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Design Day 2013 - Apply - Johns Hopkins University

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G<br />

May 7, <strong>2013</strong><br />

8 a.m.-3:00 p.m.<br />

Armstrong Building<br />

1600 McElderry Street<br />

Baltimore, Maryland 21205<br />

<strong>Design</strong> <strong>Day</strong> <strong>2013</strong><br />

1


Introduction<br />

Welcome to BME <strong>Design</strong> <strong>Day</strong> <strong>2013</strong>!<br />

The Department of Biomedical Engineering at <strong>Johns</strong> <strong>Hopkins</strong> <strong>University</strong> is internationally<br />

recognized as a leader in biomedical science and technology. In addition, the department<br />

is rapidly emerging as a leader in the translation of scientific and technical advances into<br />

clinical applications that improve patient care. One example of that effort is the <strong>Johns</strong><br />

<strong>Hopkins</strong> <strong>University</strong> Center for Bioengineering Innovation & <strong>Design</strong> (CBID).<br />

CBID’s dual mission is to educate the next generation of leaders in medtech innovation<br />

and to develop solutions that are clinically and commercially impactful. Each year, about<br />

20 graduate and undergraduate teams, along with <strong>Johns</strong> <strong>Hopkins</strong> clinicians and faculty,<br />

tackle some of the most challenging healthcare needs of the US and global markets. This<br />

year we are especially honored to host Dr. Omar Ishrak, chairman and CEO of Medtronic,<br />

as our keynote speaker. Dr. Ishrak brings a rare unified perspective on the need for<br />

innovation for both types of markets and patients, from the most advanced and wealthy<br />

to the most needy.<br />

Success in such an effort depends on close collaboration with a wide range of<br />

stakeholders and experts. Our design teams benefit from access to volunteer advisors<br />

from investment, regulatory affairs, reimbursement, and other critical perspectives. In<br />

addition, through the generosity of donors who share our vision, we are able to provide<br />

teams with the resources needed to build and test their ideas. These donors and partners<br />

are listed on the last page of this program.<br />

Our key stakeholders are front-line healthcare workers and their patients. Each of the<br />

projects you will see today has been developed with regular mentorship, and in some<br />

cases co-invention, by a clinician or other community health worker, mainly from <strong>Johns</strong><br />

<strong>Hopkins</strong> Medicine and our main global health innovation partner, Jhpiego. These mentors<br />

devote many hours to ensure each team fully understands the problem and develops a<br />

clinically viable solution.<br />

To all our partners and sponsors, on behalf of all the students and faculty in CBID and<br />

BME and the patients who will benefit from their innovations, we say “THANK YOU!”<br />

Sincerely,<br />

Youseph Yazdi, PhD, MBA<br />

Executive Director<br />

Assistant Professor,<br />

Department of Biomedical Engineering<br />

Elliot R. McVeigh, PhD<br />

Massey Professor and Director<br />

Department of Biomedical Engineering<br />

2


<strong>Design</strong> <strong>Day</strong> Agenda<br />

7:00 a.m. Registration and Breakfast Available<br />

8:00–8:15 a.m. Welcome and Opening Remarks<br />

• Youseph Yazdi, Executive Director, CBID<br />

• Elliot R. McVeigh, Massey Professor and Director,<br />

<strong>Johns</strong> <strong>Hopkins</strong> Department of Biomedical Engineering<br />

• Nicholas P. Jones, Benjamin T. Rome Dean,<br />

<strong>Johns</strong> <strong>Hopkins</strong> Whiting School of Engineering<br />

8:15–9:00 a.m. Undergraduate Innovation Presentations<br />

• Introduction: Robert Allen, Undergraduate Program Director, CBID<br />

• Introduction of new <strong>2013</strong>-2014 <strong>Design</strong> Team Leaders<br />

9:00–10:00 a.m. MSE Innovation Presentations<br />

• Introduction: Soumyadipta Acharya, Graduate Program Director, CBID<br />

10:00–10:15 a.m. Break<br />

10:15–11:00 a.m. Keynote Address<br />

• Introduction of Speaker: Paul B. Rothman, Frances Watt Baker, M.D. and<br />

Lenox D. Baker, Jr., M.D., Dean of the Medical Faculty and CEO,<br />

<strong>Johns</strong> <strong>Hopkins</strong> Medicine<br />

• Omar Ishrak, Chairman and Chief Executive Officer of Medtronic<br />

11:00–1:15 p.m. Medical Innovation Showcase<br />

• Over 20 Medical Device Innovation Teams Presenting<br />

• Table-top demonstrations and exhibits<br />

Noon<br />

Lunch Served<br />

1:15–1:45 p.m. Undergraduate Innovation Presentations, Continued<br />

• Introduction: Robert Allen, Undergraduate Program Director, CBID<br />

1:45–2:45 p.m. MSE Innovation Presentations, Continued<br />

• Introduction: Soumyadipta Acharya, Graduate Program Director, CBID<br />

2:45–3:00 p.m. Awards and acknowledgements<br />

• Elliot R. McVeigh, Director, Department of Biomedical Engineering<br />

• Thank You to Clinicians: Clifford Weiss, Clinical Director, CBID<br />

• Final Acknowledgements: Youseph Yazdi, Exec Director, CBID<br />

3:00 p.m. Adjourn<br />

3


Graduate student projects<br />

GRADUATE MEDTECH<br />

OmniSom Solutions—The Lyra At-Home PSG<br />

Student Team: Christopher Lee, Dana Schultz, David Shin, Michelle Zwernemann<br />

Clinical Advisors: Alan Schwartz, MD; Philip L. Smith, MD; Jason Kirkness, PhD; Hartmut Schneider,<br />

MD, PhD, <strong>Johns</strong> <strong>Hopkins</strong> Sleep Disorders Center<br />

Clinical Advisors: Susheel Patil, MD, PhD, JHU Sleep Disorders Center;<br />

Soumyadipta Acharya, MD, PhD<br />

Technical Advisors: Drs. Soumyadipta Acharya; Jerry Prince, Department of Electrical and<br />

Computer Engineering; Youseph Yazdi<br />

Over 39 million Americans suffer from sleep apnea (SA), a serious medical condition that causes<br />

people to periodically stop breathing during sleep. SA leads to many downstream clinical diseases<br />

such as heart disease, stroke, and cognitive atrophy. In addition, undiagnosed and untreated SA<br />

has an annual cost of $45–80 billion in medical costs and up to $165 billion in total downstream<br />

economic costs in the United States. Despite these serious consequences, approximately two-thirds<br />

of Americans with SA remain undiagnosed.<br />

To overcome the diagnostic bottleneck imposed by limited clinic test infrastructure, at-home sleep<br />

monitors have been introduced that allow patients to be screened from their own bedrooms.<br />

However, no home system exists that can be self-applied by patients to record all 10 necessary<br />

physiologic signals needed for a comprehensive diagnosis. Our team is developing the Lyra, the<br />

first sleep apnea diagnosis system that effectively transitions the gold standard of sleep apnea<br />

diagnosis to the home setting. The Lyra integrates traditional sleep diagnostic technology and novel<br />

dry electrodes into comfortable, sleep-friendly form factors, a headset and chest strap, which record<br />

a complete dataset equivalent to an in-clinic sleep study. Our first prototype focuses on home<br />

appropriate EEG, the missing element from current home systems. In conjunction with Quasar, a<br />

leader in novel, dry EEG electrode technology, we have developed a headset that can record EEG<br />

necessary for SA diagnosis and can be self-applied by the patient. Our efforts were specifically<br />

focused on reducing motion-related noise and optimizing sensor application pressure. We have<br />

developed a unique electrode suspension system that achieves both these critical factors.<br />

EchoSure: Vascular Anastomosis Monitoring<br />

Student Team: Kaitlyn Harfmann, Ting-Yu Lai, Adam Lightman, David Narrow, Devin O’Brien-Coon<br />

Clinical Advisors: Seth Goldstein, MD, and Ying-Wei Lum. MD, Department of Surgery; Gedge<br />

Rosson, MD, Department of Plastic Surgery; Eduardo Rodriguez, MD, <strong>University</strong> of Maryland/<br />

R. Adams Cowley Shock Trauma Center, Division of Plastic Surgery; Emad Boctor, MD, Department<br />

of Radiology<br />

Technical Advisors: Soumyadipta Acharya, PhD; Jerry Prince, PhD, Department of Electrical and<br />

Computer Engineering; Youseph Yazdi, PhD, MBA<br />

4


Each year 50 thousand patients in the U.S. alone will undergo free flap reconstruction, about 15%<br />

of whom will experience non-preventable vascular complications. These surgeries have the power<br />

to restore patients’ lives, yet too often they result in failure. If signs of a vascular flow problem are<br />

detected early, surgeons can repair the vessels before it is too late − thus, monitoring is pivotal<br />

to the success of these cases. However, half of these patients suffer from costly and morbid total<br />

flap failure due to inherent flaws in current monitoring devices, despite the fact that hospitals are<br />

paying hundreds to thousands of dollars to monitor each patient after surgery.<br />

EchoSure has developed a novel monitoring technology with the power to prevent thousands of<br />

surgical failures and avoid unnecessary and expensive re-operations, while saving hospitals over<br />

$2,200 per surgery. Current competitors have high false positive rates, non-definitive outputs, and<br />

significant time delays to identify a problem—these factors lead to decreased surgical success,<br />

unnecessary procedures, and clinical frustrations. Our unique, clinically driven insight was that<br />

Doppler ultrasound was the ideal technology for monitoring—if it could be de-skilled so front-line<br />

clinicians could use it. The result was EchoSure, a dual-component system comprised of EchoMark<br />

and EchoFind. EchoMark is an implantable, resorbable marker placed beneath the vessels of<br />

interest, which acts as a homing beacon for nurses tasked with monitoring post-operative<br />

patients. EchoFind, a software application, is used to help guide users to the ideal position with<br />

the ultrasound at which point critical information about the vessel health is gathered and used<br />

to assess the patient. This technology will help save hospitals over $180 million annually while<br />

decreasing unnecessary procedures and improving outcomes.<br />

SympSolutions’ AccuRIGHT: Treatment for Resistant Hypertension<br />

Student Team: Anmol Chopra, Hiren Mistry, Michael Batista, Hina Shah, James Su, Stephen Dria<br />

Clinical Advisors: John Sperati, MD, MHS, Department of Medicine; Robert Fitzgerald, PhD,<br />

Department of Medicine; Ying-Wei Lum, MD, Department of Surgery<br />

Technical Advisors: Inder Makin MD, PhD; Youseph Yazdi, PhD, MBA<br />

Hypertension, or high blood pressure, affects a third of all Americans, increases the risk for<br />

heart disease, stroke and renal disease, and is directly associated with 350 thousand American<br />

deaths annually. In the US the annual cost attributable to hypertension is $250 billion in medical<br />

expenses. Even with the use of multiple antihypertensive drugs, the only treatment, 20 percent<br />

of hypertensive Americans cannot control their blood pressure. These patients have resistant<br />

hypertension. Two experimental device-based treatments have shown promise but exclude patient<br />

populations and are associated with procedural complications. Therefore, there is a need for a<br />

novel device-based treatment to help the millions with resistant hypertension.<br />

SympSolutions has developed AccuRIGHT, a novel system to treat resistant hypertension within<br />

a clinician’s office. The device utilizes the well-established technology of high intensity focused<br />

ultrasound to noninvasively eliminate the carotid body, a central contributor to hypertension.<br />

Surgical removal of the carotid body in animal and human trials has proven safe and effective,<br />

creating reductions in pressure sufficient to restore patient’s blood pressure values to normal.<br />

5


For treatment cardiovascular clinics and hypertension centers would purchase our system, which<br />

includes the device housing the ultrasound transducers as well as a unique disposable cover<br />

to ensure safe operation. In terms of development, initial feasibility animal trials have begun,<br />

ultrasound simulations have been performed to evaluate initial safety profiles, and a therapeutic<br />

ultrasound setup has been proven to generate lesions sufficient to eliminate the carotid body.<br />

With AccuRIGHT, patients will see improved health outcomes, health care providers will gain a new<br />

source of revenue and the cost burden to the healthcare system will be reduced.<br />

PathoS’ Clearview: Reducing Re-Operation Rates in Breast<br />

Conserving Surgery<br />

Student Team: Anjana Sinha, Hector Neira, Qing Xiang Yee, Vaishakhi Mayya<br />

Clinical Advisors: James Shin and Ashley Cimino-Mathews, MD, Department of Pathology;<br />

Melissa Suzzane Camp, MD, MPH, <strong>Johns</strong> <strong>Hopkins</strong> Breast Center<br />

Patients undergoing breast conserving surgery (BCS) have a one in five chance of requiring a<br />

reoperation because surgeons cannot determine if the entire tumor has been removed. During<br />

the course of other cancer surgeries a surgeon sends the excised tumor to the pathologist who<br />

prepares microscopy slides to assess tumor margins before the surgery ends. This process, known<br />

as intra-operative histology, is generally accepted as the standard of care for surgical cancer<br />

treatment. However, the inherent mechanical properties of breast tissue make slide preparation<br />

for this assessment nearly impossible within the accepted 20 minute window. ClearView allows<br />

pathologists to produce the high-quality histology slides required within minutes, enabling intraoperative<br />

assessment of tumor margins for BCS patients. This could prevent up to 66 thousand<br />

revision BCS procedures in the U.S. annually.<br />

Using representative animal models, PathoS has demonstrated the ClearView system simplifies<br />

preparation of histology slides of mechanically weak tissue while preserving the internal tissue<br />

structures evaluated during margins assessment. Based on these favorable animal trials, PathoS is<br />

currently conducting testing on human breast cancer specimens.<br />

ClearView is comprised of a reusable applicator and proprietary disposable film. Using ClearView<br />

a typical BCS procedure will require $120 of disposables, which will be covered by insurance<br />

companies under existing reimbursement codes. According to FDA regulations ClearView is a Class<br />

I device, the lowest-risk device category. This affords a quick time to market, with minimal testing<br />

and regulatory requirements.<br />

6


GRADUATE GLOBAL HEALTH<br />

Managing Birth Asphyxia<br />

Student Team: Stephen Dria, Kaitlyn Harfmann, Christopher Lee, David Narrow<br />

Clinical Advisors: Janine Bullard, MD, Department of Neonatology, JHU<br />

Other Advisors: Helge Myklebust, Laerdal; Harshad Sanghvi, MD, Jhpiego<br />

Sponsors: <strong>Day</strong> of Birth Alliance (CBID, Jhpiego and Laerdal Global Health)<br />

Annually, there are over four million global neonatal deaths primarily occurring in resourceconstrained<br />

environments. This accounts for over 38 percent of deaths in children under the age<br />

of five. When performed properly neonatal resuscitation is an effective means to revive newborns<br />

that are unable to properly breathe. Statistics indicate that birth asphyxia accounts for 23<br />

percent of all neonatal deaths. Additionally, another one million newborns suffer from permanent<br />

disabilities due to insufficient oxygen at time of birth. Effective newborn resuscitation alone can<br />

prevent millions of newborn deaths. Neonatal resuscitation requires the use of a ‘bag-valve-mask’<br />

or BVM. The BVM channels ambient air from the atmosphere into a one-way valve when the user<br />

compresses the bag-component. Gas is then expelled through the mask and into the trachea,<br />

bronchus and lungs of the infant. Due to the technical difficulties associated with the procedure,<br />

newborns who otherwise would have been resuscitated die because of ineffective equipment<br />

operation and improper technique—a function of the burden of training and skill retention.<br />

Thus, it is critical to reduce the amount of skill required for providing an effective and consistent<br />

resuscitation, especially in peripheral health care centers of the developing world.<br />

Failed resuscitations are attributed to poor head positioning and an inadequate seal between the<br />

mask and the baby’s mouth. However, air is forcibly pushed into the lungs through ventilation<br />

only when proper mask seal and head positioning are addressed together. After significant<br />

research, chest rise is a variable that is most cost-effective to quantify successful resuscitation<br />

instantaneously. Thus, a tool to quantify lung expansion would be revolutionary to the<br />

resuscitation protocol, providing low-skilled health workers real-time feedback throughout the<br />

procedure. Our innovation will mitigate existing inadequacies attributed to constrained resources,<br />

diminished skill retention over time and difficulty using devices associated with resuscitation. Our<br />

technical solution quantifies chest expansion and guides the user through a proper resuscitation,<br />

improving the results of attempted resuscitations and successfully managing birth asphyxia.<br />

PanDiagnostics: Expanding Availability of MDR-TB Diagnostics in<br />

the Developing World<br />

Student Team: Anjana Sinha, Hiren Mistry, Anmol Chopra, Hector Neira, Devin O’Brien-Coon<br />

Clinical Advisors: Gyanu Lammichane, PhD, Yukari Manabe, MD, Derek Armstrong, MHS, Center<br />

for TB Research; Stacie Stender, RN, Jhpiego<br />

Sponsors: Center for Tuberculosis Research Laboratory, Jhpiego<br />

Globally, only 60 thousand of the estimated 310 thousand new cases of multi-drug resistant<br />

tuberculosis (MDR- TB) are diagnosed. The situation is even more dismal in the 27 nations that<br />

account for 80 percent of MDR-TB cases, where less than 5 percent of patients receive an official<br />

diagnosis. MDR-TB diagnostics are typically available only at reference level facilities, two or<br />

7


three levels above where patients actually seek treatment. Clinicians are therefore forced to treat<br />

these patients with highly ineffective drugs for at least six months prior to modifying treatment.<br />

In the meantime, patients are likely to become increasingly resistant to treatment and to spread<br />

this airborne infection within their community. Progression of MDR-TB cases into extensively drug<br />

resistant (XDR-TB) cases is a major public health concern because XDR-TB strains are virtually<br />

untreatable. Our team is developing a self-contained assay comprising effective, yet inexpensive<br />

components, to bring the gold standard of care, culture-based diagnosis, to rural healthcare<br />

facilities. User-centric design is being employed to assure the final system enables minimally<br />

trained personnel to conduct MDR-TB testing safely, without sophisticated laboratory equipment.<br />

Expanding availability of MDR-TB diagnostics to rural health facilities will lead to adequate<br />

treatment for patients while they are still responsive to available drugs.<br />

HemoGlobe: A Point-of-Care System for Diagnosing Anemia<br />

Student Team: Dana Schultz, Hina Shah, James Su, Michelle Zwernemann, Vaishakhi Mayya<br />

Advisors: Brandon M. Togioka, MD, Department of Anesthesiology and Critical Care Medicine,<br />

Harshad Sanghvi, MD, Jhpiego; Lynn Kanyuuru, Jhpiego Kenya; Dr. Kusum Thapa, Jhpiego Nepal<br />

Sponsor: Jhpeigo and USAID- Saving Lives at Birth<br />

Moderate to severe anemia is a major public health problem, particularly dangerous during<br />

pregnancy for both the mother and the baby. Every year, 100 thousand maternal deaths and 600<br />

thousand neonatal deaths worldwide are attributable to anemia. The prevalence of anemia in the<br />

developing world is staggering and affects 50 percent of pregnant women. Treatment at early<br />

stages can prevent maternal deaths. However, most diagnoses are based on subjective assessments<br />

or are invasive. Further, there is no mechanism to assess the impact of existing public health<br />

initiatives to control and/or treat anemia.<br />

HemoGlobe is a non-invasive anemia screening device that leverages existing cell phone<br />

technology to provide a cost effective method for screening for anemia. The mobile platform<br />

connected to a central server provides real time surveillance, thus allowing the health care workers<br />

and the associated public health officials to identify the mothers at highest risk.<br />

The non-invasive sensor is based on a novel technique of photo-plethysmography to measure<br />

the hemoglobin concentration. The sensor communicates with basic cellphones for subsequent<br />

processing, display, and data transfer to a central server. The server displays the population level<br />

anemia maps to aid the analysis of individual pregnant women and also provide surveillance data.<br />

The device that is able to track patient data geographically and over time would facilitate macroscale<br />

public health policy by enabling the targeting of health care initiatives to areas in need and<br />

by providing feedback on interventions.<br />

8


Inspiraid: Improving the Availability of Oxygen in the<br />

Developing World<br />

Student Team: Ting-Yu Lai, Adam Lightman, David Shin, Qing Xiang Yee<br />

Clinical Advisors: John Sampson, MD, Department of Anesthesiology and Critical Care<br />

Medicine; Dr. Lynn Kanyuuru, Jhpiego Kenya; Dr. Kusum Thapa, Jhpiego Nepal<br />

Sponsor: Jhpiego<br />

Oxygen is a critical, life saving medicine. It is used to manage childhood pneumonia, COPD,<br />

obstetric emergencies and is necessary for performing surgeries. Unfortunately, oxygen is<br />

generally not available below the district hospital level in the developing world. There are<br />

multiple technologies available for supplying patients with oxygen in the developing world, yet no<br />

technology has proven to be a sustainable solution for resource starved clinics.<br />

Our team has analyzed oxygen delivery from the perspectives of technological solutions, business<br />

model innovations, and policy level efforts. We have developed a novel business model to deliver<br />

oxygen to lower level clinics by incentivizing decentralized production and distribution of oxygen.<br />

In our model, a local entrepreneur purchases a kit containing an affordable oxygen concentrator<br />

combined with oxygen bottling equipment. The entrepreneur will then sell filled oxygen cylinders<br />

to health facilities within a catchment area. Similar to a milkman delivering milk, the entrepreneur<br />

ensures that every facility has the oxygen it needs, on hand for a fraction of current price. The<br />

cylinders will be delivered on motorcycles, which can traverse difficult terrain and overcome the<br />

logistical issues that plague truck delivery.<br />

Additionally, this model effectively overcomes bottlenecks related to continuous electric supply,<br />

and routine maintenance. The model is financially sustainable, with the initial investment being<br />

paid off within the first three years. This model is the first of its kind to make oxygen affordable to<br />

primary health centers and peripheral level hospitals.<br />

9


underGraduate student projects<br />

UNDERGRADUATE MEDTECH<br />

ShunTube: IVC Trauma Repair<br />

Student Team: Bijan Abar, Wes Bernier, Calvin Chang, Emily Hsiao, Arianne Papa,<br />

Sohini Sengupta, Jiarui Wang, Jennifer Yang, Amadeus Zhu<br />

Clinical Advisors: James H. Black, M.D., FACS, Department of Surgery<br />

Trauma injuries to the inferior vena cava (IVC) are a serious, fatal matter with a patient mortality<br />

rate that exceeds 70 percent. Due to the high rate of blood flow through the IVC, it is imperative<br />

for the surgeon to stop the bleeding from the vein as quickly as possible. However, this is difficult<br />

to achieve in an open surgery setting due to the placement of the IVC within the body. We have<br />

developed the ShunTube, an adjustable double balloon catheter that can be deployed without<br />

the need for open surgery. The device includes two occlusion balloons, located above and below<br />

the site of injury, that are both inflated with saline in order to seal off the wound. Blood will<br />

enter the device through pores located beneath the lower balloon, travel upward bypassing the<br />

wounded region, then exit above the upper balloon and return to the heart. Our device can be<br />

rapidly deployed to improve patient outcome and reduce medical expertise required for surgical<br />

intervention. Aside from treating trauma injuries, our device can also be modified for use in liver<br />

cancer treatment, deep vein thrombosis treatment, and as a substitute for veno-venous bypass in<br />

tumor resection procedures.<br />

The HUMS Device: Minimally Invasive Treatment of Peripheral<br />

Vascular Disease (PVD)<br />

Student Team: Joshua Budman, Valeriya Aranovich, James Frick, BaDoi Phan, Paul Tershakovec,<br />

Doran Walsten, Ben Wheeler, Alp Yurter<br />

Clinical Advisors: Jennifer Monti, MD, MPH, Department of Internal Medicine<br />

Peripheral vascular disease (PVD) is a general term that describes obstructions of the large<br />

arteries excluding the coronary artery, the aortic arch and the brain. PVD affects about 10 million<br />

Americans and is associated with significant morbidity and mortality. To help treat the millions of<br />

sedentary patients with PVD we have developed. The Human-Ultrasonic Mesenchyme-Stimulating<br />

(HUMS) device that applies high frequency stimulation, in the ultrasound frequency range, to<br />

areas with a high density of mesenchymal tissue to mimic the longitudinal stresses of exercise<br />

in these areas. Three piezoelectric massage crystals are placed within a cuff that the health care<br />

provider places around one of the patient’s thighs during treatment. Once energized, these<br />

crystals vibrate to a specific amplitude and frequency capable of exciting endothelial progenitor<br />

cells (EPCs) from the mesenchyme into the peripheral blood, thereby reducing PVD symptoms.<br />

Research has shown an increase in EPC count has a causal relationship with a reduction in PVD<br />

symptoms. Research on mice using scaled down models of the device will reveal the extent of<br />

the device’s ability to increase EPC count, with estimates suggesting a 50% increase based on<br />

porcine models.<br />

10


OralCheck: Early Detection of Oral Cancer<br />

Student Team: Manjima Dhar, Yun-An Chen, Alex Dakos, W. James Melvin, Justine Yu,<br />

Jennifer Zheng, Tony Wu<br />

Clinical Advisor: Elliott Schwartz, DDS<br />

Oral cancer has a 45 percent fatality rate within five years of diagnosis. This high fatality rate is<br />

due to late stage detection. The symptoms of oral cancer are lesions in the oral cavity. However<br />

these symptoms are not unique to oral cancer, therefore clinicians cannot easily distinguish<br />

cancerous lesions by visible inspection. To help screen for oral cancer we have designed<br />

OralCheck, a portable cell analyzer. OralCheck has two components: a brush for sample<br />

collection from the mouth and a microfluidic chip for analysis. The brush is able to collect cells<br />

from the lower levels of the oral cavity epithelium where cancer arises. A syringe is attached<br />

to the inlet to allow easy sample insertion. The microfluidic analyzer uses electric fields to sort<br />

the cancer cells from benign cells into separate compartments. The sorted cells will react with a<br />

chemical to give a color change that is visible to the naked eye. A positive result will show two<br />

visible dots (one in each well) and a negative result will show only one. OralCheck gives the<br />

dentist a point-of-care method to screen for cancer cells, which will allow for earlier treatment of<br />

the cancer, thereby improving clinical outcomes.<br />

Remote Assessment of Parkinson’s Disease<br />

Student Team: Nick Gisolfi, Steven Albers, Anthony Alers, Margaret Chow, Ran Liu,<br />

Travis Wallace<br />

Clinical Advisor: Ray Dorsey, MD, Department of Neurology<br />

In order to allow movement disorder specialists to make more informed decisions when<br />

prescribing treatment alterations, we have developed a system that assesses the severity of<br />

various symptoms of Parkinson’s disease in a patient’s home. This system includes a wearable<br />

accelerometer that is capable of quantifying tremor as well as other motor symptoms of<br />

Parkinson’s disease. Additionally, we have developed a web application for use on any tablet<br />

device that is capable of characterizing the handwriting of Parkinson’s patients. Both of these<br />

components communicate to an online database that stores the results of tests that patients<br />

complete at home. This database can be accessed by patients who will be able to track their<br />

own test results as well clinicians who will have access to all patients accounts. Testing involves<br />

calibrating the accelerometer based device for different motor tests as well as making the user<br />

interface more simple and intuitive.<br />

Tool to Aid Mechanically Difficult Birth<br />

Student Team: Tonia Wu, Garren Angacian, Ashley Cook, Gaby Frid, Woojin Kim, Jennifer Hui,<br />

Barry Leybovich, Molly Moore, James Verdone<br />

Clinical Advisor: Edith Gurewitsch, MD, Department of Gynecology and Obstetrics<br />

11


To assist obstetricians during forceps delivery, we designed, developed, and tested an instrument<br />

that will mitigate the risks of complications to the mother while safely delivering the fetus. The<br />

project quantified a safe range of angle of traction and the point at which the fetal head clears<br />

the pubic symphysis during an instrument-assisted vaginal delivery. The OB Compass will guide the<br />

physicians during the backward pull of the obstetric forceps by providing physicians with real-time<br />

feedback of angle of traction and position of the forceps relative to the mother’s pubic bone.<br />

OB Compass will deliver haptic feedback to alert the physicians if the angle of traction exceeds<br />

45 degrees, a value that significantly increases the chance of tear in the pelvic floor muscle as<br />

shown by our mathematical and experimental values. It will also provide visual position feedback<br />

for the physicians with regard to the fetal head clearance of the pubic symphysis. Efficacy will be<br />

demonstrated by a comparative study of the new device and classical forceps as applied to birth<br />

simulators. The OB Compass aims to improve clinical techniques and clinical outcome significantly.<br />

Haptact: Preventing OR Sponge Retention<br />

Student Team: Jonathan LeMoel, Jay Bhasin, Rob Hubbard, Sean Reeder, Jimmy Su,<br />

Grant Kitchen, Inez Lam, Annie Mao<br />

Clinical Advisor: Hien T. Nguyen, MD, Department of Surgery<br />

In about three thousand open surgeries each year, a surgical sponge is inadvertently left inside<br />

the patient, requiring a second surgery to remove it, at a cost of $700M to health care system.<br />

This is in spite of a “correct sponge count” by the nurses and OR technicians after every surgery.<br />

To reduce the number of these second operations, we have developed a wrist-mounted device<br />

worn by the circulating nurse integrating seamlessly into the existing workflow of the OR. Our<br />

device, Haptact, uses radio-frequency antennae affixed to the wrist of the nurse’s sterile sleeve<br />

to detect unique RF identification tags on the sponges. As the nurse picks up the sponge during<br />

the customary manual count, Haptact keeps track of that sponge’s unique tag number, preventing<br />

duplicate counts and keeping a running update of exactly what is “checked out” and in use and<br />

what has been “checked in” and returned after the surgery. Haptact thereby supplements the<br />

manual counting technique to reduce the need for a second operation.<br />

Subcutaneous Injection of Therapeutic Monoclonal Antibodies<br />

Student Team: Truc Nguyen, Daniel Adler, Catherine Bernstein, Alexia Haralambous,<br />

Jonathan Hunt, Thomas Nguyen, Antonio Spina, Lucia Tellez<br />

Sponsor: Mitch Zhao, Ph.D, Janssen Research & Development<br />

In order to facilitate subcutaneous delivery of therapeutic monoclonal antibody (mAb) suspensions,<br />

we developed Syr-Q, an injection device. Syr-Q resuspends sedimented mAb particles that would<br />

otherwise clog the needle, leading to incomplete drug delivery. Syr-Q features an eccentric rotating<br />

mass (ERM), which adequately resuspends sedimented mAb particles by generating vibrations<br />

through centripetal acceleration. The ERM is attached to a timing circuit, which resuspends the<br />

particles for 15 seconds before shutting off and allowing the patient to safely self-administer<br />

the medication. Preliminary testing has shown that our resuspension mechanism is capable<br />

of decreasing the injection force from 80 N to less than 25 N, with statistical significance of<br />

p


The PrestoPatch: A Novel Device to Improve Shock Delivery in<br />

Cardioversion and Defibrillation<br />

Student Team: Piyush Poddar, Aaron Chang, Melinda Chen, Peter Malamas,<br />

Sandya Subramanian, Joon Eoh, Kevin George, Rohil Malpani<br />

Sponsor and Clinical Advisor: Todd Cohen, MD, Cardiac Inventions<br />

To improve shock delivery in cardioversion and defibrillation, we have designed and developed<br />

a device that 1) reduces the difficulty of switching the path that current takes through the body<br />

and 2) reduces the difficulty of applying standardized external pressure to the patches to reduce<br />

transthoracic impedance. The switching component of the PrestoPatch System utilizes a high-load<br />

switch that gives clinicians the option to manually switch the shocking vector between the first and<br />

second patch and the first and third patch during subsequent shocks. The placement of the three<br />

patches on the patient is fully customizable based on user preference, thus allowing for flexibility<br />

in producing a wide variety of shocking vectors and switching scenarios. The PrestoPatch System’s<br />

compression component utilizes an adjustable tightening strap and pressure-concentration devices.<br />

In practice, the pressure-concentration devices are placed over the electrode patches and the<br />

attached strap is tightened prior to shock delivery. This combination of tightened strap and pressureconcentrators<br />

provides a mechanical advantage that focuses the pressure exerted over the electrode<br />

patches. Subsequently, the transthoracic impedance of the patient during defibrillation is decreased,<br />

leading to more efficient delivery of electrical current to the heart.<br />

UNDERGRADUATE GLOBAL HEALTH<br />

Instalimb: Prosthesis for the Developing World<br />

Student Team: Rowan Cade, Rochelle Dumm, Ian Graham, Brian Jeon, Kevin Keenahan,<br />

Kevin Moon, German Om, Emily Rencsok<br />

Clinical Advisors: Mark <strong>Hopkins</strong>, PT, MBA, Department of Physical Medicine and Rehabilitation;<br />

Lew Schon, MD, Union Memorial Hospital<br />

To solve the problem of appropriate prosthetics in the developing world, we have designed,<br />

fabricated, and tested a novel system for directly fitting patients with re-moldable complete<br />

prosthetic legs. This reduces or eliminates the need for costly replacement devices and could save<br />

the amputee thousands of dollars over a lifetime. In addition, we are decreasing fitting time from<br />

one week to only hours by eliminating the need for expensive and time-consuming mold making<br />

procedures. Our device can be molded directly to a patient’s limb and sized and assembled in one<br />

visit. We are hopeful our device will be successfully implemented and will assuage the suffering of the<br />

nearly 10 thousand new amputees every year who are denied access to appropriate prostheses.<br />

Point of Care Malaria Diagnostic<br />

Student Team: Maher Khalil, Arjun Khakhar, Christina Jacob, Theodore Leclere, James Chuang,<br />

Jesse Zhang<br />

Faculty Advisors: Marc Ostermeier, PhD, Department of Chemical and Biomolecular Engineering;<br />

David Sullivan, MD, Department of Medicine<br />

Clinical Advisors: Robert Hamilton, PhD, Department of Pathology<br />

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To help clinicians in the developing world test for the presence of malaria, we have designed a<br />

point-of-care diagnostic device without the need to draw blood. Our device is a lateral flow assay<br />

that is able to detect malaria during the early stages of infection. Our novel platform replaces the<br />

antibodies that are generally used in such assays with bacteria expressing evolved scaffold proteins<br />

on their surface. Additionally, the device tests a patient’s urine for our biomarker, which obviates<br />

the need for skilled professionals to draw blood. Our point of care test can diagnose malaria<br />

quickly enough so that only patients requiring treatment receive it, thereby reducing the spread of<br />

drug resistant malaria. The device is suitable for implementation in areas with limited pre-existing<br />

healthcare infrastructure and limited training of healthcare workers.<br />

Neo2Inspire: A Global Health Perspective on NeoNatal Resuscitation<br />

Team Members: Anne Pigula, Malvi Hemani, Hyun Soo Jang, Yong Kim, Megan Lamberti,<br />

Angelica Herrera, Barbara Kim, Brian Gu<br />

Clinical Advisor: Sheena Currie, RM, Jhpiego<br />

Sponsors: Laerdal Global Health and Jhpiego<br />

Roughly one million newborns die every year due to difficulty breathing at birth, but many of these<br />

lives could have been saved by proper neonatal resuscitation. To address this problem, we have<br />

developed Neo2Inspire, a suite of tools to aid healthcare workers resuscitate newborns properly.<br />

First, we have developed a plastic mat that provides support while positioning the infant to achieve<br />

an open airway. This mat folds up into a box, which contains the bag-valve-mask resuscitator and<br />

other tools. Secondly, we have incorporated elastic straps to secure the mask onto the infant’s face,<br />

ensuring an airtight seal. Finally, to keep newborns warm, we have integrated a heat-producing<br />

mechanism within the mat that utilizes a reusable chemical packet. Neo2Inspire is inexpensive,<br />

easy to clean, sterilizable, and is supported by extensive end-user and laboratory testing.<br />

OcuRex: Automated Early Glaucoma Screening<br />

Student Team: Vikram Rajan, John J. Kim, Connor Jacobs, Tony Wei, Daniel Levenson, Edric Tam,<br />

Ivan Kuznetsov, Monica Rex, Ravi Gaddipati<br />

Clinical Advisor: Michael V. Boland, MD, PhD, Wilmer Eye Institute<br />

Faculty Advisor: Xingde Li, Ph.D., Department of Biomedical Engineering<br />

Glaucoma is the leading cause of irreversible vision loss. Astonishingly, up to 80 percent of afflicted<br />

individuals in developing nations are unaware of their illness. To mitigate the impact of glaucoma,<br />

we have designed an affordable and accurate glaucoma screening device. Based on the principles<br />

of fundus imaging, this device outputs a structural image of the retina that functions as an<br />

indicator of the developing pathology of the disease. The novel features of our device are designed<br />

to make the learning curve for healthcare workers short. The device’s components are optimized to<br />

lower cost while not sacrificing intended screening-grade functionality. Costs and time are further<br />

minimized by segmented imaging and analysis hardware.<br />

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Keynote Speaker<br />

Omar Ishrak, PhD<br />

Chairman and Chief Executive<br />

Officer of Medtronic<br />

Omar Ishrak has served as Chairman and Chief Executive Officer of Medtronic since<br />

June 2011. Medtronic is the world’s leading medical technology company, with<br />

more than $16 billion in annual revenue, and operations reaching more than 120<br />

countries worldwide. Medtronic provides therapies that are used to treat a wide<br />

range of conditions, including cardiac and vascular diseases, diabetes, neurological<br />

and spinal conditions, and more. The Medtronic Mission is to alleviate pain, restore<br />

health, and extend life for millions of people around the world.<br />

Omar joined Medtronic from General Electric Company, where he spent 16 years,<br />

most recently as President and CEO of GE Healthcare Systems, a $12 billion division<br />

of GE Healthcare, with a broad portfolio of diagnostic, imaging, patient monitoring<br />

and life support systems. Omar also served as an Officer and a Senior Vice President<br />

of GE.<br />

Earlier in his career, Omar amassed 13 years of technology development and<br />

business management experience, holding leadership positions at Diasonics/<br />

Vingmed, and various product development and engineering positions at Philips<br />

Ultrasound.<br />

He grew up in Bangladesh, earned a Bachelor of Science Degree and Ph.D. in<br />

Electrical Engineering from the <strong>University</strong> of London, King’s College.<br />

Omar is a member of the Board of Trustees of the Asia Society and is also on the<br />

Health Leadership Council of the Save the Children Foundation.<br />

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Our Sponsors:<br />

GE Foundation<br />

GlaxoSmithKline<br />

Jhpiego<br />

Laerdal Global Health<br />

Medtronic<br />

National Collegiate Inventors and Innovators Alliance<br />

Richard M. and Rachel A. Swirnow<br />

The Center for Bioengineering Innovation & <strong>Design</strong><br />

(CBID) brings <strong>Johns</strong> <strong>Hopkins</strong> clinicians and engineers<br />

together with experienced external aspects to<br />

design, build, and commercialize solutions to<br />

significant medical challenges. CBID design teams<br />

deliver innovations with high clinical impact, strong<br />

commercial potential, and global reach.<br />

As part of the nation’s top-ranked Department of<br />

Biomedical Engineering, CBID has equal footing in the<br />

<strong>Johns</strong> <strong>Hopkins</strong> Whiting School of Engineering and the<br />

School of Medicine. We welcome your partnership!<br />

Contact Us:<br />

Center for Bioengineering Innovation & <strong>Design</strong><br />

Department of Biomedical Engineering<br />

3400 N. Charles Street<br />

Clark Hall 208<br />

Baltimore, MD 21218<br />

410.516.0786<br />

cbid@jhu.edu<br />

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