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.

Chronic Venous Insufficiency (CVI) is characterized by chronic venous hypertension from blood pooling in the lower limbs. The resulting symptoms include leg pain, varicose veins, fatigue, venous edema, skin pigmentation, inflammation, induration, and ulceration. Reflux from incompetent venous valves is a factor in up to 94% of individuals with CVI. Current treatments of CVI include compression stockings, drug therapy, vein disabling, venous stenting, and surgical correction with varying rates of success. However, a minimally invasive correction of deep venous reflux does not currently exist. A transcatheter prosthetic venous valve has the potential to be an effective, minimally invasive treatment for deep venous reflux which could treat up to 1.4 million individuals in the United States suffering from venous ulceration and make more than 1.7 billion dollars each year. Previously developed prosthetic venous valves have had problems with competency, patency, thrombogenicity, biocompatibility, and incorrect sizing. To meet the clinical need a prosthetic valve needs to be developed which succeeds where previous valves have failed. This thesis describes the design, analysis, pre-clinical testing, and evaluation of a novel prosthetic venous valve. Design specifications for an effective prosthetic venous valve were created. Verification tests were developed and performed which demonstrated that the valve met every design specification. Finite element and computational fluid dynamics simulations were performed to analyze the valve and calculated a maximum shear rate of 2300 s-1 in the valve during the high forward flow after a Valsalva maneuver. The valve is made of a biocompatible material that has low thrombogenicity, Poly(vinyl-alcohol) cryogel. On the average, the valve allows less than 0.5 mL/min of reflux at low and high retrograde pressures even after 500,000 cycles, indicating that it will reduce the reflux of individuals with venous reflux by more than 99.4%. The valve closes in less than 0.07 seconds and allows the distal pressure to rise to an average of 7% of the equilibrium pressure 30 seconds after a simulated ankle flexion. The valve increases the outflow resistance an average of 2.3 mmHg*min/L which is much less than obstruction levels,≥ 5 mmHg*min/L. The valve can fit in a 16 French catheter and is capable of percutaneous delivery. The base of the valve is 1.5 times the diameter of the vein in which it is to be implanted to help correct orientation upon deployment. Fluid behind the valve’s leaflets is ejected with a forward flow rate of 400 mL/min, suggesting that thrombus formation will not occur at this location. A stented valve remained patent in a porcine blood flow loop for 3 hours. The valve remains competent without buckling in a constricted vein at rest. The valve can expand to fit a vein with a maximum diameter 1.4 times the valve's initial diameter with low risk of tearing or leaflet prolapse. An IACUC protocol for a 12 week study to test the valve in sheep was prepared and approved. A study to evaluate the valve in humans is proposed with endpoints that can be tested for statistical significance and compared with other treatments for CVI. A set of valves which will correct reflux in the majority of common femoral, femoral, and popliteal deep veins is proposed and a sizing guide for surgeons is provided. The minimum distance between prosthetic valves placed in the same vein segment is 13 cm. A comparison of this valve with previously developed prosthetic venous valves and recommendations for work to be performed in the future are given. The valve proposed in this work is the only valve to meet all design specification for an effective prosthetic venous valve, and therefore shows great potential to be a minimally invasive treatment for deep venous reflux.

This Master's Thesis deals with the introduction of the new type of contact lenses ACUVUE to the Czech market. The thesis is divided into three parts. The first is focused on theoretical analysis of the standard procedure for introducing of new products to the market which is possible to find in professional publications. The practical part analyses the introduction procedure of new ACUVUE contact lenses in Vision Care Division of Johnson & Johnson company. Final part of this thesis includes evaluation of the Vision Care marketing strategy and recommendations which can improve the introducing procedure for the future. The required outcome of this work is the evaluation of the analysis and set a few recommendation for improvement of the introduction process for the future.

Les dispositifs médicaux (DM) innovants offrent sans cesse de nouvelles options thérapeutiques et diagnostiques et contribuent à améliorer la prise en charge des malades à l’hôpital. Toutefois, ces innovations, potentiellement onéreuses, ne disposent pas toujours de données probantes garantissant leur efficience. Par conséquent, pour guider le choix des décideurs hospitaliers, une évaluation à l’échelle de l’hôpital est souvent nécessaire afin de lever le maximum d’incertitudes avant leur acquisition. Cette démarche, appelée évaluation des technologies de santé (ETS) en milieu hospitalier, s’est beaucoup développée à l’étranger, mais reste méconnue en France. A travers notre travail, nous avons montré que les CHU français proposaient des modèles d’organisation pour l’évaluation des DM innovants tout à fait comparables à ceux rencontrés dans d’autres pays. Parmi les modèles d’ETS en milieu hospitalier, la mini-ETS semble être le plus généralisable et pourrait concourir à l’harmonisation des pratiques entre CHU. Ce modèle en plein essor existe sous de multiples formes dans le monde. La confrontation des critères d’évaluation identifiés dans les modèles assimilables à la mini-ETS à ceux utilisés dans les CHU français nous a permis d’isoler 26 critères d’évaluation d’intérêt pour l’évaluation des DM innovants. Enfin, nous avons élaboré puis testé, en situation réelle, un outil d’aide multicritère à la décision dérivé des précédents critères identifiés. / Innovative medical devices offer solutions to medical problems. However, medical devices arriving on the European market have generally little evidence about efficiency. To manage the uncertainty surrounding the introduction of innovative medical devices, hospitals and university hospitals have developed worldwide hospital-based health technology assessment (HTA) processes to guide the selection of expensive and innovative products. Nevertheless, little is known about hospital-based HTA activities in France. We demonstrated that French models of hospital-based HTA are comparable to those found elsewhere and presented sometimes a combination of several HTA models. We also underlined that a mini-HTA like model could easily be applied to French university hospitals. Mini-HTA has become widespread in many different forms across the world. We compared criteria of different mini-HTA forms to criteria used in French university hospitals and identified 26 relevant criteria to assess innovative medical devices. Finally, we developed and tested in real conditions a multiple-criteria decision tool derived from these 26 criteria.

This research used human factors methods to investigate the relationship between no fault found (NFF) incident frequency and device usability. NFF reporting occurs when a medical device sent for repair is found to be operating normally. NFF incidents are one of the most recurrent failure modes, and therefore have considerable impact on cost, dependability and safety. An analysis of medical equipment maintenance data was conducted and six devices with a high NFF reporting frequency were identified. Semi-structured interviews and heuristics evaluations revealed that usability issues likely caused many of the NFF incidents. Other factors suspected to contribute to increased NFF reporting include accessory issues, intermittent faults and environmental issues. Finally, in order to validate the results, usability testing was conducted on three of the devices. 23 usability-related design flaws were identified. Therefore devices containing latent usability-related design flaws can be identified through analysis of medical equipment maintenance data.

This research used human factors methods to investigate the relationship between no fault found (NFF) incident frequency and device usability. NFF reporting occurs when a medical device sent for repair is found to be operating normally. NFF incidents are one of the most recurrent failure modes, and therefore have considerable impact on cost, dependability and safety. An analysis of medical equipment maintenance data was conducted and six devices with a high NFF reporting frequency were identified. Semi-structured interviews and heuristics evaluations revealed that usability issues likely caused many of the NFF incidents. Other factors suspected to contribute to increased NFF reporting include accessory issues, intermittent faults and environmental issues. Finally, in order to validate the results, usability testing was conducted on three of the devices. 23 usability-related design flaws were identified. Therefore devices containing latent usability-related design flaws can be identified through analysis of medical equipment maintenance data.

The objective of the proposed research is to advance the power efficiency of wireless neural stimulating systems in inductively powered implantable medical devices (IMD). Several innovative system- and circuit-level techniques are proposed towards the development of power-management circuits and wireless neural stimulating systems with inductive power transmission to improve the overall stimulation power efficiency. Neural stimulating IMDs have been proven as effective therapies to alleviate neurological diseases, while requiring high power and performance for more efficacious treatments. Therefore, power-management circuits and neural stimulators in IMDs should have high power efficiencies to operate with smaller received power from a larger distance. Neural stimulating systems are also required to have high stimulation efficacy for activating the target tissue with a minimum amount of energy, while ensuring charge-balanced stimulation. These features provide several advantages such as a long battery life in an external power transmitter, extended-range inductive power transfer, efficacious and safe stimulation, and less tissue damage from overheating. The proposed research presents several approaches to design and implement the power-efficient wireless neural stimulating IMDs: 1) optimized power-management circuits for inductively powered biomedical microsystems, 2) a power-efficient neural stimulating system with adaptive supply control, and 3) a wireless switched-capacitor stimulation (SCS) system, which is a combination structure of the power-management circuits and neural stimulator, to maximize both stimulator efficiency (before electrodes) and stimulus efficacy (after electrodes).

Minimally invasive or laparoscopic surgery has completely changed the focus of surgery becoming an alternative to various types of open surgery. Minimally invasive surgery avoids invasive open surgery as the operation is performed through one or more small incisions in the abdomen and using a small camera called laparoscope. Through these incisions, surgeons insert specialized surgical instruments to perform the operation resulting in less postoperative pain, shorter hospital stay, and faster recovery. However, the main problems during minimally-invasive surgery are the limited space for operating instruments and the reduced visibility and range of motion inside the patient’s body. During minimally-invasive surgery, one of the most difficult and time consuming surgical procedures is suturing and knot tying. This procedure significantly increases the operation time as it requires advanced techniques and extensive experience by surgeons.The main goal of this research is to investigate, design, and develop a new suturing instrument to facilitate suturing procedures during minimally invasive surgery.Qualitative research data was collected through interviews with a surgeon and six indepth observations of minimally invasive surgeries at Tampa General Hospital. Different design concepts and mechanisms were created using SolidWorks CAD software, and tested using SimulationXpress in order to identify dimensions, materials and expected performance of the design and its components. The prototypes of the device were made using a Dimension SST 768 FDM machine and tested by the surgeon to ensure that the final design meets the specified needs and criteria. This new device will eliminate the use of many different devices during the operation and allow the use of any type of suture. The proposed suturing device aims to benefit both patients and surgeons. For surgeons, the new device aims to decrease the number of steps for laparoscopic suturing through an intuitive and ergonomic design. For patients, the proposed device will reduce time during surgery and under general anesthesia leading towards improved health care.

Pelvic Inflammatory Disease (PID) is one of the most common causes of morbidity in women. PID is a polymicrobial infection of the female reproductive tract, and is associated with pelvic pain, abnormal uterine bleeding, and tubal damage that can lead to ectopic pregnancies and infertility. It is curable but the effects of PID can be permanent if not properly diagnosed and treated. PID presents as a spectrum of disease and is often missed at early stages; even acute PID can be difficult to diagnose, as there is no single conclusive diagnostic test. Currently, PID is identified and treated syndromically because pelvic pain is the only consistent clinical finding. The Center for Disease Control and Prevention (CDC) recommends doxycycline, a broad-spectrum antibiotic, for treatment but doxycycline can cause gastrointestinal irritation and local inflammation leading to an incomplete treatment. Most cases of PID are polymicrobial infections of the tubes and endometrium, which are not accessible to culture due to the difficulty of procuring samples above the naturally contaminated vagina and distal cervix. Given the difficulty of properly diagnosing PID and the limitations and side effects of the current treatments, there is an urgent need for new approaches for improving the accuracy for diagnosis and treatment of PID. We propose a new and practical approach to collect sterile specimen samples from the endometrium for more accurate PID diagnosis, and to treat the reproductive tract locally using doxycycline-loaded nanoparticles. The proposed research presents a novel sterile uterine sampler cover (SUSC) device that can safely and effectively collect uncontaminated specimen samples from the uterus, and also deliver nano-encapsulated drugs directly to the site of infection. The analysis of uncontaminated endometrium samples is expected to provide an understanding of uterine flora in symptomatic and asymptomatic women, and will lead to the identification of infective microbes in symptomatic women for pathogen-specific treatment. The use of nano-encapsulated doxycycline will enable localized drug delivery to lower drug dosage and minimize side effects for the patient. The doxycycline-loaded nanoparticles are characterized and evaluated based on their drug release properties, size distribution, and tissue response in vitro. This research will lead towards a more effective approach for the diagnosis and treatment of PID while freeing women from prolonged systemic treatments and their adverse effects. Moreover, this research will increase our understanding of the uterine biome under various hormonal and pathologic conditions, in symptomatic and asymptomatic women.

Submitted by Jean Medeiros (jeanletras@uepb.edu.br) on 2018-05-24T13:56:57Z No. of bitstreams: 1 PDF - Danielle de Oliveira Lima Nascimento.pdf: 16716834 bytes, checksum: ed94111495a5f456cc286aef5258ca8b (MD5) / Approved for entry into archive by Secta BC (secta.csu.bc@uepb.edu.br) on 2018-06-05T11:33:52Z (GMT) No. of bitstreams: 1 PDF - Danielle de Oliveira Lima Nascimento.pdf: 16716834 bytes, checksum: ed94111495a5f456cc286aef5258ca8b (MD5) / Made available in DSpace on 2018-06-05T11:33:52Z (GMT). No. of bitstreams: 1 PDF - Danielle de Oliveira Lima Nascimento.pdf: 16716834 bytes, checksum: ed94111495a5f456cc286aef5258ca8b (MD5) Previous issue date: 2017-04-06 / Nanotechnology refers to the application of scientific knowledge in the control of matter at the nanoscale, in the range between 1nm and 100nm. Recent studies point to the risks that this new technology can cause to human life and to the environment, due to the insufficient knowledge of its properties and effects, being necessary the regulation of these products, their ethical implications and vigilant organs that accompany the discoveries Technological developments. Thus, this study aimed to perform an updated diagnosis based on national and international technical standards that govern the application of nanotechnology in health products through an integrative review. A total of 524 articles were found in three databases, LILACS, Scielo and PubMed, of which 61 articles were read from the final set. The methodology consisted of five steps: definition of the guiding question, search of studies in different databases, selection of studies, critical evaluation of studies and synthesis of data. The results obtained in the integrative review show that nations such as Japan, USA and of EU have demonstrated the highest level of development in nanotechnology, being representative in this study in order to compare with the advances of nanoscience in Brazil, therefore that there is no unanimous global regulation for nanotechnology worldwide, given the lack of scientific evidence regarding the risk to human health and the environment, suggesting that the regulation adopted should be based on the precautionary principle and be assessed on a case by case basis. This work served as a synthesis in the diagnosis of the needs for the construction of a regulation that is followed worldwide. / A nanotecnologia refere-se à aplicação de conhecimento científico no controle da matéria na escala nanométrica, na faixa entre 1nm e 100nm. Estudos recentes apontam para os riscos que essa nova tecnologia pode causar a vida humana e ao meio ambiente, devido ao insuficiente conhecimento das suas propriedades e efeitos, havendo a necessidade de regulamentação desses produtos, de suas implicações éticas e de órgãos vigilantes que acompanhem as descobertas tecnológicas. Assim, este trabalho teve como objetivo realizar um diagnóstico atualizado baseado nas normas técnicas nacionais e internacionais que regem a aplicação da nanotecnologia em produtos para saúde através de uma revisão integrativa. Foram encontrados 524 artigos em três bases de dados consultadas: LILACS, Scielo e PubMed sendo que, do conjunto final foram lidos incluídos neste estudo 61 artigos. A metodologia constou com cinco etapas: definição da questão norteadora, a busca dos estudos em diferentes bases de dados, a seleção dos estudos, avaliação crítica dos estudos e a síntese dos dados. Os resultados obtidos na revisão integrativa denotaram que nações como Japão, EUA e da UE demonstraram destaque com o maior nível de desenvolvimento em nanotecnologia, sendo representativas nesse estudo de forma a comparar com os avanços da nanociência no Brasil, concluindo portanto que mundialmente não existe regulação para nanotecnologia que seja unânime para todas as nações, tendo em vista a falta de comprovação científica quanto ao risco a saúde humana e ao ambiente ,sugerindo que a regulação adotada deva ser baseada no princípio de precaução e que seja avaliado caso a caso. Este trabalho serviu como uma síntese no diagnóstico das necessidades para construção de uma regulamentação que seja seguida em âmbito mundial.