Baylor Global Innovations and Biologics Modular, LLC BAA

Baylor Global Innovations and Biologics Modular, LLC
Sharmila Anandasabapathy, M.D.
Baylor College of Medicine
One Baylor Plaza, Cullen 271A
Houston, TX
[email protected]
(713) 798-8105
BAA-EBOLA-2014
The Ebola Smart Pod (ESP): A DeployReady, Modular, Infectious Disease Facility
Goal: To develop a robust, lower-cost, transportable, deploy-ready Ebola facility with training and process pathways,
and patient/supply tracking systems for emergency response management in low-resource regions.
Background: The current West Africa Ebola outbreak has escalated into the largest in history with 9,178 cases and
4,194 deaths in 6 months. 1 The burden of disease has risen due to a variety of operational challenges, including
inadequate medical facilities, lack of trained personnel, complex infection control procedures, and cumbersome
personal protective equipment (PPE). A standardized, robust, portable, scalable Ebola management facility with welldefined and easily-understood provider pathways would be invaluable in enhancing current efforts to provide a
more effective and safer environment for patients and staff.
Aims: We propose to design and develop a modular, portable Ebola management unit that is rapidly scalable and
easily deployed to low-resource, remote global regions. The ESP will be developed as an academic-industrial
collaboration between the Baylor College of Medicine, Baylor-St. Luke’s Medical Center and Biologics Modular, LLC a
company with experience designing, manufacturing, and deploying transportable, GMP modular clinical and
laboratory facilities, utilizing freight shipping containers. The prototype unit will be developed in conjunction with a
mobile training app and instruction manual to facilitate dissemination and training, as well as a bar-code scanning
system for use with mobile apps to track patients and supplies – a critical feature during outbreaks (and natural
disasters).
1
“2014 Ebola Outbreak in West Africa-Case Counts.”CDC.gov. Last Modified October 20, 2014.
http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/case-counts.html.
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Team:
Key Personnel
Sharmila Anandasabapathy,
MD
Project lead
Role
Clinical
Institution
Baylor College of
Medicine
Clark Byrum Jr.
Business & financial lead
Engineering/
Business
Biologics
Modular, LLC
Amy Cress, PhDc, MPH, PMP,
CSP
Quality & safety lead
Peter Hotez, MD, PhD
Content expert, Ebola
Facilities/
Regulatory
Baylor-St. Luke’s
Medical Center
Clinical/
Scientific
Baylor College of
Medicine
Bobby Kapur, MD, MPH
Emergency preparedness &
rapid response lead.
Clinical
Baylor College of
Medicine
Stephanie Kreml, MD
Technology consultant
Clinical/
Engineering
BCM
Technologies
Sarah Michel, MPH
Project administrator
Margaret Price, PhD
Infection Control lead
Caroline Popper, MD, MPH
Baylor lead for regulatory and
commercialization
Chris Wernimont, MS Chem, PE
Engineering lead
Program
Manager
Clinical/
Regulatory
Clinical/
Business
Baylor College of
Medicine
Baylor-St. Luke’s
Medical Center
Baylor College of
Medicine
Technologies
Biologics
Modular, LLC
Engineering
Expertise
Director, Baylor Global Initiatives; Professor of Medicine. Baylor Global
Initiatives brings together specific expertise of physicians and scientists to
address infection control and other global diseases. The college has a long
history of clinical capacity building in Africa.
President & CEO, Biologics Modular. Biologics Modular, LLC, designs and
manufactures modular facilities to serve as bio-manufacturing suites, selfcontained bio-repositories, and analytic labs.
Environmental safety and regulatory Director at Baylor-St. Luke’s Medical
Center. Dr. Cress will develop standard operating procedures for patients,
staff, and providers working in the ESP.
Founding Dean, National School of Tropical Medicine (NSTM) at Baylor
College of Medicine, Professor of Pediatrics. Dr. Hotez is a renowned
leader in global health, and was recently appointed by Governor Perry to
the Texas Task Force on Infectious Preparedness and Response for Ebola.
Associate Chief and Associate Professor of Emergency Medicine. Recent
Leader for Baylor Ebola Control Team deployed to Nigeria to provide
training to >1600 health sector personnel and members of the
community. As part of this trip, educational content was developed that
will be adapted to the mobile apps proposed.
Principal, BCM Technologies; Business Strategy and product development.
Dr. Kreml is a surgeon and engineer by training. She will be a technology
consultant for the mApps and tracking systems.
Senior Project Manager, Baylor Global. Ms. Michel will provide
administrative and budgetary oversight of the project.
Director of Infection Control, Baylor-St. Luke’s, who will provide training,
oversight & evaluation of the ESP.
President, BCM Technologies. Dr. Popper and product experts will directly
advise on build out and monitoring/evaluation of the Ebola Smart Pod.
VP Engineering and Operations, Biologics Modular LLC. and lead design
and manufacturing engineer for ESP
Project Plan
Unit Design: The ESP will be designed in self-contained, modular units which can be rapidly built and easily
interconnected for consistent and rapid scale-up. Baylor clinicians, facilities, and emergency response experts will
work with Biologics Modular design and industrial engineers to maximize protocol compliance, efficient workflow, and
patient/provider comfort. All facilities will have controlled access, using a keypad to enter an anteroom. In this clean
area (between 2 interlocking doors), personnel will put on PPE. A pass-through, plexiglass window on the 2nd door will
allow supplies to be passed into the ward without direct entry. The facility will be cooled with a commercial grade
HVAC system. To maintain a clean environment, the facilities will be equipped with a HEPA filtration system. Eight
patient areas will be separated by plexiglass barriers, allowing visibility from a central nurses’ station. The facilities will
include waste disposal and disinfection systems. In each patient cubicle, power wash drain systems will be
incorporated with monolithic walls and floor drains that lead to effluent waste-water systems. Rooms and all surfaces
can be washed down with bleach or other disinfectants and then defogged using an EPA-registered Sanosil HALO™
Disinfectant Fogger. 2 The modular design for each medical ‘pod’ will permit rapid deployment to waste pods or EDS
systems.
Process Flow and Features: In order to empower and better protect healthcare workers, each facility will have a
standard design to support patient and staff safety, efficient care and standard work processes. Process flows will be
used to enhance the modular unit design features. Standard work flow will be a focus of the process design allowing
for rapid deployment by decreasing the time necessary to train staff and make units operational. Standard work will
2
(n.d.). Retrieved November 3, 2014, from http://www.medeffect360.com/products/sanosil-halo-room-fogger/
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be supported by simple, highly visible features, such as color coding of work areas, to prompt unidirectional flow.
Process flows will focus on improving efficiency by reducing waste in the process. One example is making supplies
readily available where needed and minimizing travel distance to supplies. Including process flows in unit design will
serve to increase the time the patient care provider spends in direct patient care activities once the unit is functional.
“Smart” Apps for Education and Training of Healthcare Workers: In conjunction, we will develop mobile applications
that will use culturally-appropriate caricatures and graphics to provide simple, easily-understood instructions on Ebola
management and facility use. The application will use BCM Technology’s StepStoneMed™ platform of interactive and
memorable virtual patients, which has been shown in a prior prospective trial to be superior to standard lecture
format. 3 The software employs a structured learning framework to reinforce clinical pathways, vivid artwork that
allows detailed customization, and culturally appropriate aides which can be expanded for community use to dispel
myths and misconceptions regarding Ebola that may discourage individuals from seeking care. In parallel, we will
develop an instruction manual which will address specific features of the unit, such as cooling, waste disposal,
ventilation, etc.
Patient and Supply Tracking System: We will adapt a handheld barcode scanning system, in disinfectant- ready
housing, for use with the units and mobile applications (wireless or 3G) to track patients and supplies. This will play a
critical role during outbreaks and natural disasters where it is necessary to insure adequate supply chains and track
patient inflow/outflow.
Business/Implementation Model: ESP units are standardized pre-engineered facility structures that can be linked by
hallways, allowing for simple scale-up of bed volume. The stream-lined and standard core design, amenable to both
customized and modular built-in components, allows efficient inventory control and appropriate pre-positioning of
units for rapid deployment.
We propose a replicated, multi-site manufacturing deployment strategy with containers transported over land via
tractor trailer to final destination. Biologics removes the larger capital outlay and longer timeline of a traditional
structure by creating facilities based upon intermodal container platforms that fit in warehouses. These GMP facilities
can be tailored to specific clinical or laboratory needs. Based on current supply chain, manufacturing time for the
initial prototype facility would be 4 weeks and cost $450,000. The first 50 units (with expanded supply chain and
manufacturing) will cost approximately <$420,000 with a production time of 8 units/2 weeks, increasing capacity to 8
units/1 week by unit 50. Based on current pricing, scaling up to > 50 units would cost $390,000 and 15 units/week
could be manufactured. This is considerably lower than a stand-alone facility which would take 6-10 months for
construction and cost > $960,000 per 8 bed unit. Thus, our approach would allow creation of a 100 bed facility in 2
weeks. This could be done at < 1/16th the time and
< ½ the cost of a standard facility, based upon current estimates.
Future Growth: Biologics Modular and Baylor Global Initiatives through BCM Technologies will partner in future
growth and marketing. Baylor will provide consultative services and the evaluation/assessment of the unique clinical
need of each client. Biologics Modular will lead implementation of design, manufacture, supply and service, leveraging
their extensive infrastructure. By combining the unique strengths inherent in each organization, we will be able to
operationalize the business immediately and cost effectively. Both organizations are committed to continuous
improvement and will maintain close connection with this product in the field, incorporating learning from field
experience.
3
Subramanian, A., Timberlake, M., Mittakanti, H., Lara, M., & Brandt, M. (2012). Novel Educational Approach for Medical Students: Improved Retention Rates
Using Interactive Medical Software Compared with Traditional Lecture-Based Format. Journal of Surgical Education, 69(4), 449-452.
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