Frontiers in medical technology最新文献

{"title":"Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan.","authors":"Makiko Mochizuki, Hideki Maeda","doi":"10.3389/fmedt.2024.1461460","DOIUrl":"10.3389/fmedt.2024.1461460","url":null,"abstract":"<p><strong>Background: </strong>Although a variety of drug delivery devices have been launched in recent years, few studies have comprehensively investigated the market trends of combination drugs and medical devices approved or certified in Japan and the regulatory challenges related to their approval. Among the drug delivery devices, autoinjectors are more convenient than traditional prefilled syringes and are designed with safety features to prevent needlestick accidents, allowing self-injection by patients. Therefore, autoinjectors have been incorporated into the treatment of various diseases and have shown significant growth among drug delivery devices.</p><p><strong>Aim: </strong>This study aimed to investigate the market trends of combination drugs approved in Japan, especially those with autoinjector formulations, and to explore the challenges in the regulatory aspects of combination drugs.</p><p><strong>Methods: </strong>Information on the number of marketed drugs and medical devices was obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) database using specific definitions. We looked at the annual changes in the number of drug delivery devices approved and certified as combination drugs or medical devices and the number of canceled certifications. We also examined the classification and main certification criteria for Japanese medical device nomenclature.</p><p><strong>Results: </strong>The study suggested that the number of combination drugs with autoinjector formulations is increasing, replacing previously approved or certified pen-type medication injectors. Moreover, 53% of all drug products were approved for autoinjector formulations after the initial authorization approval in Japan, and more than half of them obtained approval for additional formulations for autoinjectors within five years of the initial authorization approval, with the largest number of cases obtaining approval for additional formulations two years later.</p><p><strong>Conclusion: </strong>The lack of clear regulatory requirements for autoinjectors may lead to confusion among applicants. Furthermore, there are challenges in filing regulatory applications, thus hindering the rapid launch of combination drug-utilizing devices with superior usability.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1461460"},"PeriodicalIF":2.7,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142010106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fluid-structure interaction simulation of mechanical aortic valves: a narrative review exploring its role in total product life cycle.","authors":"Mariachiara Arminio, Dario Carbonaro, Umberto Morbiducci, Diego Gallo, Claudio Chiastra","doi":"10.3389/fmedt.2024.1399729","DOIUrl":"10.3389/fmedt.2024.1399729","url":null,"abstract":"<p><p>Over the last years computer modelling and simulation has emerged as an effective tool to support the total product life cycle of cardiovascular devices, particularly in the device preclinical evaluation and post-market assessment. Computational modelling is particularly relevant for heart valve prostheses, which require an extensive assessment of their hydrodynamic performance and of risks of hemolysis and thromboembolic complications associated with mechanically-induced blood damage. These biomechanical aspects are typically evaluated through a fluid-structure interaction (FSI) approach, which enables valve fluid dynamics evaluation accounting for leaflets movement. In this context, the present narrative review focuses on the computational modelling of bileaflet mechanical aortic valves through FSI approach, aiming to foster and guide the use of simulations in device total product life cycle. The state of the art of FSI simulation of heart valve prostheses is reviewed to highlight the variety of modelling strategies adopted in the literature. Furthermore, the integration of FSI simulations in the total product life cycle of bileaflet aortic valves is discussed, with particular emphasis on the role of simulations in complementing and potentially replacing the experimental tests suggested by international standards. Simulations credibility assessment is also discussed in the light of recently published guidelines, thus paving the way for a broader inclusion of <i>in silico</i> evidence in regulatory submissions. The present narrative review highlights that FSI simulations can be successfully framed within the total product life cycle of bileaflet mechanical aortic valves, emphasizing that credible <i>in silico</i> models evaluating the performance of implantable devices can (at least) partially replace preclinical <i>in vitro</i> experimentation and support post-market biomechanical evaluation, leading to a reduction in both time and cost required for device development.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1399729"},"PeriodicalIF":2.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141621969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: New technologies improve maternal and newborn safety.","authors":"Jieyun Bai, Yaosheng Lu, Huishu Liu, Fang He, Xiaohui Guo","doi":"10.3389/fmedt.2024.1372358","DOIUrl":"10.3389/fmedt.2024.1372358","url":null,"abstract":"","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1372358"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11169838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141319350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evolutionary trends and innovations in cardiovascular intervention.","authors":"Vincenzo Vento, Salomé Kuntz, Anne Lejay, Nabil Chakfe","doi":"10.3389/fmedt.2024.1384008","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1384008","url":null,"abstract":"<p><p>Cardiovascular diseases remain a global health challenge, prompting continuous innovation in medical technology, particularly in Cardiovascular MedTech. This article provides a comprehensive exploration of the transformative landscape of Cardiovascular MedTech in the 21st century, focusing on interventions. The escalating prevalence of cardiovascular diseases and the demand for personalized care drive the evolving landscape, with technologies like wearables and AI reshaping patient-centric healthcare. Wearable devices offer real-time monitoring, enhancing procedural precision and patient outcomes. AI facilitates risk assessment and personalized treatment strategies, revolutionizing intervention precision. Minimally invasive procedures, aided by robotics and novel materials, minimize patient impact and improve outcomes. 3D printing enables patient-specific implants, while regenerative medicine promises cardiac regeneration. Augmented reality headsets empower surgeons during procedures, enhancing precision and awareness. Novel materials and radiation reduction techniques further optimize interventions, prioritizing patient safety. Data security measures ensure patient privacy in the era of connected healthcare. Modern technologies enhance traditional surgeries, refining outcomes. The integration of these innovations promises to shape a healthier future for cardiovascular procedures, emphasizing collaboration and research to maximize their transformative potential.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1384008"},"PeriodicalIF":0.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11098563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hemodynamics of the VenusP Valve System™-an <i>in vitro</i> study.","authors":"Huang Chen, Milad Samaee, Michael Tree, Lakshmi Dasi, Ajit Yoganathan","doi":"10.3389/fmedt.2024.1376649","DOIUrl":"https://doi.org/10.3389/fmedt.2024.1376649","url":null,"abstract":"<p><p>This study aims to evaluate the fluid dynamic characteristics of the VenusP Valve System™ under varying cardiac outputs <i>in vitro</i>. A thorough hemodynamic study of the valve under physiological cardiac conditions was conducted and served as an independent assessment of the performance of the valve. Flow fields downstream of the valve near the pulmonary bifurcation were quantitatively studied by two-dimensional Particle Image Velocimetry (PIV). The obtained flow field was analyzed for potential regions of flow stasis and recirculation, and elevated shear stress and turbulence. High-speed en face imaging capturing the leaflet motion provided data for leaflet kinematic modeling. The experimental conditions for PIV studies were in accordance with ISO 5840-1:2021 standard, and two valves with different lengths and different orientations were studied. Results show good hemodynamics performance for the tested valves according to ISO 5840 standard without significant regions of flow stasis. Observed shear stress values are all well below established hemolysis limits.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1376649"},"PeriodicalIF":0.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11098565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: Understanding the impact of lung ventilation heterogeneity.","authors":"Brooks Kuhn, Igor Barjaktarevic","doi":"10.3389/fmedt.2024.1332958","DOIUrl":"10.3389/fmedt.2024.1332958","url":null,"abstract":"","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1332958"},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10944995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140159780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Animal models in medical translation: the grand challenge of developing new treatments for human diseases.","authors":"Philip V Peplow","doi":"10.3389/fmedt.2024.1367521","DOIUrl":"10.3389/fmedt.2024.1367521","url":null,"abstract":"","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1367521"},"PeriodicalIF":0.0,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10904654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex-specific outcomes in cancer therapy: the central role of hormones.","authors":"Parisa Bakhshi, Jim Q Ho, Steven Zanganeh","doi":"10.3389/fmedt.2024.1320690","DOIUrl":"10.3389/fmedt.2024.1320690","url":null,"abstract":"<p><p>Sex hormones play a pivotal role in modulating various physiological processes, with emerging evidence underscoring their influence on cancer progression and treatment outcomes. This review delves into the intricate relationship between sex hormones and cancer, elucidating the underlying biological mechanisms and their clinical implications. We explore the multifaceted roles of estrogen, androgens, and progesterone, highlighting their respective influence on specific cancers such as breast, ovarian, endometrial, and prostate. Special attention is given to estrogen receptor-positive (ER+) and estrogen receptor-negative (ER-) tumors, androgen receptor signaling, and the dual role of progesterone in both promoting and inhibiting cancer progression. Clinical observations reveal varied treatment responses contingent upon hormonal levels, with certain therapies like tamoxifen, aromatase inhibitors, and anti-androgens demonstrating notable success. However, disparities in treatment outcomes between males and females in hormone-sensitive cancers necessitate further exploration. Therapeutically, the utilization of hormone replacement therapy (HRT) during cancer treatments presents both potential risks and benefits. The promise of personalized therapies, tailored to an individual's hormonal profile, offers a novel approach to optimizing therapeutic outcomes. Concurrently, the burgeoning exploration of new drugs and interventions targeting hormonal pathways heralds a future of more effective and precise treatments for hormone-sensitive cancers. This review underscores the pressing need for a deeper understanding of sex hormones in cancer therapy and the ensuing implications for future therapeutic innovations.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"6 ","pages":"1320690"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10867131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Framework for creating a qualified medical device development tool of autoinjectors.","authors":"Marlon Luca Machal","doi":"10.3389/fmedt.2023.1281403","DOIUrl":"10.3389/fmedt.2023.1281403","url":null,"abstract":"<p><strong>Objectives: </strong>Autoinjectors are pivotal for precise self-administration of medications across a wide range of medical conditions. Nevertheless, the absence of a dedicated Medical Device Development Tool (MDDT) for autoinjectors represents a gap that may result in variations in the quality and regulatory compliance of autoinjectors as components of combination products. This research aim is to utilize the recently introduced Primary Functions outlined in ISO 11608-1:2022 with the title \"Needle-based injection systems for medical use. Requirements and test methods. Part 1: Needle-based injection systems\" to create a comprehensive MDDT framework tailored specifically for autoinjectors.</p><p><strong>Methods: </strong>To support the creation of the framework, the analysis of the FDA MDDTs that were already approved, FDA's design controls regulations, FDA's guidance related to autoinjectors, and the Primary functions outlined in ISO 11608-1:2022 were utilized.</p><p><strong>Results: </strong>The research identifies the Primary Functions in autoinjector to be Holding Force, Cap Removal Force, Activation Force, Extended Needle Length, Injection Time, Dose Accuracy and Needle Guard Lockout. Leveraging these Primary Functions and the FDA's MDDT approach, the research aims to bridge the gap by proposing a structured framework for the development of a specific MDDT tailored to autoinjectors.</p><p><strong>Conclusion: </strong>This study presents a MDDT framework tailored to the development of autoinjectors for drug delivery. This framework provides a structured methodology to support predictability and effectiveness of the autoinjector development and support regulatory review process, thereby expediting FDA approval for autoinjectors as part of combination product.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"5 ","pages":"1281403"},"PeriodicalIF":0.0,"publicationDate":"2023-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10733859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138833702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designing for flexibility in hybrid care services: lessons learned from a pilot in an internal medicine unit.","authors":"Nirit Putievsky Pilosof, Michael Barrett, Eivor Oborn, Galia Barkai, Eyal Zimlichman, Gad Segal","doi":"10.3389/fmedt.2023.1223002","DOIUrl":"10.3389/fmedt.2023.1223002","url":null,"abstract":"<p><p>Digital transformation in healthcare during the COVID-19 pandemic led to the development of new hybrid models integrating physical and virtual care. The ability to provide remote care by telemedicine technologies and the need to better manage and control hospitals' occupancy accelerated growth in hospital-at-home programs. The Sheba Medical Center restructured to create Sheba Beyond as the first virtual hospital in Israel. These transformations enabled them to deliver hybrid services in their internal medicine unit by managing inpatient hospital-care with remote home-care based on the patients' medical condition. The hybrid services evolved to integrate care pathways multiplied by the mode of delivery-physical (in person) or virtual (technology enabled)-and the location of care-at the hospital or the patient home. The study examines this home hospitalization program pilot for internal medicine at Sheba Medical Center (MC). The research is based on qualitative semi-structured interviews with Sheba Beyond management, medical staff from the hospital and the Health Maintenance Organization (HMO), Architects, Information Technology (IT), Telemedicine and Medtech organizations. We investigated the implications of the development of hybrid services for the future design of the physical built-environment and the virtual technological platform. Our findings highlight the importance of designing for flexibility in the development of hybrid care services, while leveraging synergies across the built environment and digital platforms to support future models of care. In addition to exploring the potential for scalability in accelerating the flexibility of the healthcare system, we also highlight current barriers in professional, management, logistic and economic healthcare models.</p>","PeriodicalId":94015,"journal":{"name":"Frontiers in medical technology","volume":"5 ","pages":"1223002"},"PeriodicalIF":0.0,"publicationDate":"2023-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10694442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138489401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}