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Bioengineering
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Medical Devices and Implants, 2nd Edition
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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 15956

Special Issue Editors

Dr. Tanvir Faisal

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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
Dr. Christine Walck

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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
Dr. Donald Sorrells

E-Mail Website
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

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

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

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Published Papers (9 papers)

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Research

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9 pages, 2037 KiB  
Article
Enteric Elongation Induced by a Novel Sleeve Device in a Live Roux-en-Y Configuration
by Joshua C. Colvin, Collyn C. O’Quin, Hannah R. Meyer, Valerie L. Welch, Giovanni F. Solitro, Jonathan S. Alexander and Donald L. Sorrells
Bioengineering 2025, 12(7), 771; https://doi.org/10.3390/bioengineering12070771 - 17 Jul 2025
Viewed by 303
Abstract
Short bowel syndrome (SBS) is characterized by insufficient intestinal length to support absorption causing malnutrition. The bowel adapts to SBS via intestinal dilation and delayed gastric emptying but still often requires long-term parenteral nutrition. Current surgical options to lengthen the bowel pose significant [...] Read more.
Short bowel syndrome (SBS) is characterized by insufficient intestinal length to support absorption causing malnutrition. The bowel adapts to SBS via intestinal dilation and delayed gastric emptying but still often requires long-term parenteral nutrition. Current surgical options to lengthen the bowel pose significant risks and often provide limited expansion. ‘Distraction enterogenesis’ has been proposed as a technique to induce intestinal lengthening for SBS. The deployment of the intestinal expansion sleeve (IES) device is hypothesized to result in significant intestinal lengthening in vivo. A Roux-en-Y was created in the jejunum of seven rats for isolated IES deployment. The IES was precontracted over a Bucatini noodle and inserted into the isolated roux limb. After 4 weeks of deployment, rats were sacrificed, Roux-en-Y length recorded, and histology analyzed. A paired t-test was performed to compare initial and final roux limb lengths and histopathological tissue remodeling. Intestinal distraction evaluated at 4 weeks post deployment of the IES resulted in a significant 30.2% elongation in roux limb length (43.6 ± 14.4 mm to 56.4 ± 20.8 mm (p = 0.043, n = 7). IES samples showed changes in mucosal and submucosal integrity and bowel wall thickness in response to IES lengthening. In samples with partial mucosal erosion, the basal/regenerative layers of the mucosa were preserved. Distraction enterogenesis with significant intestinal lengthening in vivo has been achieved with the IES device. Histologic changes suggest all bowel functional layers and attributes are maintained through distraction enterogenesis. Future constructs of the IES may benefit from the addition of immunomodulators. Increasing intestinal mass with these devices may complement the treatment paradigm for SBS. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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18 pages, 1615 KiB  
Article
Effects of Physiological Loading from Patient-Derived Activities of Daily Living on the Wear of Metal-on-Polymer Total Hip Replacements
by Benjamin A. Clegg, Samuel Perry, Enrico De Pieri, Anthony C. Redmond, Stephen J. Ferguson, David E. Lunn, Richard M. Hall, Michael G. Bryant, Nazanin Emami and Andrew R. Beadling
Bioengineering 2025, 12(6), 663; https://doi.org/10.3390/bioengineering12060663 - 16 Jun 2025
Viewed by 621
Abstract
The current pre-clinical testing standards for total hip replacements (THRs), ISO standards, use simplified loading waveforms that do not fully replicate real-world biomechanics. These standards provide a benchmark of data that may not accurately predict in vivo wear, necessitating the evaluation of physiologically [...] Read more.
The current pre-clinical testing standards for total hip replacements (THRs), ISO standards, use simplified loading waveforms that do not fully replicate real-world biomechanics. These standards provide a benchmark of data that may not accurately predict in vivo wear, necessitating the evaluation of physiologically relevant loading conditions. Previous studies have incorporated activities of daily living (ADLs) such as walking, jogging and stair negotiation into wear simulations. However, these studies primarily used simplified adaptations that increased axial forces and applied accelerated sinusoidal waveforms, rather than fully replicating the complex kinematics experienced by THR patients. To address this gap, this study applied patient-derived ADL profiles—jogging and stair negotiation—using a three-station hip simulator, obtained through 3D motion analysis of total hip arthroplasty patients, processed via a musculoskeletal multibody modelling approach to derive realistic hip contact forces (HCFs). The results indicate that jogging significantly increased wear rates compared to the ISO walking gait waveform, with wear increasing from 15.24 ± 0.55 to 28.68 ± 0.87 mm3/Mc. Additionally, wear was highly sensitive to changes in lubricant protein concentration, with an increase from 17 g/L to 30 g/L reducing wear by over 60%. Contrary to predictive models, stair descent resulted in higher volumetric wear (8.62 ± 0.43 mm3/0.5 Mc) compared to stair ascent (4.15 ± 0.31 mm3/0.5 Mc), despite both profiles having similar peak torques. These findings underscore the limitations of current ISO standards in replicating physiologically relevant wear patterns. The application of patient-specific loading profiles highlights the need to integrate ADLs into pre-clinical testing protocols, ensuring a more accurate assessment of implant performance and longevity. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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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 473
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 1070
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 2029
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 1898
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
Cited by 1 | Viewed by 1592
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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40 pages, 1353 KiB  
Review
Wearable Devices in Scoliosis Treatment: A Scoping Review of Innovations and Challenges
by Samira Fazeli Veisari, Shahrbanoo Bidari, Kourosh Barati, Rasha Atlasi and Amin Komeili
Bioengineering 2025, 12(7), 696; https://doi.org/10.3390/bioengineering12070696 - 25 Jun 2025
Viewed by 854
Abstract
Scoliosis is one of the most common spinal deformities, which affects millions of people worldwide. Bracing and physiotherapy exercises represent the first-line, non-invasive approaches for managing scoliosis. In recent years, the use of wearable devices has spread as a novel approach to the [...] Read more.
Scoliosis is one of the most common spinal deformities, which affects millions of people worldwide. Bracing and physiotherapy exercises represent the first-line, non-invasive approaches for managing scoliosis. In recent years, the use of wearable devices has spread as a novel approach to the treatment of scoliosis. However, their effectiveness in treatment planning and outcomes has not been thoroughly evaluated. This manuscript provides a scoping review of the classification and application of wearable devices and the role of artificial intelligence (AI) in interpreting the data collected by wearable devices and guiding the treatment. A systematic search was carried out on Scopus, Web of Science, PubMed, and EMBASE for studies published between January 2020 and February 2025. A total of 269 studies were screened, and 88 articles were reviewed in depth. Inclusion criteria encompassed articles focusing on wearable devices integrated into smart braces, rehabilitation systems for scoliosis management, AI and machine-learning (ML) applications in scoliosis treatment, virtual reality (VR), and telemedicine for scoliosis care. The literature shows that the use of wearable devices can enhance scoliosis treatment by improving the efficiency of braces and enabling remote monitoring in rehabilitation programs. However, more research is needed to evaluate user compliance, long-term effectiveness, and the need for personalized interventions. Future advancements in artificial intelligence, microsensor technology, and data analytics may enhance the efficacy of these devices, which can lead to more personalized and accessible scoliosis treatment. Full article
(This article belongs to the Special Issue Medical Devices and Implants, 2nd Edition)
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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 4 | Viewed by 5883
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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