JENNA MUELLER, UNIVERSITY OF MARYLAND
In health care systems located in low- and middle-income countries, addressing the growing burden of cancer diagnosis and surgery may require a new vision — one that leverages affordable, portable, electricity-independent, and accessible biomedical technologies. Technologies that leverage biomedical optics are poised to meet this need because they can capture relevant morphological and physiological information that guides cancer diagnoses and excisions. These technologies can also be developed to enable procedures that are fast, low-cost, noninvasive, and nondestructive to tissue, making such devices potentially well suited for areas where surgical space is limited.
According to the World Health Organization, 4.8 billion people worldwide lack access to safe, timely, and affordable surgical care and anesthesia. The vast majority of these people reside in low- and middle-income countries, where over 70% of the global cancer-related deaths now occur.
To develop technologies enabled by biomedical optics, engineers are turning to human-centered design during product development, an approach that involves the perspective of the end user — the surgeon and surgical staff that work in the operating room — throughout the design process. Through an iterative process of designing devices together with the perspective of end users in lower-income areas, researchers from the University of Maryland and other institutions recently learned about key design considerations involving adaptability in the field that were not initially apparent to system designers.
These more accessible medical devices could ultimately reduce the burden of disease experienced by the most marginalized populations.
The initial cost for purchasing devices can be an obstacle, but ongoing costs are also an impediment to the implementation of new technology. For example, it costs more than $130,000 to purchase laparoscopic equipment to outfit a single operating room for laparoscopic surgery. To maintain equipment in higher-income countries, medical device companies sell expensive service contracts to hospitals and typically keep representatives on call who can perform repairs in between or during surgical procedures.
Our collaborators in East Africa, who would like to perform a majority of their surgeries laparoscopically — due to the significant and well-documented benefits to patients compared to traditional open surgery — applied for a grant and coordinated with their Ministry of Health to secure state-of-the-art laparoscopic equipment. However, their laparoscope remains largely unused due to the need for ongoing maintenance that is not affordable or locally accessible.
Another key design consideration for lower-income areas is that consumables are often inaccessible, including anything from medical consumables (catheters, needles, syringes, gloves, drapes, oxygen, and carbon dioxide) to infrastructure consumables (electricity and running water). Biomedical technologies for these lower-income areas should ideally be designed to avoid the constant need for consumables. This would cut down on ongoing expenses because many procedures require hundreds of dollars in consumables for each patient. Our group is exploring whether gasless laparoscopy, which does not require carbon dioxide, is possible by mechanically lifting the abdomen, for example.
When devices are properly designed for low- and middle-income countries, the designers must also navigate the complex world of regulatory bodies. Due to a lack of established regulatory bodies in these countries, many medical device companies choose to pursue the expensive and time-consuming process of going through the U.S. FDA or the European Medicines Agency. Our group and others have called for a streamlined regulatory process that would facilitate bringing medical devices to African markets.
As engineers with expertise in optics, we have an opportunity to increase global access to health care by developing biomedical technologies designed with these key considerations in mind. These more accessible medical devices could ultimately reduce the burden of disease experienced by the most marginalized populations. Additionally, these redesigned devices could facilitate more equitable access to health care in rural areas in higher-income countries, where patients often face similar obstacles to accessing health care services.
Meet the author
Jenna Mueller, Ph.D., is an assistant professor in the Fischell Department of Bioengineering at the University of Maryland and in the Department of OB-GYN and Reproductive Science at the university’s School of Medicine. She is also a member of the Program in Oncology at the university’s Marlene and Stewart Greenebaum Comprehensive Cancer Center. She received her bachelor’s degree in bioengineering, with a minor in global health technologies, from Rice University, and received both a master’s degree and a doctorate in biomedical engineering at Duke University for her work developing optical systems and automated algorithms to improve the accuracy of cancer excision during surgery. She completed her postdoctoral training at Duke University, during which she worked with a multidisciplinary team to develop the Pocket colposcope, an optical device to diagnose cervical pre-cancer in women in low- and middle-income countries; email: [email protected].
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