Biodesign is a program developed at Stanford University a little over 20 years ago. “When you look at the world of start-ups and medical technologies and what technologies succeed, you see that the one who succeeds is the one bought by the big giants with the ability to distribute to hospitals and health systems,” explains Dr. Jonah Weisbuch, director of the Biodesign program and ENT doctor A senior Maimonides, who studied at Stanford and was trained in the biodesign program while there, returned to Israel and established and manages the program in Israel.
“Over the years, experts have realized that the secret to success is startups that focus on the problem itself, start with it and become the experts on the same problem. It is possible to use this technology, if it is suitable at all, and in the end they do not always succeed. ”
Rambam-Biodesign uses a methodology developed at the prestigious Stanford University to crack the formula for successful innovation projects in medicine and process management efficiently in terms of time and decision making, to encourage fresh and creative thinking based on need and not technology seeking application. How does it work? Engineers and two businessmen, with a significant emphasis on integrating women, brothers and sisters, teams from the periphery as well as young students, along with experienced experts, including students of Clover – College of Design and Visual Communication, who offered design solutions for various projects and developments.
“For example, 40 years ago no one thought about the end user, everyone thought only about the technology and what it was supposed to do. The idea of connecting doctors, engineers and business people from day one,” says Weisbuch, “is aimed at streamlining operations and shortening time. We see that in the world of medtech, biotech and medical equipment, it sometimes takes more than a decade for technological products to reach the market, and this must be streamlined from the first moment. ”
How is it done?
“The process is done from day one. Suppose we have a niche that we have researched and we understand its need, before we start thinking about a technological solution, then into the prototype’s considerations we put business considerations: how we get to market and who will use it. Our goal at BioDesign is Not only to produce a patent that we manage to sell, but also to get with it to the end, to the patient, and to do that one has to consider who will pay for it and who will use it, and all these things are done in the first place.
“This is in contrast to what happens in startups, where you take an engineer or a doctor with an invention that is connected to an engineer, and go into a kind of accelerator that you see that he has a chance to advance, form a company and only end up bringing in a CEO. The engineers in Israel are running straight towards the solution, and that’s not the whole point. The problem is to understand the product market and how to bring it to market. ”
Weissbuch, as mentioned, with the support of Stanford and the cooperation of Rambam Hospital, founded the Israeli Biodesign, which has been running for the second year in a row. But it is also important to understand the global markets. ”
Recall that this is a national program that has the cooperation of the Technology Division of the Ministry of Health, with this year eight groups completing the second cycle, which was very successful, manifested not only in cooperation with the Health Hub of the Technology Division of the Ministry of Health, but also in the interest of medical institutions, academia And industry.
Among the groups working on groundbreaking developments are a group that develops a special mask that will increase patients’ responsiveness to the use of a home device to prevent sleep apnea and a group that finds a technological solution for early detection of delirium – a condition of confusion that many hospitalize and causes complications, morbidity and mortality.
The results are visible in the field
Lower back pain, for example, is a serious problem that affects about 600 million Americans each year, and most of them have no known source of pain. “There are various treatments, most of which do not really work. Many use painkillers, sometimes to the point of addiction, and in severe cases offer a pacemaker implant solution to reduce pain. We are developing a wearable technology that will disrupt the electrical signals of the central nervous system and prevent invasive surgery,” says Tamir. Israeli, a 31-year-old high-tech entrepreneur from Palmachim.
“I was looking for a solution to a personal medical problem, and that’s how I heard about Rambam Biodesign. I applied and was accepted, “explains Israeli.” Today there is a partial solution – a pacemaker that is inserted into the spine during surgery, and its purpose is to transmit electrical pulses that disrupt the signal of pain. We have developed a wearable prototype that will be attached to the lower back and operate on the electromagnetic fields but from the outside. ”
“If the investment is found for further development, we are a few months away from cracking electrical signal modification models and clinical feasibility testing. We are currently focusing on pain, but when we know how to produce the electrical signal modification models, the technology can be adapted to a very wide range of health conditions. “Electrical signals from the central nervous system, such as situations of sleep apnea,” notes Israeli. “The size of the pain treatment market is estimated at about $ 79 billion as of 2021, and the potential for penetration, even if it is 1%, is huge, because it is possible to reach a turnover of $ 400 million from the beginning,” he emphasizes.
Another group that is of interest is the group that deals with the prevention of reoperations for joint replacement. “We are aiming for joint replacement in general, but we are starting with knee replacement surgery. Every year, about 600,000 knee replacement surgeries are performed in the United States. In 10% of cases patients will develop severe infections that require reoperation. Patients do not feel that an infection develops until too late, and this is a difficult and common problem that has no solution today, “says Karin Brisker, 29, from Herzliya, a data researcher (data scientist) from Microsoft and a member of Rambam-BioDesign.
“I really liked the methodology, because we did not run straight to the solution. First we studied the problem, and then we tested whether the technology we would need to develop would not require additional expenditure on the current operating costs. We went to find the solution and progressed pretty quickly, “says Brisker.
“We are developing a sensor with an internal sensor that will be implanted inside the implant and will warn of the onset of infection early, where antibiotics can still be treated and in a way that will prevent re-implantation and great suffering in the surgeons. The patient for treatment before deterioration. ”
“We have a primary prototype for a sensor to be mounted on the implant, we are clinically testing the sensor’s ability to detect the development of inflammatory processes, and we have already developed an application infrastructure that can receive the messages from the implant,” says Shmuel Whitman, a sixth-year medical student at the Technion. “Assuming the investment is found, we estimate that large-scale development could be used within a few years, as the market size of US knee joint surgery alone is estimated at $ 6.5 billion, and due to population aging it is expected to grow by another 4.1% per year.
Of these, our penetration potential is relatively high because there is full insurance coverage, and the sensor should be inserted in the same procedure, without it significantly increasing the expense. Even if there is initially only a 20% penetration, it is a turnover of $ 1.3 billion, and that is without even calculating the joint replacement market in the US and the world at all.
Tamir back pain group without tag (Photo: Rambam Hospital)The solution to heat waves
Development of technologies in the field of gynecology FemTech is a hot field, but it focuses mainly on pregnancy and childbirth. Menopause is neglected and lacks much knowledge in the field. “We found that one of the problems not known to the general public is the fact that the first signs of menopause begin about a decade before menopause – in the late 30s and early 40s of women. There is no public awareness, neither among women nor among doctors,” says Inbar. Gerbler, an entrepreneur in the field of medical innovations and a member of the group.
“Sometimes the consequences are severe. Early symptoms can be treated easily and effectively. But menopause is undiagnosed, so doctors interpret the symptoms as separate diseases, and women receive medication for years without justification. For example, instead of appropriate hormone therapy, women receive medication. For anxiety, osteoporosis, sleep disorders and depression sometimes for years. ”
According to her, menopause is not a point in time, but a process that with the increase in life expectancy may take several decades. “Today 700 million women are in menopause, and by 2030 there will be more than a billion – 52% of them over the age of 40. Today the whole process of diagnosing menopause is completely subjective, because there are no clear criteria for diagnosis. While studying the subject a patient told us “Estrogen for a year and a half without having any deficiency in this hormone, and because of the excess it began to develop diseases.”
“The solution?” It is a home test, “explains Gerbler.
“Today there is a comprehensive hormonal test, but it is done in a lab, it is a relatively expensive test and too few women are tested. We develop a relatively simple home test, like saliva and urine in a small kit, that measures hormone levels over time to gauge changes and volatility,” she adds. . On the process of germinating the venture, Gerbler says: “The envelope of researchers, doctors and mentors from the industry, who are also full of knowledge in international markets and regulation of all kinds, has greatly shortened and focused the thought process.
Much of the entrepreneurship in Israel is based on technological people. Many health startups have failed because they often adapt technological solutions to the Israeli market, which does not necessarily fit the US market structure, and discover after years of development that no one will pay for it. The second problem is that technologies in the medical world come from other worlds, from security. “And the army is trying to solve a problem that is not a problem and that no one is interested in solving.”
Gerbler notes that at Rambam-Biodesign for half a year they only learned about the problem from all aspects: “We started developing the technology in the second stage. There is no test today for replacements – this is something new, so our economic calculation was based on $ 120 per woman per year and 42 million women aged 35-55, which means a virgin market of $ 5 billion, with the global market age of menopause estimated at $ 14.7 billion “.
In this regard, Dr. Weisbuch, one of the program’s directors, notes: “Everyone says that medicine should be at home and that is the future, but in the end, the participants in the world’s biodesign programs are only brought to hospitals. We have changed that in Israel: we are the only ones in the world examining the continuum of treatment in hospitals, health funds, the community and at home. That is why the members of the groups come from all these worlds. ”
Jenny Agassi, a midwife in charge of women’s health at Maccabi Health Services, has joined another prominent group that has set itself the ambitious goal of developing a home test for early detection of lung cancer. “Every year, 2 million cases of lung cancer are diagnosed worldwide, and this is the first cause of death. In Israel, about 2,500 new cases are diagnosed each year.
The main problem is that most cases are only discovered when symptoms begin, i.e. at a very late stage, so survival rates are very low. In addition, the average time for diagnosing lung cancer in Israel and around the world is between 3 and 6 months on average, “she says.
“The rapid diagnosis has significant implications for the patient’s health, as a tumor that can be operated on as close as possible to the initial symptoms continues to grow during the months leading up to the diagnosis, continues to spread and may make the surgical procedure irrelevant,” said Dr. Yaniv Dotan Lung at Maimonides and mentor in the program. He emphasizes that Rambam seeks to be at the forefront in the field of early diagnosis, rapid diagnosis and multidisciplinary treatment of lung cancer.
The group’s goal was to find a solution for early diagnosis. “Today there is an increasing demand for personalized medicine at home and in the community, so we decided to develop a cheap, available, simple and effective home test that will be based on a saliva test. Markers. We believe that it will be possible to reduce and pinpoint the biological markers that indicate the development of lung cancer, “says Dr. Ron Golan, a physician at Ziv Hospital in Safed, a specialist in biomedical engineering and a member of the Rambam-Biodesign group.
He says: “With the right investment within 3-4 years it will be possible to develop a home test with an insurance indemnity in a route similar to other tests available on the market today. Every year there are 14 million Americans at risk for developing lung cancer, and the disease diagnosis market rolls in $ 850 million. “We believe that in the first year we will sell home diagnostic kits for 1%, and within five years – for 20% of the 14 million in the risk group. We believe we can enter a thirsty and desperate market for a solution that will save millions every year.