Medical Devices-Evidence and Research最新文献

{"title":"Comparison of a Novel Posterior Integrated Transfixation Sacroiliac Joint Fusion Approach to the Posterolateral and Lateral Approaches: A Cadaveric Biomechanical and Computational Analysis of the Fixation, Invasiveness, and Fusion Area.","authors":"Oluwatodimu Richard Raji, Joshua H Tandio, Sarah Mayer, Alexander Escobar, Brett A Himmelwright, Douglas P Beall, David L Caraway, Jeremi M Leasure","doi":"10.2147/MDER.S474734","DOIUrl":"https://doi.org/10.2147/MDER.S474734","url":null,"abstract":"<p><strong>Purpose: </strong>To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.</p><p><strong>Methods and materials: </strong>Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.</p><p><strong>Results: </strong>The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes (<i>P</i> > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, <i>P</i> <0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P<0.10), introduced 200%-270% more implant surface to the joint space (P<0.01) and decorticated 75%-375% more joint surface area (<i>P</i><0.01).</p><p><strong>Conclusion: </strong>The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"385-399"},"PeriodicalIF":1.3,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548270","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":"Investigation into the Acceptability of Moderate-to-Large Volume Subcutaneous Injections in Healthy Volunteers: Results from a Single-Center Randomized Controlled Study.","authors":"Chika Akinseye, Andrew Fiorini, Emily Louise Jarvis, Michelle Fry, Abid Raza, Sara Soleman, Stephanie Igwe, Mark Palmer","doi":"10.2147/MDER.S479507","DOIUrl":"10.2147/MDER.S479507","url":null,"abstract":"<p><strong>Purpose: </strong>Therapeutic proteins are often delivered by subcutaneous (SC) autoinjector to enable self-administration. Autoinjectors typically deliver up to 1 mL injected volumes per dose. Delivery of larger volumes may be limited by injection site discomfort, including pain, swelling, and redness. Delivery at a slower rate may mitigate this discomfort. This single-center, randomized, crossover study evaluated the acceptability and tolerability of varying volumes and delivery rates of SC saline in healthy volunteers.</p><p><strong>Patients and methods: </strong>Eligible participants were adults (18-65 years) with a body mass index of 18.5-32.0 kg/m². Participants (N = 24) were randomized to multiple sequences of infusions over five visits, with infusions ranging from 1 to 5 mL at rates of 1.50-6.00 mL/minute (min) and including a 1 mL SC infusion in 10 seconds (s) at a rate of 6.00 mL/min. The primary objective was to identify acceptable volume and delivery rates of SC saline, as assessed by visual analogue scale (VAS) pain scores, a tolerability and acceptability questionnaire, and infusion leakage.</p><p><strong>Results: </strong>Infusions that met the acceptability criteria were 1 mL in 10s, 4 mL in 58s, and 3 mL in 2 mins. Higher delivery volumes and rates were associated with higher VAS pain scores but remained within the VAS acceptability criteria.</p><p><strong>Conclusion: </strong>These findings may support the development of larger-volume injectors for self-administration of future medicines.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"369-384"},"PeriodicalIF":1.3,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548272","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":"Problems Related to Endotracheal Intubation as an Input for the Design of a New Endotracheal Tube.","authors":"Gorka Ramirez, Miguel Angel Campanero, Ane Miren Zaldua, Nerea Jauregizar","doi":"10.2147/MDER.S475964","DOIUrl":"10.2147/MDER.S475964","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of the current review is to identify the main problems of endotracheal intubation, which will serve as a basis for the design requirements for a novel endotracheal tube.</p><p><strong>Methodology: </strong>A PICO systematic search was conducted in PubMed up to December 2021 to identify issues related both to the endotracheal intubation procedure and device-specific factors.</p><p><strong>Results: </strong>Two primary categories of problems were identified during endotracheal intubation: a) Issues related to laryngotracheal symptoms such as cough, hoarseness, aphonia, dysphonia, dysphagia, swallowing difficulties and the risk of stenosis with long-term intubation. The underlying pressure, abrasion and/or decubitus phenomena should be considered in a new design approach. b) Issues related to the cuff sealing and microaspirations, where the risk of ventilator-associated pneumonia (VAP) highlights the need to improve the design.</p><p><strong>Discussion & conclusion: </strong>This review has yielded valuable input for rethinking the design of endotracheal tubes to ensure an efficient and safe airway. This new design should focus on the protection of anatomical structures, avoid or reduce the phenomena of laryngotracheal symptoms, and even reduce the risk of ventilator-associated-pneumonia (VAP) and/or prevent the need for certain tracheostomies.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"349-367"},"PeriodicalIF":1.3,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11514703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523308","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":"Discrepancies in CDE and Measured Phaco Tip Energy: Comparison of Energy Produced in Longitudinal and Torsional Ultrasound Using Calorimetry.","authors":"Reiker G Ricks, Ivan A Cardenas, Jenna L Jensen, Tanner K Nelson, Randall J Olson, Jeff H Pettey","doi":"10.2147/MDER.S484843","DOIUrl":"10.2147/MDER.S484843","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to investigate the differences between the heat energy produced during cataract surgery and Cumulative dissipated energy (CDE). CDE is often used as a medium for understanding the energy delivered to the eye during cataract surgery. However, the actual energy produced at the tip level of the tip is not well understood. We propose that a discrepancy may exist between the CDE reported by the surgical machine and the actual energy delivered to the eye.</p><p><strong>Methods: </strong>About 50 mL of distilled water were degassed and placed in an isobaric calorimeter. Using the Alcon Centurion and Ozil handpiece fitted with the balanced tip, an investigator immersed the phaco tip into the water and pressed the foot pedal to position 3. The device was set to 100% continuous power, vacuum to 0 mmHg, with aspiration 12 mL/min aspiration. To prevent system changes in the system within the calorimeter, the aspiration tubing was occluded. Temperature change recorded by another investigator was observed from 0 to 60 seconds. After 60 seconds the first researcher immediately released the pedal and removed the phaco tip from the water. Trials were performed 10 times using solely torsional or longitudinal settings and averaged. CDE also was recorded and averaged.</p><p><strong>Results: </strong>No significant difference was seen in the temperature change or energy calculated in Joules between ultrasound modalities, with torsional producing a magnitude of 163 J and longitudinal producing 172 J (P = 0.2). However, the CDE generated in the 60 seconds period was significantly different, with a magnitude of 61 for longitudinal compared to 24 for torsional (P < 0.001).</p><p><strong>Conclusion: </strong>Significantly more energy was generated using torsional ultrasound than longitudinal at the tip level of the tip. CDE did not appear to accurately reflect these differences. This suggests that other factors should be considered when evaluating CDE and surgical outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"339-348"},"PeriodicalIF":1.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11492905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142485981","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":"Computed Tomographic Characterization for Basivertebral Nerve Ablation Utilizing a Radiofrequency Multitined Expandable Electrode.","authors":"Dawood Sayed, Douglas P Beall, Amitabh Gulati, Eric Hyman, Jon E Block","doi":"10.2147/MDER.S487201","DOIUrl":"https://doi.org/10.2147/MDER.S487201","url":null,"abstract":"<p><strong>Background: </strong>A growing body of clinical evidence has demonstrated that intraosseous minimally invasive basivertebral nerve (BVN) ablation results in significant and durable improvements in vertebrogenic back pain. Thus, it is important to develop, refine and validate new and additional devices to accomplish this procedure.</p><p><strong>Methods: </strong>Using reconstructions of 31 patient computed tomography (CT) scans of the lumbosacral spine (L1-S1), the primary objective was to simulate the intravertebral placement of a novel multitined expandable electrode in bipolar configuration at the targeted ablation site and determine if the proper trajectories could be achieved in order for the device tips to be in the correct position for lesion formation at the BVN plexus. Successful device deployment required that the distance between tips was between 10 mm and 20 mm.</p><p><strong>Results: </strong>The mean distances between device tips ranged from 11.35 mm (L5) to 11.87 mm (L3), and there were no statistically significance differences across the six vertebral levels (F = 0.72, p = 0.61). The percentage of successful intraosseous device placements within the tip distance acceptable range (≥ 10 mm to ≤ 20 mm) was 90% (162 of 180), with no tip-to-tip distances > 20 mm. There was a notable association between decreasing vertebral level and mean degree of angulation between contralateral devices ranging from 50.90° at L1 to 91.51° at S1, and the difference between across the six vertebral levels was significant (F = 89.5, p < 0.01).</p><p><strong>Conclusion: </strong>Feasibility evidence is provided from real world CT imaging data that validates using the multitined electrode for proper intraosseous placement within the vertebral body to effectively ablate the BVN plexus.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"323-337"},"PeriodicalIF":1.3,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11412689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298537","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":"Emerging Trends and Hot Topics of Non-Invasive Electroencephalography Research in the Elderly: A Bibliometric Analysis from 2014 to 2023.","authors":"Chunyong Tang, Yanhua Peng, Jing Sui, Wencai Jiang, Rui Zhou","doi":"10.2147/MDER.S480900","DOIUrl":"10.2147/MDER.S480900","url":null,"abstract":"<p><strong>Background: </strong>Electroencephalography (EEG) has been rapidly developed and is widely used in both clinical and scientific fields. Original studies on non-invasive EEG in the elderly have been of great importance owing to the global aging trend. The present study aimed to provide a bibliometric overview on current status and trends in this research field.</p><p><strong>Methods: </strong>We searched the Web of Science Core Collection for articles published during 2014 and 2023. Synonyms for EEG and the elderly were combined as a retrieval strategy. Invasive EEG and secondary studies were excluded. Online filters and manual reviews were applied to select eligible articles. Basic bibliometric parameters were analyzed and visualized using VOSviewer and Excel software.</p><p><strong>Results: </strong>A total of 1656 publications were filtered, and 655 of which were finally included. In general, publication counts have steadily increased over the last 10 years. A sharp rise in publications occurred in 2021, and then remained at a high level. Authors and institutions from high-income countries/regions such as the United States of America (USA), China, and Germany were more productive and made significant contributions. Journals specialized in neuroscience, such as Frontiers in Aging Neuroscience, Neurobiology of Aging, and Clinical Neurophysiology, were popular among authors. Articles on aging, Alzheimer's disease (AD), mild cognitive impairment (MCI), dementia, memory, event-related potentials, attention, and the brain were more likely to use EEG. The newer topics included anesthesia, postoperative delirium (POD), confusion assessment method, connectivity, validation, and power.</p><p><strong>Conclusion: </strong>This bibliometric study provides fundamental knowledge on the current status and hot spots of the original studies on EEG in elderly, which is beneficial to researchers in paving future investigations of neuroscience and neural diseases.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"311-322"},"PeriodicalIF":1.3,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113364","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":"Evaluation of Radiant Power of the Light Curing Units Used in Clinics at Governmental and Privates Dental Faculties.","authors":"Sami Abdulsalam Ali Hasan, Ibrahim Zaid Al-Shami, Mohsen Ali Al-Hamzi, Ghadeer Saleh Alwadai, Nada Ahmad Alamoudi, Saleh Ali Alqahtani, Arwa Daghrery, Wafa H Alaajam, Mansoor Shariff, Hussain Mohammed Kinani, Mohammed M Al Moaleem","doi":"10.2147/MDER.S478042","DOIUrl":"10.2147/MDER.S478042","url":null,"abstract":"<p><strong>Background: </strong> To evaluate the radiant power of the light cure units (LCUs) in relation to their type, radiant exitance, number of years in clinical use, and condition of LCUs tips in governmental and public clinics in Dental Faculties in Sana'a City.</p><p><strong>Materials and methods: </strong>LCUs were collected from different colleges at Sanaa City, Yemen, then LCU data as type, clinical age (<1 year, between 1-5 and ˃ 5-years), tip condition was visually inspected for damage and adhering debris, and the radiant exitance values of the tested LCUs. Radiant exitance values were subcategorized into three groups: <400, 400-850, and >850 mW/cm², labeled as inadequate, marginal, and adequate radiant exitances, respectively. A Woodpecker radiometer was used with a mode lasting of 20 seconds was used with each LCU. Descriptive statistics of the different parameters were evaluated with SPSS version 25. One-way ANOVA and Mann-Whitney tests were performed to determine the mean difference between the groups with a significance value of ˂ 0.05 was considered.</p><p><strong>Results: </strong>Two hundred twenty-three LCUs were surveyed, and the majority were Light-emitting diode (LED). Forty-nine (21.9%), 117 (52.4%), 57 (25.6%) recorded lesser than, 400-850, and more than 850 mW/cm², respectively. Radiant exitances of < year-old units were found to be higher than those of units used for ˃ 5 years with significant differences (p=0.001). The ANOVA test showed significant differences between the radiant exitance with clinical age and LCU tip conditions and a strong correlation p ˃ 0.050.</p><p><strong>Conclusion: </strong>LED curing lights were the most used in the tested Dental Faculties. More than half of the used LCU offered sufficient radiant exitance. Clinical age, the presence or absence of composite buildups, and damage to curing tips showed significantly affect radiant exitance values.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"301-310"},"PeriodicalIF":1.3,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11363918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113365","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":"Improving Radial EBUS Signal with Creation of False Airway to Target Lesion During Electromagnetic Navigational Bronchoscopy: A Case Series.","authors":"Jennifer Wong, Monika Kakol, H Erhan Dincer","doi":"10.2147/MDER.S478541","DOIUrl":"10.2147/MDER.S478541","url":null,"abstract":"<p><p>Navigational bronchoscopy is increasingly used to target peripheral pulmonary nodules using electromagnetic navigational platforms (ENB), fluoroscopic navigation, or robotic-assisted bronchoscopy. The selection of equipment largely depends on the availability of technology, expertise, and the characteristics of the nodule and patient. Radial EBUS (r-EBUS) is often combined with these techniques for real-time confirmation of the nodule location. A bronchus sign is considered to have a higher diagnostic yield when biopsy tools can directly reach the nodule. We describe a case series of creating a false airway into the nodule when an eccentric r-EBUS signal is seen to subsequently obtain a concentric signal.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"295-300"},"PeriodicalIF":1.3,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11335003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142009692","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":"Innovative Hematology Analysis Using Menstrual Blood.","authors":"Endah Wulandari, Rr Ayu Fitri Hapsari","doi":"10.2147/MDER.S468500","DOIUrl":"10.2147/MDER.S468500","url":null,"abstract":"<p><strong>Purpose: </strong>The main aim of this study was to compare and analyze hematological profiles using menstrual blood, as an alternative to peripheral blood.</p><p><strong>Patients and methods: </strong>This study used menstrual and peripheral blood samples from women who were menstruating. The design of this research is analytical observational.</p><p><strong>Results: </strong>Menstrual blood can show an overall hematological profile similar to peripheral blood. Data shows the detection of blood component parameters, white blood cells and reticulocytes in MB with a range within and outside normal blood. Data on MB that show higher values (WBC, MCH, MCHC, PLT, RDW-CV, PDW, MPV, P-LCR, PCT, neutrophils, lymphocytes, monocytes, basophils, reticulocytes, LFR, Ret-He) and lower values lower (RBC, HGB, HCT, MVC, RDW-SD, Eosinophils, IRF, MFR, HFR) when compared with peripheral blood controls. The hematological profiles of Menstrual and peripheral blood showed significant differences (p < 0.01) for several parameters, while several other parameters did not show significant differences (p > 0.05) according to the Wilcoxon test.</p><p><strong>Conclusion: </strong>All hematological profile parameters were detected in menstrual blood. The new concept that menstrual blood can be used as a supporting medium for hematological examinations opens up opportunities for developing independent hematological detection tools in productive women.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"285-293"},"PeriodicalIF":1.3,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11313484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141917731","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":"Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented Simulated Use Study with Pen Injectors.","authors":"Jakob Lange, Andreas E Schneider, Christoph Jordi","doi":"10.2147/MDER.S478141","DOIUrl":"10.2147/MDER.S478141","url":null,"abstract":"<p><strong>Background: </strong>While formative and summative usability testing is essential to confirm safe and effective product use, it may not be sufficient to comprehensively understand user capabilities and limitations in device interactions. Therefore, this research aims to quantify user handling forces for different device handling steps of pen injectors through sensor-augmented simulated use studies.</p><p><strong>Research design and methods: </strong>The study involved 46 participants who were divided into two groups: a healthy control group and a group of users with dexterity impairments. All participants were instructed to perform simulated handling steps using non-functional dummy devices equipped with force and torque sensors. Each handling step was performed twice: first at what participants considered a comfortable force level and then at their maximum force. The study then analyzed force data to investigate the impact of user characteristics and device geometry on force exertion during the different handling steps.</p><p><strong>Results: </strong>The study demonstrates differences in the perceived comfortable and maximum force levels between the control and patient groups. These force levels decrease slightly with the user's age and level of dexterity impairment. Furthermore, the forces applied by the users are dependent on the geometry of the device and the holding pattern.</p><p><strong>Conclusion: </strong>The results highlight the significance of sensor-augmented simulated use studies as a tool for providing quantitative insights into users' ability to exert force while handling self-injection devices. These data offer comprehensive insights that inform the definition of performance requirements and specifications for injection device design, thereby supporting the advancement of future self-injection devices.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"271-283"},"PeriodicalIF":1.3,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890405","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}