Contributed Commentary by Matan Ben David and Erez Shor
July 21, 2020 | Medical progress has always aspired to replace educated guesswork with certainty. During the past 150 years or so, medical technology has made several positive leaps forward, with two new technologies emerging in the late 19th century that can be identified as game-changers for the sector. The first was Augustus Waller putting the ECG into use in 1887, and the second was Karl Matthes’ development of the first two-wavelength ear O2 saturation meter in 1935. These technologies transformed the world of diagnostics, enabling us to monitor internal conditions and processes non-invasively.
Nearly 80 years after these inventions matured and became the gold standard in their fields, new technologies emerged. For example, the modern ventilator can adjust itself to lung compliance and provides respiratory support while using “lung protective” measures and has been proven particularly useful during the COVID-19 pandemic. Such technologies have resolved many larger problems in the form of new life-saving devices and procedures, which can cure or control conditions that in the past were considered imminently fatal. Nevertheless, in many situations the medical condition of the patient remains unclear, causing treatment delays and sometimes leading to severe morbidity and fatality. Can the latest progress in biological integration and data science resolve these issues and usher in a new era of medical treatment?
The convergence of technology with the human body has transformed into an industry in its own right, integrating biology with engineering, big data, AI, physics, computation, nanotechnology, materials science or advanced genetic engineering. The field of bio-convergence is making clinicians smarter and more informed than ever about the human condition and is addressing unmet needs in health and other industries.
Bio-convergent technologies are making a major impact in health. From the early implanted pacemakers for the heart, we now have implanted defibrillators and sophisticated resynchronization pacemakers for heart failure. Furthermore, we now pace the brain for Parkinson’s disease, the stomach for gastroparesis and the sacrum for neuromodulation of the urinary bladder. Wearable robotics are helping amputees function and cochlear implants restore hearing. More recently we are witnessing the emergence of implanted sensors that can monitor heart function and blood pressure in real time.
Yet, there are still many areas in medicine in which physicians are left to make their clinical decisions based on suspicions, anecdotal evidence or “gut feelings.” Lacking data on some of these internal processes can delay decision making to the point of a patient’s health entering a catastrophic state. There is, therefore, still a significant unmet need to reveal additional layers of internal processes to inform current blind spots in clinical decision making.
Tissue healing data is an untapped source of clinical insight
One of the areas currently sorely lacking in available data is post-operative wound and tissue healing. There are four phases that tissue must undergo in order to heal: hemostasis, inflammation, proliferation, and remodeling. Infectious complications often interrupt this process and lead to detrimental implications for the patient and subsequently place a huge burden on the health system.
However, with no way to monitor how well the tissue is healing postoperatively and specifically monitor for infectious complications, there arises a need. We believe that bio-convergence, specifically the use of implantable, biodegradable sensor technologies, can effectively monitor complex physiological processes in the healing tissue and that sensor-tissue integration will enable clinicians to unlock new data for better patient monitoring to support clinical decision making.
The benefits of this technology can be seen clearly using gastrointestinal (GI) surgery as an example. Due to how these surgeries are performed, whereby a piece of the GI tract is removed, and the remaining parts are reattached, there is a major risk of an anastomotic leak (AL), a leak of luminal enteric contents from a surgical join to the abdominal cavity. Incidences of AL in colorectal surgery can be as high as 10% and may result in fatality or life-threatening and debilitating complications. AL is the problem that keeps GI surgeons awake at night, and regardless of a specific surgeon’s skill level, the only surgeons that have never had a patient with an anastomotic leak are those that haven’t performed GI surgery.
Neither advancements in surgical techniques nor the addition of more sophisticated tools such as surgical staplers have helped decrease the prevalence of leaks. Current tests and imaging modalities can only somewhat reliably detect the leak starting from the fourth to fifth postoperative day, which may already be life threatening for a patient. The best way to circumvent these complications is by detecting the leak as early as possible or perhaps before it actually happens. Doing so would allow clinicians to intervene, such as in the cases of early initiation of IV-based antibiotic treatment, or surgical re-intervention earlier in the process, which can improve significantly the patient’s outcome.
The benefits of tissue monitoring in GI applications
Detection can be achieved by using a biosensing system which is implanted near the surgical site. These implantable sensors are able to detect physiological conditions of the tissue, and with advanced machine learning algorithmic analysis, determine if the healing is on track, or if there is any deterioration that may lead to complications. These insights can then be used by clinicians to assess the patient’s healing process, enabling them to intervene before the leak becomes life threatening, or alternatively, to allow a patient to be discharged earlier if the tissue is healing properly thereby reducing in-hospital admission days.
This method would have a minimal impact on the surgical procedure, add negligible risk and minimal patient discomfort and biodegrade leaving no or minimal evidence of ever having been there. Yet, the difference it can make for clinical decision making for post-op patients would be game-changing.
Of course, this is just one example where sensor-tissue integration can be employed to improve clinical care outcomes. Future applications may include monitoring for inflammation and angiogenesis in tissue, which could have an important impact on how cancer patients are treated. The common denominator is deploying a new sensor technology that can uncover a previously unknown layer of data that can support clinicians in making data-driven decisions for care where currently there is none.
With technology advancing at the rate it is, the imagination need no longer be entirely restrained by reality. By leveraging the newest sensor technologies, and integrating them with human biology in new ways, we can uncover never-before-seen data sets on the body’s physical condition, enabling clinicians to work smarter and make data-driven decisions to improve patient outcomes every time.
Erez Shor is the CEO of Exero Medical (www.exeromedical.com), A MEDX Xelerator Portfolio Company. For more than 20 years Erez has been developing disruptive technologies from academic discovery and conceptualization through productization and go-to market. Erez holds a PhD in Biomedical Engineering from the Technion, MSc in Computer Vision from Tel Aviv University and Bsc in Electrical Engineering from the Technion. He can be reached at erez.shor@exeromedical.com.
Matan Ben-David is an upper gastrointestinal surgeon and a medical device enthusiast and entrepreneur. Matan founded Exero Medical during his residency in general surgery at the Rabin Medical Center, one of Israel’s leading Hospitals. He is currently completing his fellowship in Sydney, Australia. In conjunction with this, he is also developing the medical device innovation space in Sydney in collaboration with the Chris O’Brien Lifehouse.