Michael Barbella , Managing Editor06.02.15
Real operating rooms are nothing like their Hollywood counterparts. They generally are devoid of the melodramatic instrumentals, the tension and the heart-to-heart confessions that accompany most fictional procedures. There is conversation, of course, but it’s usually limited to general discussion topics (sports, politics, weekend plans, home improvement projects, etc.) and patient-specific exchanges about heart rate, blood pressure, medical history and surgical strategy.
Contrarily, television and film dramatizations omit the meticulous prep work required before a procedure can even begin—moving in furniture, damp dusting all surfaces, preparing IV lines/solutions, opening surgical cases, placing sterile supplies (in sequence), and checking for contamination. Nor does Tinseltown delve into the complications that can arise in the operating room, from nuisances like ringing telephones and staff shortages to concerns like powdered latex glove use (the cornstarch powder contributes to delayed wound healing and postoperative complications), flip-flopped X-ray images and disease progression.
Such snafus, however, can be a launching pad for medtech innovation. Some of the most radical inventions of late have come from surgeons inspired by their operating room experiences.
Nikolai Begg, for instance, used his observations of laparoscopic surgeries as motivation for a new puncture access mechanism. The mechanical engineer/Ph.D. devised a tool with a blade that automatically retracts the moment it passes completely through the skin; its tip is designed to withdraw within 1/100th of a second. The mechanism—purely mechanical in nature—is scalable for use in nearly any medical puncture device.
Begg’s invention is intended to reduce the laparoscopic surgical complications that arise from trocar access (internal trauma, infection and pain, according to a 2003 U.S. Food and Drug Administration report). “The truth in medicine is puncture is everywhere,” Begg said in a speech last summer. “If we take just three of the procedures that involve some tissue puncture step—laparoscopic surgery, epidurals, and cranial drilling—they account for over 30,000 [surgical] complications every year. I call that a problem worth solving.”
Amir Belson, M.D., found 64 worthy issues during his tenure as a flight surgeon with the Israeli Air Force and physician within a neonatal intensive care unit. He parlayed nine of those ideas into viable companies, aiming to improve minimally invasive procedures, intravenous catheters, hypothermia therapy, radiation protection, large vessel access/closure, and surgical incision closure.
Theodore Gerstle’s innovation, on the other hand, was borne entirely out of frustration. The Harvard University-trained plastic surgeon was working at a prominent Boston, Mass., hospital several years ago when he encountered a patient with squamous cell cancer of the lower jaw. Gerstle and his medical team spent six weeks with an off-site manufacturer designing the man’s new jaw using custom implants.
On the day of the surgery, the oncologic surgeon had to remove more bone than anticipated because the cancer had progressed further than doctors had realized. The unexpected twist rendered the custom implant useless, forcing Gerstle to develop a new model and the patient to undergo additional procedures.
“Scenarios like this play out in hospitals across the United States every day, costing millions of dollars and resulting in countless unnecessary surgeries,” Gerstle noted. “What if a 3-D custom implant design studio could be put inside every operating room—empowering surgeons to print implants, cutting guides and surgical tools in minutes during surgery, instead of days and weeks over several surgeries?”
Gerstle’s vision triggered the founding of Osiris Biomedical 3D, an aspiring startup that has applied for a patent for single anesthetic reconstructive surgery, a process that will allow a patient to be scanned and a custom device or implant printed, sterilized, and surgically implanted “on the operating table,” all in one procedure. The company also has developed a highly mobile 3-D printing CONEX (contingency employment exercise) for the military that can establish operating suites in the field, reducing time to surgery for wounded soldiers.
Gerstle’s company is rapidly gaining notice in the 3-D printing industry. Last fall, Osiris Biomedical was awarded $10,000 in a Shark Tank-like contest sponsored by the Greater Philadelphia Veterans Network, and in April the firm topped four other competitors in MecklerMedia’s Startup Competition during the Inside 3D Printing Conference and Expo in New York, N.Y.
While the winner receives no monetary prize, the acclaim in winning the hottest pitch event in the industry—with participants raising more than $6 million in 2014—clearly is reward enough.
Osiris executives claim the company’s business model will help decrease surgery lead time, the number of procedures and hospital visits for patients, and perhaps most importantly, the cost to patients, hospitals and health insurers.
“If you suffer a trauma, the doctors scan you, they do a surgery to patch you up, they order an implant based on the scans and then send you home for three or four weeks. Then you have to come back to the hospital to have that second surgery. That takes a huge amount of time and money,” Osiris Chief Operating Officer Christopher Gerstle (Theodore’s brother) told Medical Product Outsourcing. “We can do it all in one surgery. Instead of eliminating a $10,000 part of a $100,000 surgery, we are eliminating a whole other surgery. And, most importantly for the patient, he or she does not have to come back in for that second surgery. All that anxiety and cost goes away.”
Contrarily, television and film dramatizations omit the meticulous prep work required before a procedure can even begin—moving in furniture, damp dusting all surfaces, preparing IV lines/solutions, opening surgical cases, placing sterile supplies (in sequence), and checking for contamination. Nor does Tinseltown delve into the complications that can arise in the operating room, from nuisances like ringing telephones and staff shortages to concerns like powdered latex glove use (the cornstarch powder contributes to delayed wound healing and postoperative complications), flip-flopped X-ray images and disease progression.
Such snafus, however, can be a launching pad for medtech innovation. Some of the most radical inventions of late have come from surgeons inspired by their operating room experiences.
Nikolai Begg, for instance, used his observations of laparoscopic surgeries as motivation for a new puncture access mechanism. The mechanical engineer/Ph.D. devised a tool with a blade that automatically retracts the moment it passes completely through the skin; its tip is designed to withdraw within 1/100th of a second. The mechanism—purely mechanical in nature—is scalable for use in nearly any medical puncture device.
Begg’s invention is intended to reduce the laparoscopic surgical complications that arise from trocar access (internal trauma, infection and pain, according to a 2003 U.S. Food and Drug Administration report). “The truth in medicine is puncture is everywhere,” Begg said in a speech last summer. “If we take just three of the procedures that involve some tissue puncture step—laparoscopic surgery, epidurals, and cranial drilling—they account for over 30,000 [surgical] complications every year. I call that a problem worth solving.”
Amir Belson, M.D., found 64 worthy issues during his tenure as a flight surgeon with the Israeli Air Force and physician within a neonatal intensive care unit. He parlayed nine of those ideas into viable companies, aiming to improve minimally invasive procedures, intravenous catheters, hypothermia therapy, radiation protection, large vessel access/closure, and surgical incision closure.
Theodore Gerstle’s innovation, on the other hand, was borne entirely out of frustration. The Harvard University-trained plastic surgeon was working at a prominent Boston, Mass., hospital several years ago when he encountered a patient with squamous cell cancer of the lower jaw. Gerstle and his medical team spent six weeks with an off-site manufacturer designing the man’s new jaw using custom implants.
On the day of the surgery, the oncologic surgeon had to remove more bone than anticipated because the cancer had progressed further than doctors had realized. The unexpected twist rendered the custom implant useless, forcing Gerstle to develop a new model and the patient to undergo additional procedures.
“Scenarios like this play out in hospitals across the United States every day, costing millions of dollars and resulting in countless unnecessary surgeries,” Gerstle noted. “What if a 3-D custom implant design studio could be put inside every operating room—empowering surgeons to print implants, cutting guides and surgical tools in minutes during surgery, instead of days and weeks over several surgeries?”
Gerstle’s vision triggered the founding of Osiris Biomedical 3D, an aspiring startup that has applied for a patent for single anesthetic reconstructive surgery, a process that will allow a patient to be scanned and a custom device or implant printed, sterilized, and surgically implanted “on the operating table,” all in one procedure. The company also has developed a highly mobile 3-D printing CONEX (contingency employment exercise) for the military that can establish operating suites in the field, reducing time to surgery for wounded soldiers.
Gerstle’s company is rapidly gaining notice in the 3-D printing industry. Last fall, Osiris Biomedical was awarded $10,000 in a Shark Tank-like contest sponsored by the Greater Philadelphia Veterans Network, and in April the firm topped four other competitors in MecklerMedia’s Startup Competition during the Inside 3D Printing Conference and Expo in New York, N.Y.
While the winner receives no monetary prize, the acclaim in winning the hottest pitch event in the industry—with participants raising more than $6 million in 2014—clearly is reward enough.
Osiris executives claim the company’s business model will help decrease surgery lead time, the number of procedures and hospital visits for patients, and perhaps most importantly, the cost to patients, hospitals and health insurers.
“If you suffer a trauma, the doctors scan you, they do a surgery to patch you up, they order an implant based on the scans and then send you home for three or four weeks. Then you have to come back to the hospital to have that second surgery. That takes a huge amount of time and money,” Osiris Chief Operating Officer Christopher Gerstle (Theodore’s brother) told Medical Product Outsourcing. “We can do it all in one surgery. Instead of eliminating a $10,000 part of a $100,000 surgery, we are eliminating a whole other surgery. And, most importantly for the patient, he or she does not have to come back in for that second surgery. All that anxiety and cost goes away.”