Navigating Breast Cancer Innovation in Uganda: Within and Without the Textbook.

The Center for Bioengineering Innovation and Design (CBID) at Johns Hopkins University (JHU) has established a comprehensive approach to addressing global health challenges. Central to CBID's modality on global health is a strategy that integrates education, research, and collaboration. Through its graduate program, CBID trains the next generation of health care innovators to address the specific needs of low- and middle-income countries (LMICs). Graduate student teams at CBID begin their year with a focus on a health care thematic area associated with a target country.

Development of a Digital Assistant to Support Teleconsultations Between Remote Physicians and Frontline Health Workers in India: User-Centered Design Approach.

BACKGROUND: Many low- and middle-income countries have adopted telemedicine programs that connect frontline health workers (FHWs) such as nurses, midwives, or community health workers in rural and remote areas with physicians in urban areas to deliver care to patients. By leveraging technology to reduce temporal, financial, and geographical barriers, these health worker-to-physician telemedicine programs have the potential to increase health care quality, expand the specialties available to patients, and reduce the time and cost required to deliver care. OBJECTIVE: We aimed to identify, validate, and prioritize unmet needs in the health care space of health worker-to-physician telemedicine programs and develop and refine a solution that addresses those needs. METHODS: We collected information regarding user needs through ethnographic research, direct observation, and semistructured interviews with 37 stakeholders (n=5, 14% physicians; n=1, 3% public health program manager; n=12, 32% community health workers; and n=19, 51% patients) at 2 telemedicine clinics in rural West Bengal, India. We used the Spiral-Iterative Innovation Model to design and develop a prototype solution to meet these needs. RESULTS: We identified 74 unmet needs through our immersion in health worker-to-physician telemedicine programs. We identified a critical unmet need that achieving optimal teleconsultations in low- and middle-income countries often requires shifting tasks such as history taking and physical examination from high-skilled remote physicians to FHWs. To meet this need, we developed a prototype digital assistant that would allow FHWs to assume some of the tasks carried out by remote clinicians. The user needs of multiple stakeholder groups (patients, FHWs, physicians, and health organizations) were incorporated into the design and features of the task-shifting tool. The final prototype was shared with the health workers, physicians, and public health program managers who expressed that the tool would be useful and valuable. CONCLUSIONS: The final prototype that was developed was released as an open-source digital public good and may improve the quality and efficiency of care delivery in health worker-to-physician telemedicine programs.

Nanofiber-coated, tacrolimus-eluting sutures inhibit post-operative neointimal hyperplasia in rats.

Post-operative complications of vascular anastomosis procedures remain a significant clinical challenge and health burden globally. Each year, millions of anastomosis procedures connect arteries and/or veins in vascular bypass, vascular access, organ transplant, and reconstructive surgeries, generally via suturing. Dysfunction of these anastomoses, primarily due to neointimal hyperplasia and the resulting narrowing of the vessel lumen, results in failure rates of up to 50% and billions of dollars in costs to the healthcare system. Non-absorbable sutures are the gold standard for vessel anastomosis; however, damage from the surgical procedure and closure itself causes an inflammatory cascade that leads to neointimal hyperplasia at the anastomosis site. Here, we demonstrate the development of a novel, scalable manufacturing system for fabrication of high strength sutures with nanofiber-based coatings composed of generally regarded as safe (GRAS) polymers and either sirolimus, tacrolimus, everolimus, or pimecrolimus. These sutures provided sufficient tensile strength for maintenance of the vascular anastomosis and sustained drug delivery at the site of the anastomosis. Tacrolimus-eluting sutures provided a significant reduction in neointimal hyperplasia in rats over a period of 14 days with similar vessel endothelialization in comparison to conventional nylon sutures. In contrast, systemically delivered tacrolimus caused significant weight loss and mortality due to toxicity. Thus, drug-eluting sutures provide a promising platform to improve the outcomes of vascular interventions without modifying the clinical workflow and without the risks associated with systemic drug delivery.

DescePrep Significantly Increases Descemet Membrane Endothelial Keratoplasty Processing Efficiency and Success Rate in Diabetic Human Donor Corneas in Comparison With Manual Dissection.

PURPOSE: The purpose of this study was to compare the safety, efficacy, and efficiency of a Descemet membrane endothelial keratoplasty (DMEK) graft processing device, DescePrep, with a manual dissection technique through the measurement of tissue yield, processing time, and graft viability in nondiabetic and diabetic donor corneas. METHODS: Nondiabetic (n = 20) and diabetic (n = 20) donor corneas were processed using DescePrep, which standardizes the liquid bubble technique. Nondiabetic (n = 20) and diabetic (n = 24) donor corneas were also processed through manual dissection. Corneas were stained, processed, and then evaluated for processing success rate and time. Randomly selected corneas (n = 5, each) were evaluated for cell viability using live/dead staining. RESULTS: One hundred percent of nondiabetic and 95% of diabetic corneas were processed successfully with DescePrep in an average of 3.37 minutes. Ninety percent of nondiabetic and 50% of diabetic corneas were processed successfully with manual dissection in an average of 9.87 minutes. DescePrep had a significantly lower processing time ( P < 0.0001) and significantly higher success rate in comparison with manual dissection. DescePrep grafts had an average cell viability of 91.1% ± 3.3% in nondiabetic and 91.5% ± 2.4% in diabetic corneas. Grafts prepared with manual dissection had an average cell viability of 89.5% ± 5.8% in nondiabetic and 88.1% ± 4.3% in diabetic corneas. CONCLUSIONS: DescePrep provides a more effective and efficient method of cornea preparation in comparison with the current standard, particularly in diabetic corneas, while providing comparable cell viability. Thus, DescePrep offers standardized DMEK processing that produces high-quality grafts at high yields, with the potential to expand access and improve the quality of DMEK graft preparation in a larger pool of donors.

Idea Generation Through Hackathon Event in Emergencies and Disasters, with Emphasis on Managing Flash Flood Disaster.

OBJECTIVE: This study was intended to demonstrate the applicability of the hackathon in idea generation for managing emergencies and disasters with a particular focus on flash floods. METHODS: A 4-day hackathon event was held, having 60 students, 9 mentors and 6 judges gathered to explore different ideas, and to solve problems of Iran flooding from mid-March to April, 2019. Of these, 10 teams with 6 students were accordingly formed to brainstorm and discuss the idea, while 9 mentors offered advice and guided them to manage their ideas. Then, all teams focused on designing their business models. Finally, the hackathon teams finalized their lean canvas and presented their ideas to the judging panel and the other participants. RESULTS: A total of 10 ideas were presented, and based on the knowledge and experience of the judges, 3 ideas that were more practical and useful were selected. CONCLUSIONS: As participants in a hackathon identify and present real-world problems, while ensuring that the prototype solutions address the end-user's needs, it could be used to drive innovation, generate ideas, promote change in emergencies and disasters, and can increase our preparedness for future events. It helps us to develop tools and applications to better respond to these events.

Evaluation of Efficacy, Efficiency, and Cell Viability of a Novel Descemet Membrane Endothelial Keratoplasty Graft Preparation Device, DescePrep, in Nondiabetic and Diabetic Human Donor Corneas.

PURPOSE: The purpose of this study was to evaluate the safety, efficacy, and efficiency of a Descemet membrane endothelial keratoplasty (DMEK) graft preparation device, DescePrep, through measurement of graft viability, yield, and preparation time in both healthy and diabetic (high-risk) donor eyes. METHODS: Twenty nondiabetic and 10 diabetic donor corneas were processed using DescePrep, which standardizes the liquid bubble technique. Corneas were stained with trypan blue and then processed. Cell counts through specular microscopy, optical coherence tomography imaging, and slit-lamp analysis were used for the evaluation of graft separation and viability in 5 nondiabetic corneas. The remaining 25 corneas (15 nondiabetic and 10 diabetic) were evaluated for preparation success rate and processing time. Ten corneas (5 nondiabetic and 5 diabetic) were randomly selected for further evaluation of global cell loss through staining. RESULTS: Ninety-seven percent of corneas (29 of 30) were prepared successfully with DescePrep. The average preparation time was 2.83 ± 1.8 minutes. There was no significant difference in the time of preparation between the nondiabetic and diabetic groups (P = 0.077). The overall average cell death after processing was 7.9% ± 3.7% for all corneas. There was no significant difference in cell viability between diabetic and nondiabetic tissues after DescePrep processing (P = 0.769). CONCLUSIONS: DescePrep is a new DMEK preparation technique that can process both nondiabetic and diabetic donor corneas at high yields in minutes. High-yield preparation of diabetic corneas may offer eye banks access to a larger donor pool, which is important because the demand for DMEK grafts continues to rise worldwide.

The role of hackathon in education: Can hackathon improve health and medical education?

To develop the next generation of healthcare innovators, students at all levels of education should be trained and encouraged to employ innovative and entrepreneurial approaches to deal with complicated challenges of today's health system. Applying innovation and entrepreneurship training to solve complex problems and focus on solution design has recently become common in medical universities all over the world. This paper clarifies the role of hackathons as an innovative educational approach in healthcare education systems. We propose a process model concerned with organizing hackathon events in the healthcare education system. This model can be used in the academic and practical design of hackathons for innovation purposes.

Ultra-thin, high strength, antibiotic-eluting sutures for prevention of ophthalmic infection.

Sutures are applied almost universally at the site of trauma or surgery, making them an ideal platform to modulate the local, postoperative biological response, and improve surgical outcomes. To date, the only globally marketed drug-eluting sutures are coated with triclosan for antibacterial application in general surgery. Loading drug directly into the suture rather than coating the surface offers the potential to provide drug delivery functionality to microsurgical sutures and achieve sustained drug delivery without increasing suture thickness. However, conventional methods for drug incorporation directly into the suture adversely affect breaking strength. Thus, there are no market offerings for drug-eluting sutures, drug-coated, or otherwise, in ophthalmology, where very thin sutures are required. Sutures themselves help facilitate bacterial infection, and antibiotic eye drops are commonly prescribed to prevent infection after ocular surgeries. An antibiotic-eluting suture may prevent bacterial colonization of sutures and preclude patient compliance issues with eye drops. We report twisting of hundreds of individual drug-loaded, electrospun nanofibers into a single, ultra-thin, multifilament suture capable of meeting both size and strength requirements for microsurgical ocular procedures. Nanofiber-based polycaprolactone sutures demonstrated no loss in strength with loading of 8% levofloxacin, unlike monofilament sutures which lost more than 50% strength. Moreover, nanofiber-based sutures retained strength with loading of a broad range of drugs, provided antibiotic delivery for 30 days in rat eyes, and prevented ocular infection in a rat model of bacterial keratitis.

Minimally invasive therapeutic ultrasound: Ultrasound-guided ultrasound ablation in neuro-oncology.

INTRODUCTION: To improve patient outcomes (eg, reducing blood loss and infection), practitioners have gravitated toward noninvasive and minimally invasive surgeries (MIS), which demand specialized toolkits. Focused ultrasound, for example, facilitates thermal ablation from a distance, thereby reducing injury to surrounding tissue. Focused ultrasound can often be performed noninvasively; however, it is more difficult to carry out in neuro-oncological tumors, as ultrasound is dramatically attenuated while propagating through the skull. This shortcoming has prompted exploration of MIS options for intracranial placement of focused ultrasound probes, such as within the BrainPath™ (NICO Corporation, Indianapolis, IN). Herein, we present the design, development, and in vitro testing of an image-guided, focused ultrasound prototype designed for use in MIS procedures. This probe can ablate neuro-oncological lesions despite its small size. MATERIALS & METHODS: Preliminary prototypes were iteratively designed, built, and tested. The final prototype consisted of three 8-mm-diameter therapeutic elements guided by an imaging probe. Probe functionality was validated on a series of tissue-mimicking phantoms. RESULTS: Lesions were created in tissue-mimicking phantoms with average dimensions of 2.5 × 1.2 × 6.5 mm and 3.4 × 3.25 × 9.36 mm after 10- and 30-second sonification, respectively. 30 s sonification with 118 W power at 50% duty cycle generated a peak temperature of 68 °C. Each ablation was visualized in real time by the built-in imaging probe. CONCLUSION: We developed and validated an ultrasound-guided focused ultrasound probe for use in MIS procedures. The dimensional constraints of the prototype were designed to reflect those of BrainPath trocars, which are MIS tools used to create atraumatic access to deep-seated brain pathologies.

Curricular Advancement of Biomedical Engineering Undergraduate Design Projects Beyond 1 Year: A Pilot Study.

A year-long design project is a typical requirement for an undergraduate engineering degree. However, the abbreviated, two-semester format limits most projects from reaching appropriate maturity for obtaining intellectual property (IP) protection, external funding, and/or peer-reviewed publications. The traditional model may be associated with some dissatisfaction with the abrupt ending of the work, as projects are often just completing their initial proof-of-concept testing after 1 year. This study reports the results of a pilot experiment that allowed such design projects to extend through a second year. We investigated three different mechanisms for continuation: research credits, a second-year curricular course (Advanced Design Teams), and extracurricular support. Students in this program continued to engage with an advisory board of clinicians, engineers, and other professionals, many of whom had assisted with the project during the first year. We investigated whether continuing the projects in a curricular fashion may provide a better avenue for productivity than extracurricular mechanisms. Based on the results of this pilot study, our department has formalized a curriculum to support teams beyond the first year, in which continuing students from the first-year teams can apply to continue their projects for credit toward their degrees.

Correction to: Curricular Advancement of Biomedical Engineering Undergraduate Design Projects Beyond 1 Year: A Pilot Study.

This erratum is to add author Nicholas J. Durr as a co-corresponding author.

A Novel Mobile Health Tool for Home-Based Identification of Neonatal Illness in Uganda: Formative Usability Study.

BACKGROUND: While early identification of neonatal illness can impact neonatal mortality rates and reduce the burden of treatment, identifying subtle clinical signs and symptoms of possible severe illness is especially challenging in neonates. The World Health Organization and the United Nations Children's Fund developed the Integrated Management of Neonatal Childhood Illness guidelines, an evidence-based tool highlighting seven danger signs to assess neonatal health. Currently, many mothers in low-resource settings rely on home visits from community health workers (CHWs) to determine if their baby is sick. However, CHWs visit infrequently, and illness is often detected too late to impact survival. Thus, delays in illness identification pose a significant barrier to providing expedient and effective care. Neonatal Monitoring (NeMo), a novel neonatal assessment tool, seeks to increase the frequency of neonatal screening by task-shifting identification of neonatal danger signs from CHWs to mothers. OBJECTIVE: This study aimed to explore the usability and acceptability of the NeMo system among target users and volunteer CHWs by assessing ease of use and learnability. METHODS: Simulated device use and semistructured interviews were conducted with 32 women in the Iganga-Mayuge districts in eastern Uganda to evaluate the usability of the NeMo system, which involves a smartphone app paired with a low cost, wearable band to aid in identification of neonatal illness. Two versions of the app were evaluated using a mixed methods approach, and version II of the app contained modifications based on observations of the first cohort's use of the system. During the posed scenario simulations, participants were offered limited guidance from the study team in order to probe the intuitiveness of the NeMo system. The ability to complete a set of tasks with the system was tested and recorded for each participant and closed- and open-ended questions were used to elicit user feedback. Additionally, focus groups with 12 CHWs were conducted to lend additional context and insight to the usability and feasibility assessment. RESULTS: A total of 13/22 subjects (59%) using app version I and 9/10 subjects (90%) using app version II were able to use the phone and app with no difficulty, despite varying levels of smartphone experience. Following modifications to the app's audio instructions in version II, participants' ability to accurately answer qualitative questions concerning neonatal danger signs improved by at least 200% for each qualitative danger sign. All participants agreed they would trust and use the NeMo system to assess the health of their babies. Furthermore, CHWs emphasized the importance of community sensitization towards the system to encourage its adoption and regular use, as well as the decision to seek care based on its recommendations. CONCLUSIONS: The NeMo system is an intuitive platform for neonatal assessment in a home setting and was found to be acceptable to women in rural Uganda.

A novel personal protective equipment coverall was rated higher than standard Ebola virus personal protective equipment in terms of comfort, mobility and perception of safety when tested by health care workers in Liberia and in a United States biocontainment unit.

BACKGROUND: During the 2014-2016 Ebola virus epidemic, more than 500 health care workers (HCWs) died in spite of the use of personal protective equipment (PPE). The Johns Hopkins University Center for Bioengineering Innovation and Design (CBID) and Jhpiego, an international nongovernmental organization affiliate of Johns Hopkins, collaborated to create new PPE to improve the ease of the doffing process. METHODS: HCWs in Liberia and a US biocontainment unit compared standard Médecins Sans Frontière PPE (PPE A) with the new PPE (PPE B). Participants wore each PPE ensemble while performing simulated patient care activities. Range of motion, time to doff, comfort, and perceived risk were measured. RESULTS: Overall, 100% of participants preferred PPE B over PPE A (P < .0001); 98.1% of respondents would recommend PPE B for their home clinical unit (P < .0001). There was a trend towards greater comfort in PPE B. HCWs at both sites felt more at risk in PPE A than PPE B (71.9% vs 25% in Liberia, P < .0001; 100% vs 40% in the US biocontainment unit, P < .0001). CONCLUSIONS: HCWs preferred a new PPE ensemble to Médecins Sans Frontière PPE for high-consequence pathogens. Further studies on the safety of this new PPE need to be conducted.

Starting a Medical Technology Venture as a Young Academic Innovator or Student Entrepreneur.

Following the footprints of Bill Gates, Steve Jobs and Mark Zuckerberg, there has been a misconception that students are better off quitting their studies to bring to life their ideas, create jobs and monetize their inventions. Having historically transitioned from manpower to mind power, we live in one of the most rapidly changing times in human history. As a result, academic institutions that are supposed to be pioneers and educators of the next generations have started to realize that they need to adapt to a new system, and change their policies to be more flexible towards patent ownership and commercialization. There is an infrastructure being developed towards students starting their own businesses while continuing with their studies. This paper aims to provide an overview of the existing landscape, the exciting rewards as well as risks awaiting a student entrepreneur, the challenges of the present ecosystem, and questions to consider prior to embarking on such a journey. Various entities influencing the start-up environment are considered, specifically for the medical technology sector. These parties include but are not limited to: scientists, clinicians, investors, academic institutions and governments. A special focus will be set on the seemingly unbridgeable gap between founding a company and a scientific career.

Use of a design challenge to develop postural support devices for intermediate wheelchair users.

The provision of an appropriate wheelchair, one that provides proper fit and postural support, promotes wheelchair users' physical health and quality of life. Many wheelchair users have postural difficulties, requiring supplemental postural support devices for added trunk support. However, in many low- and middle-income settings, postural support devices are inaccessible, inappropriate or unaffordable. This article describes the use of the design challenge model, informed by a design thinking approach, to catalyse the development of an affordable, simple and robust postural support device for low- and middle-income countries. The article also illustrates how not-for-profit organisations can utilise design thinking and, in particular, the design challenge model to successfully support the development of innovative solutions to product or process challenges.

Voluntary medical male circumcision in resource-constrained settings.

Throughout East and Southern Africa, the WHO recommends voluntary medical male circumcision (VMMC) to reduce heterosexual HIV acquisition. Evidence has informed policy and the implementation of VMMC programmes in these countries. VMMC has been incorporated into the HIV prevention portfolio and more than 9 million VMMCs have been performed. Conventional surgical procedures consist of forceps-guided, dorsal slit or sleeve resection techniques. Devices are also becoming available that might help to accelerate the scale-up of adult VMMC. The ideal device should make VMMC easier, safer, faster, sutureless, inexpensive, less painful, require less infrastructure, be more acceptable to patients and should not require follow-up visits. Elastic collar compression devices cause vascular obstruction and necrosis of foreskin tissue and do not require sutures or injectable anaesthesia. Collar clamp devices compress the proximal part of the foreskin to reach haemostasis; the distal foreskin is removed, but the device remains and therefore no sutures are required. Newer techniques and designs, such as tissue adhesives and a circular cutter with stapled anastomosis, are improvements, but none of these methods have achieved all desirable characteristics. Further research, design and development are needed to address this gap to enable the expansion of the already successful VMMC programmes for HIV prevention.

A new model for graduate education and innovation in medical technology.

We describe a new model of graduate education in bioengineering innovation and design- a year long Master's degree program that educates engineers in the process of healthcare technology innovation for both advanced and low-resource global markets. Students are trained in an iterative "Spiral Innovation" approach that ensures early, staged, and repeated examination of all key elements of a successful medical device. This includes clinical immersion based problem identification and assessment (at Johns Hopkins Medicine and abroad), team based concept and business model development, and project planning based on iterative technical and business plan de-risking. The experiential, project based learning process is closely supported by several core courses in business, design, and engineering. Students in the program work on two team based projects, one focused on addressing healthcare needs in advanced markets and a second focused on low-resource settings. The program recently completed its fourth year of existence, and has graduated 61 students, who have continued on to industry or startups (one half), additional graduate education, or medical school (one third), or our own Global Health Innovation Fellowships. Over the 4 years, the program has sponsored 10 global health teams and 14 domestic/advanced market medtech teams, and launched 5 startups, of which 4 are still active. Projects have attracted over US$2.5M in follow-on awards and grants, that are supporting the continued development of over a dozen projects.