106
D. L. Teodorescu et al.
outcomes in lengthy, complex procedures by providing more intensive control of the
intraoperative environment. LMICs will be interested in this device because of its
affordable price for creating a sterile environment for surgery that meets or exceeds
US and European standards, leading to a general improvement in surgical outcomes.
Within the second market segment, this device addresses a distinctive problem,
the unsafe and unsterile ad hoc operative location. Some stakeholders from NGOs
shared that they sometimes had to operate in open air. We expect the early adopters
to be surgeons from higher income countries working in disaster zones and in low
resource settings. While in disaster zones our device is a direct fit as there is no infrastructure at all, in low resource settings it addresses the main concern of their current
inability to provide the standard of hygiene and infection mitigation to which they are
accustomed. In addition, it also enhances provider safety by offering them a reduction
of exposure to the patient’s bodily fluids and aerosols. During the Ebola outbreak,
physicians and organizations promulgated and implemented standards for appropriate drapes and protective equipment for operating on possibly infected patients.
SurgiBox is in line with such protective efforts.
9.4.2.2 Production
To support advanced development of SurgiBox and pilot deployment, our collaboration is able to leverage our position at the intersection of academia and nongovernmental organization to seek both competitive grant funding and mutually beneficial
partnerships with other nongovernmental or governmental organizations. As a social
venture, we further benefit from the robust small business and social entrepreneurship
resource infrastructure available in the United States in general and in the Boston
area in particular, including funding initiatives.
SurgiBox’s design and prototyping process have emphasized minimizing not only
the cost of raw materials but also of manufacturing and packaging. By finding alternatives to complex, high-variance, high-cost components, we expect that the device
should be able to be manufactured to consistently high quality to comply with United
States Federal Drug Administration General Controls and similar regulations. Indeed,
it is conceivable that we can eventually engage with regional or local manufacturing
entities during scale-up stage, recognizing the importance of maintaining quality
controls compatible with a medical device. With the “cost of goods sold” for benchtop prototypes stabilizing, we are now conducting this analysis in the real world
setting.
9.4.2.3 Distribution
SurgiBox itself will be distributed as ultraportable, fully self-contained, ready-to-use
kits suitable for hand luggage, backpacks, drones, and other limited spaces. These
kits will contain the reusable component, one or more of the patient-contacting
components all individually wrapped, and batteries: all the items needed for full use
D. L. Teodorescu et al.
outcomes in lengthy, complex procedures by providing more intensive control of the
intraoperative environment. LMICs will be interested in this device because of its
affordable price for creating a sterile environment for surgery that meets or exceeds
US and European standards, leading to a general improvement in surgical outcomes.
Within the second market segment, this device addresses a distinctive problem,
the unsafe and unsterile ad hoc operative location. Some stakeholders from NGOs
shared that they sometimes had to operate in open air. We expect the early adopters
to be surgeons from higher income countries working in disaster zones and in low
resource settings. While in disaster zones our device is a direct fit as there is no infrastructure at all, in low resource settings it addresses the main concern of their current
inability to provide the standard of hygiene and infection mitigation to which they are
accustomed. In addition, it also enhances provider safety by offering them a reduction
of exposure to the patient’s bodily fluids and aerosols. During the Ebola outbreak,
physicians and organizations promulgated and implemented standards for appropriate drapes and protective equipment for operating on possibly infected patients.
SurgiBox is in line with such protective efforts.
9.4.2.2 Production
To support advanced development of SurgiBox and pilot deployment, our collaboration is able to leverage our position at the intersection of academia and nongovernmental organization to seek both competitive grant funding and mutually beneficial
partnerships with other nongovernmental or governmental organizations. As a social
venture, we further benefit from the robust small business and social entrepreneurship
resource infrastructure available in the United States in general and in the Boston
area in particular, including funding initiatives.
SurgiBox’s design and prototyping process have emphasized minimizing not only
the cost of raw materials but also of manufacturing and packaging. By finding alternatives to complex, high-variance, high-cost components, we expect that the device
should be able to be manufactured to consistently high quality to comply with United
States Federal Drug Administration General Controls and similar regulations. Indeed,
it is conceivable that we can eventually engage with regional or local manufacturing
entities during scale-up stage, recognizing the importance of maintaining quality
controls compatible with a medical device. With the “cost of goods sold” for benchtop prototypes stabilizing, we are now conducting this analysis in the real world
setting.
9.4.2.3 Distribution
SurgiBox itself will be distributed as ultraportable, fully self-contained, ready-to-use
kits suitable for hand luggage, backpacks, drones, and other limited spaces. These
kits will contain the reusable component, one or more of the patient-contacting
components all individually wrapped, and batteries: all the items needed for full use