By Avigayil Kadesh
Four unique, cost-effective products for unmet medical needs are “graduating” from the new Biodesign Innovation Program, a joint effort of the Hebrew University of Jerusalem and Hadassah Medical Center.
One product fights obesity, one makes better dentures faster, another eases the procedure of inserting an intravenous line and the fourth lends robotic accuracy to the intubation process.
Dr. Yaakov Nahmias, director of the Hebrew University’s Center for Bioengineering, explains that the vast majority of medical device ideas never make it to market because they fail due to the complexity of integrating clinical, engineering, legal and business expertise.
Intending to create Israeli devices with input from the best and brightest in these disciplines, he modeled his program on Stanford University’s successful Biodesign, with input from the prestigious California university.
Biodesign Innovation Program -- the first academic medical innovation accelerator in Israel – is directed by Nahmias and Prof. Chaim Lotan, director of Hadassah Medical Center’s Heart Institute, in cooperation with Prof. Dan Galai, former dean of the Hebrew University Business School.
One year after starting with 20 students and medical fellows, the program produced four projects that passed through the proof-of-concept stage. They are protected by provisional patent applications and could transform the market if they are successfully commercialized.
MetaboShield
MetaboShield is a curvy plastic gastric sleeve that blocks food absorption without damaging the intestine. It is intended as a non-surgical weapon against the obesity epidemic that is estimated to cost the American economy some $140 billion annually due to loss of productivity and medical complications.
“The idea was to follow the shape of the duodenum, a curved structure at the beginning of the intestine,” said Dr. Ishay Benuri-Silbiger, a pediatric gastroenterologist at Hadassah Medical Center, and the Biodesign group’s clinical expert. The natural C-shape anatomy of this region helps keep the sleeve in place after it is inserted under local anesthesia.
MetaboShield could appeal to millions of obese individuals who do not want to risk going through currently available surgical gastric bypass procedures.
“This is a huge untapped market,” said Yair Timna, an MBA student leading the project’s business development. He and Benuri-Silbiger worked with Dr. Elad Spitzer, a Hadassah orthopedic surgeon, MBA student Gabi Menagen, and engineering student Esther Feldblum.
Nahmias notes that a five- to 10-year developmental, clinical and regulatory road lies ahead for MetaboShield. Biodesign currently seeks a strong clinical partner to take the device to the next level.
SAGIV for easier, safer IVs
For many hospital patients, nourishment and/or medication comes through an intravenous (IV) catheter inserted in their arm. Yet this common procedure (a $900 million market) is not simple to do, especially in children and infants, and routinely causes pain, distress and frustration.
SAGIV is a semi-automatic handheld device for rapid and safe IV insertion, using infrared sights and electrical sensing to identify veins, insert the needle into the correct location, and withdraw it in a single, rapid robotic movement. The prototype was tested on difficult pediatric IV insertion cases at Hadassah Medical Center.
Nahmias says SAGIV already has preliminary approval for funding from Israel’s Chief Scientist’s Office, and several US investors are looking into it.
“Inserting an IV is a demanding procedure, and many times children need to be pricked five, six or more than 10 times for successful insertion,” said Dr. Yotam Almagor, the group’s clinical expert, “leading to a lot of pain and frustration.”
The group’s prototype developed by Lev Lavy, an engineering graduate student, was tested successfully in the pediatrics ward of Hadassah Medical Center. “We got a lot of excited parents asking that we use the device. Children who used to be pricked numerous times in every visit can now be connected in a single attempt.”
Other students in the group include Gahl Levy, founder of EnergySmart Solutions, as well as Yifat Castel and Alex Wainshtok, who completed MBA degrees in June.
GuideIN Tube for robotic intubation
If you ever watched a TV medical drama, you’ve seen intubation -- the placement of a plastic tube into the lungs that allows anesthetized or critically ill patients to breathe.
Like putting in an IV, intubation is tricky. The physician or paramedic must visually guide the tube into the lungs via the trachea. Unlike with an IV, a botched procedure can be deadly. Worse, intubation sometimes has to be carried out in the field, during military operations, or on patients who have obstructions blocking the respiratory pathway.
GuideIN Tube, a robotic intubation device, automatically navigates toward the lungs using an infrared source. The device, targeting a $3 billion market, was successful tested on cadavers, and clinical trials could begin next year.
“We really thought about the paramedic in the field,” said Itai Hayut, the leading engineering student on the project. “We wanted something simple, compact, that they could trust without fail. I think we hit it on all marks.”
“I strongly believe that GuideIn Tube represents the future of intubation,” said Dr. Elchanan Fried, director of the general intensive care unit in Hadassah Medical Center, and the group’s clinical expert. Others in the group include Tommy Weiss-Sadan, a biology graduate student, and MBA students Sarah Horwitz and Ariel Shrem.
According to Nahmias, several companies in the US, Australia and Japan are looking into setting up clinical partnerships to further develop GuideIN Tube.
One-stop dentures
If false teeth do not fit perfectly, they lead to mouth sores and pain. Anyone needing dentures has to make repeated visits to have exact measurements of the mouth made with casting procedures, and then has to wait for them to be delivered from a dental lab.
“The process hasn’t significantly changed in the last 100 years,” said Dr. Anat Sharon, director of the maxillofacial prosthetics clinic at Hadassah Medical Center.
Through Biodesign, Sharon recruited engineering and business students to help her develop Digital Complete Dentures Impression (DCDI). The system uses a unique optic tray composed of a multi-line camera array and an integrated pressure source.
“Digital recording is simply carried out at different pressures,” said Elishai Ezra, a bioengineering graduate student, “so we can measure everything at once, produce a 3D model, and 3D print the entire thing in a single visit.”
The technology has a potential $7 billion market in the United States alone, but the group hopes the system will also allow aging populations in developing countries to benefit from a simple, cost-efficient technology.
“Dentures are a major issue,” says Nahmias. “Hundreds of millions of people will need them in the next few years, especially in the developing world.” He believes the DCDI could be fast-tracked once the right developmental partner signs on.
Others in the group include Dr. Shmuel Chen of Hadassah Medical Center, and MBA students Yana Mazurovsky and Amit Zilbershtein.
Magic in the multidisciplinary approach
In one academic year, the Biodesign Innovation Program has accomplished what takes many startups two or three times longer, thanks to its structured multidisciplinary approach integrating not only different disciplines but also industry and academic experts.
“We recruited amazing fellows and biomedical graduate students, we mentored and guided them, but they did most of the process themselves,” says Nahmias in a phone interview from the medical school of Harvard University, where he taught for five years and does summer research projects.
The Hebrew University teams started with a list of unsolved medical problems, then evaluated each for clinical relevance and economic viability.
“This is a foreign way of thinking to most scientists In my research, I am more interested in whether something is a significant problem, not if someone is willing to pay for solving it,” says Nahmias. “But in medical devices you need a product that will do more than just make doctors and patients happier. You also need insurance companies to be willing to be pay for it, and it has to have an economic return. Otherwise you will never be able to reach the market.”
Choosing the four viable needs was harder than designing solutions, he says.
“Finding the solutions is easier than most people think. There are many tools that didn’t exist when I was studying at the
Technion. It is becoming trivial to create amazing prototypes. The problem is that you need to create a solution you can defend using a patent. Many times, the optimal solution has been patented a long time ago, and even if no product ever came to market, ‘prior art’ already exists. We had to find solutions we can protect legally.”
Nahmias says that even if just a few Biodesign companies succeed, they can completely transform the Israeli medical device sector.
“This is an annual program, and we are trying to raise funding to run it in perpetuity,” he says. “We think we can run four to eight groups per year and there is a lot of interest in that. We hope to get the industry much more involved. Stanford’s program has been running over a decade and is a major source of income, and we think we can do this for Jerusalem, where the government has an initiative to create a biotechnology hub.”
Added Lotan: “The Biodesign program has increased Stanford University biomed startup success rates four- to five-fold over the last decade. We envision a similar revolution in Jerusalem, where 50 percent of the medical research in Israel is already taking place."
Based on his experience at both Hebrew University and Harvard, Nahmias says “there is something unique about the Israeli psyche. Students are older in Israel, having finished the army, and have industry experience at this stage of their lives. They are very driven to create something new and succeed economically, and in many ways you don’t see that in the US where students are much younger. We think this spirit is captured in Biodesign.”