100
D. L. Teodorescu et al.
eries, leading to both poor availability and poor provider adherence. Thus, surgical
teams are vulnerable to infections from patient bodily fluids.
9.1.4 SurgiBox: Solution Concept for the Double Challenge
in Safe Surgery
The SurgiBox platform moves away from the assumption that the surgical space of
interest is the operating room. Fundamentally, the space that matters is the incision
and immediate surgical field over the patient. This recognition literally shrinks the
challenge down from over thousands of cubic feet of space to well under 10 cubic feet
to be kept sterile. The nature of protection actually changes, as contamination can
come from patients themselves, providers, and the external environment. Creating
a physical barrier from contamination completely from the latter two, and significantly from the patients themselves, theoretically permits more robust protection
than would the classic, costly combination of sterile room, sterile scrub suit, and
sterile drapes. A system that can effectively maintain a sterile field in this limited
space, as presented here, provides a low-cost, ultraportable platform for regulating
intraoperative conditions at the surgical site, making safe surgery more accessible. At
the same time, isolating the surgical field blocks potentially infectious particles and
fluids from reaching providers at all. This is a more efficient system than capturing
with individual PPE after they have already left the surgical field.
This paper is organized as follows. Section 9.2 describes SurgiBox’s iterative
prototyping and evaluation methods. Section 9.3 presents the design and our results
to date. Section 9.4 discusses ongoing as well as future efforts in device development
and deployment. Section 9.5 discusses SurgiBox’s broader implications.
9.2 Methods
9.2.1 Patient- and Stakeholder-Centered Development
The objective of SurgiBox overall is to provide a low-cost, ultraportable system to
maintain sterile conditions during invasive procedures, even when performed in contaminated settings. However, as with any medical device, particularly one intended
for developing settings, other complex requirements are critical to stakeholder acceptance (Caldwell et al. 2011). A key risk was the rejection of the device by the end user
despite technical success, so extensive measures were taken to mitigate this. Extensive preliminary interviews as well as ongoing stakeholder interviews were conducted, and input was received from physicians who work in the developing world,
surgical researchers, biomedical and device engineers, global health and development researchers as well as other workers, members of the medical device industry,
D. L. Teodorescu et al.
eries, leading to both poor availability and poor provider adherence. Thus, surgical
teams are vulnerable to infections from patient bodily fluids.
9.1.4 SurgiBox: Solution Concept for the Double Challenge
in Safe Surgery
The SurgiBox platform moves away from the assumption that the surgical space of
interest is the operating room. Fundamentally, the space that matters is the incision
and immediate surgical field over the patient. This recognition literally shrinks the
challenge down from over thousands of cubic feet of space to well under 10 cubic feet
to be kept sterile. The nature of protection actually changes, as contamination can
come from patients themselves, providers, and the external environment. Creating
a physical barrier from contamination completely from the latter two, and significantly from the patients themselves, theoretically permits more robust protection
than would the classic, costly combination of sterile room, sterile scrub suit, and
sterile drapes. A system that can effectively maintain a sterile field in this limited
space, as presented here, provides a low-cost, ultraportable platform for regulating
intraoperative conditions at the surgical site, making safe surgery more accessible. At
the same time, isolating the surgical field blocks potentially infectious particles and
fluids from reaching providers at all. This is a more efficient system than capturing
with individual PPE after they have already left the surgical field.
This paper is organized as follows. Section 9.2 describes SurgiBox’s iterative
prototyping and evaluation methods. Section 9.3 presents the design and our results
to date. Section 9.4 discusses ongoing as well as future efforts in device development
and deployment. Section 9.5 discusses SurgiBox’s broader implications.
9.2 Methods
9.2.1 Patient- and Stakeholder-Centered Development
The objective of SurgiBox overall is to provide a low-cost, ultraportable system to
maintain sterile conditions during invasive procedures, even when performed in contaminated settings. However, as with any medical device, particularly one intended
for developing settings, other complex requirements are critical to stakeholder acceptance (Caldwell et al. 2011). A key risk was the rejection of the device by the end user
despite technical success, so extensive measures were taken to mitigate this. Extensive preliminary interviews as well as ongoing stakeholder interviews were conducted, and input was received from physicians who work in the developing world,
surgical researchers, biomedical and device engineers, global health and development researchers as well as other workers, members of the medical device industry,