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Biomedical Engineering Symposium

Fall 2017

School of Biological and Health Systems Engineering SBHSE

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Table of Contents

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Welcome 4Acknowledgements 5

BME Capstone Projects

1. Viragel: An Adenovirus Delivery System for Treating Hepatocellular Carcinoma 6

2. Critical Care Compact IV Pump 6

3. NormaTherm: Surgical Patient Temperature Management System 6

4. Sleep Switch The Original Circadian Metronome™ 7

5. Enhanced Laminectomy Excision Device (ELED) 7

6. CryoRelease: Temperature Regulating Dynamic Splint for Spasticity Relief 8

7. Alzheimer’s Monitoring and Alert Wearable 8

8. ClariVision: Endoscopic Lens Self-Cleaning System 8

9. Cervical Collar With Detachable Jaw Piece 9

10. EsophaCool: A Thermoregulatory Device for the Monitoring and Cooling of the Esophagus

during Cardiac Ablation Procedures 9

11. Stethosound: A Combination Ultrasound Stethoscope Device 9

12. Ventriculoperitoneal Shunt Distal Catheter Retainment Device 10

13. Breast Microcalcification Biosensor 10

14. The Nitpick: A Micro-Machined Apparatus for the Treatment of Pediculosis 11

15. Wearable Blood Pressure Sensor Employed to Detect Preeclampsia 11

16. Optimization of a HDACi-Loaded PLA-PEG Nanoparticle for the Treatment of TBI 11

17. I-CON: Ocular Tracking Device for Traumatic Brain Injury 12

18. Outpatient Wearable Technologies: A Wearable Optical Sensor for Non-Invasive Respiration

Rate Monitoring 12

19. Integrated Bioinformatics for Orthopedic Braces 12

20. User-Centric, Modular-Component Dog Prosthesis 13

21. SpineAlign: Scoliosis Intraoperative Load Sensor 13

22. BRiCS: Cell Isolation and Addressing System 13

23. Adjustable Percutaneous Transluminal Angioplasty Balloon Catheter 14

24. Hydra Cell: Engineered Electroreceptive Cell for Brain Computer Interfacing 14

25. EndoViper: Upper Gastrointestinal Foreign Body Extractor 14

26. Mechanical Transtibial Prosthetic Device 15

27. Stroke Induced Hemiparesis Rehabilitation Device 15

28. A Locking Cap for Spine Fixation 16

29. CranioSure: Non-Invasive, ICP-Based Risk Assessment Device 16

30. Patient Warming System for Use in Spinal Surgery 16

31. Advanced Wound Reading Technology 17

32. Early Detection and Diagnosis Stent for Acute Myocardial Infarction . 17

33. Duodetect: Multi-Marker Sensor Capable of Simultaneous Detection of Insulin and Glucose

for Patients with Diabetes Mellitus 18

34. Positive Expiratory Pressure Device with Temporal Monitor 18

35. EZ Tilt: A Pediatric CT Head Holder Designed to Reduce Radiation Exposure 18

36. Transcutaneous Trigeminal Neurostimulator 19

37. Epidural Fibrosis Cutting Device 19

38. Wearable Range of Motion Measuring Device 19

39. Partial Weight Bearing Monitor for Physical Therapy Rehabilitation 20

40. Continuous Fall Monitoring and Prevention Stabilizing Exoskeleton 20

41. Wearable Maternity Support Belt With a Monitoring System 20

42. Breathe EZ - Motorized Controllable Intubation Stylet 21

43. Spinal Deviation Diagnostic System 21

44. PremaKare - Wireless Monitoring of Preterm and Low-Birth Weight Infants under Kangaroo Mother Care 22

45. Measureless Vision: Smart White Cane 22

Masters Applied Projects

1. Analysis of sEMG Data from Testing Participants Wearing a Soft Inflatable Exosuit on the Lower Limbs 23

2. Investigating the Neural Characteristics of Motor Learning in the Time-Frequency Domain 23

3. Continuous Wearable Health Monitoring Device to Reduce Hospital Readmission Rates 23

4. Impedance Mapping of an Ex-Vivo Rat Nerve 24

5. Improving Osteogenesis and Mineralization within Diabetic In Vitro Cell Culture Models 24

6. Development of an Automated Metabolomics Workflow to Achieve Omics Integration for

Molecular Phenotyping 24

7. Sex Implications on the Neuroinflammatory Response Resulting from Traumatic Brain Injury 25

8. The Effect of Perturbation Training on The Reorganization of Gait by Measure of Local Dynamic Stability 25

9. Do Clearing Agents Used in Decellularization Make a Difference in Adm Properties? 26

10. Gender Differences in Human Ankle Stiffness 26

11. Construction of an Artificial Bladder 27

12. Analysis of Current Quality Standards in Biomanufacturing of Specialized 3D Tissue and Organ

Systems to Evaluate the Technical and Economic Feasibility of Advanced Biomanufacturing Concepts 27

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WelcomeOn 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.

A testament to SBHSE’s entrepreneurial capacity building is the fury of recent successes of our biomedical engineering senior capstone design teams taking top honors in local (ASU New Venture Challenge), regional (BioAccel Solutions Challenge) and national (NIH DEBUT) design competitions, among others. Likewise, SBHSE is very pleased to welcome our newest global partner, Kwame Nkrumah University of Science and Technology (KNUST), in Kumasi, Ghana and five of their senior engineering students who joined this year’s biomedical engineering capstone design class. Please come join us, in celebrating the success of this year’s SBHSE students who have embarked upon this exciting and rewarding journey!

Marco Santello, PhDDirector, SBHSEHarrington Endowed Chair & Professor

Vincent Pizziconi, PhDFounder & Director SBHSE Design Studio

Biomedical Engineering Capstone Design & Masters Applied Project Instructors

James Abbas, Associate ProfessorBradley Greger, Associate Professor

Jeffrey Kleim, Associate ProfessorVincent Pizziconi, Associate Professor

Biomedical Engineering Faculty Advisory Design Group

Jerry Coursen, LecturerMichael Caplan, Associate ProfessorEmma Frow, Assistant ProfessorAntonio Garcia, ProfessorKarmella Haynes, Assistant Professor

Jeffrey Kleim, Associate Professor Jeffrey La Belle, Assistant ProfessorVincent Pizziconi, Associate ProfessorBarbara Smith, Assistant ProfessorMichael VanAuker, Lecturer

Capstone Teaching AssistantsChi-En Lin, MS CandidateCory Riecken, PhD Candidate

FacilitatorsHany Arafa, MS CandidateSamantha Brenna, MS CandidateDavid Probst, MS CandidateFrancis Taguinod, MS Candidate Nicholas Walker, Equipment Safety Assistant

Design Studio StaffMichael Sobrado, Lab Coordinator Sr.

Faculty and MentorsDr. James Abbas, Assoc. Professor, SBHSEMr. Abdulrahman Alshareef, CIDSEDr. Bruno Azeredo, Asst. Professor Polytechnic CampusDr. Dianna M.E. Bardo, Phoenix Childrens HospitalDr. Jennifer Blain-Christen, Assoc. Professor, SECEEDr. Michael Bohl, Barrow Neurological InstituteDr. Mitesh Borad, Mayo ClinicDr. David Brafman, Asst. Professor, SBHSEMr. Tedd Brandon, Faculty Assoc., SBHSEDr. Christopher Buneo, Assoc. Professor, SBHSEDr. Michael Caplan, Assoc. Professor, SBHSEDr. Jerry Coursen, Lecturer, SBHSEDr. Mo Ebrahimkhani, Asst. Professor, SBHSEDr. David Frakes, Assoc. Professor, SBHSE Dr. Emma Frow, Asst. Professor, SBHSEDr. Antonio Garcia, Professor, SBHSEDr. Matthew Green, Asst. Professor, SEMTEDr. Bradley Greger, Assoc. Professor, SBHSEDr. Karmella Haynes, Asst. Professor, SBHSEDr. Steve Helms Tillery, Assoc. Professor, SBHSE Dr. Claire Honeycutt, Asst. Professor, SBHSEDr. Tony Hu, Assoc. Professor, SBHSEDr. Samira Kiani, Asst. Professor, SBHSEDr. Jeff Kleim, Assoc. Professor, SBHSEDr. Stephanie Klocke, CR Bard, IncDr. Vikram Kodibagkar, Assoc. Professor, SBHSEDr. Tesfay Kubrom, T&T FabricationDr. Jeffrey La Belle, Asst. Professor, SBHSEDr Andrew Little, Barrow Neurological InstituteDr. Thurmon Lockhart, Professor, SBHSEDr. Steve Massia, Assoc. Professor, SBHSEDr. Michael Mooney, Barrow Neurological InstituteDr. Jit Muthuswamy, Assoc. Professor, SBHSEDr. Mehdi Nikkhah, Asst. Professor, SBHSEDr. Vincent Pizziconi, Assoc. Professor, SBHSEDr. Christopher Plaisier, Asst. Professor, SBHSEMs. Casey Rockwood, CR Bard, Inc

Dr. Rosalind Sadleir, Asst. Professor, SBHSEMr. Edgar Sanchez Garcia, CR Bard, IncDr. Marco Santello, Director & Professor, SBHSEDr. Sydney Schaefer, Asst. Professor, SBHSEDr. Sylvain Sidi, Banner Desert Medical CenterMr. Brandon Simmons, CR Bard, IncDr. Rachael Sirianni, Barrow Neurological Institute Dr. Barbara Smith, Asst. Professor, SBHSEDr. Aijaz Sofi, Arizona Center for Digestive HealthDr. Sarah Stabenfeldt, Assoc. Professor, SBHSEDr. Joel Strom, University of South Florida School of MedicineDr. Justin Tanner, Postdoc Research Asoc., SBHSEDr. Xiaojun Tian, Asst. Professor, SBHSEDr. Jamie Tyler, Assoc. Professor, SBHSEDr. Michael VanAuker, Lecturer, SBHSEDr. Brent Vernon, Assoc. Professor, SBHSEDr. Xiao Wang, Assoc. Professor, SBHSEMr. Ron Whiteside, Hanger

SBHSE Advising StaffLaura Hawes, Academic Success Specialist

Jessica Meeker, Academic Success Specialist, Sr.

Keli Palmer Greenhagen, Assistant Director, Academic Services

Elizabeth Tripodi, Academic Success Specialist

Robbie Runk, Academic Success Specialist

Kellie Speer, Student Services Coordinator Associate

SBHSE StaffTammera Cameron, Business Operations Specialist, Sr.

Mark DiStasi, Associate Director of Development

Debbi Howard, Business Relations Coordinator

Jessica Jensen, Business Operations Specialist

Jayson Johnson, Research Advancement Admin

Sean Jones, Research Advancement Admin Manager

Alana La Belle, Laboratory Manager

Sarah Matheus, Research Advancement Administrator

Elaine Miller, Executive Administrative Support Specialist

Solo Pyon, Systems Support Analyst

Michael Sobrado, Lab Coordinator, Sr.

Tomi St John, Business Operations Manager

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BME Capstone Projects

1: Viragel: An Adenovirus Delivery System for Treating Hepatocellular Carcinoma

Michael Nguyen, Aaron Raber, Gurpaul Sidhu

Mentors: Dr. Mitesh Borad - Mayo Clinic | Dr. Brent Vernon - SBHSE

Hepatocellular Carcinoma, or liver cancer, has several technological barriers that prevent many treatments from being effective. The tumor environment has an especially acidic environment, which results in many chemotherapy drugs not being able to exist at the tumor site. This, when coupled with the liver’s natural ability to break down drugs and the ability for tumors to develop resistances to chemotherapy results in such treatments being ineffective. Additionally, radiation therapy is seldom used due to the liver tissue’s intolerance to radiation damage. For this reason, genetically modified viruses are being researched as a method for treating liver tumors. Such treatments have the advantage of being able to specifically target the tumor cells, as well as being self replicating, resulting in only a relatively low dose being required. However, certain factors prevent this treatment from being effective as well. For one, due to the viral nature of the treatment, the immune system will be activated, resulting in the destruction of the viruses. Furthermore, the virus must be localized at the site to ensure that the treatment is as effctive as possible. Current methods of virus delivery do not allow for either of these main factors, as the primary delivery method involves the injection of the viruses in saline near the site. For this reason, a polymer based delivery vehicle is being developed to address these problems. Such a method would allow for both shielding from the immune system, as well as provide a release mechanism that would allow for sustained release of the virus. Our main target specifications include greater than 75% of the virus payload reaching the tumor and ALT levels less than 1500 in the body.

2: Critical Care Compact IV Pump

Itai Kreisler, Francisco Lopez, Abraham Rosengard

Mentor: Dr. Jitendran Muthuswamy – SBHSE

IV infusion has become the standard method for drug delivery. In many cases the rate at which the infusion is given is crucial for adequate treatment. Impoverished communities and third world countries often don’t have the resources to acquire this device. This often leads to nurses to use less reliable technologies for drug delivery, that may end up causing harm to the patient or even his or hers death. Another important issue to the adequate use of IV pumps is that with emerging technologies, experienced nurses feel less confident or are less likely to use new pumps. This often results in hospitals spending money on pumps that will rarely get used or adds to the training cost of each nurse.This is why the Maimonides Medical Management team has decided to create a compact, affordable alternative for the current IV infusions available in the market. Currently the team is looking at technologies that could drive the cost of IV pumps down. The main focus of the team is to provide low income communities and urgent care facilities with an infusion pump that’s easy to use, doesn’t require a pole, and can run on little power. The main customer the team has identified are nurses and caretakers. The secondary customer will be the patients who are treated by the pump and finally insurance companies who will decide whether or not they will reimburse hospitals and principal care facilities for buying our device. The pump will need to produce a maximum of 200ml/Hr, be able to modulate the flow within .01 ml of accuracy and keep a laminar flow.

3: NormaTherm: Surgical Patient Temperature Management System

Scott Boege, Kyle Lindley, Amanda Nguyen, Luc Tieu

Mentors: Dr. Michael Bohl - Barrow Neurological Institute | Dr. Matthew Green - SEMTE

During spinal surgeries, the combination of anesthesia and the large incision area causes tremendous heat loss in the patient. Hypothermia is a serious concern that can lead to various medical issues such as impaired wound healing and cardiac complications. Surgeons currently use forced-air devices: an inflatable drape is placed over the patient and warm air is blown through it. Problems include bulkiness, fragility, and patient contact with non-sterile air. NormaTherm is an incremental improvement to this device by using a resistive heating method to deliver heat to areas of high heat transfer efficiency to the patient’s core such as the neck, axillae, and groin. This allows for a more effective use of power without the use of non-sterile fluid convection. The device will be comprised of the heating unit with a user interface, display screen, and attachable heating pads. Patient temperature will be displayed with options of multiple heating levels. The warming unit will transfer energy to the heating pads and operate through a feedback mechanism to regulate the patient’s temperature. A heating element incorporated in the heating pads will provide

heat when placed on target areas. NormaTherm will have five reusable heating pads, each less than 4cm thick, and can be setup in less than a minute. It will have a lower profile than current devices, allowing for easier access to the site of the surgery. The primary customers for the NormaTherm are medical professionals. It is designed to be used in spinal surgeries, but future plans may include diversification into other procedures. The neurosurgery market, NormaTherm’s primary market segment, was valued at $8.7 billion nationally and $13 billion globally in 2016. This includes the use of surgical instruments in millions of spinal surgeries.

4: Sleep Switch The Original Circadian Metronome™

Alina Kilic, Taylor Little, Aleksandra Radchenko

Mentor: Dr. William Tyler - SBHSE

Imagine being able to go to sleep with the touch of a button on your smartphone. SleepSwitch intends to do just that to aid the 60 million Americans who suffer from chronic sleeplessness. [NW1] The current means to treat chronic sleeplessness are usually pharmaceutical, however these treatment options can cause drug dependencies as well as a buildup of tolerance. Other forms of treatments try to use a more therapeutic approach through the alteration of cognition and behaviors, however most find the course of treatment taking too long to get the results they desire causing customers to stray away from this treatment option. The concept that our team has developed is the essence of engineering innovation; set to produce groundbreaking results with those who struggle with maintaining the sleep-wake cycle. [NW2] The SleepSwitch works through the stimulation of the suprachiasmatic nucleus (the part of the brain which regulates the circadian rhythm), acting as a sort of a metronome for the sleep cycle. Using the SleepSwitch is as simple as shutting off a light as the device will be activated by one simple tap on the designated smartphone app which will be available across all major mobile platforms. The SleepSwitch will be designed to help the user fall asleep in 10 minutes or less[NW3] , lasting at least 6 hours to leave them well rested and refreshed. While some may seem weary at first about getting an implantation they will surely reconsider after finding how quickly the benefits of a good night’s sleep will outweigh the recovery time of the surgery. [NW4] The main target specifications of the product are a battery that lasts longer than 7 years, as well as working neurosurgeons to help hammer down a procedure which is safe, less than 4 hours long, and helps us with figuring out the correct current to stimulate the brain at (as it varies person to person).

5: Enhanced Laminectomy Excision Device (ELED)

Framarz Alam, Aron Lopez-Jimenez, Ethan Marschall, Ivanna Revel

Mentors: Dr. Michael Bohl - Barrow Neurological Institute | Dr. Jit Muthuswamy - SBHSE

Laminectomy procedures can be variable depending on the surgeon operating and the need of the patient. Currently, there can be multiple surgical tools that can be used to complete a laminectomy, which increases procedure time. Additionally, depending on the surgical tool used, there can be an increased risk of durotomies, most likely due to the lack of real-time feedback. Although experienced surgeons learn how to use tactile feedback, there is always an associated risk of durotomy, or spinal cord injury, as the tools get deeper into the spine. As one of the most common neurosurgical operations, there are about 13 million people each year who receive laminectomies to relieve back pain. And with approximately 3,689 neurosurgeons in the US throughout 5,700 hospitals, there is a large need for a simplified and safer alternative of performing a laminectomy. The approachable solution will have to have quick, efficient, and safe properties to meet all customer needs. The suggested approach is a single step lamina removal with the option of removing multiple lamina at once. This will allow for surgeons to still be in control of the procedure, but allow for a sustainable and efficient approach. Device features include: a sharp chisel (customizable depending on the length of the patient’s vertebra) and a stable mounting guide system. Top priorities are focused on creating a stable mechanism that provides maximal visibility and feedback to the surgeon. To comply with these needs, the clamps will be unobtrusively mounted on neighboring spinal process to create a larger surgical field. From the customer needs and product specifications, projected outcomes from ELED will yield results in terms of total procedure time, cycles till failure, and number of successful blade cuts on bone. These results will then determine the overall efficiency of the device and conclude whether the mission of the device is met. Further statistical analysis will validate the results obtained from testing and will solidify ELED’s capability to deliver an efficient procedure time and reduce the risk of durotomies, significantly.

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6: CryoRelease: Temperature Regulating Dynamic Splint for Spasticity Relief

Brandon Dorr, Cole Hunter, Chris Wiedeman

Mentor: Dr. Jeffrey Kleim - SBHSE

Muscle spasticity is a chronic condition in which affected muscles are constantly activated, leaving joints immobile. Because spasticity is a condition often resulting from neurodegenerative diseases, such as cerebral palsy, stroke, and multiple sclerosis, over 12 million people suffer from spasticity worldwide. Over half of post stroke-patients with spasticity develop contractures, or permanent shortening of muscles and tendons, because the condition is often left untreated. Furthermore, muscle spasticity greatly inhibits the effectiveness of physical therapy for neurodegenerative diseases, and while treatments exists, these current treatments are time-consuming, require in-person professional care, or carry adverse effects.

CryoRelease provides a novel approach to relieving spasticity by utilizing both cryotherapy and kinesiotherapy in a single automated device. Through a customer need analysis involving physical therapists and patients, the team behind CryoRelease determined that patients need a device that can relieve hand spasticity at home and directly before therapy sessions. The device must also be safe, easy to operate, and non-invasive. As a result CryoRelease is currently developing a wearable hand splint that can that both stretch and cool the hand to greatly reduce spasticity in under fifteen minutes of use. The efficacy of physical therapy is often tied to patient compliance outside of therapy, and the high rate of contractures shows the low compliance at the home. A simple product that can be used on a daily basis will not only decrease the rate of contractures in patients and increase the effectiveness of in-person therapy when used before sessions, but will also give these patients greater relief and independence.

7: Alzheimer’s Monitoring and Alert Wearable

Kyle Brague, Catherine Piatak, Marissa Seelhammer, Stacy Stoddard, Brittney Wong

Mentor: Dr. Jit Muthuswamy- SBHSE

Currently, there are only a few devices on the market intended to improve at-home care given to Alzheimer’s patients. Most devices currently marketed for Alzheimer’s patients only include GPS location or an emergency alert button pendant and are easily taken off or forgotten. Instead, caretakers are required to constantly supervise patients and purchase multiple medical devices to monitor biometrics manually. More than 5 million people in the United States alone are battling Alzheimer’s disease, and the prevalence of Alzheimer’s is expected to rise in coming years due to the aging population. These patients suffer from loss of autonomy, dignity, and higher risk of stroke or heart attack. Alzheimer’s and dementia patients as well as their caregivers need more freedom without risking the health or safety of the patient. The BOSCK team is aiming to develop a wearable monitoring and alert system according to best practices that will target this problem. This wellness device will be sold to the caregivers of geriatric patients that are suffering from Alzheimer’s and will enhance the lives of both the patient and the caregiver. The device will be made to improve caretakers’ peace of mind by providing them access to the health metrics and safety of the patient while providing a cost-effective solution for improving communication. Additionally, the device will be integrated into the everyday clothing of the patient to increase use. The target specifications will ensure the final product accurately communicates the patient’s heart rate and blood oxygen levels, and sends alerts of dangerous biometric abnormalities and falls detected directly to the caregiver.

8: ClariVision: Endoscopic Lens Self-Cleaning System

Patrick Conely, Reaghan Fletcher, Isaiah Gonzales, Alexandra Torres

Mentors: Andrew Little - Barrow Neurological Institute Michael Mooney - Barrow Neurological Institute Jit Muthuswamy - SBHSE

Current nasal endoscopes do not embody a self-cleaning system for the lens as debris and bodily fluids obstructs the user’s visualization. Typically, manual cleaning of the lens is the only effective method to improve visualization. The manual cleaning method is very time consuming and frustrating for users as it requires them to retract the endoscope in order to clean the lens. Other common mechanisms used to clean endoscopic lenses are irrigation systems, but users indicate that as these systems are effective they do not keep the lens continuously free from debris. ClariVision has been developed to improve visualization as well as decrease overall operating time. Primary customers for this device are neurosurgeons, otolaryngologists, and ophthalmologist as they typically perform nasal endoscopic surgeries in the operating room. There are 38,000 practicing surgeons and specialists that use nasal endoscopes within the United States. ClariVision is an attachment for existing endoscopes therefore hospitals do not have to

repurchase the device. Market expansion may take place, as the ClariVision attachment can be easily adapted to fit a wide range of endoscopes. Several design concepts have been carefully examined, these concepts include chemical and mechanical mechanisms. The favored design concept is a mechanical mechanism. The attachment itself is comprised of multiple components that work together to provide a continuously clear view inside the human body. The current design concept utilizes ultrasonic waves to disperse fluids and debris while keeping the integrity of the endoscopes field of view. The device also contains a vacuum system that removes bodily fluids without compromising the size of the device.

9: Cervical Collar with Detachable Jaw Piece

Danielle Beach, Sara Gubrud, Lauren Tuttle

Mentor: Dr. James Abbas - SBHSE

In emergency trauma situations, clearing and maintaining airway functionality is critical for positive patient outcomes. In patients with an injury to the cervical spine, cervical collar prevent secondary injuries by immobilizing the cervical spine. However, cervical collars can restrict medical personnel from performing other emergency medicine techniques. Currently, cervical collars have to be completely removed from the patient during intubation as the design does not allow the jaw to fully open. Removing the cervical collar is dangerous to the patient because the cervical spine is not immobilized, which increases the probability of the patient developing a secondary injury. It is our mission at SoLiD to support emergency medical professionals by improving the ease of use of the current cervical collar while reducing the risk to the patient. The market size consists of 5 million trauma patients a year requiring spinal immobilization. Currently, the concept that this team is proposing is to add a mechanism on the cervical that allows the jaw to open for intubation without compromising the structural integrity of the device. A component of the device below the jaw will be detachable, allowing the jaw to open. This detachable component will allow for the facilitation of life saving airway treatment while still providing immobilization of the cervical spine, as the cervical collar will not need to be taken off of the patient in order to perform intubation. Main target specifications for the final product will include that the cervical collar allow less than 2 degrees of lateral and vertical rotation, and that the detachable component allows the jaw to open 2 inches.

10: EsophaCool: A Thermoregulatory Device for the Monitoring and Cooling of the Esophagus during Cardiac Ablation Procedures

Fahhad Ashour, Sebastian Fonseca, Bakir Mousa, Jacob Packer

Mentors: Dr. Jitendran Muthuswamy – SBHSE | Dr. Tedd Brandon - SBHSE

Atrial Fibrillation (AF) is the most common type of heart arrhythmia in the Unites States, affecting at least 2.7 million people. Typified by an irregular or quivering heartbeat, AF is caused by an abnormal firing of conductive tissue in the upper chambers (or atria) of the heart, thereby disrupting the normal physiological circuitry of the heart. AF alone is classified more as a low risk medical condition rather than a life threatening disease, but is of high interest to cardiologists because of its link to various dangerous diseases and conditions. For example, patients are five times more likely to experience stroke when diagnosed with AF. One minimally invasive procedure used to correct AF is cardiac ablation. In this procedure, catheters (thin, wire-like devices) are inserted into the body, typically through the femoral vein. Using these catheters, the heart’s electrical signals are mapped, the problematic conducting tissue is located, and a specialized catheter is then used to introduce either extreme heat (radiofrequency ablation) or extreme cold (cryo-ablation) to the affected area. This ablation catheter typically creates scar tissue, disrupting the abnormal circuitry occurring in AF. A problem that arises in these surgeries is the increased risk of formation of fistulas, or abnormal passages, between the left atrium and esophagus, which when developed, results in death in nearly 70% of cases. These fistulas form due to necrosis (cell death) brought about by increased heat (or freezing, in the case of cryo-ablation) of the area from ablation. The EsophaCool Thermoregulatory system aims to accurately measure the temperature of the external esophageal wall during ablation and regulate temperature spikes caused by ablation. This thermoregulatory device would employ a controlled endothermic reaction to bring the temperature of the esophagus down to appropriate physiological levels.

11: Stethosound: A Combination Ultrasound Stethoscope Device

Spencer Cobb, Justin Mieth, Zachary Ticktin

Mentor: Dr. William Tyler - SBHSE

Traditionally, the stethoscope is the main tool used during a patient’s physical exam due to its cost-effectiveness and simplicity of design, allowing for vital organs to be monitored with ease. However, the stethoscope is not enough when a patient presents

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a potentially threatening condition, causing further diagnostics to be required. The ultrasound global market is expected to reach $6.86 billion by 2021 at an annual growth rate of 5.9%. However, the market is stepping away from traditional ultrasound machines. Currently, the market seeks cost-effective, reliable point of care ultrasound devices that are also easy to use and implement in a clinical setting to reduce wait times. The Stethosound addresses the market needs by providing a familiar and easy to use device that incorporates the simplistic nature of the stethoscope with the enhanced imaging diagnostic capabilities of point-of-care ultrasound. The device can quickly transition from auscultation during a physical exam to imaging the cardiovascular and pulmonary systems using B-mode and Doppler imaging. This allows the doctors to Primary customers of the device include primary health care providers, clinicians, and EMTs. The submarkets that this device addresses are medical schools and educational settings for student and instructor use. Further market expansion includes use within urgent care facilities and third world countries where traditional ultrasound devices are not commonly found or used. The mission of the Stethosound is to provide a device that can seamlessly transition between acoustic signal capturing and point of care ultrasonic imaging for fast and accurate diagnosis of various conditions while maintaining a low cost of use.

12: Ventriculoperitoneal Shunt Distal Catheter Retainment Device

Mohammad Alhusayni, Ryan Giudice, Karthik Nambiar, Gareth Palas

Mentors: Dr. James Abbas - SBHSE | Dr. Jennifer Blain-Christen - SECEE | Dr. Michael Bohl - Barrow Neurological Institute

A recurring issue which develops from the implantation of ventriculoperitoneal shunts is the distal catheter tubing that delivers cerebrospinal fluid to the abdominal cavity backs out of the peritoneal incision. This leads to the neurosurgeon having to carry out a revision surgery in order to place the distal catheter tubing into the abdominal cavity to prevent further issues which may be caused by cerebrospinal fluid penetrating other parts of the patient’s body. A potential solution to this problem is the attachment of a device to the catheter tubing that ensures it does not back out of the abdominal cavity while being designed to not further inhibit the patient’s ability to move freely without risk of shunt dislodgement. That solution is what the design team is in the process of developing. The primary customer for this type of device would be neurosurgeons that perform hydrocephalus shunt placement surgeries, as well as hospitals and other care facilities that perform ventriculoperitoneal shunt placement surgeries. Adult patients with hydrocephalus and receive the retainment device are also customers for the design team’s device. Another important customer in the market of the device are shunt manufacturer’s that may consider including the retainment device with future sales of their current shunt technology. The market segment for the device is centered around adults with hydrocephalus that received VP shunts. Around 700,000 adults in the United States have normal pressure hydrocephalus and if the device were adapted to be used in pediatric hydrocephalus, this market would increase exponentially. The concept the design team is creating would deploy upon entering the patient’s abdominal cavity and retract at the discretion of the neurosurgeon. This allows for unobstructed and efficient placement of the retainment device that would not inhibit shunt performance. The primary target specifications for the final product will include use in abdominal cavity pressures between 50-80 mm Hg and a Young’s Modulus tolerance of 20-25 kPa.

13: Breast Microcalcification Biosensor

Adam Grula, Shreya Ramkumar, Marvin Vergara, Robert Wen

Mentor: Dr. Michael Caplan - SBHSE | Ranjani Kumaran, CR Bard, Inc | Tyson Anderson, CR Bard, Inc

Microcalcifications are small deposits of calcium oxalate or hydroxyapatite that exist in differing patterns within breast tissue. These deposits can act as an early indicator for breast cancer. About one of eight women in the United States will develop invasive breast cancer during her lifetime. Adding to that, approximately 230,000 out of 290,000 new cases of breast cancer diagnosed each year end up as invasive. The current method used for microcalcification detection involves a mammogram of the breast followed by confirmation through a stereotactic biopsy and pathological analysis. The typical stereotactic biopsy procedure involves using low-dose X-ray images to locate the regions and take multiple biopsy samples for confirmation. In this procedure, the patient lies in a face down prone position with the breast compressed through a hole in a table. Typical procedures last between 30 and 45 minutes, while the patient lies in this uncomfortable position. Microcalcifications are not easily seen with ultrasound imaging, often considered the gold standard for breast biopsy imaging. An alternative solution to this problem is to develop a bioimpedance sensor for the detection of microcalcifications that can place patients in a more comfortable position during a biopsy procedure. Impedance measurement studies have been performed, but not in a clinical setting due to a low sensitivity and specificity. We are hoping to overcome this challenge with the development of a highly accurate impedance probe that can be used to improve the biopsy experience for the patient and physician. The customers for this product include interventional radiologists as well as patients with microcalcifications in their breast tissue. Our future work will include prototype improvement and verification/validation testing.

14: The Nitpick: A Micro-Machined Apparatus for the Treatment of Pediculosis

Michael Catchings, Kaylena Conklin, Robert Culibrk, Andre Nguyen

Mentor: Dr. Bruno Azeredo - Polytechnic Campus

According to the CDC, an estimated 6 -12 million people in the United States have lice each year, and over $400 million are spent annually on over the counter treatments. However, these treatments are becoming less effective because of the evolution of “super lice,” which are more resistant to these treatments. The current effective treatment methods are expensive, but have unfortunate side effects such as varying levels of dermal irritation and potential carcinogenic effects. New treatment methods on the market are often not covered by insurance, and are unavailable for low income families. The Nitpick offers an effective, single-step treatment method that takes less than 6 hours from start to finish to use. The device consists of 40-60 tines, spaced less than 400um apart with micro-abrasive regions between the teeth to better treat pediculosis at the microscale level without damaging hair or with any adverse side effects. Primary customers would be parents of children with pediculosis, while secondary customers include school nurses, pediatricians, and rural clinicians. Market expansion may include clinics in developing countries. As pediculosis affects predominantly children 3-11 years of age, and has a high degree of returning after treatment, The Nitpick provides an innovative, intuitive, single-step rapid treatment method for lice that reduces hand fatigue when compared to other similar devices on the present market. Hand held, comfortable, and reusable, The Nitpick caters to the needs of busy parents by treating lice faster.

15: Wearable Blood Pressure Sensor Employed to Detect Preeclampsia

Lexi Bounds, Megan McGuire, An Tran

Mentor: Dr. William Tyler – SBHSE

Preeclampsia (PE) is the third leading cause of maternal death worldwide and accounts for 5-8% of pregnancy-complications in the United States. PE is characterized by elevated blood pressure, abnormal kidney tests, low platelet count, liver abnormalities, and pulmonary edema. If left untreated, the condition can progress to Hemolysis Elevated Liver Enzymes Low Platelets Counts (HELLP) syndrome and can lead to the onset of eclampsia, or convulsions during labor. The exact mechanisms underlying the pathology remain unknown, with delivery of the child and placenta the only available treatment method. Thus, it is critical to develop an accurate and reliable diagnostic tool to detect preeclampsia before the condition progresses in severity. The goal of this biomedical device is to provide an early detection method essential to improving prenatal health outcomes for pregnant women while supplying clinical professionals additional tools in maternal care. We aim to develop a wearable blood pressure monitoring device, supplemented with a smart phone application, capable of (i) recording prenatal metrics at specified time intervals, (ii) transmitting the measurements to the user’s smart phone or tablet, and (iii) exporting patient medical files to clinical personnel. Specifically, the device will measure blood pressure and heart rate using LEDs to obtain ECG and photoplethysmogram signals. Future work includes developing algorithms for signal processing, validating the accuracy and sensitivity of the measurement method, and generating prototypes of the device.

16: Optimization of a HDACi-Loaded PLA-PEG Nanoparticle for the Treatment of TBI

Peter Hillebrand, Ethan Mathew, Gergey Mousa

Mentors: Dr. Sarah Stabenfeldt - SBHSE | Dr. Rachael Sirianni - Barrow Neurological Institute

Over 3 million people per year in the U.S. suffer from traumatic brain injuries (TBIs). Additionally, TBI plays a role in roughly 30% of all injury deaths annually. Current treatments alleviate secondary physiological symptoms from TBI and do not address underlying pathological mediators of neuropathology. One approach to combatting this is through epigenetic modifications that have the potential to aid in neurological recovery. Our team aims to evaluate and optimize a quisinostat-loaded, histone deacetylase inhibiting (HDACi) nanoparticle to treat TBI. The primary customers for this device will be hospitals and neurotrauma experts. The market segment for this product would be sizable considering TBI patients currently have minimal treatment options available and the market size will be substantial since there are over 3 million TBI patients per year in the U.S. alone. The current concept task is to optimize existing HDACi-loaded nanoparticles for TBI using a small animal pre-clinical model; this nanoparticle system was previously developed by Dr. Rachael Sirianni for glioblastoma applications. The nanoparticle will be injected systemically, cross the transient break in the blood-brain barrier, and passively accumulate within the injury penumbra of a contused brain. The efficacy of the nanoparticle at various concentrations will be evaluated by measuring HDAC activity at the injury site post-administration using immunohistochemistry. The dosages of the nanoparticles tested will be informed by a mathematical model simulating the endogenous neural environment. Further, the efficacy will be evaluated through a biodistribution/pharmacokinetic assay involving mass spectroscopy of various tissues at a range of time points post-administration. The primary target specifications for the final product will be a 30% increase in histone acetylation in the brain as compared to a control at 24 hours post-administration and a 90% decrease in the systemic concentration of the nanoparticles between the 1 hour and 5 day time points post-administration.

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17: I-CON: Ocular Tracking Device for Traumatic Brain Injury

Michael Bejarano, Sara Belko, Christina Monteilh, David Shumate

Mentors: Dr. Jennifer Blain-Christen – SECEE | Dr. Sydney Schaefer - SBHSE

Currently, traumatic brain injury (TBI) is the leading cause of death and disability worldwide with approximately 1.7 million people sustaining a TBI annually. As the United States spends 48.3 million dollars per year on hospitalization and deaths related to TBI, the need for a consistent and effective measure for TBI is apparent. Current techniques to diagnose TBI and concussions includes the Sport Concussion Assessment Tool (SCAT), the Bess balance assessment, the ImPACT assessment, and the King Devick test. The current standards encompass many areas of interest for diagnosing TBI including neurocognitive, eye, balance, and memory. However, problems with the current techniques include lengthy examination time, expensive operations, and subjective interpretations by primary health care providers. TBI diagnosis is also primarily dependent on the patient’s verbal feedback, which can be subjective. Current standard clinical eye tests include horizontal and vertical saccades, horizontal and vertical vestibulo-ocular reflex, convergence, reverse convergence, pupil dilation, smooth pursuit, and gaze holding. The I-CON solution will create a standardized way to track the eyes to assist in diagnosing TBI by automating the standard eye tests and interpreting the results quantitatively. The I-CON solution is an ocular encapsulated recording device that will incorporate an LED system to simulate the current clinical eye tests and two cameras, one for each eye, to track movement and pupil dilation. All video images will be sent via Bluetooth to an iOS application where image processing will proceed to compare the velocities and magnitudes between pupil dilations to a baseline reading. Main target specifications for the product will include accuracy on recording eye movement, run time of fifteen seconds per test, and a battery life of four hours. This device will be advertised to the market segments of athletics and emergency departments with the customer being primary care providers and healthcare professionals.

18: Outpatient Wearable Technologies: A Wearable Optical Sensor for Non-Invasive Respiration Rate Monitoring

Bryce Gonzales, Mohammed Almaimani, Zach Fisher

Mentor: Dr. Jeffrey La Belle - SBHSE

Outpatient Wearable Technologies is introducing a new wearable device for users to accurately monitor their respiration rate from at home. Patients suffering with COPD, congestive heart failure, and pneumonia account for the highest rate of hospital readmissions within thirty days. Health organization’s quality in the United States are measured by the rate of readmission. A health organization with a lower readmission rate will be rated higher on a quality scale, whereas a health organization with a higher readmission rate will be rated lower on a quality scale. We are focusing on readmission within the first thirty days after the patient is discharged from these health organizations. We plan on selling these devices to health organizations to distribute to patients for home monitoring purposes. Our market size includes about 3.3 million patients. The multiaxial continuous respiration rate monitor utilizes a computer mouse optical sensor that tracks and records the movement of lungs. Through this, the device is able to monitor breathing rate and volume. The intended purpose of our device is to assist health organizations to reduce readmission rates by maintaining constant monitoring of the patient after discharge. The multiaxial optical continuous respiration rate monitor is a basic optical sensor based device that tracks the movement of lungs. The sensor is programmed to translate the lung’s movement into respiratory rate. By keeping constant attention on respiration rate, health organizations can identify possible issues with a patient outside of the hospital before their issue becomes critical. In conclusion, continuous monitoring to respiration rate will aid health organizations and discharged patients to keep track of their health and be identified of health events before it is too late.

19: Integrated Bioinformatics for Orthopedic Braces

Riley Baranek, Andrew Carlson, Jordan Shinn

Mentors: Dr. Michael Bohl - Barrow Neurological Institute |

Dr. Michael VanAuker - SBHSE | Ron Whiteside - Hanger

Millions of people use orthopedic braces each year, yet compliance is exceptionally low. This lack of compliance makes it difficult for physicians to determine if their treatment plan is working. When patients do not comply to their treatment plan, their recovery takes longer and is less effective. One reason for low compliance is that patients are overestimating how long they are wearing their brace by up to 150%. In addition, while some patients may be using their brace, they are not always wearing them in the correct manner. Our teams goal is to instill digital vigilance by creating a bioinformatics/compliance monitoring system comprised of various temperature and pressure sensors, as well as a display. This device will track how often the patients are wearing their brace, and if they are wearing it correctly. The compliance data will be displayed on a screen for the patients viewing, and be sent in real time to the patient’s physician via an app. Improving comfort is another avenue to aid in increased compliance. Thus, the design is modular and will allow for outputs to fans in order to reduce the heat felt by these braces. Important product specifications for our final

design include an app update time of 10 minutes or less and a battery life of at least 20 hours. Our device can be incorporated into any orthopedic brace, therefore our market segment will be global orthopedic braces and supports; which has been valued at $3.76 billion as of 2017. With the key customers within the segment being brace fabricators and prescribing orthopedic physicians. This product supports the quality based outcome models insurance companies and hospitals have adopted; therefore, they would also benefit from this design.

20: User-Centric, Modular-Component Dog Prosthesis

Bjorn Houman, Jacob Irwin, Rachel Ponstein

Mentor: Dr. Sydney Schaefer - SBHSE

Veterinary medicine has been making the change from surgery-centric treatment to the more common use of pet prosthesis, and with that there has been a shift from full-limb amputation to amputation with prosthetic candidacy in mind. The use of a prosthetic allows animals to treat injuries or maintain a standard quality of life without the use of invasive surgical procedures. Unfortunately, there are very few dedicated pet prosthetists in the US and the process of custom prosthetic fabrication often excludes face-to-face interactions leading to device discrepancy. The goal of the MediPaw Pet Prosthetic is to create a user-centric design that allows for the replacement of the modular components to accommodate the dog’s needs. To achieve this, gait analysis is being performed to determine the relationship between the foot shape and the elbow angle per gait cycle for dogs with and without prosthetics. This analysis will be used to compare the natural gait cycle of an uninjured dog to that of a dog using the MediPaw Pet Prosthetic with the intention to create a natural gait cycle. This data analysis and the utilization of mathematical models will allow the creation of a device that the animal can comfortably wear, and the owners can easily modulate to fit the animal’s needs. The expected results will show that the design of the prosthetic will allow for easy modulation intended for the treatment of animals with varied amputation sites. This design will allow owners to replace heavily worn parts with new ones, without the inconvenience of shipping the prosthetic back to a busy prosthetist (forcing the animal to go without during this time). This user-centric, modular-component dog prosthetic will ensure that the animal has natural gait and is comfortable and safe when wearing the prosthetic for extended periods of time while performing standard tasks.

21: SpineAlign: Scoliosis Intraoperative Load Sensor

Priscilla Hernandez, Jinglin Liu, Amanda Smith, Megan Wieser

Mentor: Dr. Jeffrey LaBelle - SBHSE

Current methods and technologies in adolescent idiopathic scoliosis surgeries, or AIS surgeries, do not provide accurate, validated measurements of spine parameters. One approach that can be used to solve this problem is creating an intraoperative instrument that can measure the load distribution in the thoracolumbar section of the spine, the most common location for abnormal curvature. Our team’s objective is to create an intraoperative sensor that can translate contact forces into a load display. This will provide surgeons and researchers with a quantitative way to measure the load instead of having the surgeons rely entirely on visual inspection and intuition. The primary customer for our device are AIS surgeons since they will be the people that use the device. The market segment for this device would be the surgical instruments segment, which is a large segment for medical devices due to the need of making procedures easier for doctors. There are about 29,000 AIS surgeries performed per year, each costing approximately $92,000. The main specification of our product is to numerically measure load in the thoracolumbar region with 5% error, which will potentially reduce the number of follow-up surgeries.

22: BRiCS: Cell Isolation and Addressing System

Calvin Baumgartner, Srekar Nagishetty, Rob Schultz, Brianna Steele

Mentor: Dr. Christopher Plaisier – SBHSE

Wider application of single-cell (SC) analysis has been limited by the lack of an easy-to-use and low-cost strategy for SC isolation that can be directly coupled to SC sequencing and SC cultivation. Current SC RNA preparation technologies are expensive to use because of highly-priced, one-time-use reagents. Highly-integrated systems present a high cost-barrier to entry for new labs looking to incorporate the technology. A convenient and flexible platform which can isolate single cells with high efficiency and is compatible with conventional protocols and instrumentation for downstream analyses (i.e. quantitative PCR or genomic sequencing on sc level) is highly desired. The conceptualized device hopes to tackle the high-cost barrier to entry by developing a flexible low-cost system, considerably speeding up and simplifying the task of isolating SCs. The market segments for this product are genomic research and cell/tissue research, which is a growing industry due to increased demand for targeted personalized medicine. BRiCS

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will be marketed to an overall customer base of 3 million researchers working on cell and tissue research in the world. The device will also add value to data acquired from its use by eliminating ambiguous and confusing data points, known as collisions. The technical specifications of the device will involve a pneumatic binary addressing system which will individually address cells through a microcomputer. This addressing system will create a spatial control of the cells to be delivered to specified wells of a microtiter plate. BRiCS will further tackle the issue of ambiguous data points during sequencing by eliminating cell doublets (cell-cell adherent complexes) through acoustophoretic cell filtering. Main target specifications for this device will involve a sample throughput (flow rate) of 5mL/hr through the system and will maintain an internal flow pressure under 0.25 Pa (to prevent cell lysis).

23: Adjustable Percutaneous Transluminal Angioplasty Balloon Catheter

Priscilla Delgado, Peter Haist, Alex Kirk, Devon Rusk, Ian Sanders

Mentors: Dr. Michael Caplan - SBHSE | Edgar Sanchez Garcia – CR Bard, Inc | Stephanie Klocke – CR Bard, Inc | Casey Rockwood – CR Bard, Inc | Brandon Simmons - CR Bard, Inc

Balloon catheters have a wide range of applications for various different heart diseases and conditions to open up multiple different vessels that have experienced some sort of obstruction or constriction to blood flow. Because of the balloon catheter’s diversity, there are currently various different codes for balloon catheters with varying lengths of the sheath and lengths and diameters for the balloon itself. A major problem from this stems from the user having to have various balloon catheters always in stock to be able to have any scenario that the user might need covered, or the consumer not having the right size to perfectly fit the vessel. Our team aims to cut down on the stock that the consumer would have to keep by creating an adjustable balloon catheter. The primary consumer for this device will be cardiologists who regularly perform balloon angioplasty procedures at various different hospitals, clinics and private practices. The market segment for this product is very large with it encompassing many patients who have some sort of heart condition, as constriction of blood flow is a side effect. The market consists of roughly 4.6 million cases each year with some sort of atherosclerosis, and the market is projected to grow to $3.4 billion by 2022. The main target specifications that the final product will include is a burst pressure for the balloon of up to 40 ATM, and a length for the shaft that can go from 50-200 cm.

24: Hydra Cell: Engineered Electroreceptive Cell for Brain Computer Interfacing

Jeremy Ellis, Joshua Hislop, Morgan Johnson, Abigail Rene

Mentor: Dr. Mo Ebrahimkhani - SBHSE

Improving interface between the nervous system of the human body and the electronic devices of modern medicine is an emerging goal of professionals and manufacturers in the field of neuroengineering. The progress of this field is hindered by flaws that are common to most, if not all, brain-computer interface devices on the market today. These problems include high noise, high dimensionality of data collected and the restriction of many major neuron-interaction devices, such as patch clamps, to in vitro functionality only. The neurological medical device manufacturers and entertainment device developers both have significant demand for the next generation of brain-computer interface; the market size for these devices is expected to reach $1.23 billion by the year 2024. The Hydra Cell is a neuron that has been engineered to produce a pair of membrane proteins traditionally found in marine animals such a sharks and rays. These proteins will make these neurons both receptive to and able to produce electric fields. These cells, in combination with a field generation device to communicate with them, will allow electronic devices to interact directly with the nervous system. These communications will be done with localized electric fields with energies on the order of 1 mV/cm in order to facilitate communication. HydraCell will allow the sending and receiving of signals to and from the body on a cell-to-cell basis, improving resolution and reducing noise associated with traditional interface electrodes. Additionally, these engineered cells will be useful beyond the lab setting. An individual’s native neurons can be non-permanently modified to carry the genes necessary to function in an electroreceptive capacity, resulting in a device that is highly biocompatible as well as functional.

25: EndoViper: Upper Gastrointestinal Foreign Body Extractor

Justin Blommer, Erik Drager, Christopher Pina, Krystal Schmitt

Mentors: Dr. Barbara Smith – SBHSE | Dr. Sylvain Sidi – Banner Desert Medical Center |

Dr. Aijaz Sofi – Arizona Center for Digestive Health

Current limitations of gastrointestinal foreign body extraction devices cause the removal of esophageal food impactions to take 30-90 minutes and involve upwards of 9 devices. Gastroenterologists must remove food bolus impactions from the esophagus

through the mouth with an endoscope and extraction devices. These devices often cause shredding of food material, require multiple passes down the scope, and increase overall procedure time. This increases the risk of pulmonary aspiration (material falling into the lungs), compromised airway, and perforation of the esophagus. The estimated annual rate of occurrence of esophageal food bolus impactions is 13 cases per 100,000 people (GIE, 2016). Common causes of food obstructions include eosinophilic esophagitis, strictures of the esophagus, and diffused motor abnormalities of the esophagus. Our product development team, JECK Medical, is developing the EndoViper upper gastrointestinal foreign body extraction device. EndoViper provides an innovative solution to esophageal food bolus impactions using industry best practices and quality systems. The device is a one-time use, disposable, three-pronged 24 mm diameter grasper featuring a security net, lasso-closing mechanism, 200 cm long catheter, and control handle. EndoViper is being developed with product specifications that are responsive to the needs of gastrointestinal healthcare staff and their patients. The device will provide a safer and more efficient method for food bolus extraction, providing procedure time savings, and faster procedure room turnover. EndoViper will also reduce average labor costs, duration of anesthesia, and decrease the risk of complications. Our team will continue development this spring with a working prototype of the EndoViper.

26: Mechanical Transtibial Prosthetic Device

Lauren Britton, Sarah Fakhoury, Ladan Kamali Sarvestani, Christina Salas

Mentor: Dr. Thurmon Lockhart - SBHSE

Transtibial amputees commonly experience joint pain and muscle fatigue caused by overcompensating with their remaining limb in order to stay comfortable while using their prosthetic device. There are many micro-controlled motorized prosthetic devices currently on the market, however, these devices are very expensive and require high maintenance over time. Current motorized devices are also known to be too heavy and have a slow reaction time during gait. Globally, the prosthetic market is worth $1.62 billion, and is expected to grow to $2.63 billion by the year 2026. Below knee amputations (BKA) are the most common type and account for about 50% of amputations, with 2 million transtibial amputees alone in the United States. This number is expected to increase by roughly 185,000 annually and Pro-Step aims to contain 3% of the total market segment. The Pro-Step team is currently developing a transtibial prosthetic device capable of providing postural stability using a cost effective mechanical device rather than an expensive micro-controlled device. The product under development uses a carbon fiber body in conjunction with mechanical joints in order to mimic natural gait movement, while providing structural stability. The prosthetic device will remain lightweight, with a target maximum product weight of 1.5 kilograms, and will be able to support users weighing up to 200 pounds. Lastly, the device aims to provide 90% efficiency for energy absorbance and return to help reduce the user’s fatigue and musculoskeletal strain during normal everyday activities. Pro-Step hopes to help transtibial amputees feel comfortable and confident, and overall, return a sense of independence to them.

27: Stroke Induced Hemiparesis Rehabilitation Device

Polette Avila, Lemlem Brook, Christopher Saar

Mentors: Dr. Jeff Kleim – SBHSE | Jitendran Muthuswamy - SBHSE

Currently, there are no cost-effective links between clinical rehabilitation for ischemic stroke hemiparesis and home rehabilitation. Patients that suffer motor function disorders due to a stroke event require immediate rehabilitation therapy to take full advantage of regaining some functionality of their impaired extremity. The process of repair is known as neuroplasticity, it is our brain’s natural ability to conform to change and is fundamental in stroke recovery. In order to increase neuroplasticity, research has shown that patients need to have an increase in rehabilitation programing for repetition and quality movement. Spending on stroke rehabilitation has been estimated at around $12,000 per patient annually, the U.S. spends approximately $34 billion per year on a population that has around 710,000 strokes per year. Our market segment would primarily be patients that are 65 and older who have had a stroke that affected their upper extremity, however there is additional expansion into traumatic brain injury, Multiple Sclerosis, and Cerebral Palsy. Currently, stroke rehab devices fall into two categories; one group is assistive in nature using rubber bands, springs or direct electrical current to assist movement. These types bypass the brain’s role in movement and do not help increase recovery through neuroplasticity. The second group of devices are more precision based, using desk mounted systems or large supporting devices with computer software to induce quality repetition. These devices are a stand-alone system that are expensive, non-portable, and are divorced from occupational therapy practice as a continuum of overall care. Our device will employ a wearable design that can be used to measure, count quality movement of the hand/wrist, provide feedback to the patient in their home using inputs set by the occupational therapist, and record data that can be displayed to show the patient’s rehab progression over time.

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28: A Locking Cap For Spine Fixation

Measho Habtemichael, Afshin Isadvestar, Alireza Momeni, Nava Nozari, Mahoro Uwiringiyimana

Mentors: Dr. Vincent Pizziconi - SBHSE | Dr. Michael Bohl - Barrow Neurological Institute & Eng Tesfay Kubrom - T&T Fabrication

Spine problems are caused by various complications such as Degenerative Disc Disease, Spondylolisthesis, Scoliosis, Spinal Tumors, and Spinal Cord Trauma. Patients with such problems have difficulties moving their bodies. Current solutions include Artificial Disc Replacement, Spinal Fusion and Spinal Instrumentation; all of which aim at stabilizing the spine and reduce the pain. Spinal Instrumentation is one of the common methods to treat spine instability and it uses different sizes and shapes of rods, screws, and locking caps to attach the different damaged parts of the spine together. Barrows Neurological Institute (BNI) uses this method to treat patients with spine problems and while they have had success with the procedure, surgeons report cases of patients who’ve had to undergo the procedure again due to the loosening of the cap screws caused by the force applied on the screws and over time. With this in mind, the team is developing a model of the locking cap that will not only withstand the friction; force and movement on the device, but it will also stay fixed on the rod; preventing the loosening of the cap screws. The primary customers will be the hospitals and neurological centers like BNI as well as the patients with spinal cord problems. The market segment is large as it includes people with spine problems such as Degenerative Disc Disease, Spondylolisthesis, Scoliosis, Spinal Tumors, and Spinal Cord Trauma. This means that our solutions could highly impact our market size of over 17 000 cases of spine problem each year. Our current concept includes a twist-lock mechanism that connects locking caps and pedicle screws together. This solution significantly reduces the chance of cap screw failure, and it helps to fix the rod that passes through pedicle screws by using a lock and key effect.

29: CranioSure: Non-Invasive, ICP Based Risk Assessment Device

Blake Bosold, Ryan Hess, Victor Huerta, Erik Parkhurst

Mentor: Dr. William Tyler - SBHSE

Intracranial pressure (ICP) is the pressure within the skull that can be harmful to the brain when elevated. This biometric is elevated after insidious head trauma, such as concussions, and a symptom of certain medical conditions, such as hydrocephalus. Currently, ICP can only be measured invasively with devices that require a craniotomy to be placed. The use of these devices is associated with a high level of risk between the placement process and increased risk of infection, and there are many restrictions on device usage because of these risks. Our group hopes to create a non-invasive intracranial pressure risk assessment device to reduce risk and improve accessibility of this potentially life-saving biometric. Customers for this device are physicians specializing in neurology, such as neurosurgeons, as well as sports medicine professionals working with contact sports such as football. Neurosurgeons are typically those that use invasive ICP monitors, so they would be obvious users of a more convenient and less risky option than those existing. Additionally, our group hopes to expand this technology to athletics where head trauma is anticipated to improve risk assessment measures on the sidelines and better protect players at risk. The market segment for this device will include collegiate and professional athletics where risk of head injury is high throughout the course of play. This may include football, hockey, soccer, auto sports, and rugby, among others. Therefore, the expected market size between neurologists and all high-contact, high-risk professional and collegiate athletic programs is nearly 100,000 customers annually. Our device will feature a displacement measurement device, likely in the form of a pair of calipers, with a force sensor mounted on the tip of each. This device and controlling hardware will also feature an accelerometer that can be hung or clipped to a bed to measure tilt and an iPhone app user interface. The device must have a resolution of 1mmHg and a range of -10 to 60mmHg. The measurement device will have a resolution of 0.01mm and be able to measure up to 12 inches. The force sensor must have a resolution of 0.1N and the accelerometer must have a resolution of 0.1 degrees. Finally, the electrical components of the device must consume less than 0.1KWh of power at peak operating capacity to preserve an operational battery life of 8 hours at minimum.

30: Patient Warming System for use in Spinal Surgery

Prince Ampofo, Pritish Char, Andrew Liu, Ferrin Thomas

Mentors: Dr. Michael Bohl – Barrow Neurological Institute | Dr. Jitendran Muthuswamy – SBHSE

Patients lose a lot of heat during spinal surgery primarily due to the ambient temperature of the operating room, loss of heat through the incision area, and the effect of anesthetics. This is not suitable because a deviation from normothermia, a core body temperature of 36-38oC, leads to increased risk of infections, which results in longer hospital stays and increased health bills. The current

strategy for patient warming involves passing warm air through tubes that go around the patient. These tubes cause an extended depth of field for the neurosurgeon and the use of forced air disturbs the laminar flow of air in the OR. Furthermore, the control unit of such systems is noisy and takes up a lot of space which is a pain for the anesthesiologist and other surgical staff. Our project will generate heat for patient warming by passing current through resistive nichrome wires. In addition, our system will maintain normothermia using a closed-loop feedback system. This approach will not only minimize the obtrusiveness and infection risk that is posed by the existing blankets, but also allow the anesthesiologist to precisely maintain a patient’s core body temperature. Main target specifications for the patient warming system includes the temperature probe measuring core temperature to be accurate to ±0.1°C and the warming blanket having a thickness of 0.9 in and capable of maintaining core temperature to about 0.1°C accuracy. Our system will connect to a wall outlet providing voltage of 120V and the input current to the resistive wires will range between 5A to 12A. The market for patient warming is estimated to be valued at $4.6 billion by 2025. Each year, patient warming devices are used to maintain normothermia for more than 25 million patients.

31: Advanced Wound Reading Technology

Brady Dennison, Virginia Fernandez, Theodore Kyriacou

Mentor: Dr. Vikram Kodigbakar - SBHSE

In the world today surgeries are common and frequently fraught with infection and other difficulties. One of the main difficulties is tracking their progress toward recovery after they leave a clinical environment. Currently, there is no standardized continuous monitoring methods in place to detect infected wounds after a surgery. Currently, the patient has an in person visit to the family physician 2 weeks later, which in that time many serious complications can arise. Once an undetected infection takes root, this can be the cause of additional surgery, removal of medical devices, and longer recovery times. Our goal is to develop an application that actively tracks and assesses the risk associated with a wound, providing an early warning system to reduce risk and harm to patients.The primary customer is doctors monitoring post-op patients and the patients themselves, lowering the risk of infection or other complications. Since this product can be used for any surgery, our market segment is in the tens of millions of people a year.

Our idea is to create an app that can track wound healing using a smartphone. This will be done by taking pictures using the smartphone camera and sending them to the physician for evaluation. The app will also detect color and wound size to monitor infection and wound healing, allowing for an easier diagnosis.

32: Early Detection and Diagnosis Stent for Acute Myocardial Infarction

Joseph Florio, Khalil Khoury, Diego Reyes, Timothy Snelling

Mentors: Dr. Michael VanAuker - SBHSE | Dr. Antonio Garcia - SBHSE | Dr. Joel Strom - University of South Florida School of Medicine

In the United States 48% of all hospital readmissions are due to heart related conditions such as congestive heart failure or cardiac dysrhythmias. As a result of high readmission rates for cardiac related episodes and the Affordable Care Act (Obamacare), hospitals are no longer being reimbursed by health insurance corporations for their care and treatment for these cases. Thus, the problem lies in the treatment and early diagnosis of such cases to enable proper treatment as soon as the cardiac episode occurs. Our team aims to develop a stent device that will detect biomarkers that indicate plaque rupture, and cross reference that information with the blood pressure through the coronary artery to predict the early onset of an acute myocardial infarction. In doing so, first responders, physicians, and other healthcare providers can properly treat the patient before the episode occurs, lowering the probability of life threatening complications. The market for this predictive device will encapsulate high risk congenital, elderly, and obese individuals; as well as diabetic patients. According to the CDC nearly 713,000 people have a heart attack every year, and 210,000 of these individuals are readmitted heart attack patients. These statistics show a need for a device that can provide early detection and diagnosis of an acute myocardial infarction which will cut costs, increase reimbursement to hospitals, and increase the quality of life for at-risk patients. Currently the concept will take form in a normal stent with the circuitry for the biomarker detection and flow rate analysis incorporated within the mesh of the stent. Dimensions of the stent will rival the dimensions of regular stents in order to keep the implantation process consistent with general surgeon practices.

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33: Duodetect: Multi-Marker Sensor Capable of Simultaneous Detection of Insulin And Glucose for Patients with Diabetes Mellitus

Meredith Bothman, Taylor Brown, Tiffany Gong, Blake Morrow

Mentor: Dr. Jeffrey La Belle – SBHSE

According to the World Health Organization, there are 422 million people with diabetes mellitus as of 2014. The U.S. diabetes market reached a value of $33 billion in 2016, and is expected to reach a value of $67 billion by 2022. Diabetes mellitus is a growing problem and can cause blindness, loss of limb, and death. According to the Center for Disease Control, it is the seventh leading cause of death, accounting for 2.9% of all deaths in the United States. Death and other severe complications can be avoided in part by better management of the disease. Aggressive glucose management methods can reduce incidence of these complications by as much as 70%, however, these methods can triple the rate of hospitalizations due to hypoglycemia. A multi-marker sensor with the capability to detect endogenous insulin and glucose will allow the patients to have a more complete picture of their overall health at any given moment. There are currently no point of care sensors on the market that measure endogenous insulin. DuoDetect’s technology will produce a point of care multi-marker carbon sensor and will utilize electrochemical impedance spectroscopy, which is label-free and capable of picomolar detection. This will help patients more efficiently manage their blood glucose levels by being able to properly adjust their insulin regimen and allow for better glycemic control.

34: Positive Expiratory Pressure Device with Temporal Monitor

Jose Tapia, Grace Kim, Eun Duk Seo

Mentor: Dr. Rosalind Sadleir - SBHSE

Chronic obstructive pulmonary disease (COPD) refers to a group of lung diseases that affects over 11 million people in the United States alone. It is the third leading cause of death in the United States, behind cancer and cardiovascular disease. Currently, there is no cure, and the number of deaths related to COPD is still increasing. Current device therapies include positive expiratory pressure (PEP) devices, high frequency chest wall oscillation (HFCWO) devices, oral high frequency oscillation (OHFO) devices, intrapulmonary percussive ventilation (IPV) devices, and incentive spirometry (I.S.) devices. Drugs to treat severe cases of COPD include theophylline and carbocisteine. Many patients have issues with both device and drug therapies. It is common to find pa-tients complaining about product quality and ease of use, as well as having a general aversion to medications. Patient compliance is a major factor in recovery and alleviation of COPD exacerbation. The global COPD market is currently estimated to be worth $11.3 billion. The concept this team is currently developing is centered around a combination of a positive expiratory pressure (PEP) mechanism with a respiratory monitor. The combination of PEP therapy with a monitoring mechanism will help increase pa-tient compliance and deter episodes of COPD exacerbation. Early detection of flare-ups can be critical to deterring patient mortali-ty or hospitalization. Main target specifications for the final product include pressure oscillations of approximately 15 Hz, providing 10-25 cm H20.

35: EZ Tilt: A Pediatric CT Head Holder Designed to Reduce Radiation Exposure

Charlie Bolton, Molly Golek, Keawepono Wong

Mentor: Dr. Dianna M.E. Bardo – Phoenix Children’s Hospital | Dr. Michael VanAuker – SBHSE

Computed tomography (CT) scanning is an increasingly popular diagnostic tool that utilizes ionizing radiation to produce a 3D anatomic image. It is favored by physicians due to its high quality images and speed, resulting in its overuse. Due to its popularity, CT scanners have increased the number of rows in the gantry from 16 to over 250 to increase the image quality, but this has prevented the scanners from being able to tilt to avoid the thyroid and optical lens. Ionizing radiation is especially damaging to pediatric patients, who are more susceptible to the damage from radiation and are often exposed to more than what is necessary. Each year approximately 5 to 9 million CT exams are performed on children in the United States, with about a third of those exams being head CT scans. In order to reduce radiation exposure, a device that can adjust the head position of pediatric patients in relation to a stationary CT gantry has been created. The goal of EZ Tilt is to remove organs such as the thyroid and optical lens from the scanning field and reduce the length of the scan, thereby reducing the overall radiation exposure. The primary customers for this device are radiology departments in children’s hospitals. The market and market segment for this device are potentially large, with roughly 220 children’s hospitals and 2 to 3 million pediatric patients in the U.S. that would benefit from reduced radiation exposure and, ultimately, a reduced risk for cancer caused by ionizing radiation. EZ Tilt aims to reduce radiation exposure by 15-20%, with a head angle tilt of 30 degrees forwards and backwards. It will also be designed to accommodate patients from 2 months to 18 years old with adjustability for the varying head diameters, neck lengths, and body sizes.

36: Transcutaneous Trigeminal Neurostimulator

Hau Nguyen, Gerrit Orthlieb, Kevin Radja

Mentors: Dr. Stephen Helms-Tillery - SBHSE | Dr. Justin Tanner - SBHSE

Today, there is no reliable, biotechnological solution to increase focus, memory, and reaction time. One method to induce improved wakefulness or cognition in the human body is through neurostimulation, inducing signals in the peripheral nervous system to produce different physiological outcomes. A problem with current devices is their lack of user flexibility or necessity of invasive implantation. Our goal is to develop an application-controlled transcutaneous neurostimulator that will produce current to the trigeminal nucleus to maximally affect performance in areas of reaction time, working memory, and wakefulness. The primary customers will be hospitals and physicians as well as the hundreds of thousands of ordinary people in the market size such as students and athletes that may require cognition enhancement. The market segment would be large as it can be used for a variety of outcomes, and many different kinds of patients may require improved memory or wakefulness. The market size could also be increased by having the device be available over-the-counter to increase distribution and those who can utilize it. Current trigeminal neurostimulation has been proven to be effective in treatment of headaches and craniofacial pain, thus the product concept draws basis from existing trigeminal systems. Rather than headaches and pain, the product will stimulate the trigeminal nucleus through electrodes to induce improved cognition or wakefulness, with a phone application to allow user inputs. The application interface will include scheduling and display features to inform the user and potentially remind them to take treatments. Target specifications for the final product include variable current output from 0-0.1 mA and frequency range of 1-5 kHz.

37: Epidural Fibrosis Cutting Device

Esteban Cruz, John Cunningham, Dakota Graham

Mentor: Dr. James Abbas - SBHSE

Chronic pain affects 100 million Americans and costs society up to $635 billion annually. Spinal cord stimulators (SCS) are proven to treat lower back and leg pain, two of the most common forms of chronic pain, and are generally used when all other conservative methods of treatment have failed. Paddle stimulators offer a permanent method of pain management. During implantation, a surgeon performs a laminotomy where a small hole is made in the lamina and the electrode is inserted into the epidural space. However, epidural scar tissue is present in 50-70% of these procedures and prohibits proper electrode placement. A second laminotomy is conducted to reach and cut the existing scar tissue. This procedure can add between 30 and 90 minutes to a typically hour long procedure. Hospital operating room time costs on average $62/min and takes up a large amount of the neurosurgeon’s time. Currently there are 51,000 SCS paddle electrodes implanted in the United States per year. Our device has the potential to save hospitals in the United States a total of $47-199 million per year by eliminating the need for a second laminotomy. Small enough to fit in the epidural space, yet strong enough to cut through scar tissue, the device is capable of combining many current tools into a quick one-step process. It is radiopaque for x-ray imaging and resembles a paddle electrode to ensure proper placement of the actual electrode. Most stimulators come in a kit with an epidural fat displacement tool and a blank electrode for proper positioning. Generic surgical tools, such as microscissors and curettes, are used for cutting the scar tissue. Our device is specialized to address areas where each tool listed is lacking. By working closely with established neurosurgeons, our device is tailored to address their specific needs.

38: Wearable Range of Motion Measuring Device

Joel Larson, Chase Radigan, Jonathan Riecker, Morgan Seburn

Mentor: Dr. Christopher Buneo - SBHSE

Current patients with injuries, diseases and deformities in upper extremities go through numerous hours of physical therapy. Those patients make weekly visits to analyze progress in the range of motion (ROM) in select joints. Specifically there are estimated 300,000 elbow injuries that occur in the U.S. every year. Of these, there are an estimated 163,000 that require elbow surgery and 295,500 rotator cuff surgeries. These come from work, sports, and accidents that happen in everyday life. Our device is aimed toward post-surgical patients due to length of therapy, but it can also be used for basic injuries. Currently, plastic goniometers are the main tools that physical therapists use to measure ROM during therapy sessions. A major problem with these devices is the need for the physical therapist to administer the measurement by holding the device up against the patient as they move resulting in human error. Our team aims to develop a new device to supply our primary users (physical therapy patients) with an in-home therapy tool that records and transmits their progression for their physicians analysis. Using a digital device to measure ROM will reduce the visits needed for the primary patients as they continue with the in-home therapies. The device will be able to operate hands-free, no

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a continues heart beat recoding system and provides information of the user calories burned and physical activates reading. Also the Baby belt have a motion detection system. The motion detection system works by using two accelerometers to detect motion in all angles. The acceleration is integrated into jerk motion which gives a limit to what level of speed they could move with. All these features presented about the Baby belt gives the product the ability to compete with the current products in the market for the wearable and monitoring medical products.

42: Breathe EZ - Motorized Controllable Intubation Stylet

Daniel Gentry, Wandasun Sihanath

Mentor: Dr. Jitendran Muthuswamy - SBHSE

Intubation is a simple procedure but patient weight, trauma, and abnormal anatomy can complicate the process. Given the importance of maintaining an airway in patient care, difficulties during endotracheal tube placement can have severe consequences especially under emergency circumstances where complications arise in 20% of intubations. Previous research and case studies have found that fiber optic bronchoscopes are useful in facilitating intubation due to its controllable tip. In these procedures, the optics of the scope are often not used, opting instead for visualization via videolaryngoscopy. The visual components of a fiber optic bronchoscopes are also very expensive on top of being the most susceptible parts of the scope therefore there exists a need for an intubation device with a controllable tip that can be used in indirect laryngoscopy. The Breathe EZ is a controllable tip intubation stylet that will provide the same level of maneuverability as a bronchoscope removing expensive optical components to prevent costly repairs and replacements. This leaves you with an intubation stylet with a motor-controlled, flexible tip that allows for maximum maneuverability and control for use during direct laryngoscopy or with videolaryngoscopes such as the GlideScope. Primary target specifications for the final product include 0-90 degrees range of motion of the tip in all directions and a directional specificity of 10 degrees, reducing the hand torque required for proper navigation of the airway. The Breathe EZ is designed for use by anesthesiologists as well as ENTs, intensivists, and other physicians that regularly intubate and shows great potential in the $20 billion airway management market.

43: Spinal Deviation Diagnostic System

Dalal Almuhaidib, Bateer Song, Marshall Treleven

Mentor: Dr. Christopher Buneo – SBHSE

The current approach to chiropractic treatment of patients with degenerative spinal conditions lacks a qualitative and quantitative evaluation method. Degenerative spinal conditions are characterized by the deviation of various spinal segments from their ideal curvature and leads to the alteration of the mechanical properties of the spine. The most prominent method for measuring a patient’s curvature relies upon manually analyzing radiographic images of the spine and performing hand calculations of the arc angle of the targeted segment. Our team is developing an automated system that applies a programmatic approach to calculating the arc angle of each spinal segment and comparing the calculated angle to the ideal angle for the patient based upon their individual spinal anatomy. Our primary customers will be chiropractic and osteopathic specialists who treat individuals with abnormal spinal curvatures. Millions of individuals seek chiropractic care for abnormal spinal curvatures in the US, indicating that our market segment for the device is substantial. Employment data from 2016 indicates that in the US, over 32,000 chiropractors are employed, with a significant estimated job growth potential. The current concept for our design approach incorporates the application of tri-axial spatial position sensors that will be affixed to the skin surface by a hydrogel strip, in combination with a custom designed program to calculate angular deviation from a personalized ideal curvature based on the peer reviewed approach of Dr. Donald Harrison’s ideal spine model. This model incorporates geometric models to calculate the arc angle of spinal segments. Our main target specification for our final product will include accurate measurements of curvature within 5% of variation from the manual radiographic analysis method.

physical therapist intervention, while taking continuous ROM measurements eliminating human error. The team’s current concept uses two inertial measurement units (IMUs) placed on the upper and lower arm to measuring the ROM of the shoulder and elbow. Our hope is to allow for detailed ROM analysis, that can be used to better quantify motion improvement, giving insurance companies a better metric for determining patient coverage.

39: Partial Weight Bearing Monitor for Physical Therapy Rehabilitation

Norah Alkhamis, Daniella Orlando, Naomi Welch

Mentor: Dr. Thurmon Lockhart - SBHSE

Current methods of partial weight bearing treatment for rehabilitation of lower leg injuries are inaccurate and do not allow for continuous monitoring of the weight applied. At present, the primary method therapists use to monitor partial weight bearing is by instructing the patient to stand on a medical scale. The therapist compares the patient’s total body weight with the partial weight applied and instructs the patient to apply only the prescribed amount during rehabilitation sessions. The partial weight bearing monitor being developed improves on this method by providing continuous real-time monitoring of partial weight being applied. Additionally, a threshold indicator alerts the patient when weight bearing limitations are approached. Such real-time monitoring could improve treatment and speed up recovery for 1,000,000 physical therapy patients yearly. More specifically, the device is intended to be used by athletes, patients suffering from degenerative arthritis, and surgical patients recovering from lower-limb or hip surgeries. Additionally, the device could ease current burdens facing over 120,000 physical therapists in the U.S. each year by allowing them to more easily monitor weight bearing in patients. Currently, the team aims to accomplish this by creating a flexible brace which could be worn by patients both in therapy sessions and at home. The brace would function via pressure sensors which would record force applied and send it to an output screen where the weight bearing percentage could then be viewed. The team aims to record weight pressure values ranging from 0.5 lbs to 200 lbs. The force values will then be converted into partial weight bearing percentage in order to obtain weight bearing values ranging from 0% - 100%.

40: Continuous Fall Monitoring and Prevention Stabilizing Exoskeleton

Adnan Alsharif, Andrew Hamidy, Jonathan Moroneso, Tuan Nguyen

Mentor: Dr. Thurmon Lockhart - SBHSE

Fall is the leading cause of injury in older adults. Every 11 seconds, an older adult is treated for a fall related injury. According to CDC, 29 million falls cause 7 million injuries, 800,000 hospitalizations, and 27,000 deaths in 2014. The cost for treating fall related injuries is $31 billion and is expected to increase to $67.7 billion. Even if the older adult survives the fall, the consequences of fall can be devastating. Fall detection and prevention is the most concerned problem for health care provider. There is no current technology for fall detection and prevention. Fall prevention is usually implemented by manual inspection. It puts strain on healthcare providers and causes an increase cost for both hospitals and patients. Therefore, the current concept is developed to address this problem. The device consists of an exoskeleton, a sensor system, and a cushion system. The exoskeleton consists of the system of spring and elastic material to store energy, reducing the energy expenditure for movement, and joint connectors that interlock to stabilize the patient or release to provide flexibility for the movement. The sensor system will monitor patient gait and pattern with real time data, detect fall event, and notify the provider. When a fall event is detected, the cushion system will be deployed in the direction of the fall to provide support and reduce the impact of the fall. The intended customer is for older adult, in both rehabilitation and home use.

41: Wearable Maternity Support Belt With a Monitoring System

Haifa Takrooni, Khalid Alqahtani, Alexandria Clark

Mentor: Dr. Thurmon Lockhart - SBHSE

There are 6 million pregnancy in one year in the US. The pregnancy issues are considered a great business for medical devices. The most known issue is with the pelvis, abdominal, and back injuries during pregnancy. The injuries are caused from lifting weights more than 25Ibs. The current solution for this issue is the support pregnancy belt. The support pregnancy belt provides a mechanical strength to the body to support the pelvis and abdomen and back so the user could support the weight of the baby. The device the team intended to design is called the Baby belt. The baby belt is design to support give support for the user in a matter to make them lift more than 25Ib easily so they could do normal activates that they used to do before being pregnant. The Baby belt provides a high mechanical strength by using a heavy-duty elastic. The Baby belt is comfortable to use and could be wear under clothes and gives a better look for users. The Baby Belt have a monitor system that records users heart beats. The heart beat recording system provides

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44: PremaKare - Wireless Monitoring of Preterm and Low-Birth Weight Infants under Kangaroo Mother Care

Eugene Ablordeppey, Shaheeda Adusei, Douglas Amoo-Sargon, Ruby Obeng

Mentor: Dr. James Abbas - SBHSE

According to the World Health Organization (WHO), 20 million low-birth-weight (LBW) infants are born each year. It was also estimated that more than 2.7 million newborns die each year, accounting for 44% of children dying under the age of 5 worldwide. In 2015, the Center for Disease Control report indicated that about 17% of infant deaths was accounted for by preterm and low birth weight infants. These figures confirm that complications of preterm birth are contributing factors to infant mortality. Kangaroo Mother Care (KMC) is an infant care method where skin-to-skin contact is maintained between mother and infants. KMC has demonstrated benefits of improving mother-baby bonding, and reducing infant mortality and hospital stay. Currently in the Neonatal Intensive Care Unit (NICU), infants are transferred from incubators to the mothers with electrodes attached to them for monitoring. Despite the merits of KMC, current issues faced in the hospitals include: disruption of procedure due to numerous wire extensions and entanglement from monitoring units, expensive wraps, more staff needed to transfer infants from incubator to mothers and mobility issues of the mother. Our innovative solution, PremaKare, is a wrap with wireless sensors embedded in it for monitoring temperature, heart rate and oxygen saturation level. PremaKare offers mothers the comfort to provide warmth for their infants whiles monitoring their vital signs during KMC. The use of wireless sensors eliminates issues with mobility and entanglement of wires. PremaKare targets NICU nurses and neonatal mothers as its primary customers and non-profit organizations with a mission to decrease preterm mortality rate as its secondary customers. These customers fall within the global neonatal and fetal market segment with a 6.7 billion USD evaluation and a projected Compound Annual Growth Rate (CAGR) of 6.88% between 2016 and 2021 according to Mordor Intelligence.

45: Measureless Vision: Smart White Cane

Mohammed Binshelail, Rayan Altayyar, Talal Alzouman

Mentor: Mr. Abdulrahman Alshareef - CIDSE

The commutes of the visually impaired can create various difficulties through guidance, speed of commute, and safety of travel. The market today offers basic assistive devices that could help the blind and visually impaired; however, meeting their needs ultimately requires a more innovative device. The team will satisfy this need by merging the standard white cane with a number of real time sensors providing feedback to the user. The Measureless Vision assistive device aims to provide the blind and the visually impaired community with a multi-feature and dynamic white cane. The market segment for our product is not solely focused on blind people, as it includes anyone who suffers from various levels of vision impairment. In terms of market size, it is estimated that over 1.3 million people in the United States are legally blind with an increase of 75,000 people per year. The product will consist of a GPS tracker implanted within the cane along with a mobile application which interfaces with the trackers. This provides the healthcare providers or relatives of the visually impaired with the current location of the user in case of emergency. In comparison with current products in the market, Measureless Vision will satisfy an unmet need by providing the user with rotational and vibrational sensors that function as detectors of objects in addition to the GPS guidance. Surveys of current users of the white cane claim that the inclusion of rotational sensors and a GPS tracker in a cost effective package could potentially decrease the risk of injuries and falls. We aim to provide the blind with a device that is simple to use in real world applications and will solve the difficulty of practice in using the white cane and the learning curve associated with its use.

Masters Applied Projects

1: Analysis of sEMG Data from Testing Participants Wearing a Soft Inflatable Exosuit on the Lower Limbs

Divya Amrelia

Mentors: Dr. Panagiotis Polygerinos - The Polytechnic School | Dr. Panagiotis Artemiadis - SEMTE | Dr. Marco Santello - SBHSE

Every four minutes someone dies from stroke – the leading cause of disability in the United States (CDC). Most survivors of stroke re-quire physical therapy to help restore their unimpaired gait. However, this therapy can be costly, making it inaccessible to many patients. Additionally, current assistive devices for walking are bulky, expensive, and rigid. This project is in support of a novel assistive device which is a lightweight, low-cost, and body-conforming soft-inflatable exoskeleton for the lower limb. Particularly, the focus of this project was to process the signals surface electromyography (sEMG) sensors on the hamstrings and quadriceps during the swing phase of the gait cycle, while walking on a treadmill with the device both on and off. Then this gained knowledge was used to evaluate the base-line muscle activity of the biceps femoris, vastus lateralis, and gluteus maximus collected from sEMG sensors during stair ascension.

2: Investigating the Neural Characteristics of Motor Learning in The Time - Frequency Domain

Matthew Daley

Mentors: Dr. Marco Santello - SBHSE | Dr. Christopher Buneo - SBHSE | Dr. Sydney Schaefer -SBHSE

Motor learning studies have repeatedly shown that humans improve performance via error-driven adaptation. Multiple models have been proposed and tested to explain what is happening in the brain during these processes. One widely accepted model is the Dual Rate – Multiple Context model in which learning is split between two rates; fast and slow. In this experiment, participants completed a force production task during which error feedback was perturbed and EEG data was collected. The dual rate – mul-tiple context model was fitted to the force production data. The hypothesis of this experiment is that the different learning rate signals – slow and fast – from the fitted model are related to specific changes in frequency band power during error detection.

3: Continuous Wearable Health Monitoring Device to Reduce Hospital Readmission Rates

Alexan Gomez

Mentors: Dr. Jeffrey La Belle - SBHSE | Dr. Leland Hartwell - Biodesign Institute | Dr. Heather M. Ross, School for the Future of Innovation in Society

Hospitalization can be very stressful for patients, and it is even more when they result from a consequent readmission. Although the US hospital readmission rate has been increased from the past years it still can be considered avoidable. Predictive medicine is a growing field that consists of probabilistic algorithms capable of predicting patient’s health future. When this is combined with wear-able technology, it allows for real-time patient data acquisition and signal triggering when patients need to take immediate reaction due to an illness, therefore preventing hospital readmission. However, current wearables technology only allows for the acquisition of already processed data, making it difficult for researchers to develop such algorithms. In this project, a low powered wearable device was developed to allow raw data acquisition and the storage of large information from body biosignals such as electrocardiogram, body temperature, and physical activity. A robust design was created to prevent mechanical noise from being introduced into the system while allowing patients to use the device for long periods of time under normal use conditions. The present prototype is under final as-sembly and will be ready for data collection under controlled experiments. Then, the device will be taken into a clinical environment to be used by actual patients with the hope of obtaining valuable information that will allow for the development of predictive algorithms.

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4: Impedance Mapping of an Ex-Vivo Rat Nerve

Ryan Keeney

Mentors: Dr. Bruce Towe – SBHSE | Dr. Jitendran Muthuswamy – SBHSE | Dr. Thurmon Lockhart - SBHSE

The purpose of this project is to obtain baseline knowledge and preliminary data for a larger project associated with an implant-able neural interface within a rat model. This project focused on getting a better understanding of the conductivity and current pathways of the rat nerve. This will provide important general knowledge of the nerve to aid in designing optimal nerve stim-ulation and modulation strategies. The experiment will also provide assistance with selection of other parameters and deci-sions down the road in the project, specifically those pertaining to diode type and placement on the sciatic nerve for the neu-ral interface. The project goal is to generate an impedance map of the rat nerve ex-vivo. This was done by probing the nerve via microelectrodes at different depths to get impedance/conductance data via a voltage divider circuit; this was done at a range of frequencies to capture any capacitive attributes of the nerve. The calculated impedances will then be used to gener-ate a sliced image/figure of nerve impedance across the nerve at varying depths. Due to the unavailability of rats, data was first collected on a harvested frog nerve. On the frog nerve, a test of the setup was conducted and the impedance changes were observed as the probes advanced further into the nerve. The project will continue forward with more impedance values cap-tured at varying frequencies within the frog nerve. Upon availability, it is also planned to repeat the experiment on a harvested rat nerve. The ultimate future work of this project would be to transfer the setup to an in-vivo study of the nerve impedance.

5: Improving Osteogenesis and Mineralization within Diabetic In Vitro Cell Culture Models

Lindsey Macias

Mentors: Dr. Julianne Holloway – SEMTE | Dr. Brent Vernon – SBHSE | Dr. Stephen Massia - SBHSE

This experiment focuses on osteogenesis of mesenchymal stem cells (MSCs) specifically in Type 2 diabetes mellitus (T2DM) pa-tients. The microenvironment for MSCs in a T2DM patient was mimicked in vitro with synthetic conditioned media. The synthetic conditioned media utilized different concentrations of glucose to parallel that of hyperglycemic prediabetic/diabetic patients. The goal of the experiment was to determine how different concentrations of glucose effect osteogenesis. Future iterations of this experiment will include implementing a natural conditioned media taken from the biopsies of prediabetic and diabetic patients. Another goal will be to determine how different growth factors can improve osteogenesis by introducing protein treatments into media changes. Research suggests that bone morphogenic protein (BMP2) shows promise in enhancing osteogenesis both in vitro and in vivo. The end goal of the experiment will be to see how BMP2 growth factor effects osteogenesis and to determine its effectiveness within a diabetic microenvironment. Several 5-week mineralization assays using characterized mesenchymal stem cells were performed to examine osteoblast differentiation using the synthetic conditioned media. Several different stains including FITC-Maleimide, Alkaline Phosphatase, Oil Red O, and Alizarin Red S were used throughout the study on days 7, 14, and 28 to im-age and quantify the amount of osteoblast formation. Glucose was predicted to inhibit mineralization and osteoblast differentiation.

6: Development of an Automated Metabolomics Workflow to Achieve Omics Integration for Molecular Phenotyping

Joshua Nowak

Mentors: Dr. Patrick Pirrotte - Translational Genomics Research Institute (TGen) | Dr. Christopher Plaisier – SBHSE | Dr. Sydney Schaefer - SBHSE

Discovery metabolomics is a technique to study the dynamics of gene and protein expression in terms of metabolites as their final downstream products, which can provide unique biological insight and allow biomarker discovery. However, metabolite profiling presents unique challenges in data processing, identifying unknown metabolites, and multilevel integration with other omics datasets. These challenges require specialized mathematical, statistical and bioinformatics tools which are still under de-velopment. This project describes the development and validation of a metabolomics pipeline that combines processing, identi-fication, and proteomics integration in a comprehensive manner to determine the metabolic phenotype of a system in the con-text of proteomic and genomic activity. The pipeline performs data conversion by means of an open-source MS file converter, data processing with XCMS’s R library, database search using an open-source metabolite search engine called LipidFinder, and omics integration linked to KEGG database. By implementing these tools locally using R scripting, the pipeline is able to com-plete simultaneous jobs at a rate 60 times faster than XCMS online and with identical data output. This novel, combined pipe-line was validated using human plasma samples and successfully identified 50% of the published human metabolome in a sin-gle LC-MS/MS separation mode. To determine metabolic composition of extracellular vesicles (EVs), the pipeline was applied to LC-MS/MS results from EVs comprising of apoptotic bodies and microvesicles (ABMVs) and exosomes from a mouse Gli-

oma cell line (GL02612). It identified 6023 metabolites in ABMVs and 6382 metabolites in exosomes from Glioma providing evidence that EVs carry a rich metabolome. Metabolomics and proteomics datasets were integrated to map metabolic pathways in EVs using the KEGG database. This integrated high-throughput pipeline will allow us to measure change in metabolites and their corresponding enzymes to advance our understanding of pathophysiological mechanisms and aid in biomarker discovery.

7: Sex Implications on the Neuroinflammatory Response Resulting from Traumatic Brain Injury

Kyle Offenbacher

Mentors: Dr. Sarah Stabenfeldt – SBHSE | Dr. Jeffrey Kleim – SBHSE | Dr. Jonathon Lifshitz - Barrow Neurological Institute and University of Arizona

There are an estimated 1.7 million cases of traumatic brain injury (TBI) resulting in more than 50,000 deaths each year in the United States. The neuroinflammatory response resulting from TBI includes resident central nervous system cells (i.e. astrocytes and microglia) and peripheral cells (i.e. monocytes and macrophages), that act to repair and restore homeostasis. Paradoxical-ly, the restorative nature of this inflammatory response results in secondary injury to the surrounding neural tissues. As the un-derstanding of this pathology emerges, new evidence suggests inflammatory response differences may exist between male and female subjects. Further validation of sex differences in TBI is needed to develop personalized novel therapeutics. The focus of this study is to explore and validate the role of sex on the inflammatory response following brain injury. A TBI was induced us-ing a moderate-to-severe controlled cortical impact model on both male and female mice. The injury was delivered by a 2-mm impactor traveling at 6.0 m/s for a dwell time of 0.1 seconds. Animals were allowed to recover for 3 hours, 3 days, and 7 days post-injury. After the recovery period, animals were anesthetized and perfused with phosphate buffer and 4% paraformaldehyde. Brains were frozen and cryosectioned. An additional group of naive animals, receiving no injury, were also sacrificed. The response of astrocytes and microglia/macrophages was measured via immunohistochemistry with primary antibodies of Glial Acidic Fibril-lary Protein (GFAP; astrocyte) and Ionized Calcium-Binding Adapter Molecule 1 (Iba1; microglia/macrophages) followed by flu-orescent secondary antibodies and visualization with an epifluorescent microscope. Image samples of the cortex, dentate gyrus and thalamus will be analyzed with ImageJ software to provide quantitative results demonstrating the level of cellular activation. GraphPad Prism software will be used to analyze the significance of the resulting data. Taken together, identifying cellular and impairment outcome differences between the sexes is important not only for delivering the optimal therapeutic approach but also for directing future research to explore novel techniques, drugs, and therapies aimed at improving recovery and reducing disability.

8: The Effect of Perturbation Training on the Reorganization of Gait By Measure of Local Dynamic Stability

Troy Ramos

Mentors: Dr. Thurmon Lockhart – SBHSE | Dr. Claire Honeycutt – SBHSE | Dr. Daniel Peterson, School of Nutrition and Health Promotion

In the United States, falls are the leading cause of non-fatal and fatal injuries in elderly adults (65 years of age and older). In 2012 alone there were 3.2 million non-fatal fall related injuries which had a direct medical cost of $30.3 billion. In the same year there were 24,190 fall related fatalities with a direct medical cost of $616.5 million [Burns, 2016]. Therefore, it is necessary to establish training programs that improve the reaction response of those most susceptible to falling. Perturbation training uses repeated exposure to perturbations, such as slips and trips, to improve the reaction response during a fall. It has been shown to be successful in training healthy young adults as well as older adults [Pavol, 2004]. In order to optimize perturbation training it is necessary to fundamentally understand how it impacts gait. This study investigates the effect that perturbation training has on the reorganization of gait by measuring the change in local dynamic stability.

The subjects were fitted with an inertial measure unit (IMU) and walked over- ground to establish their natural gate speed and dynamic stability. The subjects were then asked to walk on the gait real-time analysis interactive lab (GRAIL) system. The speed of the system was set to the subject’s previously established gate speed and they walked normally for ten minutes. Following the ten minutes, perturbations were administered by way of slip, trip, sway, or incline. The perturbations were administered at random time intervals and occurred as the subject’s heel contacted the platform. Immediately following perturbation training, the subjects were fitted with an IMU and walked over-ground in order to measure gait and dynamic stability. After 30 minutes the subjects repeated the walk over-ground using the IMU. After an additional 30 minutes the subjects walked over-ground one final time wearing the IMU. The local dynamic stability was quantified (using Lyapunov exponents) before and after perturbation training using the IMU data.

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9: Do Clearing Agents used in Decellularization Make a Difference in ADM Properties?

Aneesha Shaik

Mentors: Dr. David Brafman – SBHSE | Dr. Mohammad Albanna - Pinnacle Transplant Technologies, LLC | Dr. Vincent Pizziconi - SBHSE

Acellular Dermal Matrices (ADMs) are widely used dermal substitutes in a wide range of biomedical applications. Different chemicals used in the processing of dermal tissue may result in different properties of the ADMs. Xylene and methyl benzoate are widely used clearing agents which clear the residual chemicals and leftover fat from the tissue at the end of the decellularization process. In vitro study is conducted to compare some of the properties of two types of ADM samples- samples processed using xylene and samples processed using methyl.

The objective of this study was to compare the results of sterility, cytotoxicity and wettability, cellular infiltration tests of ADMs processed with Xylene(ADM-X) to ADMs processed with methyl benzoate (ADM-M).

Two aseptically processed ADMs, ADM-X and ADM-M are compared using the following methods:

Sterility Test: ADMs are inoculated with microorganisms and sterilized using different techniques (UV, Betadine, Sodiumhypochlorite-NaOCl, 70% Ethanol). Sterilized samples are then cultured on agar plates to check for bacterial growth under certain conditions.

Cytotoxicity Test: Dermal fibroblast cells are cultured in 24 well plates for 24 hours to allow attachment. Cells are then subjected to different conditions: (1) A sample of sterile ADM is added to the wells in contact with the cells to serve as contact cytotoxicity test (2) Growth media of dermal fibroblast cells is switched to residual media (media that was in contact with ADM for at least 48 hours to out residuals) to serve as extract cytotoxicity test (3) Dermal fibroblast cells in regular growth media to serve as control. Cell viability in all conditions is followed over one week using alamar blue assay.

Wettability Test: ADM samples of different thicknesses are hydrated in PBS for different time points. Changes in weight and thickness at each time point are recorded and analyzed.

Cellular Infiltration Test: Dermal fibroblasts are seeded onto sterile ADM samples and allowed to attach for about 5 days. Seeded ADMs are then fixed, processed and embedded for histological evaluation.

Results to-date from the sterility test indicate that NaOCl, Betadine and UV failed to sterilize ADM-M tissue whereas,70% Ethanol passed the test.

10: Gender Differences in Human Ankle Stiffness

Jessica Trevino

Mentors: Dr. Hyunglae Lee – SEMTE | Dr. Thurman Lockhart – SBHSE | Dr. Claire Honeycutt - SBHSE

The ankle serves as the initial contact point to the ground at foot touchdown and is a critical component in absorbing shock, sustaining impacts, and propulsion in locomotion. The incidence of musculoskeletal injury in females is much higher than in males participating in similar activities and it has been repeatedly shown that women have poor stability and increased risk of injury as compared to men due to innate differences in their musculoskeletal and neuromuscular systems. The ankle is a complex and essential joint in balance and gait, but gender difference in neuromuscular control of the ankle and its contribution to stability is unknown. Ankle stiffness has been known as one of the most important components contributing to the maintenance of lower body stability. This project aims to identify gender differences in human ankle stiffness, which can be used by clinicians to develop gender-specific training programs to ensure productive and efficient ankle rehabilitation or injury prevention. We characterized ankle stiffness in 20 young, healthy men and 20 young, healthy women to determine if gender differences exist in human ankle stiffness. Given the importance of the ankle’s contribution in the sagittal and frontal planes, we characterized ankle stiffness in both planes. A wearable ankle robot together with stochastic system identification was used to quantify multi-dimensional ankle stiffness over a range of muscle activation levels, from relaxed to 20% of the maximum voluntary co-contraction of the ankle muscles. In this 40-subject study, with equal proportions of male and female subjects, the significant effects of gender were found to influence ankle stiffness both in the sagittal plane and the frontal plane. Further analysis of anthropometric data showed that height and weight are significantly correlated with ankle stiffness in both degrees of freedom, as evidenced by statistically significant Pearson’s correlation coefficients in all measurement conditions.

11: Construction of an Artificial Bladder

Jake Turner

Mentors: Dr. Jeffrey LaBelle – SBHSE | Dr. Vincent Pizziconi – SBHSE | Dr. Hiep Nguyen - Cardon Children’s Medical Center of Urology

The human bladder is mainly responsible for the storage and excretion of urine. However, there are many complications of the bladder that can cause backflow into the kidney or leakage into the abdomen. These issues often have fatal results. The only current treatment for a damaged bladder is through bladder donation and transplantation. Therefore, there is a severe clinical need for an artificial, implantable bladder. This proof of concept prototype simulates an artificial bladder using common materials found in a research lab. This portion of the project focuses on the connection between the bladder and the ureters. The ureters are responsible for transporting urine from the kidney to the bladder. To prevent backflow or unnecessary leakage, the junction between the ureters and the bladder must be securely fastened while only allowing one-way flow into the bladder. A variety of one-way valves were tested for functionality comparable to the biological interaction between the ureters and the bladder. Minimal flow rates and pressures were tested to appropriately draw fluid into the artificial bladder. Failure mode analysis testing was performed to determine “breaking points” of the valves. The failure of the valves is intended to represent leakages and backflow. The understanding of potential device complications is extremely vital, especially for implantable devices. The ultimate goal is to optimize the functionality and biocompatibility of the artificial bladder for improved treatment options, leading to improved quality of life.

12: Analysis of Current Quality Standards in Biomanufacturing of Specialized 3D Tissue and Organ Systems to Evaluate the Technical and Economic Feasibility of Advanced Biomanufacturing Concepts

Jakob G. Wells

Mentors: Dr. Vincent Pizziconi – SBHSE | Dr. Stephen Massia – SBHSE | Dr. David Lott -Mayo Clinic Arizona

The emerging field of regenerative medicine is believed to represent a true paradigm shift in healthcare. With a cumulative annual growth rate of 25%, the current trajectory projects the global regenerative medicine market to soar to $67 billion by 2020. However, the full potential of regenerative medicine relies to a large degree on the development of bioreactor platform technologies capable of large scale adoption by the medical technology industry for use in GMP facilities for the biomanufacturing of specialized3D tissue and organ systems. A key factor envisioned to contribute to their large-scale adoption is the ability to monitor and control the production of 3D tissue products with a high level of quality assurance utilizing fully automated and, ideally, minimally invasive process control systems. However, exactly what to monitor and when to control the production of 3D tissues is not exactly clear, as the applied science of regenerative medicine is still evolving. One possible scenario is a monitoring system to track endogenous biomarkers during key stages of 3D tissue development to ensure the correct phenotype of a fully functional tissue can be verified in-vitro. The aim of this applied project is to assess the current state of manufacturing 3D tissue and to use this as a benchmark to evaluate the technical and economic feasibility of advanced biomanufacturing concepts which rely on emerging biomedical sensor technologies and bioinformatic algorithms which can be implemented in GMP facility.

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“Engineering is the closest thing to magic that exists in the world”

Elon Musk

Thank youOn behalf of the SBHSE Design Studio, we sincerely thank our BME alumni, industry and clinical partners, and all the mentors for your continued support of our Senior Capstone Design Students and Masters Applied Project Graduates. Please be sure to join us again at our BME Symposium next spring to witness the culmination of our senior capstone design team efforts and the accomplishments of a new group of Masters Applied Project Graduates.

School of Biological and Health Systems Engineering

SBHSE