Medical Devices and Implants, 2nd Edition

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biomedical Engineering and Biomaterials".

Deadline for manuscript submissions: 31 October 2025 | Viewed by 11723

Special Issue Editors


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Guest Editor
Department of Mechanical Engineering, University of Louisiana at Lafayette, Lafayette, LA, USA
Interests: computational and experimental biomechanics; machine learning; orthopaedic biomechanics; 3D Printing

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Guest Editor
Department of Mechanical Engineering, Embry-Riddle Aeronautical University, Daytona Beach, FL, USA
Interests: computational and experimental biomechanics; biomedical systems engineering; machine learning; robotics; space physiology

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Guest Editor
Department of Surgery, LSU Health Shreveport, Shreveport, LA 71103, USA
Interests: surgical devices; robotics; 3D printing; tissue engineering

Special Issue Information

Dear Colleagues,

We invite contributions to a Special Issue of Bioengineering focused on the design, prototyping, manufacturing, and experimentation of medical devices and implants. Considering the increased demand for these devices and thus increased healthcare costs, the clinical deployment of these solutions results in many challenges that need to be overcome. The regulatory compliance, absence of standardized testing procedures, manufacturability, and efficacy of these devices are examples of issues that need to be addressed to launch or maintain a product on the market with satisfactory clinical results. Embedded artificial intelligence in diagnostic tools, big-data-driven design processes, wireless communications for real-time monitoring, and finite element modeling for verification and validation are all examples of novel but now well-established technologies that have positively impacted product development. Further, the widespread use of additive manufacturing has boosted patient-specific design and implant development. More recently, bioprinting has been used in medicine to help to study or recreate almost every tissue, cartilage, and organ in the body. The translational role of these solutions is often overlooked, and they are not well covered in clinical journals. Therefore, this Special Issue aims to collect studies performed on medical devices and implants, strictly related to their development, prototyping, efficacy, and safety. Discussions and critical analyses of existing testing methods and standards are welcome, as are original studies on new concepts. We look forward to receiving your groundbreaking contributions.

Dr. Tanvir Faisal
Dr. Christine Walck
Dr. Donald Sorrells
Guest Editors

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Keywords

  • implant
  • medical devices
  • prototyping
  • 3D printing
  • scaffolds
  • tissue engineering
  • additive manufacturing

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Published Papers (6 papers)

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Research

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13 pages, 3416 KiB  
Article
Modification of a Two-Part Cancellous Locking Screw: A Pilot Study on Increasing Resistance to Axial Pullout Strength
by Chia-Hao Hsu, Nin-Chieh Hsu, Sung-Yen Lin, Cheng-Chang Lu, Yin-Chih Fu, Hsuan-Ti Huang, Chung-Hwan Chen and Pei-Hsi Chou
Bioengineering 2025, 12(5), 444; https://doi.org/10.3390/bioengineering12050444 - 23 Apr 2025
Viewed by 170
Abstract
Background/Objectives: The pullout failure of conventional locking screws (LSs, screws with a locking mechanism) may occur in patients with osteoporosis, particularly when inserted near joints or across periarticular fractures (e.g., proximal humerus). The two-part locking cancellous screw modification (TP-LCS, screws composed of two [...] Read more.
Background/Objectives: The pullout failure of conventional locking screws (LSs, screws with a locking mechanism) may occur in patients with osteoporosis, particularly when inserted near joints or across periarticular fractures (e.g., proximal humerus). The two-part locking cancellous screw modification (TP-LCS, screws composed of two parts) in metaphyseal cancellous bone is hypothesized to increase bone purchase and holding power. This study aimed to test the hypothesized advantages of TP-LCS over LSs. Methods: An MTS 370 series frame with an axial/torsional load cell was used to test driving torque and axial pullout strength, following ASTM F543-07 standards. The TP-LCS group featured a newly modified screw design made from titanium alloy (Ti6Al4V), while conventional LSs (Synthes) were used for the control group. Statistical significance was assessed for selected comparisons relevant to the research objectives, including driving torque and axial pullout strength. Results: The driving torque test showed that TP-LCS had a significantly higher maximum insertion torque (4.9 ± 0.4 N·cm) compared to LSs (4.2 ± 0.4 N·cm) (p = 0.0269), although no significant difference was found in maximum removal torque (p = 0.1046). The axial pullout test revealed that TP-LCS had significantly higher pullout strength (223.5 ± 12.2 N) compared to LSs (203.5 ± 11.5 N) (p = 0.0284). Failure during the axial pullout test often involved cracking of the test block material around the screw threads, causing the screw to pull out. Conclusions: These results support the hypothesis that TP-LCS may offer improved axial pullout resistance compared to LSs, making it a potentially beneficial modification for LSs in osteoporotic metaphyseal regions or near joints. This study provides biomechanical insights into the advantages of the modified screw design over conventional LSs. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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11 pages, 4855 KiB  
Article
Novel Subperiosteal Device Geometry and Investigation of Efficacy on Surrounding Bone Formation and Bone-Bonding Strength
by Yoshiya Kaisaka, Masayoshi Uezono, Masaki Inoue, Kazuo Takakuda and Keiji Moriyama
Bioengineering 2024, 11(11), 1122; https://doi.org/10.3390/bioengineering11111122 - 7 Nov 2024
Viewed by 935
Abstract
To develop a safer bone-bonding device that promotes early osseointegration with cortical bone perforation, novel subperiosteal device geometries were proposed and evaluated for their ability to facilitate surrounding bone formation and enhance bone-bonding strength. This study used animal experiments and mechanical testing to [...] Read more.
To develop a safer bone-bonding device that promotes early osseointegration with cortical bone perforation, novel subperiosteal device geometries were proposed and evaluated for their ability to facilitate surrounding bone formation and enhance bone-bonding strength. This study used animal experiments and mechanical testing to assess the performance of these designs. The experimental device consisted of two main components: a rounded rectangular plate and a centrally positioned cylinder. To promote the recruitment of bone-marrow-derived factors, slits were incorporated into the cylinder, and a center hole was created directly above it. Four device variations, differing by the presence or absence of the slits and center hole, were fabricated and then subjected to tensile tests for mechanical property evaluation. In the animal experiments, the devices were bilaterally placed on rat tibiae, and after four weeks, bone-bonding strength tests were performed. Additionally, micro-computed tomography and histological analysis of undecalcified sections were conducted. All devices demonstrated early osseointegration, and geometric design differences, specifically the presence or absence of the slits and center hole, significantly affected the mechanical properties and bone induction. However, no significant differences in bone-bonding strength were detected. These findings suggest that the newly formed bone inside the slits and center hole contributes to the reinforcement of the device. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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17 pages, 4652 KiB  
Article
Optimizing Production, Characterization, and In Vitro Behavior of Silymarin–Eudragit Electrosprayed Fiber for Anti-Inflammatory Effects: A Chemical Study
by Foram Madiyar, Liam Suskavcevic, Kaitlyn Daugherty, Alexis Weldon, Sahil Ghate, Takara O’Brien, Isabel Melendez, Karl Morgan, Sandra Boetcher and Lasya Namilae
Bioengineering 2024, 11(9), 864; https://doi.org/10.3390/bioengineering11090864 - 25 Aug 2024
Viewed by 1829
Abstract
Inflammatory Bowel Disease (IBD) is a chronic condition that affects approximately 1.6 million Americans. While current polyphenols for treating IBD can be expensive and cause unwanted side effects, there is an opportunity regarding a new drug/polymer formulation using silymarin and an electrospray procedure. [...] Read more.
Inflammatory Bowel Disease (IBD) is a chronic condition that affects approximately 1.6 million Americans. While current polyphenols for treating IBD can be expensive and cause unwanted side effects, there is an opportunity regarding a new drug/polymer formulation using silymarin and an electrospray procedure. Silymarin is a naturally occurring polyphenolic flavonoid antioxidant that has shown promising results as a pharmacological agent due to its antioxidant and hepatoprotective characteristics. This study aims to produce a drug–polymer complex named the SILS100-Electrofiber complex, using an electrospray system. The vertical set-up of the electrospray system was optimized at a 1:10 of silymarin and Eudragit® S100 polymer to enhance surface area and microfiber encapsulation. The SILS100-Electrofiber complex was evaluated using drug release kinetics via UV Spectrophotometry, Fourier-Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), and Differential Scanning Calorimetry (DSC). Drug loading, apparent solubility, and antioxidant activity were also evaluated. The study was successful in creating fiber-like encapsulation of the silymarin drug with strand diameters ranging from 5–7 μm, with results showing greater silymarin release in Simulated Intestinal Fluid (SIF) compared to Simulated Gastric Fluid (SGF). Moving forward, this study aims to provide future insight into the formulation of drug–polymer complexes for IBD treatment and targeted drug release using electrospray and microencapsulation. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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11 pages, 3120 KiB  
Article
Smart Drill for a Streamlined Estimation of the Drilling Angle and Channel Length in Orthopedic Surgical Procedures
by Arsen Ivanišević, Zvonimir Boban, Josip Jurić and Katarina Vukojević
Bioengineering 2024, 11(6), 630; https://doi.org/10.3390/bioengineering11060630 - 19 Jun 2024
Cited by 1 | Viewed by 1706
Abstract
The estimation of distances and angles is a routine part of an orthopedic surgical procedure. However, despite their prevalence, these steps are most often performed manually, heavily relying on the surgeon’s skill and experience. To address these issues, this study presents a sensor-equipped [...] Read more.
The estimation of distances and angles is a routine part of an orthopedic surgical procedure. However, despite their prevalence, these steps are most often performed manually, heavily relying on the surgeon’s skill and experience. To address these issues, this study presents a sensor-equipped drill system which enables automatic estimation of the drilling angle and channel length. The angular accuracy and precision of the system were tested over a range of inclination angles and proved to be superior to the manual approach, with mean absolute errors ranging from 1.9 to 4.5 degrees for the manual approach, and from 0.6 to 1.3 degrees with the guided approach. When sensors were used for simultaneous estimation of both the inclination and anteversion angles, the obtained mean absolute errors were 0.35 ± 0.25 and 2 ± 1.33 degrees for the inclination and anteversion angles, respectively. Regarding channel length estimation, using measurements obtained with a Vernier caliper as a reference, the mean absolute error was 0.33 mm and the standard deviation of errors was 0.41 mm. The obtained results indicate a high potential of smart drill systems for improvement of accuracy and precision in orthopedic surgical procedures, enabling better patient clinical outcomes. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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17 pages, 5085 KiB  
Article
Removal Forces of a Helical Microwire Structure Electrode
by Amelia Howe, Zhanda Chen, Kyle Golobish, Victoria R. Miduri, Derrick Liu, David Valencia, Morgan McGaughey, Emily Szabo, Manfred Franke and Stephan Nieuwoudt
Bioengineering 2024, 11(6), 611; https://doi.org/10.3390/bioengineering11060611 - 13 Jun 2024
Viewed by 1457
Abstract
(1) Background: Medical devices, especially neuromodulation devices, are often explanted for a variety of reasons. The removal process imparts significant forces on these devices, which may result in device fracture and tissue trauma. We hypothesized that a device’s form factor interfacing with tissue [...] Read more.
(1) Background: Medical devices, especially neuromodulation devices, are often explanted for a variety of reasons. The removal process imparts significant forces on these devices, which may result in device fracture and tissue trauma. We hypothesized that a device’s form factor interfacing with tissue is a major driver of the force required to remove a device, and we isolated helical and linear electrode structures as a means to study atraumatic removal. (2) Methods: Ductile linear and helical microwire structure electrodes were fabricated from either Gold (Au) or Platinum–Iridium (Pt-Ir, 90-10). Removal forces were captured from synthetic gel models and following chronic implantation in rodent and porcine models. Devices were fully implanted in the animal models, requiring a small incision (<10 mm) and removal via tissue forceps. (3) Results: Helical devices were shown to result in significantly lower maximal removal forces in both synthetic gel and rodent studies compared to their linear counterparts. Chronically (1 yr.), the maximal removal force of helical devices remained under 7.30 N, for which the Platinum–Iridium device’s tensile failure force was 32.90 ± 2.09 N, resulting in a safety factor of 4.50. (4) Conclusions: An open-core helical structure that can freely elongate was shown to result in reduced removal forces both acutely and chronically. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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Review

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36 pages, 2812 KiB  
Review
Emerging Medical Technologies and Their Use in Bionic Repair and Human Augmentation
by Albert Manero, Viviana Rivera, Qiushi Fu, Jonathan D. Schwartzman, Hannah Prock-Gibbs, Neel Shah, Deep Gandhi, Evan White, Kaitlyn E. Crawford and Melanie J. Coathup
Bioengineering 2024, 11(7), 695; https://doi.org/10.3390/bioengineering11070695 - 9 Jul 2024
Cited by 3 | Viewed by 4696
Abstract
As both the proportion of older people and the length of life increases globally, a rise in age-related degenerative diseases, disability, and prolonged dependency is projected. However, more sophisticated biomedical materials, as well as an improved understanding of human disease, is forecast to [...] Read more.
As both the proportion of older people and the length of life increases globally, a rise in age-related degenerative diseases, disability, and prolonged dependency is projected. However, more sophisticated biomedical materials, as well as an improved understanding of human disease, is forecast to revolutionize the diagnosis and treatment of conditions ranging from osteoarthritis to Alzheimer’s disease as well as impact disease prevention. Another, albeit quieter, revolution is also taking place within society: human augmentation. In this context, humans seek to improve themselves, metamorphosing through self-discipline or more recently, through use of emerging medical technologies, with the goal of transcending aging and mortality. In this review, and in the pursuit of improved medical care following aging, disease, disability, or injury, we first highlight cutting-edge and emerging materials-based neuroprosthetic technologies designed to restore limb or organ function. We highlight the potential for these technologies to be utilized to augment human performance beyond the range of natural performance. We discuss and explore the growing social movement of human augmentation and the idea that it is possible and desirable to use emerging technologies to push the boundaries of what it means to be a healthy human into the realm of superhuman performance and intelligence. This potential future capability is contrasted with limitations in the right-to-repair legislation, which may create challenges for patients. Now is the time for continued discussion of the ethical strategies for research, implementation, and long-term device sustainability or repair. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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