2017
Global Health Innovations
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THE TEAM
Student Team: Taryn Amatruda, Tessa Bronez, Katie Kan, Arvind Mohan, Thai Nguyen, Rachel Yung
Advisors: Youseph Yazdi, PhD. Soumyadipta Acharya, MD, PhD., Aditya Polsani, BDS, MS, Yong Cho, PhD., Daniel Flo, Nathan Grenz, Jonathan Zimmer, Julia Chen, PhD., Shu Peng, MD, Ronald Berger, MD, PhD., Victor Yu, MSEABSTRACT
Currently only a small number of patients with bradycardia (abnormally slow heart rate) in China receive optimal treatment for their disease, as there are about 31 pacemaker implants per million population in China, compared to 272 in Japan and 767 in the United States. Pacemakers are used to treat patients with bradycardia and are a safe, effective, life-improving and often life-saving treatment. Thus, in collaboration with Medtronic, we set out to identify the root causes behind the low pacemaker adoption rate in China and develop a solution to begin to address this significant problem. Following our first ethnographic research trip to China in August 2016, we determined that patients diagnosed with bradycardia and recommended to receive a pacemaker are often hesitant to receive this life-improving treatment. Our findings showed that about one third of patients refuse to receive a pacemaker because they do not truly understand their diagnosis and the rationale behind needing a pacemaker. Variable patient education, the lack of reliable medical sources available for patients, and the very limited time (less than 5 minutes) physicians spend with their patients are all influential on the lack of patient understanding regarding pacemakers. In order to test our hypotheses about patient understanding and receive feedback on our potential solutions to address this unmet need, we interviewed more Chinese patients in January of 2017. With post-implantation pacemaker patient feedback, we determined the most impactful way to move forward. Thus, we have developed a patient-centered wearable smartwatch, called BradyBand, to improve pacemaker understanding in bradycardia patients. This consumer device empowers patients to track their health and understand how their symptoms and low quality of life are correlated with their heart condition. Although diagnostic devices for arrhythmias exist, they merely provide data to the physician about the patient’s disease state. BradyBand is the first device designed for post-diagnosis patients, providing them with clear data about their own cardiac health. It consists of a plethysmographic sensor to constantly track the patient’s heart rate, a button to track symptoms, and a clear summary of instances when the patient’s low heart rate is correlated with their symptoms. The device is designed with the end user in mind and therefore has a low-price point and intuitive user-interface. Through empowering patients to be more cognizant of their cardiac health, we believe BradyBand will help bradycardia patients receive the appropriate pacing treatment to improve their lives.
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THE TEAM
Student Team: Rachel An, Andrew Jann, Matthew Lerner, Polly Ma, Mohit Singhala
Advisors: Soumyadipta Acharya, MD, PhD; Azadeh Farzin, MD; Christopher Golden, MD; Alain Labrique, PhD; Youseph Yazdi, PhDABSTRACT
Approximately 2.7 million newborns die each year, with 75% of these deaths occurring during the first week of life. One approach to tackle this problem has been to send community health workers, or CHWs, to the home to assess the neonate during this high risk period. The CHW assesses the neonate based on the WHO guidelines: difficulty feeding, convulsions, chest indrawing, movement only when stimulated, respiratory rate greater than 60bpm, and temperature greater than 37.5°C or less than 35.5°C. Identification of even one of these danger signs is indicative of severe neonatal illness and result in referral of the neonate to a facility. However, the limited number of community health workers and infrequency of visits create a bottleneck, and the timing of proper assessment aligning with the onset of symptoms is happenstance. During the times in the first week when the CHW is not present, sick neonates may be identified too late to impact survival. By improving the frequency and quality of neonate assessment during the first week of life, our innovation aims to tackle preventable neonatal deaths caused by delayed identification of illness. NeMo (neonatal monitoring) aims to task-shift neonatal assessment from CHWs to mothers and provide tools for them to identify neonatal illness in the first week of life. The NeMo system consists of a smartphone application to guide the mother through the assessment based on the evidence-based WHO guidelines and a proprietary ultra low-cost disposable sensor that measures the respiratory rate and temperature of the neonate. The mother will use the system everyday for the first week of the neonate’s life, allowing for more frequent assessment of the neonate compared to the current standard of care.
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THE TEAM
Student Team: Brittany Allen, Katherine Czerniejewski, Phani Gaddipati, Arman Mosenia, Doran Walsten
Advisors: Youseph Yazdi, PhD., Soumya Acharya, MD, PhD, Tigistu Adamu, MD, Rachel Willardson, Mike Shanley, James BonTempo, Ed HuttonABSTRACT
The World Health Organization estimates that up to 70% of all biomedical equipment in low- and middle-income countries (LMICs) is partially or completely nonfunctional, most of which can be repaired using generalized skills and no extra parts. The lack of functional biomedical equipment is one of the underlying problems contributing to the lack of access to essential surgical care for 5 billion people globally. Unavailability of biomedical equipment results in delays of surgery due to fewer available operating rooms and referrals to higher-level hospitals. Even when the necessary equipment is present, it might be only partially functioning and lead to a higher risk of complications or death. TechConnect leverages the existing network of smartphones to distribute troubleshooting and repair guides to hospital technicians. The guides interactively guide the technician through the process of troubleshooting and repair step-by-step, providing relevant media and resources exactly when they are relevant. It also enables communication between technicians and clinical engineers, allowing them to share tips and tricks. TechConnect, in collaboration with Jhpiego, is preparing to distribute the application to technicians across East Africa in June. By collecting feedback, TechConnect can continue to improve the biomedical equipment repair experience – a step closer to providing safe and affordable surgical care across the globe.
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THE TEAM
Student Team: Marc Chelala, Kyle Cowdrick, David Gullotti, Sritam Rout, Amir Soltanianzadeh, Maria Torres
Advisors: Soumyadipta Acharya, MD PhD; Youseph Yazdi, PhD; Jay Pasricha, MD; Ashish Nimgaonkar, MD, Mouen Khashab, MD; Vivek Kumbhari, MD; Nick Durr, PhD; George Coles, PhD; James Beaty, PhD, Aditya Polsani, BDS, MSSponsor: Boston Scientific Endoscopy —Laura Christakis; Barry Weitzner; Jason Vankherhoven
ABSTRACT
With a population of 1.25 billion, 70% of patients living in rural villages, and a physician-patient ratio of 1:1674, there are distinct challenges for patient access to appropriate care in the Indian healthcare system. In partnership with Boston Scientific Endoscopy, our objective was to analyze both the technical and systemic challenges associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) in India to identify innovation targets that may increase patient access to ERCP in developing nations. Based on our insights from over 40 interviews with physicians in both India and the Johns Hopkins Medical Institutions, we have determined that a solution to facilitate the process of selective cannulation of the common bile duct during ERCP may have the highest clinical impact as it would reduce the training barriers for ERCP and increase the safety of the procedure. ERCP entails navigating an endoscope into the duodenum and gaining access into hepatobilitary tree to treat various diseases. At the start of the procedure the physician is tasked with threading a small guidewire (0.035” diameter) through a muscular sphincter to then enter the pancreaticobiliary tree in a process called “selective cannulation”. Once access has been established, physicians are able to perform therapies such as: retrieving obstructing gallstones, expanding tissue strictures, or placing a stent to relieve obstruction from malignancies. The most feared complication of this procedure is pancreatitis, which is a life-threatening condition that occurs in 5% of cases and is in part due to multiple failed cannulation attempts leading to tissue irritation. The high degree of technical skill and precision required for this procedure creates a steep learning curve, and it has been cited to require up to 400 cases for a physician to achieve an 80% success rate in selective cannulation. Our team is developing solutions to deskill the process of selective cannulation by addressing the two greatest challenges that our stakeholders have cited for performing ERCP: (1) visualization of the orientation of the common bile duct behind the papillary opening, and (2) increased control of the accessories (guidewire and sphincterotome) to decrease the risk of miscannulation into the pancreatic duct. Initial successes in ex-vivo experiments of our proof-of-concept prototypes have led us to pursue live porcine animal testing to validate their clinical efficacy. Results from the animal tests will further inform design decisions and future development iterations for this innovation target. We believe that our developments have the promise to positively impact therapeutic endoscopy by reducing training barriers for physicians and making safe ERCP more universally accessible for patients in the developing world.
U.S. Healthcare Innovations
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THE TEAM
Student Team: Brittany Allen, Taryn Amatruda, Phani Gaddipati, Arvind Mohan, Thai Nguyen
Advisors: Youseph Yazdi, PhD, Soumyadipta Acharya, MD, PhD, Bashar Safar, MBBS, Steven Wexner, MD. Neil Hyman, MD, Joseph Carmichael, MDABSTRACT
There are over 320,000 colorectal resection surgeries performed annually in the United States. One of the most devastating complications associated with these surgeries is an anastomotic leak, which causes digestive contents and fecal matter to spill into the abdominal cavity. The spillage causes infection in the surrounding tissue, resulting in agonizing pain, septic shock, and even death. Every year, over 30,000 patients suffer from anastomotic leak, and over 7,000 patients die as a result. Although some innovations have attempted to address anastomotic leak, they have either not gained widespread adoption or have been removed from the market. Difficult deployment methods, complicated fixation mechanisms, and high migration rates have been cited by physicians to be the primary reasons behind these previous device failures. MedConnect is developing RemovAL: an intraluminal barrier to prevent the spillage of digestive contents into the abdominal cavity during the anastomosis’ critical healing period. It’s not only time-effective and easy to deploy, but it is passed naturally after several weeks, eliminating the need for an additional procedure. Even if an anastomotic perforation occurs, the intraluminal barrier prevents any leakage of fecal matter into the abdominal cavity. Without fecal matter escaping the bowel, the risk of infection and sepsis is greatly diminished. As a result, RemovAL will reduce the significant morbidity and mortality associated with colorectal resections. In addition, hospitals are highly incentivized to adopt RemovAL to reduce the high annual economic burden of $1.2 billion currently associated with anastomotic leak re-interventions.
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THE TEAM
Student Team: Rachel An, Andrew Jann, Matthew Lerner, Polly Ma, Mohit Singhala
Advisors: Bashir Zikria MD, John Wilckens MD, Russell Taylor, PhD, Soumyadipta Acharya MD, PhD, Aditya Polsani, BDS, MSABSTRACT
The anterior cruciate ligament (ACL) is a key ligament in knee function and stability. Over 750,000 people suffer from an ACL tear in the United States every year, and incidence rates are increasing every year. In order to restore the function of the ACL, an ACL reconstruction surgery is performed to replace the torn ACL with a graft. During a reconstruction surgery, the torn ACL is removed so the surgeon can see the original ACL attachment sites on the bone (known as the ACL footprints). Tunnels are then drilled into the femur and tibia bone to make anchor points for the graft. The graft is then passed through the tunnels and fixed in place. 400,000 ACL reconstruction procedures are performed every year in the United States. Of these, 20% fail due to incorrect tunnel placement, resulting in about 57,600 patients who undergo a revision surgery. This amounts to a $360 million cost to the healthcare system each year. For the patients, a failed reconstruction surgery can result in decreased range of knee motion, decreased knee stability, increased rehabilitation time, and for most cases, a revision surgery. As most of these injuries typically occur during physical activity and is more common for teens and adolescents, the return to the original quality of knee function is particularly important. Additionally, when these injuries occur for budding or high-profile athletes, an ACL tear can be especially devastating and has the potential to end a career. With current techniques and tools for ACL tunnel placements, it is difficult for surgeons to reproducibly create anatomical tunnel placements. This is especially true for less experienced surgeons, who perform less than 10 ACL reconstruction surgeries per year. Thus, our team proposes a solution – Orthotract – to provide orthopedic surgeons with a tool that will facilitate more anatomical and reproducible tunnel placements for ACL reconstruction surgeries, in order to reduce failures and revisions.
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THE TEAM
Student Team: Tessa Bronez, Katherine Czerniejewski, Katie Kan, Arman Mosenia, Doran Walsten, Rachel Yung
Advisors: Antoine Azar, MD, Jody Tversky, MD, Franklin Adkinson, MD, Emily Heil, PharmD, Jason Woo, MD, MBA, Michael Albert, MDABSTRACT
Antibiotic resistance occurs when bacteria adapt to reduce the effectiveness of drugs, and is expected to be a leading cause of death worldwide by 2050. The use of broader-spectrum antibiotics, such as vancomycin and fluoroquinolones, are known to result in the more resistant organisms connected to antibiotic resistance. In order to combat this, Former President Barack Obama issued a federal mandate for hospitals nationwide to implement antimicrobial stewardship programs over the next 5 years. These broader-spectrum antibiotics are commonly prescribed to the 30 million Americans reporting a penicillin allergy. The problem is that 90% of this population are not actually allergic and as such, are forcing physicians to prescribe these unnecessary alternatives resulting in poor patient outcomes and excessive medical expenditures. This is why most hospitals, in compliance with the federal mandate, are looking to implement penicillin allergy testing on the large-scale. There is currently a gold standard method to penicillin allergy testing with FDA-approved reagents, but only 0.1% of patients reporting a penicillin allergy have been tested because the test is only performed in allergy clinics. It is currently not applicable to the hospital setting due to the lack of time and trained personnel, so patients remain untested. PCN Medical offers a solution that addresses the challenge areas of current penicillin allergy testing and easily fits into the current workflow while still aligning with the accepted gold standard. For the short term, our team is focusing on developing AssistID: an EMR-integrated software application that determines the likeliness of a positive allergy for a patient given their clinical history and an automated precision injection technology. By answering specific questions relating to a patient’s history, the software determines the chances of a positive allergy for each patient. This result then supplies healthcare professionals with the proper information in order to move forward with the best testing and treatment protocol. The automated injection technology consists of a motorized base unit that is compatible with current syringes on the market and utilizes proprietary needle attachments that as a system, inject a solution precisely enough to form the necessary bleb to get a result.
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THE TEAM
Student Team: Marc Chelala, Kyle Cowdrick, David Gullotti, Sritam Rout, Amir Soltanianzadeh, Maria Torres
Advisors: Nicholas Theodore,MD, Daniel Sciubba, MD, Jean-Paul Wolinsky, MD, Mari Groves, MD, Jeff Siewerdsen, PhD, Amir Manbachi, PhD, Youseph Yazdi, PhD, Soumyadipta Acharya, MD, PhD., Mitchell Foster, Chuck Montague, PhD, Ashish Nimgaonkar, MD, Aditya Polsani, BDS, MSABSTRACT
Approximately 55,000 patients undergo corrective surgery for spinal deformity every year. These surgeries involve the placement of screws and rods to reconstruct the patient’s spine to correct for their misalignment. Despite efforts to obtain optimal outcomes, up to 68% of cases remain misaligned postoperatively. In addition, approximately 10% of these misaligned patients have severe enough residual deformity that they require revision surgeries, as spinal imbalance is strongly correlated with decreased quality of life. The patients who do not require revisions must live with this remaining deformity and associated reduced quality of life. Postoperative misalignment is attributed in part to the fact that tools for an intraoperative assessment of alignment are lacking. Currently, preoperative planning platforms allow the surgeon to simulate surgical techniques that should result in the optimal alignment outcomes for their patients. However, this workflow breaks down as there is not currently an adequate mechanism of feedback in the operating room to inform the surgeon with high fidelity if their alignment goals have been achieved. For instance, surgeons can intraoperatively obtain radiographs of the patient’s spine, but most intraoperative machines only offer a limited field of view (3-4 vertebrae at a time). In addition, these options entails excess radiation, significant disruption to workflow, and the challenge of assessing spinal alignment across the full spinal column (encompassing up to 25 vertebrae). SpineAlign proposes a novel platform that empowers the surgeon to make real-time, intraoperative assessments of alignment of the spine with an emphasis on minimizing disruption to the surgical workflow. Conceived by a highly interdisciplinary team of engineers, surgeons, and computer scientists, the high quality product offered by SpineAlign will improve the surgeon’s confidence during surgery, reduce the risk of postoperative misalignment, and will better enable all surgeons to achieve their desired alignment outcomes for their patient every time.
