9 Developing a Low-Cost, Ultraportable, Modular …
105
of the system’s barrier function, we also plan to correlate with settle plate testing to
assess colony-forming unit counts. The second limitation is that the tests are conducted in static conditions. Ongoing work is using standardized rigs to simulate use
conditions.
While we do strive to simulate field conditions in the lab and to assess ease of
use of the prototypes by stakeholders with experience in LMIC settings, we are
planning to work with LMIC community partners abroad to supply SurgiBox kits
to the field. By performing ex vivo setups in truly field conditions, we can collect
further data and feedback to identify any additional issues requiring optimization as
well as impacts on workflow. These will most likely occur in India and Uganda. By
supplying SurgiBox kits with a variety of frame and port components, we hope to
encourage community partners to tinker with the prototypes to suit their needs.
While we have striven at every step to make SurgiBox as user-friendly as possible,
we recognize that there will likely be resistance if it were presented on the basis of
in vitro sterility data only. After all, there are many determinants of safe surgery.
Therefore, even though SurgiBox would qualify as a CE Mark IIA device that does
not require efficacy studies, we still plan to voluntarily conduct trial surgeries on
animals in simulated field conditions to assess impact on clinical outcomes such as
wound contamination rates and SSI rates.
9.4.2 Road to the Market
The key to deploy SurgiBox worldwide is to understand the existing market, the
needs, and how the device can fill the void. Our major considerations fall into three
main categories: market segmentation, production, and distribution.
9.4.2.1 Market Segmentation
The first step is to segment the market into different categories. There are two main
segments that SurgiBox strives to target: on one hand, it can be used to reinforce
protections available in existing medical infrastructures. On the other hand, it can
be used as part of an ultraportable kit that gives access to surgery in places where
there is no medical care, such as war zones, natural disaster areas, and even remote
villages only accessible by foot.
Through different interviews with surgeons from LMICs, we discovered that many
existing infrastructures such as district hospitals are austere: due to their very high
cost, ventilation systems are often absent from operating rooms, which also often have
doors open throughout surgeries, sometimes even directly showing to the main road.
All these highly increase the probability for the patients to develop SSIs. SurgiBox
is therefore expected to reduce healthcare costs by permitting surgical procedures to
be performed in less-expensive procedure rooms, and reduce SSIs if used in tandem
with existing facilities. In tertiary care centers, it can conceivably offer improved
105
of the system’s barrier function, we also plan to correlate with settle plate testing to
assess colony-forming unit counts. The second limitation is that the tests are conducted in static conditions. Ongoing work is using standardized rigs to simulate use
conditions.
While we do strive to simulate field conditions in the lab and to assess ease of
use of the prototypes by stakeholders with experience in LMIC settings, we are
planning to work with LMIC community partners abroad to supply SurgiBox kits
to the field. By performing ex vivo setups in truly field conditions, we can collect
further data and feedback to identify any additional issues requiring optimization as
well as impacts on workflow. These will most likely occur in India and Uganda. By
supplying SurgiBox kits with a variety of frame and port components, we hope to
encourage community partners to tinker with the prototypes to suit their needs.
While we have striven at every step to make SurgiBox as user-friendly as possible,
we recognize that there will likely be resistance if it were presented on the basis of
in vitro sterility data only. After all, there are many determinants of safe surgery.
Therefore, even though SurgiBox would qualify as a CE Mark IIA device that does
not require efficacy studies, we still plan to voluntarily conduct trial surgeries on
animals in simulated field conditions to assess impact on clinical outcomes such as
wound contamination rates and SSI rates.
9.4.2 Road to the Market
The key to deploy SurgiBox worldwide is to understand the existing market, the
needs, and how the device can fill the void. Our major considerations fall into three
main categories: market segmentation, production, and distribution.
9.4.2.1 Market Segmentation
The first step is to segment the market into different categories. There are two main
segments that SurgiBox strives to target: on one hand, it can be used to reinforce
protections available in existing medical infrastructures. On the other hand, it can
be used as part of an ultraportable kit that gives access to surgery in places where
there is no medical care, such as war zones, natural disaster areas, and even remote
villages only accessible by foot.
Through different interviews with surgeons from LMICs, we discovered that many
existing infrastructures such as district hospitals are austere: due to their very high
cost, ventilation systems are often absent from operating rooms, which also often have
doors open throughout surgeries, sometimes even directly showing to the main road.
All these highly increase the probability for the patients to develop SSIs. SurgiBox
is therefore expected to reduce healthcare costs by permitting surgical procedures to
be performed in less-expensive procedure rooms, and reduce SSIs if used in tandem
with existing facilities. In tertiary care centers, it can conceivably offer improved