Relevant bibliographies by topics / Orthopaedic implant industry

Academic literature on the topic 'Orthopaedic implant industry'

Author: Grafiati
Published: 10 December 2022
Last updated: 29 January 2023

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Journal articles on the topic "Orthopaedic implant industry"

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Henshaw, Frederick, Eleni Karasouli, Richard King, Usama Rahman, David Langton, June Madete, Fred Otsyeno, et al. "Engineering standards for trauma and orthopaedic implants worldwide: a systematic review protocol." BMJ Open 8, no. 10 (October 2018): e021650. http://dx.doi.org/10.1136/bmjopen-2018-021650.

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IntroductionDespite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area.Methods and analysisThis protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards.Ethics and disseminationNo ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.
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Michalíková, Monika, Teodor Tóth, Viktória Rajťúková, and Jozef Živčák. "The Digital Pre-Operative Planning of Hip Surgical Interventions." Solid State Phenomena 199 (March 2013): 350–55. http://dx.doi.org/10.4028/www.scientific.net/ssp.199.350.

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Computer technology has many applications in different fields of industry, health care and medicine. This encompasses paper-based information processing as well as data processing machines (Hospital information system or Clinical information system) and image digitalization of a large variety of medical diagnostic equipment (e.g. computer images of X-ray, MR, CT). The aim of the computer technology in medicine is to achieve the best possible support of patient care, preoperative surgery planning and administration by electronic data processing. At the present time in many countries of the worlds preoperative planning of interventions for lumbar joint is realized with caliper, protractor, plastic templates and x-ray images. Orthopaedic surgeons use transparent template radiographs as part of pre-operative planning in order to gauge the suitability and correct size of an implant. The newly developed CoXaM software offers a simple solution of the problems by using the digital x-ray images and handmade transparent plastic templates. The CoXaM software was developed in Visual Studio 2005 in the Visual C++ programming language at the Department of Biomedical Engineering and Measurement at the Faculty of Mechanical Engineering, Technical University of Kosice. The software was designed for pre-operative planning and helps to determine on the X-ray image a length dimensions, a center of rotation, an angle values. It enables the digitalization of plastic templates from several producers, which will assess the suitability of the type of implant.
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Gagliardi, Anna R., Ariel Ducey, Pascale Lehoux, Thomas Turgeon, Sue Ross, Patricia Trbovich, Anthony Easty, Chaim Bell, and David Urbach. "Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices." BMJ Quality & Safety 27, no. 3 (August 2, 2017): 190–98. http://dx.doi.org/10.1136/bmjqs-2017-006481.

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BackgroundPostmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.MethodsQualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.ResultsTwenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.ConclusionsThere may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.
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Al Qahtani, Waleed M. S., and Mohamed I. El-Anwar. "Advanced Computational Methods in Bio-Mechanics." Open Access Macedonian Journal of Medical Sciences 6, no. 4 (April 8, 2018): 742–46. http://dx.doi.org/10.3889/oamjms.2018.149.

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A novel partnership between surgeons and machines, made possible by advances in computing and engineering technology, could overcome many of the limitations of traditional surgery. By extending surgeons’ ability to plan and carry out surgical interventions more accurately and with fewer traumas, computer-integrated surgery (CIS) systems could help to improve clinical outcomes and the efficiency of healthcare delivery. CIS systems could have a similar impact on surgery to that long since realised in computer-integrated manufacturing. Mathematical modelling and computer simulation have proved tremendously successful in engineering.Computational mechanics has enabled technological developments in virtually every area of our lives. One of the greatest challenges for mechanists is to extend the success of computational mechanics to fields outside traditional engineering, in particular to biology, the biomedical sciences, and medicine. Biomechanics has significant potential for applications in orthopaedic industry, and the performance arts since skills needed for these activities are visibly related to the human musculoskeletal and nervous systems.Although biomechanics is widely used nowadays in the orthopaedic industry to design orthopaedic implants for human joints, dental parts, external fixations and other medical purposes, numerous researches funded by billions of dollars are still running to build a new future for sports and human healthcare in what is called biomechanics era.
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Ness, M. G. "The effect of bending and twisting on the stiffness and strength of the 3.5 SOP implant." Veterinary and Comparative Orthopaedics and Traumatology 22, no. 02 (2009): 132–36. http://dx.doi.org/10.3415/vcot-08-03-0030.

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SummaryLocking plates are becoming increasingly popular in veterinary orthopaedics. The SOP is a novel locking plate system, which can be contoured with 6° of freedom and which utilises standard bone screws. The purpose of this work was to investigate the mechanical consequences of contouring the 3.5 SOP plate to support the formulation of clinical guidelines. The implants were loaded in four point bending using an industry standard protocol. The uncontoured SOP was found to be significantly stiffer and stronger than the uncontoured 3.5 DCP. Bending, and to a lesser extent, twisting, diminished the SOP’s stiffness and strength but the contoured SOP remained at least as stiff and strong as the untouched DCP.
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Sharma, Akash, and Gaurav Luthra. "Role of Regulatory Affairs in a Medical Device Industry." Current Journal of Applied Science and Technology, August 12, 2022, 1–7. http://dx.doi.org/10.9734/cjast/2022/v41i2931797.

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Regulatory Affairs experts are the important part of the Medical Device industry since it is concern about the orthopaedic Implant/Instruments lifecycle, it gives key, strategic and functional bearing and backing for working inside guidelines to speed up the turn of events and conveyance of protected and compelling orthopaedic products to people all over the globe. The responsibility of regulatory affairs is to create and execute an regulatory system to guarantee that the medical device product is approvable by worldwide different regulatory authorities, but on the other hand is separated from the opposition somehow or another and furthermore is to guarantee that the organization's exercises, from non-clinical exploration through to publicizing and advancement, are lead as per the guidelines and rules laid out by Regulatory Authorities. Regulatory Affairs is an appealing profession decision for graduate understudies from a logical foundation who appreciate correspondence and cooperation, are compatible with performing various tasks and are anxious to grow their insight in the wide domains of the Medical world. Regulatory Affairs is a fulfilling, mentally invigorating and exceptionally respected department inside Medical device companies. In this research article different regulatory authorities worldwide are taken into the contrast for medical devices approvals and regulatory controls. The role and importance of the regulatory affairs professional is pictured as a bridge between the medical device industry and different regulatory authorities worldwide.
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Vanlommel, Luc, Enrico Neven, Mike B. Anderson, Liesbeth Bruckers, and Jan Truijen. "The initial learning curve for the ROSA® Knee System can be achieved in 6-11 cases for operative time and has similar 90-day complication rates with improved implant alignment compared to manual instrumentation in total knee arthroplasty." Journal of Experimental Orthopaedics 8, no. 1 (December 2021). http://dx.doi.org/10.1186/s40634-021-00438-8.

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Abstract Purpose The purpose of this study was to determine the learning curve for total operative time using a novel cutting guide positioning robotic assistant for total knee arthroplasty (raTKA). Additionally, we compared complications and final limb alignment between raTKA and manual TKA (mTKA), as well as accuracy to plan for raTKA cases. Methods We performed a retrospective cohort study on a series of patients (n = 180) that underwent raTKA (n = 90) using the ROSA Total Knee System or mTKA (n = 90) by one of three high-volume (> 200 cases per year) orthopaedic surgeons between December 2019 and September 2020, with minimum three-month follow-up. To evaluate the learning curve surgical times and postoperative complications were reviewed. Results The cumulative summation analysis for total operative time revealed a change point of 10, 6, and 11 cases for each of three surgeons, suggesting a rapid learning curve. There was a significant difference in total operative times between the learning raTKA and both the mastered raTKA and mTKA groups (p = 0.001) for all three surgeons combined. Postoperative complications were minimal in all groups. The proportion of outliers for the final hip-knee-ankle angle compared to planned was 5.2% (3/58) for the mastered raTKA compared to 24.1% (19/79) for mTKA (p = 0.003). The absolute mean difference between the validated and planned resections for all angles evaluated was < 1 degree for the mastered raTKA cases. Conclusion As the digital age of medicine continues to develop, advanced technologies may disrupt the industry, but should not disrupt the care provided. This cutting guide positioning robotic system can be integrated relatively quickly with a rapid initial learning curve (6-11 cases) for operative times, similar 90-day complication rates, and improved component positioning compared to mTKA. Proficiency of the system requires additional analysis, but it can be expected to improve over time. Level of evidence Level III Retrospective Therapeutic Cohort Study.
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Festas, A. J., S. Carvalho, A. Horovistiz, A. Ramos, and J. P. Davim. "Comparative study of titanium alloys machinability used for medical applications." Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering, January 25, 2022, 095440892210748. http://dx.doi.org/10.1177/09544089221074852.

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CNC machining manufacturing is critical to the development of biomedical industries, especially orthopaedic implants. Understanding a material's machinability under different cutting conditions is essential for component design as well as for optimizing the machining process. Despite their widespread use in the biomedical industry, α + β-type titanium (Ti) alloys, such as Ti-6Al-4V and Ti-6Al-7Nb, are being replaced by β or near β-type Ti alloys like Ti-13Nb-13Zr Ti alloy due to issues associated with Vanadium and Aluminium toxicity and lower modulus of elasticity. By simulating the machining of a functional cone of the hip prosthesis femoral component, this work aims to investigate some aspects of the machinability of titanium alloys: Ti-6Al-4V, Ti-6Al-7Nb, and Ti-13Nb-alloy 13Zr. Cutting forces values were registered during the tests. Using correlative microscopy, machined surfaces were examined by measuring roughness and topographic examination. According to the results obtained, the new titanium alloy Ti-13Nb-13Zr alloy presents lower cutting forces and a worse surface finish for a lower feed rate. However, when the feed rate was increased to double the initial value, this alloy had the smallest increase in Ra, compared with the other alloys under test The effect of federate is highly significant in cutting forces and surface finish, with increases in cutting forces of 35%, 45% and 66% on cutting forces for Ti-13Nb-13Zr, Ti-6Al-4V and Ti-6Al-7Nb, respectively.
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Al-Mansour, Ali Hamad Mohammed, Abdullah Nasser Gvin Al Rizk, Hamad Mohammed Shaman Al-Mansour, Hadi Salem Faraj Al Mahamed, Hussain Saleh Muidh Al Sharmah, Ali Mohammed Al-mahamed, Jaber Mohammed Al-hattab, and Fahad Mohammed Hamad Almansour. "Updates in the Use of 3D Bioprinting in Biomedical Engineering for Clinical Application: A Review." Journal of Pharmaceutical Research International, December 24, 2022, 42–53. http://dx.doi.org/10.9734/jpri/2022/v34i587263.

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Three-dimensional (3D) printing is one of the most well-liked new innovative and promising manufacturing techniques, which has demonstrated tremendous potential for the creation of biostructures in tissue engineering, particularly for bones, orthopaedic tissues, and related organs. 3D printing for the medical industry was considered a lofty pipe dream. Time and money, though, made it a reality. Today's 3D printing technology has a significant possibility to assist pharmaceutical and medical corporations in developing more specialised pharmaceuticals, enabling the quick creation of medical implants, and transforming how doctors and surgeons approach surgical planning. In today's practise of precision medicine and for individualised therapies, patient-specific anatomical models that are 3D printed are becoming increasingly helpful tools. In contrast to the conventional use of 3D printing to create cell-free scaffolds, 3D bioprinting requires various technical methods, such as biomimicry, autonomous self-assembly, and mini-tissue building blocks, to create 3D structures with mechanical and biological properties suitable for the deposition of living cells and the restoration of tissue and organ function. Cells, bioinks, and bioprinters are all necessary components of the bioprinting process, and each one of them has biological, technological, ethical, and cost- and clinically-effectiveness-related issues. As a result, there are several difficulties in integrating 3D bioprinting into widespread clinical practise. Currently, there are multiple applications for 3D bioprinting such as in surgery, cardiovascular system, musculoskeletal and even in drug screening. All of which will be discussed in this review.
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Dissertations / Theses on the topic "Orthopaedic implant industry"

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De, Beer N., D. Dimitrov, and der Merwe A. Van. "Manufacturing of custom-made medical implants for cranio / maxillofacial and orthopaedic surgery - an overview of the current state of the industry." Journal for New Generation Sciences, Vol 6, Issue 2: Central University of Technology, Free State, Bloemfontein, 2008. http://hdl.handle.net/11462/502.

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Published Article
Extensive work has been done in the area of manufacturing implants for medical purposes, and more recently the development of customised implants. Areas of application include cranio/maxillo-facial implants, dental drill guides, hip, knee and shoulder replacements, as well as different implants for the spine. Due to their high prevalence and complex anatomical geometry the purpose of this study is to investigate the current state of the industry regarding customised medical implants for cranio/maxillofacial and orthopaedic surgery. Implant customisation has far-reaching benefits, and a collective approach to solving current difficulties will require an in-depth study of successes already achieved. Several issues in this regard are examined, including what defines customisation, regulatory issues that govern customisation and design constraints, trends in different areas of application, suitable materials, and finally which manufacturing techniques are being employed, with a focus on the use of Layer Manufacturing technologies and their role in custom-made medical implants.
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Books on the topic "Orthopaedic implant industry"

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Frost & Sullivan., ed. Orthopaedic implants & allied products market outside the U.S. New York, N.Y. (106 Fulton St., New York 10038): Frost & Sullivan, 1989.

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Book chapters on the topic "Orthopaedic implant industry"

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Silverio, Bruna Luciana, and Christiane Ribeiro. "The Interrelationship Between Industry/Medical/Patient in the Analysis of Failures in Orthopaedic Implants." In XXVI Brazilian Congress on Biomedical Engineering, 559–63. Singapore: Springer Singapore, 2019. http://dx.doi.org/10.1007/978-981-13-2119-1_87.

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Goharian, Amirhossein. "Conception of Osseointegration in Development of Orthopedic Implant Industry." In Osseointegration of Orthopaedic Implants, 163–83. Elsevier, 2019. http://dx.doi.org/10.1016/b978-0-12-813384-2.00008-4.

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