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Chapter 9
Developing a Low-Cost, Ultraportable,
Modular Device Platform to Improve
Access to Safe Surgery
Debbie L. Teodorescu, Dennis Nagle, Sashidhar Jonnalagedda, Sally Miller,
Robert Smalley and David R. King
9.1 Introduction
9.1.1 Surgical Care as Part of the Global Health
Armamentarium
Over 30% of the global disease burden requires surgical therapy, which could
prevent over 18 million deaths and save USD $200 billion annually. The condi-
tions amenable to surgical therapy range broadly, from traumatic to obstetrical to
infectious to oncological and beyond. Yet, in low–middle-income countries (LMICs),
an estimated two billion people have effectively no access to surgical care, and another
D. L. Teodorescu (B)·D. Nagle
MIT D-Lab, Cambridge, USA
e-mail: DLTeodor@surgibox.org; debbiepl@mit.edu
D. Nagle
e-mail: dennisnagle8@gmail.com
S. Jonnalagedda
Program Essential Tech Cooperation and Development Center EPFL, Lausanne, Switzerland
e-mail: sashidhar.jonnalagedda@alumni.epfl.ch
S. Miller
MIT Department of Mechanical Engineering, Cambridge, USA
e-mail: millersa@mit.edu
R. Smalley ·D. R. King
Harvard Medical School, Boston, USA
e-mail: rob@surgibox.org
D. R. King
e-mail: dking3@mgh.harvard.edu
D. R. King
Massachusetts General Hospital Department of Surgery, Boston, USA
© The Author(s) 2018
S. Hostettler et al. (eds.), Technologies for Development,
https://doi.org/10.1007/978-3-319-91068-0_9
97
98 D. L. Teodorescu et al.
two to three billion have access only to surgeries performed in unsterile settings such
as general-use buildings or even outdoors (“Global Surgery 2030”, 2015; Disease
Control Priorities Project 2008). In addition to this chronic deficiency in surgical
access, field surgical zones in disaster-affected areas are often exposed to frank par-
ticulate and insect contamination.
9.1.2 Patient Safety in Surgery: Infrastructural Challenges
to Sterility
In LMICs, surgical patients develop disproportionate rates of surgical site infec-
tions (SSIs), particularly the deep infections characteristic of intraoperative con-
tamination. Meta-analyses (Allegranzi et al. 2011) have found that 0.4–30.9 per
100 surgical patients in LMICs develop SSIs. In particular, even in clean and clean-
contaminated wounds, which had not previously been contaminated by traumatic skin
breaks, uncontrolled gut flora spillage, etc., the median cumulative incidences were
still, respectively, 7.6% (range 1.3–79.0%) and 13.7% (1.5–81.0%), all several times
higher than in higher income countries (Ortega et al. 2011). Most alarmingly, these
figures represent early postoperative infections of deep visceral spaces and organs,
not superficial tissues, a finding underscored by Nejad et al. (2011) meta-analysis
that showed 6.8–46.5% incidence of deep infections in postoperative patients, and
10.4–20.5% of infections in organ spaces. Bjorklund et al. (2005) analysis showed a
particularly unfortunate interaction between immunosuppression—all too common
in the developing world due to poor nutrition, untreated illness, and HIV—and unster-
ile surgical conditions in producing very high rates of severe infection following
c-sections. These infections translate into longer stays at already-overcrowded hos-
pitals: eight additional days on average in Tanzanian and Ethiopian studies, 10 days
in a Burkina Faso study comparing surgical patients with and without SSIs (Eriksen
et al. 2003; Taye 2005; Sanou et al. 1999). In nascent healthcare systems with lim-
ited infrastructures, SSIs that effectively double or triple patient stay lengths fetter
institutions’ ability to cope and reduce the volume of new patients that could be
accommodated. Taye (2005) noted that SSIs were associated with 2.8-fold increased
mortality (10.8% vs. 3.9%).
Numerous factors impact surgical site infection rates. These have been most
authoritatively summarized by the Lancet Commission on Global Surgery (2015) and
range from preoperative antibiotic administration to drape selection to handwashing
and beyond. A particularly pernicious and challenging one to address has been that of
the contaminated environment. Whyte et al. (1982) and Edmiston et al. (2005)have
described the general link between airborne contamination and SSIs, with an esti-
mated 30–98% of wound bacteria attributable to airborne contaminants, depending
on the ventilation system in an operating room. In higher income countries, invasive
procedures are typically performed by scrub-attired personnel striving to reduce con-
tamination in operating rooms with meticulously filtered air. In LMICs, such facil-
9 Developing a Low-Cost, Ultraportable, Modular … 99
ities and infrastructure are frequently unavailable. Procedures instead often occur
wherever dedicated space could be found, whether general-use rooms, outdoors, or
other suboptimal settings. Pathogen-carrying insects, dust particles, provider skin
squames, and numerous other dangers frequently breach the sterile field. Even in
state-of-the-art operating rooms, relatively modest breaches due to events such as
door openings have been associated with increased SSI rates. Indeed, decreasing the
number of times doors was opened decreased SSI rates by 36% in one study and
51% in another (Van der Slegt et al. 2013; Crolla et al. 2012). The absence of any
door at all, or of effective surgical suite ventilation, in the LMIC operating space is
therefore quite a concern.
The need to provide safe surgical care outside of traditional surgical facilities
is certainly not a new problem. However, solutions to the challenge have typically
started from the assumption that the core problem is to provide a sterile operating
room outside of a standard facility. This mindset informs solutions such as surgical
tents, operating rooms mounted on trailers or trucks, semi-portable laminar airflow
systems, and most other solutions to date. These devices unfortunately tend to share
several significant limitations in practice. They are challenging to transport to remote
or disaster-affected areas, requiring both time and logistical capability. Once at the
desired site, they require significant setup time. For example, surgical tents can take
a full team of technicians working around the clock for 72 h to fully set up. Several
of these systems have at least one external dependency, particularly availability of
electricity or requirement of flat terrain. They require significant resources not only
for sunk cost but also for marginal cost of each procedure. Personnel, a particularly
scarce resource, is also required to set up and maintain these complex systems. These
systems are not always robust to the high levels of external contamination, with sand
particulate ingress into the tents a particularly notorious phenomenon in the field
(e.g., as described by Stevenson and Cather 2008). Finally, any contamination in
these systems, including that generated by providers through squame shedding, can
still contaminate the surgical site.
9.1.3 Provider Safety in Surgery: Protecting Surgical Teams
Patients are not the only ones who can get infected during surgeries. Some 85,000
medical providers worldwide are infected every single year by patient bodily fluids,
with the vast majority of surgeons and obstetrician/gynecologists having experienced
at least one exposure in the past year (Butsashvili et al. 2012). Despite the lower vol-
ume of invasive procedures occurring in austere settings, 90% of providers infected
were working in such settings (World Health Organization 2011). Such chronic risks
were thrust into sharp relief during the Ebola epidemic, when, for instance, Sierra
Leone’s surgeons encountered 100-fold infection rate increases compared with the
general population, resulting in the death of 25% of the surgeons in the main teaching
hospital of the capital (Yasmin and Sathya 2015; Bundu et al. 2016). Unfortunately,
personal protective equipment (PPE) is costly and cumbersome to wear during surg-
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 signif-
icantly 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 con-
taminated settings. However, as with any medical device, particularly one intended
for developing settings, other complex requirements are critical to stakeholder accep-
tance (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. Exten-
sive preliminary interviews as well as ongoing stakeholder interviews were con-
ducted, and input was received from physicians who work in the developing world,
surgical researchers, biomedical and device engineers, global health and develop-
ment researchers as well as other workers, members of the medical device industry,
9 Developing a Low-Cost, Ultraportable, Modular … 101
Table 9.1 Stakeholder-generated device specifications
Ultraportable Entire system should fit into a backpack or duffel bag
Quick setup Setup time should not interfere with surgical prep
Ergonomic Should fit well into existing surgical workflow
One size fits all Can be used for all sizes of patients by all types of users
Low cost Cost should not exceed the cost of surgical drapes
Self-contained Battery-powered
Sterile Meets or exceeds operating room standards
Good visibility User’s view of surgery must be unobstructed
Protective Prevents bodily fluid splashes and aerosols from reaching users
and innovation strategists. These discussions generated the objectives and specifi-
cations as shown in Table 9.1. We used existing data from anthropometric tables
(with the aim to accommodate the 5th through 95th percentiles of providers and
of patients), surgical ergonomics research, and operating room design guidelines to
populate design specifications for the prototypes.
Throughout the design process, the prototype has been split into modules to
improve team efficiency. The overall design concept was split into enclosure design,
ports design, and environmental control system design.
9.2.2 Proof of Concept Testing
In addition to evaluating ergonomic and workflow acceptability, we focused on
whether the system actually provides a level of sterility consistently equivalent to or
exceeding that available in state-of-the-art operating rooms.
We actually proved this for two separate setups of SurgiBox, both set up in a mixed-
use machine shop at MIT D-Lab. In an earlier iteration, as reported in Teodorescu
et al. (J Med Dev 2016), the prototype utilized a rigid external frame and therefore
started with a full internal volume of contaminated air. The environmental system
was based on an off-the-shelf powered air purifying respirator system calculated to
supply 110 air changes per hour from a simple hole-in-side inlet. Measurements were
then taken at the xiphoid as the approximate center point of a large surgery combining
laparotomy and thoracotomy as may occur to address trauma or hemorrhage, as well
as at the flanks to assess particle pooling. These were repeated with armports and
material ports open. In the more recent iteration, as detailed in Teodorescu et al. (in
press, IEEE Xplore), the enclosure is inflated from flat packaging, but intentionally
not sterile as it would be in real life, to mimic contamination that could occur during
introduction of the instrument tray during setup. Air was supplied at 66 air changes
per hour by a HEPA-motor-power setup that we built ourselves. The system then
used a special manifold setup to distribute airflow in laminar fashion through the
102 D. L. Teodorescu et al.
enclosure. Material ports were kept closed; armports were kept in neutral position.
Particle counts were then benchmarked against Wagner et al. (2014) data correlating
particle counts and colony-forming units in operating rooms.
9.3 Results
9.3.1 Device Design
SurgiBox is an ultraportable, modular system to provide sterile intraoperative envi-
ronments over surgical sites. This product went through extensive evolution. Initially,
the design comprised a reusable box-like system with hinged clear panels of poly-
carbonate that could be collapsed into a flat package. Based on stakeholder feedback
regarding sterilization capabilities, bulk, ergonomics, and modularity potential, the
design was iterated upon and became a disposable, patient-contacting plastic enclo-
sure with a minimal frame, and reusable environmental controls. The arm ports
were redesigned several times to ensure that the system was ergonomic for the users
and minimized the chances of contamination. By contrast, whereas we had origi-
nally planned for material ports to be hermetic airlock-inspired systems, feedback
on impact to workflow prompted redesign to quick-opening ports with a single layer
of sealing, and this design was shown to not compromise sterility through environ-
mental testing. Throughout the design process, each iteration was tested with local
surgeons, ensuring that each new design improved upon the previous.
The final design comprises a low-density polyethylene enclosure with a high-
visibility vinyl window. The enclosure adheres to the patient’s surgical site with
an adhesive iodine-infused antimicrobial drape and is inflated with HEPA-filtered
air. There is an optional minimal frame that can be used with the enclosure, but
the enclosure can also be used alone and the positive pressure within provides its
structure. In the case that a port needs to be opened to move materials in or out, the
airflow can simply be increased to accommodate the extra outflow. The inflow system
is designed such that the filtered air enters the enclosure directly over the surgical site,
in the same way that air is introduced to state-of-the-art hospital operating rooms.
There are four sets of arm ports to accommodate up to four users at any given
time. The arm ports were designed so the users can perform the same motions that
they would use in a standard operation, and can pass tools back and forth easily.
There are also four material ports so materials (such as tools or even an infant in the
case of a cesarean section) can quickly be passed in or out of the surgical field.
Based on serial testing of workflow, it was found that the time of patient being
positioned on the operating table to time of first incision was consistently less than
85 s for users naïve to the system. Per qualitative report from the medical members
of the team, this timing compares favorably to that of existing patient and provider
preparation. We note that system does not preclude users from donning additional
9 Developing a Low-Cost, Ultraportable, Modular … 103
Fig. 9.1 Schematic of surgeons and nurses performing a surgical procedure with SurgiBox
personal protective equipment or further draping the patient but reduces the burden
of both (Fig. 9.1).
A rechargeable battery powers a microcontroller and fan so the system can be used
off-grid. The airflow is high initially for rapid system inflation but is subsequently
turned down to a maintenance flow to maintain the pressure inside the enclosure
(Fig. 9.2).
9.3.2 Particle Testing
The rigid frame system consistently achieved 0 particle count at all test sites within
90 s, or after 2.75 air changes. The minimal frame system consistently achieved
target thresholds even before completion of insufflation. Importantly, both systems
maintained acceptable thresholds with open ports.
104 D. L. Teodorescu et al.
Fig. 9.2 Range of motion demonstrated as shown from inside SurgiBox
9.4 Discussion
9.4.1 Ongoing and Future Research
Our efforts to further optimize SurgiBox with our existing iterative prototyping work-
flow are ongoing. At the time of submission, we are completing two major prototyping
tasks in parallel. First, we are preparing advanced human factors testing with full-
length simulated procedures. Second, we are optimizing for manufacturability. To
date, the latter efforts have yielded over 12-fold decrease in system cost. The cost-
determining portions are fully reusable between patients for an estimated 10,000
cases depending on airflow requirement, based on the life expectancies of the battery
and the filter cartridge, both of which are replaceable to permit continued use of the
system.
The patient-contact components are ideally disposable because in many cases
setting up reliable reprocessing can in fact be more logistically challenging than
stockpiling disposable components, especially ones of minimal bulk. In any case,
once the design has been optimized, it will be important to continue work with
medical logisticians and hospital administrators to estimate the setup and recurring
costs that constitute the total cost of ownership needed to meet each institution’s
needs, based on procedures and personnel.
In addition, the current experimental setup has two main limitations. First,
although particle testing is a well-validated way to obtain dynamic measurements
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 con-
ducted 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
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 infras-
tructure 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 appro-
priate 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 collabora-
tion is able to leverage our position at the intersection of academia and nongovern-
mental 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 alter-
natives 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 bench-
top 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
9 Developing a Low-Cost, Ultraportable, Modular … 107
of the system. Users can therefore continue to utilize their preferred skin disinfectant,
lighting source, instrument trays, gloves on top of the universal-sized thinner gloves
in place, and other things to best preserve workflow.
At this stage, we are working on finalizing strategic partnerships critical to pilot
deployment and eventually distribution success in the future. Supply and demand bot-
tleneck analyses of the expected uptake challenges along the value chain are ongoing,
as highlighted above. In the market segment we are first targeting, procurement is
primarily by each mission-sponsoring entity—most commonly militaries, surgical
relief organizations, hospitals, and device companies—or by individual providers.
Upstream, many of the former have relationships with procurement superstructures
such as the World Health Organization, which in 2015 reported allocating the plu-
rality ($333 million) of its procurement budget to strategic category products, which
cover most key surgical devices, tools, and kits. For the second market segment, we
plan to contact Ministries of Health and Defense in LMICs. Certainly, engaging with
all of these diverse stakeholders is critical to success.
9.5 Conclusion
Taken together, the growing interest in surgery as an inalienable part of global health,
as well as the ethical as well as practical need to provide this surgical care in a
safe manner, provides a rich opportunity for innovative solutions to the complex
challenges entailed.
In this paper, we described one such innovation in the form of a co-designed,
ultraportable sterile field platform. By shifting the site of regulation from the oper-
ating theater to the incision itself, we introduced a novel paradigm more amenable
to flexible, cost-effective solutions.
To reduce this paradigm to practice, we closely engaged user–stakeholders by
starting with a systematic needs analysis, then using feedback to drive the evolu-
tion and refinement of SurgiBox. We presented the device design and results from
benchtop testing that showed how SurgiBox can rapidly create a particle-free envi-
ronment. Ultimately, deploying SurgiBox to LMICs and beyond requires continued
close stakeholder engagement in the form of robust relationships along the production
and supply chains.
Acknowledgements We thank D-Lab’s Amy Smith and Victor Grau Serrat (now of Color Inc) for
consistent support over the years. Stephen Odom and Dana Stearns have provided key design input
and implementation insights. We are further grateful to Marissa Cardwell, Jim Doughty, Fabiola
Hernandez, and Kerry McCoy of MIT’s Environmental Health Services for technical assistance and
device design feedback. Kristian Olson offered invaluable advice on implementation and deploy-
ment strategy. Jack Whipple has provided machine shop assistance. Christopher Murray, Thomas
Shin, and Robert Smalley have provided design and developmental input. This work was supported
by the Harvard Medical School Scholars in Medicine Office.
108 D. L. Teodorescu et al.
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