé et réalisé afin d’analyser le comportement des implants cardiaques. Plusieurs configurations ont été étudiées. Sur 54 implants cardiaques actifs testés (43 stimulateurs et 11 défibrillateurs) à des niveaux de champs électriques très élevés (100 kV/m) générés par notre dispositif expérimental, aux fréquences de 50-60 Hz, aucune défaillance n’a été observée pour des niveaux d’exposition publics et pour la plupart des configurations (+99%) sauf pour six stimulateurs cardiaques dans le cas d’une configuration « pire cas » peu réaliste en clinique : mode unipolaire avec une sensibilité maximale et en détection auriculaire. Les implants configurés avec une sensibilité nominale en mode bipolaire résistent bien à des champs électriques dépassant les valeurs seuils telles que définies par 2013/UE/35. / The European Directive 2013/ 35 / EU specify minimum requirements for the protection of workers exposed to electromagnetic fields and define with implants as “workers at particular risk”. Regarding the implantable cardioverter defibrillator wearers (ICD) or pacemaker (PM), exposure to electric or magnetic field of extremely low frequency creates inductions inside the human body that generate interference voltage which may cause the dysfunction of the implant. This thesis investigates the electromagnetic compatibility of cardiac implants subjected to an electric field low frequency (50/60 Hz). Computational simulations are effectuated in order to design an experimental bench for the exposure of a phantom including pacemakers or implantable defibrillators. A provocative study is established to define the electric field thresholds for preventing any malfunction of the implant. In numerical simulations; a virtual human model (digital phantom containing a cardiac implant) was placed in an upright position in a vertical exposure to an electric field. The finite element method was used to define the inductions in the cardiac implant level with a resolution of 2 mm (CST® software). In the experimental part, a test bench designed to allow generating an electric field up to 100 kV / m at frequencies 50-60 Hz was constructed, optimized and employed to investigate the behavior of cardiac implants.Several configurations were studied. 54 active cardiac implants (43 pacemakers and 11 defibrillators) are submitted to very high electric field of 50-60 Hz (up to 100 kV / m) inside the experimental bench. No failure was observed for public exposure levels for most configurations (+ 99%) except for six pacemakers in the case of a configuration clinically almost inexistent: unipolar mode with maximum sensitivity and atrial sensing.The implants configured with a nominal sensitivity in bipolar mode are resistant to electric fields exceeding the low action levels (ALs), even for the most high ALs, as defined by 2013 / 35 / EU

Macromolecular biomaterials often require covalent crosslinking to achieve adequate stability and mechanical strength for their given application. However, the use of auxiliary chemicals may be associated with long-term toxicity in the body. Oppositely-charged polyelectrolytes (PEs) have the advantage that they can self-crosslink electrostatically and those derived from marine organisms are an inexpensive alternative to glycosaminoglycans present in the extracellular matrix of human tissues. A range of different combinations of PEs and preparation conditions have been reported in the literature. However, although there has been some work on complex formation between chitosan (CS) and carrageenan (CRG), much of the work undertaken has ignored the effect of pH on the consequent physicochemical properties of self-crosslinked polyelectrolyte complex (PEC) gels, films and scaffolds. Chitosan is a positively-charged polysaccharide with NH3+ side groups derived from shrimp shells and, carrageenan is a negatively-charged polysaccharide with OSO3- side groups derived from red seaweed. These abundant polysaccharides possess advantageous properties such as biodegradability and low toxicity. However, at present, there is no clear consensus on the cell binding properties of CS and CRG or CS-CRG PEC materials. The aim of this study was to explore the properties of crosslinker-free PEC gels, solvent-cast PEC films and freeze-dried PEC scaffolds based on CS and CRG precursors for medical applications. The objective was to characterise the effect of pH of the production conditions on the physicochemical and biological properties of CS-CRG PECs. Experimental work focused on the interaction between PEs, the composition of PECs, the rheological properties of PEC gels and the mechanical properties of PEC films and scaffolds. In addition, cell and protein attachment to the PEC films was assessed to determine their interactions in a biological environment. For biomedical applications, these materials should ideally be stable when produced such that they can be processed to form either a film or a scaffold and have mechanical properties comparable to those of collagenous soft tissues. FTIR was used to confirm PEC formation. Zeta potential measurements indicated that the PECs produced at pH 2-6 had a high strength of electrostatic interaction with the highest occurring at pH 4-5. This resulted in stronger intra-crosslinking in the PEC gels which led to the formation of higher yield, solid content, viscosity and fibre content in PEC gels. The weaker interaction at pH 7-12 resulted in higher levels of CS incorporated into the complex and the formation of inter-crosslinking through entanglements between PEC units. This resulted in the production of strong and stiff PEC films and scaffolds appropriate for soft tissue implants. The PECs prepared at pH 7.4 and 9 also exhibited low swelling and mass loss, which was thought to be due to the high CS content and entanglements. From the range of samples tested, the PECs produced at pH 7.4 appeared to show the optimum combination of yield, stability and homogeneity for soft tissue implants. Biological studies were performed on CS, CRG and PECs prepared at pH 3, 5, 7.4 and 9. All of the PE and PEC films were found to be non-cytotoxic. When the response of three different cell types and a high binding affinity protein (tropoelastin) was evaluated; it was found that the CS-CRG PEC films displayed anti-adhesive properties. Based on these experimental observations and previous studies, a mechanistic model of the anti-adhesive behaviour of PEC surfaces was proposed. It was therefore concluded that the CS-CRG PECs produced might be suitable for non-biofouling applications.

Made available in DSpace on 2016-01-26T12:51:50Z (GMT). No. of bitstreams: 1 margareteartico_dissert.pdf: 621420 bytes, checksum: d6484338aa944f835c788d5909f93257 (MD5) Previous issue date: 2006-05-17 / The reuse of health care products [medical and supply hospital products] is a practice carried out by several countries. The hemodynamic catheters, which are used for diagnosis examination and cardiac procedures, such as coronary angioplasty, are the most reutilized ones. The technical difficulties to reprocess the products and the adverse events are important issues for those who decide for the reutilization of these products. Objectives: To describe the adverse events presented by the patients during and after the coronary angioplasty possibly related to the reuse of health care products [medical and supply hospital products], and to quantify and identify the reasons to discard the products in relation to both the first use and to the reuse. Casuistic and Method: Of 60 patients who were submitted to coronary angioplasty, 33 (55%) were men. The age ranged from 42 to 88 years-old, 63 ± 10 years [mean ± SD]. According to the anamnesis, 22 patients (36.7%) presented hypertension, and 10 (16.7%) had diabetes. Of this group, 15 patients (25%) were smokers, and 8 (13.3%) were alcoholics. Of the 60 patients, 29 (48.3%) presented unstable angina, 27 (45%) had AMI (acute myocadial infarction), and 4 (6.6%) other diagnoses. During the procedure and the permanence in the Intensive Care Unit (ICU) the occurrences of adverse events, such as fever, hypertension, hypotension, chills, sudoresis, bleeding, nausea, and vomit presented by the patients have been observed. Seven medical devices have been evaluated: introductor, guiding catheter, guidewire 0.35, guidewire 0.014, balloon catheter for angioplasty, a syringe with manometer to insufflate the balloon (indeflator), and a three-way (3) stopcock (manifold). Of these, 76 were first-use products and 410 reprocessed products. It was verified if the same products were discarded before or during the procedure, and which were the reasons that led these products to be discarded. The categorical variables have been analyzed with the chi-square test (&#967;2 test). The discrete quantitative variables have been analyzed with a nonparametric statistical test for ordinal data (Mann-Whitney test). A type I error of 5% was admitted. Results: The results have highlighted that 26 patients presented adverse events. Hypotension was the most clinically significant adverse event and occurred in 11 (18.3%) of the patients. There was not, however, a statistical significance between the hypotension adverse event and the reuse of the products. Four first-use products and 80 reused products have been discarded. Three first-use products and 55 reused products have been discarded because they were damaged. We want to emphasize that all the syringes used to insufflate the balloon, which have been discarded, have been so for this reason. Conclusions: The adverse events presented by the patients submitted to angioplasty are not related to the reuse of the health care products. The medical devices integrity and functionality have been the main reason of the discards. / O reuso dos produtos médico-hospitalares é uma prática realizada por vários países. Os cateteres de hemodinâmica que são empregados para os exames de diagnósticos e intervenções cardíacas como a angioplastia coronária, são os mais reutilizados. As dificuldades técnicas para o reprocessamento dos produtos e os eventos adversos são questões importantes para quem decide pela reutilização desses produtos. Objetivos: Descrever os eventos adversos apresentados pelos pacientes durante e após a angioplastia coronária, possivelmente relacionadas ao reuso dos produtos médico-hospitalares além de quantificar e identificar os motivos de descarte dos produtos em relação ao primeiro uso e ao reuso. Casuística e Método: Foram estudados 60 pacientes submetidos a angioplastia coronária. Deste grupo 33 (55%) eram homens. A idade variou de 42 a 88 anos, com média e desvio padrão de 63 ± 10 anos. De acordo a anamnese 22 (36,7%) apresentavam hipertensão arterial e 10 (16,7%) tinham diabetes. Deste grupo 15 (25%) eram fumantes e 8 (13,3%) eram etilistas. Dos 60 pacientes, 29 (48,3%) apresentavam angina instável, 27 (45%) IAM e 4 (6,6%) outros diagnósticos. Durante o procedimento e na permanência na Unidade Intensiva Coronariana (UCOR), foram observadas as ocorrências dos eventos adversos, febre, hipertensão, hipotensão, calafrios, sudorese, sangramento, náuseas e vômitos, apresentados pelos pacientes. Foram avaliados, sete produtos médico-hospitalares, introdutor, cateter guia, fio guia 0.35, fio guia 0.014, cateter balão para angioplastia, seringa com manômetro para insuflar balão (indeflator) e torneirinha de 3 vias descartável (manifold), sendo 76 de primeiro uso e 410 reprocessados. Verificou-se se os mesmos foram descartados antes ou durante o procedimento e quais os motivos que levaram a esses descartes. As variáveis categóricas foram analisadas com o auxilio do teste Qui Quadrado. As variáveis quantitativas discretas foram analisadas com o auxilio de teste não paramétrico (Mann-Whitney). Foi admitido erro alfa de 5%. Resultados: Os resultados evidenciaram que 26 (43,3%) dos pacientes apresentaram eventos adversos. A hipotensão foi o evento adverso mais relevante clinicamente e ocorreu em 11(18,3%) dos pacientes. Não houve, porém, significância estatística entre o evento adverso hipotensão e o reuso dos produtos médico-hospitalares. Foram descartados 4 produtos de primeiro uso e 80 dos reutilizados. Por não estarem íntegros, foram descartados 3 produtos de primeiro uso e 55 produtos dos reutilizados. Destaca-se que todas as seringas de insuflar balão, que foram descartadas, o foram por esse motivo. Conclusões: Os eventos adversos apresentados pelos pacientes submetidos à angioplastia não estão associados ao reuso dos produtos médico-hospitalares. A integridade e funcionalidade foram os motivos principais de descartes dos produtos médico-hospitalares.

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.