This session represents peer-reviewed contributed papers presented as posters.
All posters listed below will be displayed from 10:00 am - 5:30 pm in the Pinnacle Foyer of the Graduate by Hilton Minneapolis. Authors will be available from 2:00-3:30pm for the interactive session.
The papers will be published in the 2025 Proceedings of the Design of Medical Devices Conference in the ASME Digital Collection.
Details
Enhancing Coloenoscopy Training: A Modular Approach with Interchangeable Polyp Segments and Adaptive Joints
Evaluation of Funnel System for Guidewire Insertion Medical Training
Unmet Needs in Fetal Interventions for Congenital Heart Disease: A Systematic Review and Biodesign-Based Assessment
There is a significant lack of medical devices designed for fetal cardiac interventions, forcing clinicians to use existing devices off-label, which carries considerable risk. To foster innovation, we aimed to identify needs that could drive potential new device solutions to address surgical challenges in fetal interventions for severe congenital heart disease (CHD). We conducted a systematic review with an electronic search of PubMed, Scopus, and the Cochrane database, analyzing data on pain points associated with these interventions. These pain points were translated into six need statements using the Stanford Biodesign methodology to inspire future innovations. The search yielded 985 results, with 24 studies reviewed. Identified pain points included challenges with fetal positioning (17 studies), catheter visualization issues (8 studies), and suboptimal tool designs such as mismatched balloon and cannula sizes (14 studies), and limited catheter control (9 studies). Significant technical complications and adverse events followed current off-label device use, proving that there is an urgent need for minimally invasive cardiac devices specifically designed for percutaneous fetal interventions.
Authors: Jhalak N. Mehta, Achu G. Byju, Cara M. Buskmiller, Michael A. Belfort, Magdalena San Cortez, Luc Joyeux, R.Brandon Hunter, Chester Koh, Madhav Erranguntla, Balakrishna Haridas
Remote Ultrasound Robot – Design Development and Prototyping
Early Value Chain Analysis for Medical Devices for Low- and Middle-Income Countries
There is tremendous need for context-appropriate medical devices in low- and middle-income countries. Despite the many frameworks and methodologies that have been published to facilitate consideration of important contextual factors during device development, many design teams discover insurmountable barriers to the implementation of their device only after the costly development process is completed. Often, these barriers arise from the nature of the value chain, which is characterized by many stakeholders with different and sometimes misaligned incentives. In this article, we articulate features of projects that are well positioned to satisfy the entire value chain. We demonstrate the employment of preliminary value chain analysis during problem screening in order to identify potentially unavoidable causes of failure early and at little to no cost. This strategy may assist design teams in avoiding embarking on projects that are likely to struggle with implementation or scaling, given the incentives present in the value chain.
Authors: Madison Reddie, Sai R. Vadhula, Rose T. Yin, Amos G. Winter V
Development of a Game-Based Robotic System to Enhance Home-Based Robot-Assisted Therapy
Each year, around 15 million people globally, including 795,000 Americans, experience a stroke. Nearly half of stroke survivors face persistent upper limb motor impairments, limiting daily activities and quality of life. This underscores the need for early, intensive, and function-focused rehabilitation. This study explores the effectiveness of integrating game-based tasks into a 3DoF end-effector robotic system to enhance upper limb rehabilitation. By incorporating an engaging "Apple Picking" game into active therapy sessions, we aim to assess improvements in motor function, reaction time, and coordination among individuals undergoing upper limb recovery. This experimental study was conducted in the BioRobotics Laboratory, involving a diverse group of participants, including post-stroke individuals (n=3) and occupational therapists (n=2). Participants engaged in active rehabilitation exercises by controlling a 3DoF robotic arm to interact with a 2D computer-based game. The robotic system, equipped with force sensors, provided adaptive guided movements, enabling participants to manipulate an on-screen basket and catch falling apples. This interactive setup was designed to enhance motor recovery by fostering active engagement and responsive control. Key outcomes included improvements in motor skills, coordination, and reaction times, as assessed through metrics like movement accuracy, response times to in-game prompts, and task completion rates. Post-session evaluations included the System Usability Scale (SUS) to gauge platform usability questionnaire to measure participant engagement and motivation. Preliminary findings suggest that the game-based rehabilitation approach significantly improves participants' motor control and coordination. The engaging nature of the apple-picking game contributed to increased motivation and participation, with participants showing enhanced ability to coordinate movements and respond promptly to game challenges.
Authors: Md Mahafuzur Rahaman Khan, Md Samiul Haque Sunny, Kishor Lakshminarayanan, Md Mahbubur Rahman, Gabriela Davila Albor, Motakabbir Hossain, Inga Wang and Mohammad H Rahman
Review of FDA Manufacturer and User Facility Device Experience Database Reports on Driveline Fractures in Heartmate 2 LVAD
Development of a Novel Intraosseous Needle Using a Large Scale 3D Imaging Study
Design and Evaluation of a Semi-Immersive Virtual Reality Driving Simulator for Institutionalized Individuals with Advanced Dementia
This study aims to investigate the impact of a Semi-Immersive Virtual Reality Driving Simulator (VRDS) as a serious game, specifically tailored for institutionalized individuals with advanced dementia, focusing on its potential to improve implicit cognitive performance. The VRDS was installed in the physical car model available at the Alzheimer’s unit of the Riverview Health Centre (RHC). To create a semi-immersive environment, the laptop screen was projected onto the front window of a physical car model, and the steering wheel and accelerator of the car model were replaced with those of the VRDS. The virtual environment features a country road leading to a destination. The road includes road and traffic sounds and incoming cars. A fan was placed to generate similar effect of breath in the car and to reduce plausible motion/cyber sickness. Ten residents with advanced dementia were enrolled and used VRDS over four months using the VRDS 3-5 times/week for 20-30 minutes each session. Data collected included time spent at different levels of the game, number of crashes, and braking responses to traffic lights and stop signs. Despite not remembering consciously due to advanced cognitive impairment, the results demonstrate a decrease in total crashes and an increase in the game score, implying improved cognitive function and reduced errors. The designed VRDS demonstrates potential as an effective intervention for improving cognitive outcomes in patients with advanced dementia.
Authors: Seyedsaber Mirmiran, Zahra Moussavi
An Experimental Approach to Determining the Friction within Glass Cartridges Used in Autoinjectors
A Speculum-Free Approach to Cervical Cancer Screening: Design, Development and Testing
Cervical cancer remains a leading cause of cancer-related deaths in low- and middle-income countries (LMICs), where effective screening has been challenging due to resource constraints. In high-income countries, methods such as pap smears and human papillomavirus DNA tests have proven effective. Visual inspection with acetic acid has been employed in low-income settings as an alternative. However, high costs, reliance on subjective interpretation, and the discomfort women experience due to the use of a speculum to visualise the cervix during these tests hinder widespread adoption in LMICs. This research aimed to develop a speculum-free digital cervical cancer screening device, the CerviScreen, to enhance VIA's diagnostic accuracy and usability. The device, comprising five subsystems—housing, visualization, liquid application, dilation, and decontamination—was designed using rapid prototyping principles. It provides a less invasive screening procedure, offering real-time video, controllable lighting, and acetic acid application for diagnosis. Verification testing aligned with ISO 8600 standards and included risk assessment to mitigate usability and functionality concerns. Although the study acknowledged design limitations, the CerviScreen showed promising diagnostic accuracy and usability. Further testing on human patients is necessary to confirm its efficacy. Based on the study feedback, refinements will be made to optimize the device.
Authors: Sudesh Sivarasu, Lehan Hefer, Chibuike Mbanefo and Rakiya Saidu
Digital Histology of Intact Organs: Iodine Perfusion of Fixed Human Hearts Allows for Contrast Enhanced Micro Computed Tomography
An Innovative Magnetic Respiratory Mask Fixation Device - Functional and Usability Evaluation
Remote Heartbeat CNN Detection System for the Early Warning of Heart Attack
The Road to Developing a Growing Conduit for Right Ventricular Outflow Tract Reconstruction for Congenital Heart Disease Patient
Design of a Lightweight Ambulation Support for In-Home Rehabilitation
Exploring Gender Differences in the Treatment of a Gunshot Wound and Patient Undressing Across Two Medical Simulation Modalities
Past work suggests there are gender disparities in the treatment of trauma patients, such as undressing efficiency and managing a gunshot wound (GSW). However, most of this research has been done with patient simulators, and little work has examined whether the magnitude of the observed gender disparities are similar when comparing training with simulation technologies to training via the treatment of humans, such as standardized patients (SPs). Combat casualty treatment of female and male patients were compared between two studies. The first study included N = 29 CLS soldiers treating patient simulators and the second study included N = 10 combat medics treating SPs. Participants made significantly more gunshot wound errors treating female SPs compared to female simulators. Across both simulation methods, participants made significantly more undressing errors on female patients compared to male patients. The estimated effect size for GSW errors was found to be very large when treating standardized patients compared to a small effect size that was found when treating patient simulators. Similar medium effect sizes were found for undressing errors across both simulation methods. The preliminary findings suggest that collaboration with SPs in combat casualty care training may more accurately demonstrate performance for certain procedures (e.g., GSW) relative to patient simulators, whereas other procedures (e.g., undressing) may be adequately trained with either simulation method.
Authors: Bradley A. Drahos, Katelyn R. Schwieters, Curtis M. Craig, Marshall L. Mabry, Eugene Floersch, Sophia J. Caffery, and Nichole L. Morris
Dielectric Characterization of Ex Vivo Porcine Cardiac Tissues for Medical Device Development
A Low-Cost Shear Wave System for Ex Vivo Regional Mechanical Characterization of Planar Soft Tissues
Shear wave elastography is a rapidly growing technique to determine material properties of soft tissues. Many of the existing devices used to initiate wave excitation in tissues of interest involve a cost that is prohibitive for experiments. Our study designed and developed a comparatively low-cost actuator and driver system to generate shear waves in ex vivo tissue specimens on the benchtop, so as to expand the current capabilities and applications of wave propagation elastography.
The device features a solenoid that creates a magnetic force on a magnet connected to the actuator arm, driving the shear motion. Out-of-plane motion is minimized by two ortho-planar springs. The motion resulting from the driver system was captured by high-speed video and was analyzed using digital image correlation (DIC). The device was tested on ex vivo porcine aortic wall. The calculated wave speed was compared to the expected wave-speed based on uniaxial characterization. While the wave speed in the axial direction was lower than the circumferential direction, as expected, the measured wave speed was lower than the predicted value for both tissue orientations.
Authors: Alexander Dufresne, Kayla Lehtola and Victor Barocas
Towards a Brachytherapy Training System: Real-Time Hand and Needle Tracking Using Machine Learning
Demonstration of Biomechanical Safety when Applying a Flowable Hydrogel Tendon Protector: A Cadaver Study
Evaluating Heart Ejection Fractions after TAVR Placement at Alternate Pacing Sites
Appliances for Cutting the Sternum, Frontal, Parietal and Occipital Bones
During median sternotomy, the movement of the sternal saw making bone incision is inward-outward. Meanwhile, saw blade pulled outward progresses by rubbing against inner surface of sternum.
Inward movement pushes necrotic bone dust into mediastinum. It lacerates periosteum and other soft tissues. Not irrigating bone cutting line with physiological saline causes necrosis of osteoblasts at the edges of line as a result of the tissue heating.
Laceration occurs on the inner surface of bone due to outward movement of saw blade.
Necrotic products pushed into mediastinum, soft tissue laceration particles, osteoblast necroses, periosteal laceration, can lead to delayed healing, osteitis, and dehiscence in bone.
Thanks to the appliance that limits depth of fissure and disk mills, since the cutting process will be performed with rotating disk and fissure mills rather than movements into and out of bone, necrotic products will not be sent to the voids under the bone. Osteoblast necrosis does not develop because physiological saline is continuously sprayed onto bone.
Since the appliances do not have a part that progresses by rubbing against the inner surface of bone, there is no laceration in soft tissues in this area.
Keywords: Dehiscence, flat bone, median sternotomy, mediastinitis, osteitis, sternum
Author: Ertürk Genç
Bench-to-Bedside: Use of Particle Image Velocimetry to Assess Iterative Development of Cerebral Bifurcation Flow Diverter and Its Proof of Principle
Gaitway: Development and Testing of a Novel Ambulation Device for Gait Rehabilitation
Towards Design and Realisation of a Low-Cost Kidney Perfusion Device
Evaluation of a Contactless Pulse and Respiration Rate Monitor
Evaluation of a Contactless Pulse and Respiration Rate Monitor Using Frequency Modulated Continuous Wave (FMCW) Radar to Reduce Sudden Infant Death Syndrome (SIDS)
Validation of a Modified Esophageal PH Probe for Monitoring Colon Health
Femtech Solutions and Devices: Technological Innovations and Their Impact on Women's Health Outcomes
Femtech, a sector dedicated to the development of technologies addressing women's health issues, holds significant potential to revolutionize healthcare for women. This study provides an overview of current Femtech solutions tailored to meet the unique needs of women. It analyzes the present landscape, highlighting key areas where artificial intelligence (AI) and generative technologies have made substantial impacts. Furthermore, the study explores strategies to foster future growth and broader adoption of Femtech within the healthcare sector with a glance at Artificial Intelligence. The ultimate objective is to advance the development of more effective, personalized, accessible, and equitable healthcare solutions for women. The study will review and categorize 56 women’s health-related applications and devices currently available on the US market, identifying existing gaps and areas for potential improvement.
Authors: Nasibeh Zanjirani Farahani, PhD, CSM, Staphanie Faubion, MD, MBA, Jamie SundsBak, Steve Bethke, MBA, Moein Enayati, PhD