The Need for Safe, Sterile Surgical Environments in the Field
Dr. Debbie Lin Teodorescu discovered a problem that she wanted to solve.
In medical school at Harvard, she learned from her faculty about the immense difficulty of performing safe surgical procedures on patients severely injured by the 2010 earthquake in Haiti. Doctors on the scene were unable to save the lives of many injured Haitians due to the lack of nearby medical facilities.
Modern surgical procedures can save the lives of individuals injured on the battlefield or during natural disasters, as well as mothers needing emergency obstetric care (such as surgery to deliver a baby by C-Section) – but only if they can be operated on in a safe, sterile surgical environment.
Much effort over the years has gone toward speeding up the process of transporting those needing surgery to medical care facilities as quickly as possible – from the establishment of temporary field hospitals in remote villages, war zones, or disaster areas to chartering medical evacuation flights to lift patients to clinics where they can receive urgent treatment – ideally within the initial “golden hour” when patients have the greatest chance of survival.
The Idea behind SurgiBox
The insight that came to Dr. Teodorescu was the possibility of reversing the way we had been thinking about this problem.
Instead of focusing on how to expedite the transfer of patients to a hospital setting, could it be possible to bring a portable surgical operating environment to the patient?
Yes, this could work, thought Dr. Teodorescu, and the idea for SurgiBox was born.
The initial concept (to date, there have been at least six different design generations) was more like a collapsible tent with a rigid plastic pipe frame that could be assembled around a surgical patient.
The plastic tent sheeting covering the frame is sealed to the patient’s skin using medical adhesive, creating a germ and fluid barrier that protects the patient as well as the medical personnel from germs and viruses.
The original SurgiBox design had six built-in gloved arm holes (4 on each side), which essentially created a laboratory “glove box” that allowed doctors to perform surgery, such as emergency C-sections, on the patient without having to wear additional cumbersome PPE fitted to their hands and arms.
Developing the SurgiBox Design Concept into a Working Prototype at MIT’s D-Lab
In 2009, Dr. Teodorescu brought her idea to MIT’s D-Lab, a startup incubator focused on innovative design solutions, where she partnered with Daniel Frey, professor of mechanical engineering and the director of faculty research director at D-Lab.
The two were able to secure a $70,000 grant from the Harvard President’s Challenge, which helped them bring on a Harvard engineering graduate student, Sally Miller, who was able to guide the project design with an eye toward easier setup and manufacturing.
Instead of the original concept that used a rigid pipe frame structure around the patient, the revised SurgiBox design is an inflatable system that lies on top of the patient.
It uses a small air pump with a HEPA filter that’s powered by a portable battery to inflate the SurgiBox to full size in just two minutes. The HEPA filter fan continues to run during use, providing positive air ventilation inside the tent to maintain a sterile environment for the patient.
The revised SurgiBox kit is small and light, even with the battery. It only weighs about 11 pounds and can fit inside a typical medium-sized backpack.
As the project grew, the team was able to bring on more people, including D. Teodorescu’s husband, Dr. Mike Teodorescu, a Harvard business and engineering grad) as well as getting additional expert advice from partner doctors at Massachusetts General Hospital (MGH), Doctors without Borders, and experienced field surgeons working for the U.S. Air Force Special Forces Alison Group (ASFOC).
The team was also able to secure initial funding thanks to a Small Business Innovation Research (SBIR) Phase I award, followed by a Phase II award.
Promoting the SurgiBox Idea and Bringing it to Market
“If you build it, they will come.” – Line from the 1989 film Field of Dreams
Despite the thinking of Kevin Costner’s character Ray Kinsella in Field of Dreams, building something new does not automatically lead to immediate success.
Marketing helps create awareness for the new mousetrap invention.
So Dr. Teodorescu and her team took the SurgiBox message on the road, promoting it tirelessly at conferences, such as the 2017 IEEE Global Humanitarian Conference (GHTC), as well as giving a Ted Talk at The Hive @TedMed.
The SurgiBox team began racking up numerous awards and recognitions from institutions such as the AAAS’s Science and Human Rights Coalition, the Humanitarian Grand Challenge (a partnership of USAID, the UK’s FCDO, the Netherlands Ministry of Foreign Affairs, and Global Affairs Canada), MassChallenge ($750,000 award winner), SAE’s Create the Future Contest, the UK Design Museum (Finalist, Design of the Year Competition), and Harvard Business School’s New Venture Competition (voted crowd favorite in 2022).
Fundraising success has followed.
In 2022, SurgiBox was able to raise $125,000 as part of a $2 million equity offering with five participating investors.
At the end of August 2023, the company reported through its Form D reports that it had raised around another $750,000 through a combination of equity, debt, and other securities.
A Long Road to Obtain Certifications and Gain Acceptance in the Field
Like any other medical device, the SurgiBox was subject to intense scrutiny as part of the certification process that would allow it to be used in surgical applications.
As a medical device manufacturer, the company elected to obtain an ISO 13485:2016 certification as a quality management system company.
It also needed to certify its electronic components under applicable international standards. In late 2022, the company obtained CE certificates for the control module that monitors the HEPA fan filter (maintaining positive pressure inside the unit for the patient) as well as for the external battery pack module.
The company has been able to support the humanitarian efforts of doctors to perform surgeries inside the conflict zones in Ukraine. To date, the company has donated over 80 SurgiBox units to five front-line hospitals in Ukraine in association with the logistics support of the Israeli Medical Mission (IMM).
Formaspace is your Partner for Healthcare Research and Innovation
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Talk to your Formaspace representative today and find out how we can make your next healthcare, research facility, or laboratory construction project a success.