fall 2016 - School of Biological and Health Systems Engineering

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Engineering Design and Economic Analysis of Integrating Solar Distillation into Salt ...... mentors: Dr. Joshua Catapano – BNI | Dr. Michael VanAuker – SBHSE |.
biomedical engineering symposium fall 2016

table of contents page 3 Welcome 4 Acknowledgements

bme capstone projects 5 1: GlucoGoals 5 2: Optogenetic Photomask for Spatiotemporal Control of Stem Cell Differentiation 5 3: NobleGuard: Prevention of Soft Spinal Tissue Tears 6 4: A Surgical Retractor That Does Not Interfere with Electromagnetic Guidance Systems 6 5: Biomimetic Lumbar Spine Testing Model 6 6: Custom Spinal Screwdrivier for Spinal Fixation 6 7: Multi-Expandable Intervertebral Implant for Lumar Spinal Fusion Surgery 7 8: Stegospine, Spinous Process Implant for Occupying and Repairing Dead Space in the Spine Following a Laminectomy 7 9: Retractable Anchored Pedicle Screw for Spinal Fusion Surgery 7 10: StepPlus: Parkinsonian Gait Visual Feedback System 8 11: C-Port 8 12: Non-Invasice Periodontal Pocket Measuring Device 8 13: HOPE - Head Orthostatics & Postural Evaluation 8 14: Project Fishbone: Myoelectric Lightweight Transradial Prosthetic Made with Advanced Manufacturing 9 15: Bio-Tac: A Point-of-Care Finger Prick Biosensor for Organ Transplant Patients 9 16: Development of a Rapid Diagnostic Tool for Navajo Neurohepatopathy 9 17: Automony Rehabilitative Technology (A.R.T) to Offer Assistance and Stability for Those Suffering From Parkinsonian Gait 10 18: NATRLS: Nucleic Acid Transport in Resource Limited Settings 10 19: Troxie: A Wearable Tracking Oximeter for Pediatric Use 10 20: Alcohol Detection in Breast Milk 11 21: Clefty, The Cleft Palate Baby Bottle 11 22: ORTHOCOOL: Cooling Cervical Orthoses 11 23: MANTIS: Adaptive Arm Prosthetic for Ice Climbing 11 24: OcuTrack: Affordable Eye Tracking for the Young Athletes 12 25: Electrochemical Pancreatic Cancer Diagnostic Device 12 26: Regulation of Amniotic Fluid via Vesicoamniotic Shunting for Bladder Outlet Obstruction In Utero 12 27: Vital Check: Home Care Wearable System for Detection of Internal Bleeding of Geriatrics Experiencing Blunt Truama From Injury-Related Falls 13 28: Syringe Solutions: A Self-Stirring Syringe Pump for Long Term Drug Infusions 13 29: 3D Tracking-Assisted Functional Region Mapping Tool for Awake Neurosurgery 13 30: Rethro - A Dynamic Splint for Prevention & Correction of Hand Deformities 14 31: Hydrate Meter 14 32: Wireless Sensor Network (WSN) for Health Care Monitoring and Emergency Alarm System 14 33: OxySaurus: Pediatric Oximeter for Hospital Settings 14 34: Continuous Lactate Flow System 15 35: Trauma Gel 15 36: IllumiLimb: Electromyographic Training Sleeve for Residual Limb Patients 15 37: Neural Stem Cell Delivery Device 15 38: Vendiadx Continuous Wound Monitoring for Venous Leg Ulcers 16 39: RISE: The Assistive Lift Shower Chair Aimed at Easing the Transition of Sitting and Standing 16 40: SteriTemp - Recyclable and Sterile Surgical Grafting Template 16 41: LCS - A Locking Cap for Pedicle Screws 17 42: External Stabilization Device for Multiple Sclerosis Autoinjectors 17 43: GASTRISLOW - Device to Slow Bolus Flow Rate into Small Intestine 17 44: Concussion Sensing Device

masters applied projects page 18 1: Determining Spatiotemporal Gait Parameters Using a Single Inertial Sensor: Application to Parkinson’s Disease 18 2: Optimizing Hyaluronic Acid - Laminin Hydrogel for Delivery of Human Neural Progenitor Cells: A Potential Treatment for Traumatic Brain Injury 18 3: The Study of Position Control vs. Velocity Control in Accuracy of EMG Signl Controlled System 18 4: Detecting Correlation of Vitamin D Levels with the Grip Strength, Postural Stability, Dynamic Stability in Community Dwelling Older Adults’ Population 19 5: An Investigation of Anti-Fatigue Cleanroom Mat Integration at The Tech Group Phoenix 19 6: Preoperative Surgical Planning of Comminuted Fracture Reconstructions in a Novel 3D Environment 19 7: Enhancing Glycemic Control via Detection of Insulin using Electrochemical Impedance Spectroscopy 19 8: 3D Visualization for Use in Pediatric Cardiac Surgical Planning 20 9: Tumor Suppressor Re-activation and Epigentic Age 20 10: Hemodynamics Laboratory and Software Design through LabVIEW for Medical Students at ATSU 20 11: Identifcation of Cardiac Arrhythmias in Electrocardiography Data using Empirical Mode Decomposition 20 12: Engineering Design and Economic Analysis of Integrating Solar Distillation into Salt Mines of the Mediterranean Sea 21 13: Effects of Perturbation Training using GRAIL System on Complexity of Human Postural Sway and Stride Time Intervals 21 14: Automatic Polyp Detection in Colonoscopy Videos Using Holistically-Nested Edge Detection

special recognition 22

BME Capstone Semifinalist teams in BioAccel’s 2016 Solutions Challenge


Marco Santello, PhD Director, SBHSE Harrington Endowed Chair & Professor

Vincent Pizziconi, PhD Founder & Director SBHSE Design Studio

On behalf of the students, staff, faculty and affiliated colleagues of the School of Biological and Health Systems Engineering, one of the six schools in the Ira A. Fulton Schools of Engineering at Arizona State University and the Harrington Bioengineering Program along with our clinical and industrial partners, it is our pleasure to once again welcome you to our annual design symposium. Proudly displayed before you in this annual symposium are the collective creative outcomes developed by our biomedical engineering senior capstone designers and masters applied project candidates that exemplify this culminating event. It is a testament to the wide range of expertise provided by our dedicated mentors and professional staff who, year in and year out, support the next generation of biomedical engineering scientists and designers who are expected to solve the pressing global grand challenges in health care. In addition, with an intensifying culture of innovation continuing to emerge at ASU and within the greater Arizona community, the growing entrepreneurial spirit will continue to provide unprecedented opportunities to our biomedical engineering students who will have acquired the skill sets to become the next generation of health care technology leaders in the 21st Century. Our ability to build our entrepreneurial capacity and engage in new global partnerships is better than ever. Please come join us in this exciting and rewarding journey!

biomedical engineering capstone design & masters applied project instructors James Abbas, professor Michael Caplan, professor

Jeffrey Kleim, associate professor Vincent Pizziconi, associate professor

biomedical engineering faculty advisory design group Casey Ankeny, lecturer Jerry Coursen, lecture Michael Caplan, associate professor Emma Frow, assistant professor Tony Garcia, professor Karmella Haynes, assistant professor


Jeffrey Kleim, associate professor Jeffrey LaBelle, assistant professor Vincent Pizziconi, associate professor Barbara Smith, assistant professor Mark Spano, research professor Michael Van Auker, lecturer

acknowledgments capstone teaching assistants Anngela Adams, MS candidate Denise Oswalt, doctoral candidate


Kristen Jeffreys, MS candidate William Langenback, MS candidate Elizabeth Lopez, MS candidate Blake W, MS candidate

design studio staff Michael Sobrado

SBHSE faculty and mentors

James Abbas, associate professor Casey Ankeny, lecturer David Brafman, assistant professor Chris Buneo, associate professor, graduate program chair Michael Caplan, associate professor Jerry Coursen, lecturer Mo Ebrahimkhani, assistant professor David Frakes, associate professor Emma Frow, assistant professor Antonio Garcia, professor Bradley Greger, associate professor Leland Hartwell, nobel laureate and professor Karmella Haynes, assistant professor Steve Helms Tillery, associate professor Claire Honeycutt, assistant professor Samira Kiani, assistant professor Jeff Kleim, associate professor, undergraduate program chair Vikram Kodibagkar, assistant professor Jeff LaBelle, assistant professor Thurmon Lockhart, professor

Steve Massia, associate professor Troy McDaniel, research assistant professor Jit Muthuswamy, associate professor Mehdi Nikkhah, assistant professor Scott Parazynski, university explorer, professor of practice Vin Pizziconi, associate professor Rosalind Sadleir, assistant professor Marco Santello, director, professor Sydney Schaefer, assistant professor Barbara Smith, assistant professor Mark Spano, research professor Sarah Stabenfeldt, assistant professor Jamie Tyler, associate professor Brent Vernon, associate professor Xiao Wang, associate professor

SBHSE advising staff

Keli Palmer, academic advising manager Laura Hawes, academic success specialist Jessica Kentgen, academic success specialist, sr. Elizabeth Tripodi, academic success specialist Robbie Runk, academic success specialist Mikaela Hall, co-editor of symposium booklet Jessica Trevino, co-editor of symposium booklet

SBHSE staff

Tammie Cameron, business operations specialist Debbi Howard, project coordinator, internships Jessica Jensen, business operations specialist Jayson Johnson, research advancement admin Sean Jones, research advancement admin, sr. Alana LaBelle, laboratory manager Solo Pyon, systems support analyst Michael Sobrado, lab coordinator, sr. Tomi St John, business operations manager


bme capstone projects 1:


Nicole Fisk, Kaleia Kramer, Fionnuala McPeake, Paige Stokes

mentor: Dr. Michael Caplan – SBHSE

Diabetes is the fastest growing chronic disease in the world. In Kenya, there is a potential market of $18 million due to the increasing prevalence of both type I and type II diabetes. Our target population is the Luo community located in a rural village called Bondo, on the border of Kenya and Uganda. Out of the 33,000 people in Bondo, Kenya, it is projected that over 1,000 of them have diabetes. The recommended amount of testing for a diabetic is between 4-8 times per day, and the average price per test strip is 25 cents each. In Kenya, the average salary is between $1.00-$2.50 per day; this creates a cost constraint with an ideal value of $0.01 per test. The current price of test strips isn’t feasible for daily testing and therefore, many diabetics don’t test their blood sugar more than a few times per week. This is serious because diabetic blood glucose levels can drop or rise to life threatening levels in the span of ten minutes. Since glucose management tools are too expensive to use regularly, a more sustainable method of measuring glucose is needed. GlucoGoals aims to provide cost-effective, sustainable solutions to diabetes management in developing countries. Costs will be reduced by ensuring that potential solutions and materials are accessible within Kenya so they can be designed and developed by local Kenyans. With hundreds of existing methods for obtaining blood sugar levels, the primary goal of GlucoGoals is to provide a cost-effective solution that still maintains a high enough level of accuracy to provide meaningful results. The leading solutions in development involve an Alkaline Ferricyanide reduction, Glucose Oxidase reduction, Hexokinase, polarimetry, and diabetic alert animals. Next steps include narrowing down potential solutions to a single concept, prototyping, designing experiments for proof of concept, and conducting validations.




Vincent Avila, Emigdio Esquivel, Suyen Go, Austin Tielke

mentor: Dr. Mohammad Ebrahimkhani – SBHSE

Stem cells offer an avenue for the investigation of developmental processes and the elucidation of disease pathologies. Their applications span a wide range of possibilities including regenerating tissue and disease modeling. Scientists consider several design principles to direct the differentiation and organization of stem cell populations, but these methods are often unpredictable and fail to accurately recapitulate the endogenous microenvironment. In current protocols, there are limited parameters for precise spatial and temporal control. The Optogenetic Photomask is a biomedical research tool solution which targets tissue engineering and regenerative medicine markets in the medical device and diagnostics industry. Projected customers include research institutes and facilities, academia, and research and development departments of regenerative medicine companies. In 2015, global tissue engineering and regenerative medicine markets were valued at $23.2 billion and $4.254 billion by Hexa Research and Allied Market Research, respectively. Hexa Research expects tissue engineering to exceed $94.7 billion by 2024 and Future Market Insights expects regenerative medicine to exceed $30.237 billion by 2022. These emerging markets exhibit an immense amount of opportunity for addressing the present health issues among humans and could contribute to the improvement of healthcare and worldwide life expectancy. The product will utilize optogenetics, a technique which employs a photolytically activatable molecule to stimulate cells or genes within a particular cell population upon exposure to light of a specific wavelength. A photomask is being developed to interface with an optogenetic blue light system (460nm +/- 10nm) to provide spatiotemporal control in stem cell cultures. It must withstand heat transfer from a 37-degree Celsius cell culture incubator. Spatial precision (100um +/- 10um) would allow for more control of gene expression across a single well and could potentially be used to differentiate cell populations into morphologically and physiologically relevant patterns such as vasculature or differentiation gradients.



mentors: Dr. Michael Bohl – BNI | Dr. James Abbas – SBHSE

Incidental durotomy is a common complication associated with spine surgery that can lead to spinal fluid leakage, chronic back pain, and longer hospitalization. According to an article published in the Journal of Medical Devices, incidental durotomy arise in roughly 16% of U.S. spine operations a year and are caused by highly skilled surgeons inadvertently piercing the tissue with their instruments. The spinal surgical device market is expected to grow to 15.7 Billion over the next 5 years and the U.S. makes up roughly one-third of this market. A surgical device that frequently causes spinal tears in neuro and orthopedic surgery is a Kerrison Rongeur; it assists in the removal of bone from the spinal column. The current concepts developed involve safety guards that would attach to current Kerrison Rongeurs preventing harm to the soft spinal tissue during an operation. The key specifications for the tip, jaw opening, and shaft length of these attachments will be 2-5 mm, 9-15 mm, and 102-203 mm respectively. Since the obstruction of the surgeon’s view is a major cause of incidental durotomy, the attachments will assist surgeons in removing any bodily fluid around the surgical site. The specifications for the suction pressure, suction flow, tube length, and inner radius will be 100-200 mmHg, 40 L/min, 15-50 cm, and 3-5 mm. The usage of disposable attachments reduces complications associated with sterilizing surgical instruments and enables hospitals to use their preferred instrument manufacturers. NobleGuard will decrease the risk of durotomy and ensure ease of operation for surgeons.




Omar Al-Fayhani, Callaway Freeland, Diego Ibarra, Taylor Olvey

mentor: Dr. Michael Bohl – BNI

Hydrocephalus is a surgery that neurosurgeons around the world perform on a daily basis, this procedure is performed by placing a shunt in brain that drains excess fluid into the abdomen. The shunts are placed using electromagnetic guided systems, but these systems are obstructed by current retractors, which are made of electromagnetically conductive materials. The interference with these systems make the operation difficult for neurosurgeons to place the shunt safely and accurately into the brain. Customers for this medical device include neurosurgeons and companies that manufacture the electromagnetic guidance systems used for surgeries. Since our product would proliferate the use of their electromagnetic guidance systems, the device would be widely used in operating rooms all around the globe. The market for this device would be focused on the distribution companies that sell their products to hospitals. Market size for this product is an estimated 21,000 new users a year. Each of these users would use our device at least once per procedure. The aim of our project is to design a specialized retractor that will allow electromagnetic guidance systems to be used during Hydrocephalus procedures unhindered. The key final specifications that will be verified by our models are based on the needs of neurosurgeons who perform hydrocephalus treatment. The primary specification is a retractor with minimum reactivity to electromagnetic waves, so that it can get an image from a guidance system that is unaffected by the retractor. Secondary specifications are a total cost of $15 or less, less than 12 centimeters in the longest axis. The retractor will be made through 3D printing using either ABS or PLA plastics.



Gonzalo Ahuactzin, Emma Alina, Jordan Krause, Robel Okbe

mentors: Dr. Brian Kelly-BNI | Dr. Michael Bohl- BNI

In order to perform biomechanical tests on the spine to gain research information or validate biomedical instrumentation devices, a testing platform that mimics the properties of a human’s spine is required. Currently, the main options available to research labs are costly synthetic spine models or a bio-hazardous cadaver spine. The main objective of this project is to economically produce a lumbar spine model that mimics the human lumbar spine accurately enough for use in the testing situations mentioned above. The intended customers for this product will be research laboratories for biomechanical testing, doctors, nurses, orthopedic industries, and medical students for surgical training and anatomical demonstrations. The market segment for this product includes research laboratories, spinal surgical training facilities, medical schools, hospitals, and orthopedic companies. It is forecasted that 445 models will be sold annually. To develop a biomimetic lumbar spine model, our team has divided the project into four different problem areas. These problems include developing the disc, the ligaments, and the vertebral body independently, and then assembling the components into a complete synthetic lumbar spine model to demonstrate the actuation properties of the human lumbar spine. The some of the most important product specifications that have been identified for the validation of our system are 9 ± 2.1 degrees of flexion, 2 ± 1 degrees of extension, 4.7 ± 2.4 degrees of lateral bending, 2.16 ± 10 N/m^2 of axial compression, and a pedicle screw pullout force of 1002 ± 50 N. These are common tests used in research labs, and successfully mimicking the human lumbar spine in these categories will demonstrate the success of our system. 6:


Caitlin Byrne, Lindsey Macias, Daylin Morgan, Alvaro Rascon

mentors: Dr. James Abbas – SBHSE | Dr. Michael Bohl- BNI

Spinal fixation is an invasive surgery performed on patients with scoliosis, spinal fracture dislocations, and other spinal deformities. The neurosurgeons performing spinal fixation have to use screwdrivers that can potentially harm the patient because of the excess movement and downward force required with the current hand motion. Neurosurgeons are the team’s primary customer group, as well as, orthopedic surgeons who are also qualified to complete this type of spinal surgery. The new custom surgical screwdriver would be a FDA Class 1 device marketed in the neurological segment. According to articles from MedDevice Online in October of 2013, the neurological device market is growing and is expected to reach an estimated 13.6 billion USD by 2019. The spinal implant market, specifically, is expected to increase 2.4 percent per year, leading to a 6.4 billion USD segment by 2025 says Dyrda writing for Becker’s Spine Review in 2015. A published study by Rajaee SS about the rate of spinal fusion surgeries shows that from 1998 to 2008 the number of surgeries performed increased 2.4-fold (138%). With the market segments increasing and surgeons seeing more patients looking for spinal fixation surgery, making advances to update driver technology is important. To improve and be competitive in the market, the team took into account the main problem: eliminating excess motion. To solve this issue, the custom spinal screwdriver will create torque using the applied work through a trigger, or squeeze, mechanism. This motion is similar to using a kerrison rongeur which neurosurgeons are already familiar with. The team made an important decision by eliminating any electrical components so the surgeon using the device still has plenty of tactile feedback. Steady progress has been made in finalizing solutions that will continue to be tested through the upcoming weeks.




Nathan Flath, Cody Gates, Veda Inamdar

mentors: Dr. Jit Muthuswamy - SBHSE | Dr. Randall Hlubek - BNI

Lumbar spinal fusion surgery is needed for patients experiencing chronic lower back pain and extreme muscle spasms associated with conditions like Degenerative Disc Disease. These problems are addressed through instrumentation of the spine with an artificial intervertebral body/cage accompanied by pedicle screw and rod fixation. However, due to the increased desire to make these surgeries minimally invasive through PLIF and TLIF a low profile device that is capable of expanding is a necessity. According to Spine-Health, 200,000 spinal fusion surgeries occur per year. Additionally, 85% - 95% of adults that are 50 years and older experience a form of spinal disk degeneration. The


current disk implants on the market have limited expansion to one dimension, meaning that they do not fill up the entire disk space. The physical nature of the vertebral bodies encompassing the disk are comprised of hard, cortical bone on the outer rim, and softer tissue in the middle of the bones. Due to these qualities, the current artificial disk implants on the market are prone to collapsing. Products like the Luna 360 are being developed but still fail to expand to full outer perimeter. We will address this problem by designing a disk implant that can expand in the x, y, and z- directions (left to right laterally, posteriorly to anteriorly, and inferiorly to superiorly). The x and y expansion will be addressed through an expansion method similar to catheters so that the product will rest primarily on the dense outer ring of the body. This will greatly reduce the risk of collapse on the implant requiring further instrumentation. This method will also allow the inner area of the device to be packed with a larger quantity of bone graft encouraging fusion. Our intended customers will be neurosurgeons and patients receiving the spinal implant.


Andrew Cable, Teo Ferrari, Aaron Frisby, Sairah Furness

mentors: Dr. Michael Bohl – BNI | Dr. Sarah Stabenfeldt – SBHSE

When a laminectomy is performed, the lamina and dorsal spinous process are removed from one or more vertebrae, allowing a surgeon access to the dura mater and spinal cord therein. However, this process leaves a large dead space over the spinal cord which is prone to fluid buildup and infections, and the severing of the muscle groups attached to the removed process can lead to issues with stability, posture, and flexibility. Furthermore, this leaves the dura mater only protected by a layer of scar tissue, resulting in greater risk to the patient in the event of future spinal surgeries. The target customers are hospitals, neurosurgeons, and orthopaedic surgeons for use in their procedures, typically spinal fusions or spinal decompressions. 413,171 fusions were performed in 2008, with 49.1% more performed per year since 1998, and the Wakayama Spine Study found that about 9.3% of people suffer from LSS, and may require decompression, around 30.69 million people in America alone. The Stegospine acts as a prosthetic spinous process, attaching to the vertebrae that have undergone the laminectomy; this implant will fill the dead space left over the spine, preventing any resultant fluid buildup and discouraging infection while also protecting the dura during future procedures. The implant will also have suture points for the connection of the severed muscle groups, allowing for the reestablishment of the posterior tension band in the back. The implant will be composed of 3D printed, biocompatible ceramic, likely either Al2O3 or CaO, allowing for per patient modifications to the CAD model for a more accurate fit and effective treatment. The muscle connections should be able to withstand at least 50 N of force from the attached muscles, and ideally should show little degradation as a permanent implant.



Eyerusalem Assefa, Angie Chan, Jossel Disengi, Mariama Salifu

mentors: Dr. Brian Kelly - BNI | Dr. Michael Bohl - BNI

An estimated 10 million people in the U.S suffer from back pain; of which, the majority face spinal problems including degenerative diseases. Among the techniques used to treat these spinal problems, fusion surgery is one of the golden standards. Spinal fusion surgery utilizes pedicle screws that are simply inserted into the pedicles and aligned to a rod to fixate the bones. However, due to the low pull-out strength of most pedicle screws, it is very likely for patients to return to the operating room post-surgery because of extruded screws from doing daily activities. To address this issue, the pull-out strength of existing pedicle screws needs to be improved to minimize the number of corrective surgeries. Spinal fusion surgery patients, neurosurgeons, orthopedic surgeons, and insurance companies are SpineX’s main customer targets. SpineX will be involved in the orthopedics and neuro medical device segment and will fall under the Surgical and Medical Instrument Manufacturing. Due to the application of spinal fusion surgeries in a wide range of spinal disorders such as scoliosis, spinal fusion implants dominate global spinal instrumentation and devices market. Spinal implants and instrumentation market is projected to exceed $19.54 billion by 2024. SpineX is a novel pedicle screw with an anchoring component that has a few horizontal projections to enhance its stability. A spring system will be installed within the anchor to push out the projections after the screw has been driven into the pedicles. In case of complications, SpineX has a retractable anchor for easy removal. The pedicle screws will be designed according to the standard length of 40 mm and an outer diameter of 8mm. To optimally stabilize the pedicle screws and avoid avascular bone necrosis, the insertion torque required to drive the system will be 76 ± 41 Ncm.



Brandon Bartels, Arianna Moreno, Maria Jose Quezada, Haley Sivertson

mentors: Dr. James Abbas - SBHSE | Dr. Narayanan Krishnamurthi - CONHI

According to the National Institute of Neurological Disorders and Stroke (NINDS), Parkinson’s disease (PD) affects 500,000 Americans, with 50,000 diagnosed each year. Symptoms associated with PD, such as asymmetric gait, freezing of gait, and shortened step length, increase PD individuals’ susceptibility to falls and ultimately hinders their quality of life. Current rehabilitation techniques include walking tasks in an effort to improve their gait overall. However, there are no sufficient at-home rehabilitation strategies to improve or prevent the progression of these symptoms, especially shortened step length. StepPlus is a wearable medical device that provides auditory, visual, and/ or haptic feedback through a smartphone application. It aims to measure and track step length in real-time, encourages users to actively make changes in their gait, and saves the user’s daily progress in a short, concise report to their neurologist or physical therapist. An inertial measurement unit (IMU) placed on the lower extremity will be used to determine acceleration, angular rotation, and the magnetic field surrounding the unit in three dimensions. Infrared emitters and detectors could be used in parallel with an IMU system as a way to determine step length. The information from the IMU provides us with information about the position of the foot during the gait cycle. Sending the step length feedback through the smartphone application will help the user regain independence when walking. Additionally, by quantifying the individual’s step-length progress, StepPlus will bridge the gap between clinicians and physical therapists to provide more specific and beneficial therapy. Solely based on the Parkinsonian population size and the 25,000 specialized rehabilitation clinics in the United States, the expected market size is approximately $157 million. StepPlus aims to prevent falls in PD populations and create opportunity on the forefront of clinical and research gait analysis.


11: C-PORT

Elizabeth Burkett, Dominick Cocciola, Danielle Eldred

mentors: Tammy DeLozier - AKDHC Clinical Research Operations Manager | Dr. Michael Caplan - SBHSE

C-Port is an innovative cardiovascular hemodialysis catheter that reduces the risk of infections and mitigates any colonization that may occur. Hemodialysis is a technique for the filtration of the blood through a hemodialysis machine. This technique is typically used for patients with stage 4 or 5 kidney disease. The cardiovascular catheter is used for patients who are unable to use a permanent access such as a fistula or graft for hemodialysis. The patients are very susceptible to infections when the cardiovascular catheter is being used for hemodialysis. Using this knowledge, we have narrowed our target market for this product to nephrologists performing cardiovascular catheter procedures. The secondary market would be patients and healthcare insurance companies involved in the usage of hemodialysis catheters. For insurance companies, about 28% of all medicare expenditures go toward Chronic Kidney Disease Patients. Costs for these patients can be upwards of about $72,000 per hemodialysis patient per year. These costs can come from anything that ranges from a hospital visit for dialysis, to a major catheter replacement due to failure of device. To solve these many issues, our team is looking at utilizing an antimicrobial coating around the catheter that will manage and minimize the colonization of tissue surrounding the catheter. The coating surrounding the catheter is an innovative antimicrobial coating that integrates current market antibiotics together in order to prevent various infections for long periods of time. With the infection being primarily centralized in the implant, the size of the exterior catheter will be reduced. The changes to the cardiovascular catheter will boost the quality of life for the user of C-Port.



Jesus Calderon, Travis Tibbs, Raymond Tulkki

mentor: Dr. Vikram Kodibagkar – SBHSE

Periodontal disease affects 47 percent of Americans over the age of 32 and periodontal pocket depth is a key factor in diagnosis. Current periodontal probes measure pocket depth through different means such as controlled pressure probing, sonar range finding, and manual probing. Manual probing is the most prevalent, however it offers ambiguous measurements and often requires two employees to probe (one to probe and one to chart the depths). Also, probing often times causes periodontal tissue bleeding, an indicator of active disease. Dentists, dental hygienists and the dental offices they work for want a device that measures with greater speed, accuracy, and automation. With over 154,000 dental offices in the United States making an estimated combined revenue of $130 billion by the end of 2016, the United States dental industry is thriving and growing steadily. The Non-Invasive Periodontal Pocket Measuring Device (or NIR Periodontal Probe for marketing) will use near-infrared and infrared light to photograph through the gum tissue to see the pocket depth. The image will undergo edge detection processing and measurements in an external program. The probing and measuring process needs to take place in under a minute with one hygienist and display periodontal pocket depths in 0.5 mm increments. Secondary design efforts will focus on the imaging of hairline tooth fractures, early cavity development, and calculus buildup. These key factors also contribute to periodontal health. A device that measures these factors will not only be innovative but necessary in the future of diagnosing a patient’s periodontal health.



Christopher Cusick, Ashley Martin, Rachel Wylde

mentors: Dr. Richard Herman – ASU | Janice Herman – Adapt Shop, Physical Therapist | Jeanine Langenbach – Physical Therapist

There are numerous diseases that contribute to severe muscular disabilities within children, for example, myotubular myopathy (MTM) or cerebral palsy (CP). These diseases affect the neck and in turn, the entire body. Thus the neck is unable to hold the weight of the head and is left hanging uncomfortably. This is extremely detrimental to the development and nourishment of children ages 0 to 5 years of age, and can lead to undesired effects in later stages of life. The CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network found Cerebral Palsy in about 1 in 323 children. From the research article “Prevalence of Muscular Dystrophies: A Systematic Literature Review”, 19.8-25.1 per 100,000 persons a year have been identified as possessing one type of muscular dystrophies. Our target customers are physical therapists and caregivers who will utilize the device at the patient’s home for assessment and treatment purposes. The device, known as HOPE, falls under the market segment of rehabilitation. Our market size is relatively large, and universality is the source of market increase. Outpatient rehabilitation is currently a $29.9 billion industry, and is expected to grow 7% annually through 2018. Market composition is 90% physical therapists at $26.6 billion, and 48% are in orthopedic therapy. There is currently no device methodology to provide therapists with quantitative feedback to make assessments and adjustments. Our team is proposing for the use of pressure sensors and an accelerometer to track the head in 3D space using indicated “zones” specified by therapists. We are striving to provide data that therapists can utilize to improve rehabilitation and prevent pressure sore discomfort. The team is aiming to make this a wearable device providing continuous feedback on head placement with the goal being to enclose the indicated zones so the patient is able to maintain an upright position.


mentor: Dr. Jeffrey LaBelle – SBHSE

According to recent estimations on the prevalence of limb loss, there are approximately 41,000 patients with upper-limb deficiencies in the United States. Recent healthcare reforms have sent insurance companies scrambling for opportunities to improve the quality of healthcare while simultaneously cutting costs. This increases the difficulty of patient approval for modern artificial limbs. The Fishbone Prosthetic is a myoelectric, press-fit, transradial hand and arm prosthetic. Made from interlocking linear and radial fins, the mechanical frame and outer shell are able to withstand large compressive forces of approximately 500lbs as well as torsional and bending forces. Unlike current market devices, the Fishbone Prosthetic is designed to safeguard the health of the patient and breaks before harm can be done to residual limbs and healthy


joints. Novel and patent pending technologies allow the Fishbone Prosthetic to be a lightweight low-cost patient point-of-care device. Current state of the market socket designs do not allow for airflow to the residual limb during the course of the day, resulting in extreme temperatures, moisture accumulation, and bacterial growth. The Fishbone Prosthetic socket is made from porous materials to create a more comfortable and healthy patient environment. 85 percent interstitial free space within the device also allows patients to shift the center of mass, changing the moment arm and applied forces on the patient’s residual limb. Application of a new electroactive polymer allows for continuous myoelectric control and reusable sensors with sensor durability lasting 3 weeks of extensive use. The Fishbone Prosthetic is actuated with staggered arrays of nitinol, a shape metal alloy that mimics the movement of muscles. This keeps the device lightweight and user friendly. Each component of the prosthetic can be used interchangeably with current market devices for patient point-of-care. Future endeavors include integration of each novel component into a comprehensive device.



Meera Doshi, Minh Pham, Nitish Peela, Swaroon Sridhar

mentors: Dr. Jeffrey La Belle – SBHSE | Dr. David E. Steidley - Mayo Clinic

There are over 500,000 transplant patients worldwide, with 30K new patients requiring transplants every year. Patients undergoing transplants require tacrolimus, an immunosuppressive drug used to prevent rejection. Due to high nephrotoxicity, neurotoxicity, and induced immunological deficiency of the drug, there is a heightened initiative to investigate such effects in more detail. Additionally, patients often must make frequent and cumbersome trips to a clinic to get blood tests done to quantify the amount of the drug in the bloodstream and ensure it is not impacting their organ and immune systems. The unique pharmacodynamic response of each patient justifies the development of a point-ofcare sensor that measures the drug concentration itself and several markers related to the side effects of the drug, which would help patients monitor their progress at home. To this end, we propose to develop an organ transplant biosensor that measures concentration of tacrolimus, Cystatin C (nephrotoxicity marker), C-100B (neurotoxicity marker), and IL-10 (immunological marker) in a finger-prick blood sample. Due to the advantages of Electrochemical Impedance Spectroscopy (EIS) in utilizing small finger-prick blood samples (<20uL), fast readout time (<1min), and versatility in elucidating specific concentrations of various biomarkers, the proposed device will utilize this technology. We have assessed various concepts regarding EIS that have heavy impact on signal detection, including electrode material, material thickness, and EIS reagent/ antibody concentrations. Market research and needs assessment led to the development of a concept design, which consists of a biosensor to be used at the point-of-care by physicians and patients. Finalizing concept design requires acquisition of calibration data for concentrations of drug and biomarker, sensor design and optimization, signal analysis, and software design, and team roles are appropriately distributed based on these categories.


Allison Marley, Courtney DuBois, and Meilin Ossanna

mentor: Dr. Michael Caplan – SBHSE

Navajo neurohepatopathy (NNH) is a fatal genetic disorder caused by the R50Q mutation in the MPV17 gene. The disease affects 1-in-1600 Navajo babies in the southwestern region of the U.S. NNH is characterized by brain damage and liver disease/failure. Upon exhibiting symptoms, children in the American Southwest region (specifically Arizona) seek help from Phoenix Children’s Hospital (PCH). Currently, differential diagnosis followed by gene sequencing is the definitive method for identifying the R50Q mutation that causes NNH. While this process is conclusive, there are limitations, as it requires both time (3-4 weeks) and money (>$700). These factors create barriers that can directly impact a patient’s quality of life. Thus, Tentacle Tech is developing a rapid diagnostic to accurately detect the R50Q mutation. The team consulted with Dr. David Carpentieri and Dr. Mitchell Shub, clinicians at PCH, in order to develop customer needs. Associated metrics focus on developing a diagnostic >95% specific and sensitive while reducing detection time and providing clear results. Other desired product specifications include: minimally invasive sample collection (less than 3.0mL), a low percentage of false positive and negative results (less than 5%), and FDA regulatory and CLIA certification approval. Tentacle Probe technology (TP) was selected as the concept design to detect the point mutation. TPs can be used with real-time polymerase chain reaction (rt-PCR) in order to obtain low-cost and quick results while maintaining efficacy. With the TP incorporated in rt-PCR, fluorescence can be measured, and the output can be used to deliver a NNH diagnosis. Tentacle Tech will continue to evaluate these concepts and ensure the steps involved are optimized and fulfill the target metric values in order to satisfy the customer needs.


Matthew Gerveler, Michelle Sigona, Michael Spina, Shawn Womack

mentor: Dr. Jitendran Muthuswamy - SBHSE

Individuals with Parkinson’s disease often experience an abnormal gait, characterized by small, shuffling steps, a difficult time beginning and ending ambulation, and episodes of frozen gait. Many Parkinson’s patients experience an issue often referred to as “freezing”, which involves the temporary, involuntary ability to move. This often occurs in the lower half of the body while momentum continues in the upper half, causing a fall that could lead to serious injury. About 60,000 Americans are diagnosed every year and about 68% of those experience falls. 6.1 million adults use assistive devices, particularly those over the age of 65, the average age of diagnosis being 62 years old for Parkinson’s. Patients with Parkinson’s will benefit from our assistive device to achieve autonomy in their daily activities along with patients with limited-stability. Ambulation assistance device distributors, specialty clinics, neurological branches and rehabilitation centers would be interested in our device, along with end users such as physical therapists, occupational therapists, rehabilitation nurses, and orthopedics. Our device will belong to the “Rehabilitative Technology” and “Personal Mobility Device” markets. Walking aids are in a market worth $4.16 Billion USD and expected to grow 11% by 2020. Our chosen concept, based off of


evaluation of customer needs will focus and consist of a visual and audio cue, unique frame for stability and maneuverability, push-down brake for limited finger dexterity, and compactibility. The device will be lightweight and compact, allowing for easy transportation, with a standard of being able to fit in the overhead bin on an airplane or backseat of a car. The device will also focus on ease of use, allowing any patient/customer to pick up and use the device without requiring complex training.



Cameron Ghods, Nolan Kern, Jordan Nelson, Christopher Stark

mentor: Dr. Barbara Smith – SBHSE

In the global effort to fight HIV and AIDS, many institutions conduct research to monitor the evolution of the virus and the response to treatment efforts. Rural research zones, particularly in sub-Saharan Africa, are often lacking in infrastructure and public resources. Research efforts in these resource limited settings require a simple and inexpensive blood acquisition device that will preserve viral nucleic acid samples for long periods of time. The primary customers of this product are the HIV/AIDS researchers who are attempting to obtain samples from a distant, resource-limited area. Secondary customers may include researchers for other diseases, as well as doctors and hospitals that may need to transfer samples to other locations for testing. We would like our device to be applicable to as many different organizations as possible so we are targeting the entire US research field for HIV/AIDS. Our secondary market will be research organizations worldwide which need quality HIV/AIDS samples. Our device will use the dried blood spot method of sample acquisition using an absorbent paper in a hand-held protective enclosure to receive and store capillary blood via finger prick. The dried blood spot method is an alternative to using dry ice that involves drying collected blood on special filter paper. It will include preservative components such as desiccants and nucleic acid fixatives in order to preserve the stability of HIV samples within the device. The goal for our device is to preserve between 50-75% viable viral nucleic acids after 3 months of storage at room temperature. Our project is currently in the alpha prototype stage after deciding which concept to pursue with parts for our device being organized for orders. We intend to continue prototyping and complete this project by the end of next semester.



Samantha Brenna, Chloe Houlihan, Maria Morrow, Courtney Van Bussum

mentor: Dr. Erica Forzani – SEMTE

Currently on the market, there are no continuously wearable pulse oximeters available for children. The lack of monitoring capabilities of blood oxygen concentration creates stress and anxiety for both children with respiratory diseases (e.g. Asthma, Sleep Apnea, and Cystic Fibrosis) and their parents, particularly when the child is sleeping and exercising. This prevents children with respiratory diseases from participating in physical activity due to fears of overexertion. Troxie offers a wearable, wrist-based pulse oximeter to monitor and track the health of children suffering from respiratory related diseases or illnesses. This device measures blood oxygen concentration from the wrist using LED reflectance in conjunction with time and acceleration based algorithms. Primary customers are parents of children with respiratory diseases, including the large population with special needs, while secondary customers include pediatricians and school nurses. Market expansion may include hospitals in developing countries, research institutions, and parents of children with cardiac diseases. With asthma alone affecting 6.3 million U.S. children (CDC), Troxie aims to focus its market on children with chronic respiratory diseases. This includes a sub-market of special needs children with respiratory diseases, which is important because this population often has difficulty communicating distress. Additionally, a secondary market is children with respiratory infections and diseases in developing countries, as in these areas respiratory infections are a leading cause of death (World Lung Foundation). In contrast to standard pulse oximeters on the market, which use bulky and inconvenient finger-based measurements, Troxie streamlines the process through a discrete, continuously wearable wristband. Lightweight, durable, elastic, and waterproof, this device caters specifically to the needs of children and accounts for the unique complexities involved with marketing in the pediatric sector. Troxie’s mission is to allow parents and children ease of mind and unlimited potential in living life with respiratory issues.


ALCOHOL DETECTION IN BREAST MILK Hillary Bratlien, Eli Jacobson, Courtney Willson

mentors: Dr. Casey Ankeny – SBHSE | Dr. Jennie Bever - CONHI

When a lactating woman consumes alcohol it is metabolized into both the blood and breast milk. If not given enough time to fully metabolize, this alcohol can then be transported to the breastfeeding baby via the mother’s breast milk. When alcohol is consumed by an infant it has proven, negative effects on the baby’s developing motor and sensor controls. To help aid mothers in monitoring the potential transfer of this alcohol, a quantitative alcohol measurement device will be developed. This device will have a target market of breastfeeding and pregnant mothers in the US between the ages of 21 to 40, with a secondary market of the breast milk banks throughout the United States. This product would fall under the diagnostic and detection device category for medical devices that will be used by consumers to measure the levels of a chemical in a biologic material. Based from information from the CDC, including birthrates, breastfeeding percentages and alcohol consumption we assume that the potential market size of 1,840,333 mothers is in the United States alone. As of 2014 there are also 18 total breast milk banks in the United States that are members of the Human Milk Bank Association of North America, with an additional 6 banks that are in the development phase. The device design has currently been looked at with two possible solutions. The first of which would be to use chemical and thermal characteristics of alcohol and breast milk in order to separate the alcohol from a known amount of breast milk. The second possible technology that has been explored would be to use spectroscopy in order to measure the amount of alcohol in a breast milk sample. The device will be sensitive enough to detect alcohol in a sample containing less than 0.131 percent alcohol with an accuracy of plus or minus 0.01 percent. This measured alcohol will be then quantitatively displayed to the user.




Callie LaMarche, Sydney Lankford, Patrick McFarland, Juan Patterson

mentors: Dr. Casey Ankeny – SBHSE | Nancy Scherer – Department of Speech and Hearing Science Chair & Professor

Infants with cleft palate are unable to latch onto bottles because of the lack of suction that the hole in the palate causes. They are unable to feed enough needed for proper growth and fall behind in both weight and development compared to normal babies. Many of the infants that have this condition receive corrective surgery to close the palate. Cleft palate bottles have a squeezable segment to allow parents to compensate for feeding, but they don’t feel comfortable because milk is commonly aspirated. Existing cleft palate bottles clog, leak, and are difficult to clean and it is difficult to properly record the amount of formula fed tothe baby. Our market segment is children, ages 0-5. The main customers of Clefty are the caretakers of infants with cleft palate and clinicians. According to the world health organization, 1 in 700 infants are born with cleft palate worldwide, which represents a market opportunity of about $50mm a year. We currently have two concepts, an electrical and nonelectrical design. The electrical concept is a bottle that dispenses milk via a battery powered peristaltic pump. A sensor provides feedback when the baby is actively suckling and then activates the pump to dispense precise amounts of formula, while shutting off when the baby finishes suckling. The other, nonelectric design is based off a gravity fed bottle, that uses a ball to seal the nipple from leaking milk until the baby pushes up the ball, which allows milk to pass. Because the bottle is inverted, gravity does the work to dispense milk. Key specifications: nipple diameter of 40-60mm, ergonomic shape, 0 bottle leaks per feeding, measurement of milk dispensed highly visible, and easily assembled.


ORTHOCOOL: COOLING CERVICAL ORTHOSES Jeremy Becker, Alison Llave, Blossom Mendonca, Sahar Mohamed

mentors: Dr. Joshua Catapano – BNI | Dr. Michael VanAuker – SBHSE | Dr. Jitendran Muthuswamy - SBHSE

According to the National Spinal Cord Injury Statistical Center (NSCISC), the number of cervical spine injuries amount to 48,000 per year with an additional 400,000 spinal fusions annually in the United States alone. A majority of these cases will require the patients to wear cervical collars for extended periods of time. However, the problem with cervical collars today is that they are highly uncomfortable, causing patient compliance issues. This is particularly true in areas of hotter climates where the patients proceed to remove the collars in an attempt to cool down their necks, risking spinal misalignment. There are current cooling solutions, although, none of them are fully compatible with the use of cervical collars and their purpose of arresting spinal movement with a maximum angle of 35 degrees. The objective of this project then is to redesign the cervical collar so that it cools the patient while remaining lightweight, with a weight of less than 16 oz. The demographics of our customer base include patients, families of patients, insurance companies, surgeons, and physical therapists. We have been collaborating with these customer groups, partnering with Barrow Neurological Institute (BNI) at St. Joseph’s Hospital and Medical Center, to produce the optimal solution. The concept selection process has led us to the design of a cervical collar with a gel insert that can be removed and cooled. The collar will also feature a battery-powered fan and air channels to promote heat dissipation and an internal temperature of at least 15°F less than ambient temperature. Currently, the development process is undergoing focus prototyping to analyze which materials would fit best with the product. For the future, we plan on expanding this design to be implemented in thoracic and lumbar orthoses.



Allison Lind, Shelby Martin, Rene Reynolds

mentor: Dr. Stephen Helms Tillery - SBHSE

The Mechanical and Natural Tool for Ice Scaling (also known as MANTIS) is an adaptive athletic arm prosthetic that will be used to help upper arm amputees continue or start their love for ice climbing. The problem that this device aims to solve is as follows: there is no current product on the market that allows upper arm amputees to continue or start ice climbing. This product targets all upper arm amputees, but will specifically try and help military veterans and amputees looking to continue living an active life. Working in the market of orthotics and prosthetic devices within the medical device industry, there are approximately 100,000 – 200,000 upper arm amputees living in America. Of that number, there are approximately 320 veterans from the Iraq and Afghanistan wars alone. The concepts for this device mimic other adaptive athletic prosthetics. It will consist of two rods of carbon fiber connected in the middle by an elbow joint. At one end will be where the device attaches to the arm, a cuff and a liner will be included, and a harness that will allow the device to hold the weight of the user’s body. At the other end of the device will be where the ice pick attaches to the rest of the arm. Some of the key product specifications include how much weight the device must hold (up to 250 kg), the temperature range the device must function in (-10 to 50 C), and that the device needs to be lightweight (less than 2.5 kg).



Ryan Bridges, Wei Lu, Ceasar Udave

mentors: Dr. Jitendran Muthuswamy - SBHSE | Dr. Javier Cardenas - BNI

Every year there are between 1.6 and 3.8 million concussions diagnosed. 78% of these concussions will take place on a field during a sports activity. 47% of these athletes will not feel or exhibit any symptoms. High school football players make up an astonishing 1 million out of 1.3 million players but have the least amount of resources for dealing with concussion diagnosis. Concussion is unfortunately unique to each individual and therefore needs a test that is unique. The current testing method is the SCAT 3 test which relies on having medical staff present assessing the patient, and is subject to prior athlete performance. OcuTrack seeks to provide a low cost, $150 per unit, eye tracking device. The current state of the art is EyeSync which is $25,000, and is sideline screening only. OcuTrack continuously records the individual’s optical behavior with a dual camera integrated helmet visor system. This system will construct a profile and compare eye movements to constructed individual baselines to find abnormalities. This comparison is performed through a cross-correlation calculation, and with a 90% discrepancy threshold to alert staff. The motion tracking system relies on the Kanade-Lucas-Tomasi (KLT) algorithm, to track user eye movement. Ocutrack is able to track eye movement efficiently by using high resolution (1024x1080) recording coupled with a high sampling of 20 frames per second allowing OcuTrack to build an accurate normality profile. OcuTrack is able to withstand the extreme environments of on field players by being


element proof, and withstanding forces of up to 20g’s. Ideally OcuTrack will have a latency of less than 5 seconds between identifying and reporting an abnormal eye movement, making it real time. Abnormalities are reported to staff members that will remove the player from play, and assess them for return.



Akshara Malla, Keerthana Murali

mentors: Dr. Jeffrey LaBelle – SBHSE

Pancreatic cancer is a very lethal disease and currently has a survival rate of seven percent. This subset of cancer is difficult to detect and is often undetected until the cancer has progressed to stage 3 or stage 4. The current diagnostic techniques for pancreatic cancer are also very time consuming and expensive. This creates a need for a cheaper and faster alternative. The aim of CDiagnostics is to create a multiplexed electrochemical-based biosensor for use in early pancreatic cancer detection. The target customers for the proposed device are pancreatic cancer patients, physicians, lab technicians and other medical professionals. Pancreatic cancer specific biomarkers will be detected in pancreatic cyst fluid and peripheral blood. Using electrochemical impedance spectroscopy (EIS), multiple pancreatic cancer indicating antibodies will be immobilized on sensors and then used to detect the corresponding antigens in patient samples. EIS detects specific antigen-antibody complexes based on their optimal binding frequencies. The device will include a voltage and current sensor to output an impedance value that correlates to the antigen concentration. Electrochemical impedance spectroscopy was picked over the other detection methods due to the specificity of biomarker detection. EIS also requires a smaller volume of patient samples than most other cancer diagnostic techniques. The market segments involved in the design and production of this device include the in vitro diagnostics industry and cancer biomarkers market. With a growing number of cancer diagnoses, about 41,780 pancreatic cancer patients are expected to die in 2016, thus indicating a large demand for this device. The market for the aforementioned industries continues to grow exponentially with the cancer biomarker industry expected to reach a value of $7.4 billion by 2020.


mentors: Dr. Sarah Stabenfeldt– SBHSE | Emanuel Vlastos MD—SLU Med

Fetuses diagnosed with Bladder Outlet Obstruction (BOO) cannot properly urinate resulting in bladder swelling which prevents organ development and causes renal failure. According to Cardinal Glennon, one in every 4100 fetuses will be diagnosed with BOO translating into approximately 31,000 fetuses a year. The fetuses also suffer from oligohydramnios, having too little amniotic fluid in the womb. The lungs are what suffer the most because the fetus needs to drink the amniotic fluid in order to develop their lungs. The current treatment for BOO is placing a shunt into the fetus’s bladder that allows continuous drainage. The problem with the current solution is the bladder muscles never develop and require multiple surgeries and patients suffer incontinence for the rest of their lives as well as chronic renal failure where many patients require a kidney transplant. The NatEvac device designed by Fetia will allow the bladder muscles to develop, as well as providing the fluid the fetus needs for drinking and lungs development. According to the physicians at Cardinal Glennon NatEvac should avoid long-term problems such as kidney failure any incontinence, negating the need for subsequent surgeries including transplant. The customers are primarily physicians and hospitals that specialize in fetal care. Our market segment is still developing because in some evaluations fetal care is in included under Fetal and Neonate Care Equipment while in others it is still included in High Risk Obstetrics and Gynecology. The market size of Fetal and Neonate Care Equipment is predicted to reach 7.8 billion (USD) by the year 2020. The NatEvac device is a shunt with a pressure-regulated valve that would allow the bladder to go through its normal filling and drainage cycle. The NatEvac will not exceed 3 mm in diameter or 3.5 cm in length to satisfy the needs set forth by BOO.


Naazaneen Maududi, Francis Taguinod, Sadaf Tahmasebi, Jason Yang

mentor: Dr. Vincent Pizziconi - SBHSE

Based on CDC statistics, falls are the leading cause of fatal and nonfatal injuries among geriatric adults aged ≥65 years in the US. Each year, 2.8 million geriatrics are treated in the emergency room for fall-related injuries. A significant fraction of the elderly who fall experience blunt trauma and those who are on blood thinners are particularly susceptible to internal bleeding, a silent killer that virtually goes undetected. With current estimates of more than one out of four elderlies who fall each taken together with the rapidly growing baby boomer population who, as a group, are turning 65 at a rate of 10,000 per month for practically every month for the next 20 years, the market for Vital Check is significant for the foreseeable future. This is especially true, from wearable diagnostic technology which is anticipated to experience a 35% increase in growth and $34 billion in sales in the US alone by 2020. The Vital Check team is currently exploring diagnostic design concepts based upon physiological markers that are deemed relevant to internal bleeding and which are detectable with noninvasive wearable technologies currently available on the market. These include heart rate, blood pressure, temperature, and respiratory rate, among others. Engineering models, currently under development, are aimed to guide the VC team in identifying exploitable physiological markers, alone or in combination, that are determined to be able to uniquely detect internal bleeding in real time. The feasibility of this key Vital Check performance specification, based upon realistic model representations of this complex dynamic flow system, is central to the development of a viable low-cost and life-saving, wearable technology for the elderly who are prone to falls..




Hannah Switzer, Casey Weinstein, Avery Witting

mentors: Dr. Brent Vernon – SBHSE | Dr. Douglas Faigel – Mayo Clinic

There is currently no existing product that is capable of actively mixing a non-neutrally buoyant drug solution during long-term infusion. A device that can address this need would extend and improve existing methods of targeted cancer drug delivery. The primary goal of the Self-Stirring Syringe Pump Project is to develop a product that mixes the contents of a syringe while simultaneously infusing the drug over an extended period of time. The device must keep a non-neutrally buoyant drug suspended within a solution as it is infused into a patient The intended customer base includes healthcare professionals in both hospital and private practice settings who work with non-neutrally buoyant drugs. This device could be of particular interest to oncologists, anesthesiologists, and interventional radiologists. A prototype has been developed and has been proven capable of effectively stirring the syringe contents by using induced magnetic fields to cause rotation of a stir bar within the syringe body, resulting in a homogeneous suspension of microbeads within solution. This prototype consists of a 3D-printed stator with copper coiling looped throughout that houses a standard 20 mL syringe. The stir rate is customizable, and it is intended that the output concentration falls within 5% of the desired concentration. Efficacy testing of the self-stirring syringe pump prototype has been performed using quantitative analysis through fluorescent spectroscopy and the analysis of micro-bead concentrations for given infusion volumes. The product must be safe, effective, and simple to use such that it provides justifiable benefits over existing methods. The final device will be easy to use, have a customizable mixing rate, and will be controllable through a streamlined user interface. The cost will be comparable to similar products on the market, but will enable long term mixing. Future work will include prototype improvement, device manufacturing, and efficacy testing.



Barrett Anderies, John Tobey, Mohammad Mousai

mentors: Dr. Marco Santello - SBSHE | Dr. Bernard Bendok - Mayo Clinic

During certain neurosurgery procedures, surgeons need to determine the precise location of critical brain regions that control motor, vision and language functions to avoid damaging these areas. Currently, intraoperative brain mapping (awake neurosurgery) is the technique utilized to map functional regions. This technique involves electrical interrogation of cortex and white matter tracts, observing patient response to stimulus, and physically marking identified regions with sterile paper tags. The paper tags serve as a visual reminder to the surgeon later in the procedure. This process is imprecise and time consuming and the paper tags are prone to accidental displacement and provide limited spatial information. Lead users have vocalized the need for integrating the process with modern neuronavigational equipment and incorporating additional features. This project aims to digitize the brain mapping process by combining a novel 3D-tracked cortical stimulation probe, real-time 3D tool tracking, and custom software for improved brain mapping functionality. The novel probe will allow interrogation of brain tissue and the application of digital tags containing 3D positional and user-customizable information. The information will be displayed through a familiar neuronavigation interface, and will provide novel haptic, auditory, and visual warning cues when certain tools enter tagged areas. The project aims to allow easy integration of the proposed system with current neuronavigational equipment. There are approximately 3,500 neurosurgeons in the United States, all of who utilize brain mapping during select cases and would benefit from this advancement. The target market for the system is a neurosurgical device, and every hospital that has a neurosurgery department is a potential customer. Key final product specifications are a spatial accuracy of 0.25 mm RMF and stimulation current between 0 and 15 mA. By providing precise digital brain mapping, the proposed device will improve safety, efficacy, and efficiency in the neurosurgical operating room.



Velia Francis, Nick Vale, Anthony Zlaket

mentors: Dr. Marco Santello – SBHSE | Jeffry Skiba - Industry

Biopharmaceutical companies commonly utilize animal models, specifically mouse models, for drug development and testing. However, these models are costly in both time and money, do not always provide accurate representations of human-drug interactions and their use creates ethical implications for drug marketing. As such, there is a need for alternative, human cell-based models in drug development. The Chromometer is a low cost chromatin state sensor integrated within a cell line designed to better understand human cell fate during exposure to epigenetic drug compounds. Pharmaceutical companies will use the device as a component of the preclinical drug testing platform. In the long term, millions of patients will be positively impacted by reduced cost of medicine. A HoxD11.12 DNA sequence that binds to polycomb group (PCGs) proteins is fused to a fluorescent reporter as a measurement of how repressed the cell’s genes are. An “on” state indicates no PCG proteins have bound to the sensor and thus the cell experiences little genetic repression. An “off” state indicates high epigenetic repression in the cell due to drug interactions. After verification to ensure stable integration, two out of twelve transfected cell lines demonstrated stability through PCR and gel electrophoresis analysis. PCR primers flanked three verification regions of the construct, each ~1kb long. For successful cell lines, gel electrophoresis showed three ~1kb bands, verifying that all three regions of the construct were inserted. Out of these two cell lines, we generated one of each prototype: Chromatin Sensor I and II. Flow cytometry data demonstrates both cell lines exhibited monomodal or bimodal distribution of fluorescence. The Chromometer has a unit manufacturing cost of $411 and a projected sale price of $2000.00. As a combinational device, the regulatory pathway includes a Request for Designation, De Novo, and 510(k).




Carilee Farrell, Davis Matthews, Hannah Spehar, Casey Weigel

mentor: Dr. Antonio Garcia- SBHSE

Many people do not know when they are dehydrated until it is too late and is already adversely affecting their bodies; dehydration can cause muscle fatigue and even cause the patient to faint if it gets too severe. According to the Arizona Department of Health Services, over 2,000 people per year in Arizona are admitted to hospitals and emergency rooms with symptoms of dehydration; once admitted, doctors do not have a specific way to test for dehydration, the primary way being that they administer fluids and hope the patient’s’ symptoms are reduced, which is inefficient if dehydration is not the cause of their ailments. The goal of Hydrate Meter is to create a product that will test human subjects for dehydration before it causes problems for them. The main consumer market will be athletes and athletic trainers. Our device will initially be used in athletes for small scale testing but with the popularity of Fitbits and other health and wellness tracking devices, our device could be extremely popular in amateur athletes as well. For market size reference, 21.4 million Fitbits were sold in 2015 according to company reports. Another important customer base would be caretakers of patients that cannot convey their needs, such as the elderly or children; this device will allow caretakers to know the state of their patients without requiring communication. In the designing process, athletes, athletic trainers and healthcare professionals were interviewed to determine what features they desired in a device. In order to determine dehydration levels, we are going to test skin impedance, which changes with hydration levels in humans.


Abdulaziz Alamal, Rakan Aldossari, Ibrahim Almuteb

mentor: Dr. Abdulrahman Alshareef-CIDSE

The level of care a patient gets within hospital premises is of the best possible quality. The patients have the medical personnel at their back and call. They are constantly monitored both by nurses as well as machines specialized to monitor body’s vital functions. In case of any kind of emergency, the problem can be detected at once and taken care of in the timeliest manner. Compared to that when the patient is discharged, the level of car is drastically dropped as the patient is now on his own. The patients usually retort towards self-diagnosis once they are sent off to their homes. The need of this project arises from all the afore-mentioned shortcomings in the current health care system. This project is being undertaken to design, simulate and implement a wireless sensor network comprising of several independent nodes communicating wirelessly with a central control device. Each node consists of multiple biomedical sensors to obtain biometric information from the patient. The biometric data from the patient is checked for critical levels and a medical alarm to summon medical personnel or first aid is triggered, if an abnormality is detected. This project does exactly that by attaching sensor nodes to the patients’ bodies and collect different kinds of physical readings such as temperature, heart rate, blood oximetry, and nasal airflow (the sensors can be changed according to the patients’ personalized needs. The global industrial wireless sensor network market size is estimated to grow from $401.23 Million in 2013 to $944.92 Million by 2020, at a CAGR of 12.96% from 2014 to 2020. The project lies in the market segment of industry wireless network and healthcare organizations. Main customers of this project include healthcare organizations, wireless network developing companies and hospitals.



Kinjal Ahir, Matthew Devera, Sharon Gooi

mentor: Dr. James Abbas - SBHSE

In 2011, the Bill and Melinda Gates Foundation reported 18% of 1.3 million children in developing countries die from pneumonia. Placing the children on oxygen concentrators can help these children by warning when the blood oxygen concentration begins to drop. Pulse oximeters are not widely available in less developed countries. The team is building a pediatric pulse oximeter, aimed at children from the ages of newborn to five years old. This pulse oximeter will be more affordable than competing devices, though just as accurate, and easy to operate and clean. The team has found nurses are the main customers for this device, since they are constantly monitoring the children’s conditions. This device is part of the pulse oximeter market, which is a subset of the vital signs monitoring device segment, according to Markets and Markets. According to Global Industry Analysts, Inc., this is one of the largest medical device markets available, and is estimated to reach up to US$2.3 billion by 2020. The OxySaurus should have 2% measurement accuracy, with a 660nm red LED, a 940nm infrared LED and a photodiode spectral range of 600 to 1000nm. The device should be able to survive a 1m drop, and have the sensor weigh less than 100g. Although a concept has not been decided on, current concept combinations are being analyzed through the use of SolidWorks to model the concept components and materials. SolidWorks can also analyze their size, weight and durability. RStudio will be used to analyze the number of trials and factors the team needs to account for when determining percentage of error.



Omar Eltohamy, Heather Feldman

mentor: Dr. Jeffrey LaBelle – SBSHE

Hospitals and trauma centers take blood lactate measurements in order to study and discern the amount of damage done to the human body after an accident or distressing situation. According to the American College of Emergency Physicians, a lactate level above 4.0 mmol/L is associated with a 27% mortality rate. As of today, hospitals and trauma centers will take one discrete measurement over a course of 2-3 hours. As a result, our overall aim is to shorten this time period from hours to minutes, as well as switch over from discrete measurements to continuous measurements. Blood will flow through a microdialysis probe to isolate the lactate before flowing to a 3-electrode-housing unit that will read the blood lactate levels by using an amperometric method. Our main customer is Dr. Ayan Sen, one of the top trauma surgeons in the country, who wishes to use this device to help any patient that walks through the hospital doors with extensive damage. Since this will be a hospital setting and environment, our main customers will be those who will use the device, such as hospitals and trauma centers, specifically doctors such as Dr. Sen. Currently, our main goal is to be able to create a working model that will be used by the Mayo Clinic, and gauge our success based off of that. We would first create models for the local scene, focusing on both Mayo Clinic campuses, and slowly spread to local


hospitals and trauma centers. One of the main goals is to keep our product affordable, and make sure that it is cheaper than a hospital standard catheter.



Pete Akerele-Ale, Justin Dombrowski, Michael Tsarouhas

mentor: Dr. Brent Vernon - SBHSE

Traumatic wound clotting devices for wounds across the thoracic and abdominal regions are outdated rudimentary in comparison to the needs of first responding medical personnel. Blood loss from deep wounds can quickly become fatal as it can take under 10 minutes to bleed out from a deep chest wound. The development of clotting biomaterials is becoming more predominant, entering a niche biomedical market with target customers expanding from EMT respondents to military personnel. There are roughly 250,000 EMT/EMS personnel and 6,000 military medical personnel in the Army alone that would benefit from the development of blood loss prevention devices. However, there are also countless other possible complications associated with a traumatic hemorrhaging wound such as pain and infection. Around 51% of combat injuries present some level of microbial growth in the wound site and the need for a device that can quickly kill any potential bacteria is great. Trauma Gel’s solution to the need for a fast acting hemostatic material is a foaming gel that promotes an increased clotting cascade, while also applying pressure to the wounded tissues from within the wound in order to stop hemorrhaging in under 3 minutes. Trauma Gel sets itself apart from its competitors with the additional long-term release (hours) of a local anesthetic and antiseptic; producing a unique clotting device that also reduces localized pain while treating the risk of bacterial infection. In addition, Trauma Gel will ease the transition from field dressing to hospital care by providing a gel that is removable via a cold saline bath, which will reduce the complications with traditional wound clotting device removal. Trauma gel seeks to improve the devices used by medical professionals dealing with traumatic wound care in hopes of improving the survivability rates of all patients who suffer from life threatening injuries.




Kenna Lum, Colby Mark, Dirk Marshall, Ross Talbert mentor: Dr. Marco Santello – SBHSE

Patients who have recently lost a limb and want to be fitted for a robotic prosthetic arm in the transhumeral or transradial location need to be trained and tested for areas of optimal muscle activity. As of 2014, there were 8,300 registered prosthetists in the United States, alone which represents our total potential customer group. The market segment will be targeted at prosthetists as well as orthopedic therapists; this population will be most the end users for this device. The patients will have had amputations due to disease, accidents or combat, and the atrophy of these muscles will interfere with easy use of a myoelectic prosthetic. After the ablation and subsequent healing of the distal part of the limb, this sleeve can be fit and used to locate areas of high myoelectric activities on muscle bellies. Additionally, the device can act to ensure that certain motions by the specific patients do not result in the stimulation of antagonistic muscles, which could interfere in myoelectric signals. Currently there are only devices that have two or three electrode contact points that need to be held onto the arm. IllumiLimb is a sleeve that will help by making the test much easier for clinicians and more accessible for patients. The need for a device that can be adjustable as well as flexible to fit various sized patients is required. It will also act as therapeutic training device to combat the atrophy that accompanies amputations. The device will have a low pass filter with a cutoff of 50 Hz and a high pass filter with a cutoff of 300 Hz to focus on myoelectric signals as well as a gain of 450 to amplify the signal. The sleeve will have elastic components and will incorporate stainless steel electrodes in the design.


NEURAL STEM CELL DELIVERY DEVICE Cory Riecken, Wade Savage, Nicholas Walker

mentor: Dr. David Brafman - SBHSE

Stem cell therapies promise to improve recovery for an increasing number of diseases, from brain cancers, to epilepsy, to traumatic brain injuries, to neurodegenerative diseases. A major problem with current therapies is generally low and variable cell viability; part of this results from shear forces, which mechanically destroy cells during injection. Our team aims to develop a delivery system to optimize stem cell viability in elective surgeries for treating neurological defects. The primary customers for this device will be hospitals and surgical units that treat diseases of the central nervous system. The surgeons that perform these procedures need to be able to control the pressure that they are applying to the brain tissue, the flow rate of the cell suspension material, prevent infections, and to disturb as little of the native tissue as possible. Flow rate is the single most critical element for cell viability, and research shows that optimal flow rate varies between lines of cells and suspension media modulus, but most will fall in the range of 1-300 μL/min. Pressure should be controlled to between 100-120 mmHg, and the outer cannula used with this device should not exceed 2 mm in diameter. Our concept will combine the best elements of surgical syringes with benchtop syringe pumps to create a constant flow rate device. Additionally, and equally as important, the surgeon needs to be able to control the dosage delivered to a given target region of the brain. Our design will be optimized for 150 μL/min flow rate and be able to precisely deliver between 1-1,000 μL of cell suspension. We plan to have an autoclavable removable syringe manipulation component to minimize patient risk of infection, and other design attributes including a 360° rotating head. Our future work will include pinpointing costs and technical prototyping.



Hany Arafa, Robert Childers

mentor: Dr. Jennifer Blain Christen - ECEE

According to the Centers for Disease Control and Prevention, there are an estimated 12 million Americans 65 years or older with diabetes. This number is increasing by roughly 2 million Americans annually. In conjunction with the exponential increase in elderly people, due to the baby boomer generation, there is a large and continually growing market. The creation of a disposable device to cost-effectively and accurately monitor a chronic wound or leg ulcer could help prevent the progression of an infection in a patient. The proposed solution to the problem is the development of a flexible disposable device that conforms to the shape of a chronic wound or ulcer. This device will incorporate a


printed sensor with immobilized biomarkers on the substrate for specific detection of certain antibodies present in wound interstitial fluid. Fluid delivery will be performed with the use of paper microfluidics and a valve system for the delayed delivery of interstitial fluid. This device relies on a colorimetric method for the confirmation of an infection. With the conjugation of an antibody/antigen, a particle will be released which changes the color of the substrate. This provides a visual indication to the patient that immediate medical attention is needed. This proposed device is meant to monitor the progression of a wound for extended periods of time and the disposable bandage being replaced periodically. The status of the device as of now is within the final concept selection phase, with the main concept being a compression-based sleeve with the capacity to change the custom sized disposable bandages when needed.


RISE: The Assistive Lift Shower Chair Aimed at Easing the Transition

of Sitting and Standing

Alex Baldwin, Akihiko Ishihara, Karthik Puncha, Andy Son

mentor: Dr. Shrake - EPICS

Customers with debilitating diseases encounter the daily struggle of transitioning into shower chairs. These people lack an affordable, and cost-effective assistive lift shower chair that has been largely ignored by the medical chair industry. Our aim is to help patients who suffer from a debilitating disease or condition that prevents them from independently being able to sit into a shower chair and get out of. These patients include the millions of Americans diagnosed with ambulatory issues and other nervous system diseases. Our product will fit the role of a traditional shower chair, including a toilet seat for waste disposal and waterproofing for shower use with the additional benefit of elevating and dropping for safer transfer back on their wheelchair. This lift assistive shower chair will allow patients to change from a resting height of 17 inches to a slightly tilted 25 inches using a scissor lift controlled by motorized crank that can be operated using a microcontroller. Similar chairs have used a 510(k) premarket notification, which is how our device is expected to be regulated. The patient will be able to utilize the shower chair with a waterproof membrane keypad interface integrated onto the armrest. The chair will be made of strong and durable PVC pipe material with housing compartments for electrical parts. For comfort the chair will have bath cushioning with included PVC foot rests. Wires will run inside the chair surrounded by insulating foam to prevent water interference. The market segment for our device includes hospitals, clinics, and nursing homes. The market size for wheelchair users according to the National Institute of Health is 2.2 million who are patients who need wheelchairs for mobility and to perform day-to-day tasks.



mentor: Dr. Rosalind Sadlier – SBHSE

During reconstructive bone flap surgeries there is currently no accurate way for a surgeon to assess how much tissue is needed. Often they must estimate and use trial and error to assess the amount of bone needed, however there are times when their best guess is incorrect and the surgical team either wastes tissue or does not have enough collected tissue to complete the procedure. Other times, the patients need a follow-up surgery in order to ensure that the wound heals properly and is functional. In addition, many hospital procedures don’t have an effective way of reusing material used for personalized surgical tools. The primary customers are the hospitals conducting reconstructive surgeries and surgeons performing grafting surgeries. This problem is general and widespread but the team is focusing on bone grafting surgeries in order to approach the problem with a degree of focus. The particular market segment is surgical appliances. The customers of the market include all hospitals in which bone flap surgeries occur. This includes most major US hospitals, as it is a fairly common practice in regards to reconstructive surgery. According to the American Academy of Orthopedic Surgeons, there are more than 3 million musculoskeletal surgeries performed in the United States every year. Of those surgeries a significant portion of them involve using grafted tissue. We present a 3D printed bone flap template that may be sterilized by a low-temperature plasma device and transported in Tyrek material. MRI data is used as the input data. 3D processing of the flap area occurs using Mimics software. The data is converted to G-Code by an add-on software into the appropriate file format for 3D printing by fused deposition.


LCS-A LOCKING CAP FOR PEDICLE SCREWS Almoustafa Abbas, Cole Landeene, Marcus Sansoni

mentor: Dr. Michael Bohl - BNI

Numerous cap screws that are used in surgeries for posterior segmental fixation of the spine loosen or completely back out over time. According to Asian Spine Journal, 40% of all spinal support system failures are caused by issues related to cap screws. When this happens patients are required to undergo a new surgery to fix the broken spinal support system. This costs the patients who are often older and have a much higher chance of surgical complications, a large amount of inconvenience and financial strain. Locking Cap Screw (LCS) is primarily marketed towards neurosurgeons who perform these operations and the administration in charge of purchasing spinal support systems for hospitals. This locking cap will be classified under the Neurological market however, future design modifications will target secondary markets for additional applications. The current market size for our product in the US market alone is $6 billion USD. The global spinal surgery devices market is currently increasing at a rate of 4% a year and is projected to reach $ 8.7 billion USD by 2018. LCS is a solution to this problem by increasing the longevity of the spinal support system, increasing patient comfort, increasing satisfaction, and reducing the need for additional surgeries. This device essentially plugs into the cap screw and uses its attached arms to hang down the sides of the bone screw to secure it in place. LCS will be just slightly larger than the cap screw of the spinal support system, which has dimension of 6.8mm in diameter, and 11.8mm in height. This locking cap will also be extremely easy to use as it will require less than three steps for installation. Alternative concepts include a locking pin that passes through the cap screw/bone screw and a small plate, which is installed above the cap screw preventing it from backing out.




Alex Bugarin, John Sherman, Quintin Woods

mentor: Dr. James Abbas - SBHSE

Relapsing, Remitting Multiple Sclerosis (RRMS), an autoimmune disease that disrupts nervous system communication, requires disease-modifying medication in order to prevent further disease progression and increased presence of relapses. Currently, there are greater than 400,000 individuals diagnosed with Multiple Sclerosis in the United States and an estimated 2.5 million individuals worldwide. 85% of patients are diagnosed with RRMS at onset with the possibility of disease progression according to treatment. In order to provide more comfort with prefilled syringe medication delivery, Multiple Sclerosis autoinjectors have become a commonplace injection method. They allow for a simple and automated injection process. 44% utilize prefilled medication syringes with a form of autoinjector, resulting in a market size for our device of 150,000 people in the United States and 935,000 worldwide. This market continues to grow at an exponential rate as the autoinjector industry is enhanced and developed. Tactility issues caused by MS and overall anxiety pose significant problems to the injection process as users are continually prevented from self-injection. As individuals with MS rotate subcutaneous injection sites across the body, a site of difficulty remains the dorsal side of the arm. Users experience limited stability causing improper injection angle and delivery resulting in dermal abrasions and increased anxiety, preventing autonomy. The current StableMate concept design is a neoprene arm sleeve that includes an adjustable Velcro feature to adapt to arm size, a rigid internal plastic cuff structure that incorporates restricted movement and an interchangeable plastic extending tube that acts as a guiding mechanism for all autoinjectors. Through this design, the StableMate seeks to locationally confine and restrict the overall movement of autoinjectors in order to ensure proper medication delivery, decrease needle anxiety and enhance an autonomous lifestyle.


GASTRISLOW – Device to Slow Bolus Flow Rate into Small Intestine

Sarah Beeman, Lorelei Gorr, Deven Govin

mentor: Dr. Vincent Pizziconi – SBHSE

Dumping syndrome is a grouping of symptoms characterized by nausea, abdominal pain, diarrhea, vomiting, and caused by lack of proper stomach function. Early dumping syndrome occurs when a large volume of partially digested food enters the small intestine too quickly. Late dumping syndrome occurs when too much unprocessed sugar enters the small intestine in a short span of time causing the body to absorb it rapidly, which then results in hypoglycemia. The main customer groups that experience dumping syndrome are patients who have undergone a gastric bypass or total prophylactic gastrectomy (complete stomach removal), but most gastric bypass subjects have found that with diet and time the problem will fade. The market focus is then on patients having prophylactic total gastrectomy to prevent cancer from forming in the cells. The lead customer in contact tested positive for Hereditary Diffuse Gastric Cancer (HDHC), which is caused by a mutation in the CDH1 gene; a discovery made only last year. The market is growing every day as more people are being diagnosed with this extremely aggressive cancer and the current method of treatment is prophylactic total gastrectomy. According to the NIH, more than 120 cases of stomach cancer have been linked to the CDH1 gene so far. The current concept choice to fix dumping syndrome in these patients is to slow the flow rate of food into the intestines with a rotating mechanism and provide an element of breakdown to possibly increase absorption rates and avoid malnutrition. This will be implantable and act as a connection between the esophagus and small intestine. The key specifications for this project are flow rate out: 120 mL/hr, ease of use, allows proper organ function, external volume: 1 – 1.5 L, and internal volume: 0.5 – 1 L.



Essang Akpan, Aaron Blank, Neema Jamali

mentors: Dr. Thurmon Lockhart – SBHSE & Dr. Rahul Soangra – SBHSE

Concussions are a pervasive issue in high-contact sports that have the potential to cause a great detriment to players’ quality of life in the long run if undiagnosed. There are approximately 100,000 NCAA football players, 200,000 high school football players, and 450,000 rugby players in the United States alone that would all greatly benefit from a concussion sensing device. People are in need of a more accurate way to detect concussions right after they occur. The targeted customer market contains contact sports athletes. Since each of these clubs and leagues have different rules and regulations they can be segmented by different sports like football, hockey, rugby, etc. Concussion sensors are meant for players but not only the players will be customers. The market is further segmented through a customer’s relationship with the athletes. Whether they be parents, coaches, or medical trainers. This device will be able to use gait-analysis methods with implementation of a three-axis accelerometer to establish baseline gait characteristics and compare them after players experience hard impacts. The information taken by these sensors will be integrated using a microcontroller, and the microcontroller will transmit this information to the user via bluetooth. We are currently creating the alpha prototype, and will have this completed in the next few months. This prototype will be worn by our target users and will transmit data to our team. Upon the conclusion of spring semester, we will have a functional concussion sensor that will be able to quickly assess concussive states. Key product specifications we have modeled are the ability to measure hits up 150g accurately, a total weight under 10 grams, and data transfers from the sensor to the app in under 3 seconds. and noise cancellation capabilities of our device. While many stethoscopes have been developed that address the problem of high ambient noise, our design combines high quality fidelity by using a 3 stage signal processing system with user convenience and cost-effectiveness. A retractable design allows a medical practitioner to perform auscultation in high stress environments easily without interfering with other tasks at hand. Our target market includes medical professionals in military, emergency, and humanitarian medicine.



Raj Ahir

mentors: Dr. Narayanan Krishnamurthi - CONHI & SBHSE | Dr. James Abbas - SBHSE | Dr. Pavan Turaga – AME & SECEE

Parkinson’s disease (PD) is a chronic and progressive disorder of the nervous system that affects movement. The most common symptoms of the disease are resting tremor, bradykinesia, muscle rigidity, gait dysfunction, and postural instability. Of these symptoms, gait impairments significantly affect independence and quality of life and are expressed as rapid short steps, trouble stopping, freezing episodes, and lead to high risks of falls. Usually, gait evaluation is performed using an instrumented walkway, motion capture cameras, or multiple inertial sensors. However, these methods limit acquiring long-term continuous gait data during every day activities at home. Obtaining long-term continuous gait data at home would greatly help to detect changes in gait due to disease severity, treatment, and/or intervention. Recently, an algorithm was presented by Del Din et al. (2016) to extract gait patterns from a single accelerometer sensor placed at lower back. For this applied project, we utilized this algorithm to develop code in MATLAB and tested it on data from wearable sensors during overground walking from 5 healthy individuals aged from 24-50 years. The MobilityLab gait system was used to collect data - six movement monitors were placed at different anatomical positions at the left and right wrists, the left and right ankles, the sternum and the lower back. The vertical acceleration signals of the sensor placed at the lower back were used to extract many gait indices such as step, stance, stride, swing times, step length, and step velocity. In future, the robustness of this code will be tested on data that will be collected from people with PD and can be utilized to monitor changes in gait difficulties due to disease and treatment/interventions modalities.


Katie Hemphill

mentors: Dr. Sarah Stabenfeldt - SBHSE | Dr. David Brafman - SBHSE | Dr. Mo Ebrahumkhani - SBHSE

Traumatic brain injury (TBI) may result in serious disabilities that current clinical interventions fail to address. Stem cell therapies may provide a potential treatment by reintroducing new, healthy cells into the damaged neural environment. However, these treatments are limited due to low transplant survival rates. Previous work with a hyaluronic acid – laminin (HA-Lm) hydrogel found high viability of mouse fetal derived neural progenitor/stem cells (NPSCs) cultured on the gel, and additionally primed NPSCs for migration by increasing levels of CXCR4, a critical cell surface receptor that promotes chemotactic cell migration. Looking toward translating to clinical populations, transplantation strategies must employ clinically relevant cell lines. As such, human pluripotent stem cell (hPSC)-derived neural progenitor cells (hNPCs), a multipotent cell population capable of extensive in vitro expansion and subsequent differentiation into the various cell types that comprise the central nervous system, could provide an unlimited source of cells for such therapies. In this study, we sought to develop an optimized HA-Lm gel to support hNPC viability and maintain CXCR4 expression. Rheology was used to optimize the stiffness of the gel to match that of the native neural tissue (1 kPa), and a flow cytometry propium iodide stain was used to determine the optimal gel based on cell viability. For hNPCs cultured on the HA-Lm gel, flow cytometry showed high levels (88.71% +/- 1.30%) of CXCR4 cell surface receptor levels maintained for 72 hours, and RT-qPCR showed CXCR4 expression at the gene level. Additionally, transwell migration assays were used to evaluate the chemotactic migratory potential of hNPCs.


Jiyao Hu

mentors: Dr. Marco Santello - SBHSE | Dr. Qiushi Fu - SBHSE | Dr. Christopher Buneo - SBHSE

Despite the non-linear and non-stationary characteristics of the electromyography (EMG) signals, many active prosthesis use EMG to respond to movement intent. In this study, we use either velocity control or position control to see which one would provide better tracking training results for subjects who are naïve to EMG control schemes. Five subjects were randomly assigned to each condition. Electrodes were attached to areas of the arm that corresponds to a pair of antagonistic muscles, either wrist flexor or extensor muscle. The EMG signals are then processed and related to a cursor position, which the subjects were asked to track to another sinusoidal wave signal of varying frequency. The accuracy of the tracking is calculated using root-mean-square error, RMSE. It is thought that the least error the subject has, the better control of the cursor that the subject has. The results of this study could give us better understanding on which control scheme is more natural and thus less errorprone for the subjects. This pilot study will also pave ways to future studies where new control schemes could be implemented to incorporate both position and velocity elements.


Varsha Joshi

mentors: Dr. Thurmon Lockhart - SBHSE | Dr. James Abbas - SBHSE | Dr. Jeffrey LaBelle - SBHSE

One of the major health hazards that older adults’ encounter are falls leading to reduced quality of life, increased presence of multiple chronic diseases, mortality and additional health care cost. The objective is to assess relationship of fall risk factors among elderly with their serum Vitamin D levels. The studies were performed in subject’s male and female above the age of 50 years. We assessed fall risk among older adults using gait parameter derived by inertial measurement units using like tri-axial accelerometer, gyroscopes and ground force measurement sensors,


grip dynamometer. These units were used to find the factors relating to fall risk assessment for community living Older adults in their community dwelling setting environment. The subjects Vitamin D levels were assessed from drawing the blood sample on the day of the fall risk assessment. The studies show the Vitamin D levels in the range of 10.9 - 64.8 ng/ml. The subjects were grouped per their vitamin D levels and then correlated with their grip strength, postural stability and dynamic stability results.injury and neuropathic pain patients, with foot and leg movement. The patients are undergoing treatment for pain, which provided the opportunity for performing the experiments. Post- surgery, the patients are asked to perform basic feet movements like flexion, extension, abduction, adduction and walking a few feet on a flat surface. The movements are captured via the Vicon motion capturing system with the help of markers and analyzed using Vicon’s Nexus software. The signals are then analyzed through MATLAB. The desired characteristics of the signals are, thus, determined from this analysis which helps in understanding the spinal circuitry better.



Rachel Juetten

mentors: Dr. Brent Vernon - SBHSE | Alison Van Putten - The Tech Group | Andrea Hyde - The Tech Group | Dr. James Abbas - SBHSE

The Tech Group Phoenix houses four cleanrooms that mass-manufacture medical devices. People who work within the cleanrooms and operate the press stations can stand on their feet for up to twelve hours, increasing their chances of contracting work related musculoskeletal disorders. Work related musculoskeletal disorders contribute to 41% of all work related illnesses, 30% of all workers’ compensation costs, and can severely decrease an employee’s quality of life. This project aims to provide ergonomic support through standing anti-fatigue mats to these cleanroom workers before they begin to feel the physical consequences of their hard work. To integrate anti-fatigue mats into The Tech Group’s practices, engineering studies focusing on safety, cleanliness, degradation, and surface characteristics were analyzed. It is concluded in this study that the methods enclosed support the proper integration of anti-fatigue mats into a ISO14644 Class 8 medical device manufacturing environment at The Tech Group Phoenix.



James Kyeh

mentors: Dr. Mark Spano - SBHSE | Dr. Justin Ryan - Phoenix Children’s Hospital | Dr. Jeffrey LaBelle - SBHSE

Comminuted bone fractures typically require open surgical reconstruction with orthopedic surgeons entering the operating room with the notion that many surgical decisions will need to be made while operating. Increased operation times result in an increase in intraoperative and postoperative complications such as infection and longer recovery times. Current techniques towards planning for these surgeries consists of using a combination of X-ray images as well as using models segmented from 3D imaging methods such as CT or MRI scans. However, there are significant limitations present with these techniques such as the inability to manipulate models or derive analytical data. By utilizing novel 3D visualization methods, orthopedic surgeons are able to plan their operations in a manner more intuitive and similar to the actual procedures. This in turn is intended to decrease the amount of surgical decisions made in the operating room and decrease operating times.


Aldin Malkoc

mentors: Dr. Jeffrey Labelle - SBHSE | Dr. Curtiss B. Cook - Mayo Clinic Arizona

Development of a rapid and label-free Electrochemical Impedance Spectroscopy (EIS) biosensor for insulin detection based on sensitivity and accuracy was proposed to fill the technology gap between increasing diabetic control. Diabetes mellitus encompasses a series of chronic metabolic diseases characterized by inadequate glucose metabolism. Currently, diabetes management involves monitoring glucose levels daily, either discretely or continuously, and sometimes monitoring glycated hemoglobin (HbA1c) levels. Due to every facet of direct diabetes management primarily involves monitoring only glucose, there is an interest in whether insulin monitoring may improve management. These limitations were significantly improved upon by using EIS to detect insulin antigen. Immobilization of insulin antibody onto gold disk electrode produced statistically significance. With an alpha of <0.05 insulin EIS detection was able to detect antigen concentration at the physiological human range. Additionally, the lower limit of detection was 3.4 pM. These results show the potential for a transformative platform technology in both continuous detection and multimarker detection of insulin with insulin like growth factors and glucose. There is a high need for the technology to become multiplexed for high-throughput applications or quick diagnostic tests for medical purposes.



Susan Sajadi

mentors: Dr. Mark Spano - SBHSE | Dr. Justin Ryan – Phoenix Children’s Hospital | Dr. Jeff Labelle - SBHSE

Children on the wait list for heart transplant have the highest mortality rate in solid-organ transplantation medicine. Heart failure can occur from a variety of diseases, including cardiomyopathies, myocarditis, faulty heart valves and congenital heart defects (the most common birth defect). Heart failure is one of the most challenging and relevant pathophysiological syndromes in industrialized nations due to high mortality, morbidity, and cost. Many devices have been developed to combat these issues including ventricular assist devices and replacement heart valves. Visualizing these in 3D in relation to specific patient anatomy can be very useful in a surgeon’s assessment of the device. This project in partnership with Phoenix Children’s Hospital aims to expand this visualization and create tools to aid in surgical planning.




Chuquan Shang

mentors: Dr. Karmella Haynes - SBHSE | Dr. David Brafman - SBHSE | Dr. Xiao Wang - SBHSE

This research is a small part of a big project related to synthetic transcription factors (PcTFs engineering), which are constructed by human Polycomb chromatin protein and homologues from other species to reactivate silenced loci in human cells. Gal4-EED is a silencer in HEK293 cells which can mediate Polycomb chromatin formation at the GAL4TK-luc transgene (luc). The expression of this silencer can be activated by dox treatment, resulting in the repression of luc and the accumulation of H3K27me3 and Polycomb proteins at the promoter. The lab has built a novel synthetic activator called Gal4-mCh-VP64 that is composed of a Gal4 DNA-binding domain (Gal4DB), a red fluorescent mCherry tag, VP64, and an SV40 nuclear localization signal. However, the efficiency of mCherry expression was not as strong as we expected, possibly due to protein misfolding, which means only a few part of cells contain the transcription activator can be found under the fluorescence microscope. In order to improve fluorescence visibility, we will construct a new transcription activator with the mCherry positioned at the N-terminus, mCh-Gal4-VP64, in a BioBrick plasmid named V0120, to see whether it can achieve higher expression efficiency. If so, the lab will use the new activator instead of the previous one in the future research. And finally, we have to transform the mCh-Gal4-VP64 into a mammalian plasmid MV10 through BioBrick method for further experiments.



Ryan Sullivan

mentors: Dr. Jitendran Muthuswamy - SBHSE | Dr. Inder Raj S. Makin - ATSU-SOMA |

Dr. Thurmon Lockhart - SBHSE

The Summit Doppler Vista AVS is a system used in physiologic examinations by medical specialists to help diagnose detrimental conditions related to blood flow occlusion, such as peripheral arterial occlusive disease (PAD). This study describes the process of adapting LabVIEW software built for the Summit Doppler Vista AVS (used for long-term data acquisition), building and testing algorithms for heart rate and amplitude derivations, and helping create a lab aimed to optimize human-machine interaction and promote learning for first-year medical students at A.T. Still University, School of Osteopathic Medicine. Two different front-end configurations of LabVIEW software were designed. In both versions, the ability to record and analyze an arterial photoplethysmograph (PPG) and pulse volume recording (PVR) were created. Differences in the software designs were in regards to the front-end complexity and user interface. A final front-end configuration was developed through an iterative process by taking features from each configuration based on feedback from students and professors. Two unique algorithms for deriving heart rate from the PPG waveform were developed. An experiment was run on a volunteer in order to test the accuracy of these algorithms, which involved comparing data from each algorithm to an established method: A Biopac three-lead electrocardiogram (ECG) waveform. The data collected from this experiment showed that both algorithms, one frequency-based and one multiplication-based, each computed an average beats per minute (BPM) measurement within 2-3 BPM of the ECG signal with less than 4% error on average for each measurement. However, the frequency-based method was found to be more sensitive because it was not bound by multiples, which was an inherent drawback of the multiplication-based algorithm. Therefore, the frequency-based algorithm was integrated into the final software design. An installer, executable file, and laboratory protocol were developed and are ready for medical school students to use at A.T. Still University. The goal of the lab will be to ensure that medical school students have a strong foundation for hemodynamic waveform analysis and understand the techniques involved in assessing patients for conditions such as PAD.



Ashwin Sundar

mentors: Dr. Jeffrey La Belle - SBHSE | Dr. Mark Spano - SBHSE | Dr. Heather Ross - SFIS

Electrocardiography (ECG) data is often subject to frequency domain techniques, such as Fourier and wavelet analysis, in order to deconstruct and understand the relationship between cardiac disease and electrical activity in the heart. However, ECG artifacts are typically brief, making frequency domain analysis challenging. An alternate method of analysis, empirical mode decomposition (EMD), may be more appropriate for analyzing short windows of data, since data analysis never leaves the time domain. EMD was applied to more than 2,000 ECG waveforms spanning a range of subjects and arrhythmia types from the MIT-BIH Arrhythmia Database. Physician annotations were used to window and sort waveforms, and EMD was used to deconstruct waveforms into intrinsic mode functions (IMF). An average IMF for each arrhythmia and the healthy ECG waveform was calculated. IMFs from each arrhythmia were then compared with IMFs from healthy ECG data. This comparison can be thought to represent a unique signature of each arrhythmia type.



Derek Titus

mentors: Dr. James Abbas – SBHSE | Dr. Barbara Smith – SBHSE | Dr. Emma Frow – SBHSE & SFIS

Approximately 1.1 billion people in the world lack access to water and 2.7 billion suffer from water scarcities for at least one month each year (www.worldwildlife.org). Countries bordering the Mediterranean Sea are experiencing severe physical water shortages, thus causing those classified as ‘water poor’ to grow from 180 million to an expected 250 million within the next 20 years (www.eea.europa. eu). Solar distillation has been found to be effective at desalinating and purifying the prevalent supply of sea water within the region, but suffers from inefficiencies due to small basin surface areas present in distillation devices utilized. This project proposes the placement of


distillation attachments onto large basin infrastructures currently used as “evaporation ponds” for the production of sea salt. In this study, 3’ X 3’ representative models were produced and tested to optimize the water evaporation and collection in evaporation pond/distillation systems. This optimization was followed by a financial analysis of sea salt and water collection revenue streams to determine the economic viability of implementing solar distillation attachments into current evaporation ponds. If this and future work makes a strong economic case for this approach, companies in charge of these “evaporation ponds” may be willing to implement these attachments to help increase clean water supplies and reduce the imminent crisis affecting millions in the region..



Sai Mahathi Yasa

mentors: Dr. Thurmon Lockhart – SBHSE | Dr. Jeffrey La Belle – SBHSE | Dr. James Abbas – SBHSE

Falls are more common in older people than in young adults and are the leading cause of injuries among U.S. citizens. About onethird of the population who are above 65 years of age fall each year. CDC has quantified that an older adult is treated in hospital due to falls for every 11 seconds. Aging has a degrading influence on human gait and postural system. It has been found that there is a loss of complexity in movement due to aging. The complexity of an individual is closely related to the adaptability of that person, the more adaptive the system is, signals from that system become more complex. Perturbation training may be one method to increase the adaptability. In this research, we used the GRAIL system to induce perturbation training to the subjects. The GRAIL system was programmed using LUA programming language, the program enables the system to initiate random perturbations at gait events such as Heel Strike and Toe-off. The gait events are detected based on the weight threshold calculated using body weight of the person. A pilot data with 5-6 young adults will be collected. The complexity of the stride time intervals and postural sway parameters will be evaluated. MSE (Multi-Scale Entropy) will be calculated from the postural sway data to estimate the complexity. Results will be interpreted based on the data.


Zijie Yuan

mentors: Dr. Jianming Liang - SCIDSE | Dr. Rosalind Sadleir - SBHSE | Dr. James Abbas - SBHSE

Colon cancer is the second cancer killer in the US. Colonoscopy is the primary method for screening and prevention of colon cancer, but during colonoscopy, a significant number (25%) of polyps (precancerous abnormal growths inside of the colon) are missed; therefore, the goal of this research is to reduce the polyp miss-rate of colonoscopy. This project presents a method to detect polyp automatically in a colonoscopy video. Holistically-nested edge detection (HED) is a new-developed algorithm that is able to extract features hierarchically and give out the regions we are interested in. It is a powerful deep learning classification algorithm modified from convolutional neural networks (CNNs). A pre-trained VGG-16 Net model is chosen for network parameter initialization. Experimental data are all from real-time colonoscopy videos that contain polyps, from which 6196 frames are in the training stage and the rest 5317 frames are for testing stage. The results show a significant improvement on the system performance.


special recognition The BioAccel’s Solution Challenge is an annual medtech entrepreneur competition designed to better align market need, with innovation and early investment to stimulate company formation and commercialization. This program is Arizona’s first innovative competition designed to discover qualified local entrepreneurs with game-changing innovations that address identified challenges being faced by todays healthcare ecosystem. Our department would like to recognize and congratulate this year’s BME Capstone Semifinalsts in BioAccel’s 2016 Solutions Challenge! The teams include: Design Team 10: Brandon Bartels, Maria Jose Quezada, Haley Siverston, Ariana Moreno Development team of the StepPlus wearable technology for Parkinson’s patients Go to page 7 read more on their project Design Team 14: Hayden McIver, Sarah McBryan, Frederick Sebastian, Kandace Donaldson, Ross Carlton Development team for the Fishbone Prosthetic Go to page 8 to read more on their project Design Team 33: Kinjal Ahir, Matthew Devera, Sharon Gooi Development team for the Wrist-Based Pulse Oximeter Go to page 14 to read more on their project Design Team 39: Karthik Puncha, Andy Son, Akihiko Ishihara, Alex Baldwin Development team for the Assistive Shower Chair Go to page 16 read more on their project Please join us in wishing them the best in representing ASU BME Capstone at the upcoming Scorpion Pit competition on December 1st! We also thank all the BME Capstone teams who participated in this year’s BioAccel’s Solution Challenge preliminary selection process.

thank you

On behalf of the SBHSE Design Studio we would like to thank BME alumni, industry partners and mentors. We hope to continue our partnership and collaborations, as well as stay connected to our seniors to be part of what future may hold for them! 22

fueling innovation — building engineers “I strongly believe you cannot have a great city without a great school of engineering.” Ira A. Fulton