Current Issue : April - June Volume : 2013 Issue Number : 2 Articles : 6 Articles
The knowledge and compliance with regulatory requirement is a key to success in development and marketing of medical devices. High quality and well-designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. For this purpose one have to review the regulations in different countries for assuring safety and efficacy of medical devices.The primary goal is to protect public health and safety. A regulatory system should ensure that valuable new technologies are made available to the clinical community and to patients and consumers expeditiously while preventing unsafe or ineffective devices from reaching the market.. Regulatory decisions must be based on strong and clear science, free of external influences and consistent with the directives of law. As the guarantor of public health, enforcement of the law must be vigorously, fairly and uniformly carried out and appropriate regulatory and legal actions taken against violators. Government-prescribed rules and procedures must be clearly articulated for those who must comply with them....
At present, titanium-based biomaterials for the production of prosthetic devices have achieved a satisfactory quality level; current research aims at improving their surgical dependability and biomechanical performances. In this contest, a crucial aspect is represented by the osseointegration process, which implies the secure association of endosseous devices with the surrounding biological tissue. Osseointegration is largely controlled by surface characteristics with regard to both chemical composition and morphological properties. Therefore, the design of such devices might be guided by the characterization of surface morphology produced by mechanical and chemical treatments.\r\n \r\nThis paper illustrates the results obtained by the application of a set of treatments on titanium (Ti2) and Ti6Al4V alloy (Ti5) samples. Mechanical treatments mainly affect the dimension of larger defects, acting on a macrometric scale and inducing specific patterns; chemical treatments (i.e., acid attack at room or higher temperature) can dissolve surface material altering defect dimensions on a micrometric scale.\r\n \r\nThis study may represent a useful tool for the rational design of implant surface characteristics....
Background: For blood purification systems using a semipermeable membrane, the\r\nconvective mass transfer by ultrafiltration plays an important role in toxin removal. The\r\nincrease in the ultrafiltration rate can improve the toxin removal efficiency of the device,\r\nultimately reducing treatment time and cost. In this study, we assessed the effects of\r\npulsatile flow on the efficiency of the convective toxin removal in blood purification\r\nsystems using theoretical methods.\r\nMethods: We devised a new mathematical lumped model to assess the toxin removal\r\nefficiency of blood purification systems in patients, integrating the mass transfer model for\r\na human body with a dialyser. The human body model consists of a three-compartment\r\nmodel of body fluid dynamics and a two-compartment model of body solute kinetics. We\r\nsimulated three types of blood purification therapy with the model, hemofiltration,\r\nhemodiafiltration, and high-flux dialysis, and compared the simulation results in terms of\r\ntoxin (urea and beta-2 microglobulin) clearance and the treatment dose delivered under\r\nconditions of pulsatile and non-pulsatile pumping. In vivo experiments were also\r\nperformed to verify the model results.\r\nResults: Simulation results revealed that pulsatile flow improved the convective clearance\r\nof the dialyser and delivered treatment dose for all three types of therapy. Compared with\r\nthe non-pulsatile pumping method, the increases in the clearance of urea and beta-2\r\nmicroglobulin with pulsatile pumping were highest with hemofiltration treatment (122.7%\r\nand 122.7%, respectively), followed by hemodiafiltration (3.6% and 8.3%, respectively), and\r\nhigh-flux dialysis (1.9% and 4.7%, respectively). EKRc and std Kt/V averaged 28% and 23%\r\nhigher, respectively, in the pulsatile group than in the non-pulsatile group with\r\nhemofiltration treatment.\r\nConclusions: The pulsatile effect was highly advantageous for all of the toxins in the\r\nhemofiltration treatment and for �Ÿ2-microglobulin in the hemodiafiltration and high-flux\r\ndialysis treatments....
Background: With increased governmental interest in value assessment of technologies and where medical device\r\nmanufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods,\r\nthe study sought to explore the levels of health economics knowledge within small and medium-sized enterprises\r\n(SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers.\r\nMethods: A short questionnaire was completed by participants attending one of five workshops on product\r\ndevelopment in the medical device sector that took place in England between 2007 and 2011. From all responses\r\nobtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the\r\nanalysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval\r\nscales. Qualitative data from participant responses were analysed to reveal emerging themes.\r\nResults: The questionnaire results revealed that 60% of SME participants (mostly company directors or managers,\r\nincluding product or project managers) rated themselves as having low or no knowledge of health economics prior\r\nto the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or\r\ncost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products\r\nto purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion,\r\ncost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise\r\nthese factors. There was no significant dependence of the use of decision-making tools in general with respect to\r\nprofessed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of\r\npotential value when deciding whether to develop a product. A majority of SMEs stated they would use a health\r\neconomics tool. Research and development teams or marketing and sales departments would most likely use one.\r\nConclusion: This study points to the need for further research into the education requirements of SMEs in the area\r\nof Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA\r\nprocesses as required by assessors such as NICE....
Background: It is well established that considering users is an important aspect of medical device development.\r\nHowever it is also well established that there are numerous barriers to successfully conducting user research and\r\nintegrating the results into product development. It is not sufficient to simply conduct user research, it must also be\r\neffectively integrated into product development.\r\nMethods: A case study of the development of a new medical imaging device was conducted to examine in detail\r\nhow users were involved in a medical device development project. Two user research studies were conducted: a\r\nrequirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in\r\nsitu approach was taken to investigate how these studies contributed to the product development process and\r\nhow the results of this work influenced the development of the technology. Data was collected qualitatively\r\nthrough interviews with the development team, participant observation at development meetings and document\r\nanalysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into\r\nproduct development.\r\nResults: A number of individual, organisational and system barriers were identified that functioned to prevent the\r\nresults of the user research being fully integrated into development. The user and technological aspects of\r\ndevelopment were seen as separate work streams during development. The expectations of the developers were\r\nthat user research would collect requirements for the appearance of the device, rather than challenge its\r\nfundamental concept. The manner that the user data was communicated to the development team was not\r\neffective in conveying the significance or breadth of the findings.\r\nConclusion: There are a range of informal and formal organisational processes that can affect the uptake of user\r\ndata during medical device development. Adopting formal decision making processes may assist manufacturers to\r\ntake a more integrated and reflective approach to development, which should result in improved business\r\ndecisions and a higher quality end product....
Background: This pilot open noncontrolled study was designed to assess the efficacy of intra-articular injections of\r\na solution combining hyaluronic acid (HA) and chondroitin sulphate (CS) in the treatment of outpatients affected\r\nby knee osteoarthrosis.\r\nFindings: Thirty patients with knee OA have been included. The primary objective was to assess clinical efficacy as\r\nmeasured by pain and Lequesne�s index. Secondary objectives were to assess potential effect of the treatment on\r\nultrasound parameters, safety and biomarkers of cartilage metabolism and joint inflammation. After a selection visit\r\n(V1), the study treatment was administered 3 times on a weekly basis (V2, V3, V4). Follow-up was planned 6 (V5)\r\nand 12 weeks (V6) after the first intra-articular injection. Efficacy results showed a reduction in mean pain at V3 and\r\nV6 and in functional impairment, the most marked changes being measured at the two follow-up visits (V5 and V6).\r\nAlthough statistical significance was not achieved due to small sample size, a clear tendency towards improvement\r\nwas detectable for ultrasound assessments as well as biomarkers. Except for a mild injection site hematoma for\r\nwhich the drug causal relationship could not be excluded, no adverse effect of clinical relevance was recorded\r\nduring the study.\r\nConclusion: Although this pilot study was performed according to an open design only, the ultrasound as well as\r\nbiomarkers changes strongly suggest a non-placebo effect. These preliminary results call now for a randomized\r\ncontrolled study to confirm the clinical relevance of the observed results...
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