Medical devices are often designed to meet the needs and regulatory requirements of high-income countries, as there are not well-established pathways for commercialization in low- and middle-income countries (LMICs).This panel will feature three DGHI-led projects that are seeking to commercialize medical devices to address needs in LMICs: KeyScope, a portable laparoscope for thoracic and abdominal surgeries; Callascope, a device to aid self-administered cervical cancer screening; and ENIyT, a flexible nasopharyngoscope to screen for throat cancers. 

Researchers will explore the common challenges they have faced working in Asia, Africa and South America. They will describe the process of designing, testing and manufacturing their innovations, as well as the unique ways they have sought to involve students, collaborate with global partners, and find avenues to bring their devices to the market. In particular, challenges in organizing clinical trials, navigating intellectual property matters and seeking regulatory approval will be addressed. The obstacles and successes of these projects in three different global contexts offer lessons for building and sustaining a culture that supports innovation within a research program. 

SPEAKERS

Tamara Fitzgerald M.D., Ph.D., (moderator) is an Associate Professor of Surgery and Associate Research Professor of Global Health. Dr. Fitzgerald’s academic interest is global pediatric surgery. Millions of children worldwide do not have access to safe surgery for congenital anomalies and acquired conditions. As a result, many children in low- and middle-income countries live with chronic disability or die before they can access surgical care.  In many cultures, congenital problems may also lead to social isolation or catastrophic health expenditure for families. In sub-Saharan Africa, for example, many countries have just a handful of qualified surgeons and some countries have no pediatric surgeons. Dr. Fitzgerald’s work focuses on surgical capacity building and surgical technology for low-income settings.  Capacity building is empowering and working with local surgeons to increase numbers of surgical providers, improve quality and increase surgical support services such as intensive care and anesthesia services.  She has several ongoing projects regarding the burden of surgical disease for patients and their families in low-and middle-income countries, surgical training and cost-effective technology solutions.

Marlee Krieger, M.S., is a founding member of the Center for Global Women’s Health Technologies, where she has served since 2007. Since being named Executive Director in 2018, Marlee has built and leads a diverse set of multidisciplinary educational programs, spearheads the Center’s international collaborations which focus on the clinical implementation of technologies developed at Duke, and has become widely successful in securing financial support for Center related research and education. Her research efforts focus on generating a deeper understanding of the scaling and adoption of novel healthcare innovations as well as the potential barriers to ultimate market acceptance. Additionally, she works with many members of the Pratt community as well as faculty, staff and students in numerous other departments across campus including, DGHI, Surgery, Ob/Gyn, Pathology and FUQUA and the Margolis Center for Health Policy. She obtained her undergraduate degree in Biology at the University of Massachusetts, where she also received a M.S. in Molecular and Cellular Biology.

Julius Mugaga is the Head of the Design Cube – a Biodesign Innovation space constructed from repurposed shipping containers and hosted at the College of Health Sciences, Makerere University. In the space, he is coordinating the construction of the KeyScope and other projects in partnership with Duke University. Julius has great enthusiasm for Biodesign Teaching, medical device design and research, and local product manufacturing. He is also driven with a great passion for applying Human-centered design, Design Thinking and the application of these principles in innovating Fit- for-Purpose solutions mainly to local healthcare challenges. He currently holds two Utility model IPs and one copyright registered in Uganda. He holds a B.S. in biomedical engineering and Msc in bioinformatics from Makerere University in Uganda. 

Walter T. Lee, M.D., MHS,  is a Professor & Chief of Staff of the Department of Head and Neck Surgery & Communication Sciences, Co-Director of the Head and Neck Program, and an affiliate faculty member at the Duke Global Health Institute. As Chief of Staff, he works closely with others to foster a culture of support, respect, and fulfillment among the faculty, staff, and trainees. He spearheads the professional and leadership development and also chairs the Departmental Appointment Promotions, and Tenure Committee (APT). As Division Chief, he oversees a world class multidisciplinary team that cares for head and neck cancer patients and their loved ones across Duke University and Duke Raleigh Hospitals.

This is a hybrid event with both in-person and remote attendance options. Attendance in person is encouraged. Lunch will be available.