The year 2017 is coming to a close, and as in years past, we look back with excitement at the medical technologies that have been gracing the pages of Medgadget. As usual, there are trends that have revealed themselves, with many research teams around the world working on similar technologies. There are also new devices that are unlike anything we’ve seen before, solving medical problems in novel and unexpected ways. Take a journey with us as we review the most innovative, full of impact, and revolutionary medical technologies of the past year!
Pills as Devices
Ingestible devices, mostly in the form of cameras or other sensors that travel and assess the insides of the GI tract, have been around for a few years now. The next generation of swallowable medical devices will monitor the body for extended periods of time in a variety of ways and devices that deliver drugs and other therapies in novel ways. To make this possible, many of such high-tech pills will have to be powered in novel ways that don’t involve batteries.
Proteus Digital and Otsuka Pharmaceutical recently won FDA clearance for the first digital medicine, ABILIFY MYCITE (aripiprazole). The pill has a tiny sensor which, when swallowed, transmits a signal to a receiving device outside the body. It allows for a way to confirm that a patient has actually taken and ingested the tablet. Although this is a groundbreaking approval for the first drug capable of doing such a feat, the underlying technology and regulatory approvals have been around for a number of years.
Rani Therapeutics is developing a novel approach for the oral delivery of large-molecule drugs such as basal insulin, which is currently delivered via injections. No one likes injections, at least seeing and experiencing them. But what about a pill that activates tiny needles to inject a drug into an intestinal wall? Rani’s protective dissolvable pills safely ferry drugs into the intestines that would be broken down by stomach juices if delivered in standard pill form. Sugar-based needles protrude from the pills to embed into the intestinal wall and the drug can then flow from the interior of the pill into the capillaries within the intestine. We interviewed Mir Imran, Chairman and CEO of Rani Therapeutics, to get a more in-depth understanding of his company’s technology.
Measuring the contents of the stomach for the pH, temperature, and other factors over extended periods of time may help gastroenterologists and other docs to closely monitor their patients. In order for swallowable pills to power the sensors and be able to transmit readings out of the body for days or weeks at a time, the pills are best powered by something other than batteries that have limited lifespans and safety concerns. Researchers at MIT and Brigham and Women’s Hospital recently presented an electronic pill powered by gut fluids. The investigators incorporated zinc and copper electrodes on the surface of their device. Once ingested, the stomach acid acts as an electrolyte and facilitates the releases of ions from the zinc anode to the copper cathode. The device produces .23 microwatts per square millimeter of anode and the team was able to power a broadcasting sensor that was able to measure the temperature inside live pig stomachs for days at a time.
Devices that help ailing hearts move blood through the body tend to come in direct contact with the blood, leading to a number of problems including strokes. The next generation of heart assist devices may instead work by pushing on the organ, making it stronger and avoiding a host of issues that come with intravascular blood pumps.
Clinicians and engineers from Harvard University and Boston Children’s Hospital have developed a heart sleeve that works kind of like a cardiac massage. The sleeve contracts with the natural rhythm of the heart, augmenting the natural cardiac output. It has a silicone exterior with tubes throughout that are powered by an external pump. The sleeve would be custom-made to match each patient’s unique anatomy and provide the necessary assistance to restore lost function. We interviewed Harvard’s Professor Ellen Roche, a co-author of the heart sleeve study, who gave us a better insight about this fascinating technology.
Another device being developed at Boston Children’s Hospital is specifically designed to help patients suffering from one-sided heart failure. It uses soft actuators that move a rigid brace that penetrates into the heart’s intraventricular septum. The action is gentle, but powerful enough to assist just one side of the heart without disturbing the other half. Like the sleeve above, this pump doesn’t come in direct contact with the blood and so it avoids many common heart pump problems. But, because one-sided right heart failure is a condition common in pediatric patients, the device is quite small. It has already been trialed in animals, but there’s still a lot more work to be done to adapt it for human use before it can be evaluated in clinical trials.
Prosthetic technology is getting better every year, and 2017 was particularly exciting in this field. Researchers at Georgia Tech developed a system that allowed an amputee to control each finger of his prosthetic hand. The system is so accurate that the patient is able to play the piano with the prosthesis. The technology relies on ultrasound to detect the different types of muscle activity near the stump.
Children with cerebral palsy are getting exoskeletons to help them walk thanks to researchers at the National Institutes of Health’s Clinical Center Rehabilitation Medicine Department. The devices are attached to the legs, providing extra power and correcting the posture and gait of the children that have been using these. While these are not ready to be used in the real world due to power issues and other problems, the technology is already helping a few kids walk better on their own.
Some people suffer from such severe disability that even basic communication is a challenge. At the Wyss Center for Bio and Neuroengineering in Switzerland, four completely locked-in people with ALS were able to communicate thanks to transcranial near-infrared spectroscopy. The technique estimates oxygenation within the brain, which can be used as a biomarker for certain brain activity. A woman used the system to ask her paralyzed father whether she can marry her boyfriend, to which she got a “No” for a reply nine out of ten times that the question was asked, demonstrating the consistency of the technology. We were lucky to have a chance to learn more in an interview with Dr. Ujwal Chaudhary of the University of Tübingen, the lead author of the research.
A group at Stanford University worked with an ALS patient and one with serious spinal cord injury, both of which have implanted brain-computer interfaces, to achieve close to normal communication speeds. The volunteers were able to move a mouse cursor on a screen by simply thinking of where they wanted it to go, clicking on letter tiles on the way. One of the individuals was able to type at 39 characters a limit. Coupling this rate with smart texting technology now available in smartphones should allow for communication comparable to how fast healthy people can type.
Artificial Womb for Premature Babies
A lot of progress has been done in the last few decades to improve the survival rates of premature children. Those born about 28 weeks or longer post gestation now have pretty good overall outcomes, but shorter time in the womb still results in major consequences. Researchers at Children’s Hospital of Philadelphia developed an artificial womb that closely resembles a natural uterine environment, allowing children to finish developing. The device consists of a pump-free arteriovenous circuit, a closed fluid environment with continuous fluid exchange, and a new technique of umbilical vascular access. The technology, which has been tried on baby sheep, creates a protective barrier between the womb and the outside world, while also helping to preserve the fluid filled lungs of the premature children.
There have been several advances in diagnostics this year, making it hard for us to pick the top few. Large strides have been made in diagnosing allergies, with Abionic, a Swiss-based company, winning FDA registration for their nanotechnology-focused assay that detects allergies to cats, dogs, trees and grasses. They already have CE marking for their device, and are set to enter the US market in 2018. Their tests can yield results in as little as five minutes, with some tests taking 20 minutes, all with a drop of blood.
For people with serious food allergies, it is not only a question of what they are allergic to, but also what foods are contaminated with the allergens. Researchers at Harvard University developed a $40 keychain device that can quickly, inexpensively, and accurately detect common food antigens. The device was developed to detect five common antigens, including those in peanuts, hazelnuts, wheat, milk, and egg whites from food particles. Impressively, it can detect antigen concentrations at levels far below industry standards.
2017 also saw a rapid increase in the number of high-throughput devices for diagnosis. MIMETAS, an organ-on-a-chip company based out of The Netherlands, in collaboration with Roche, grew 350 perfused gut tubes in a matter of days that replicate the structure of the intestine. The team hopes to use this system in preliminary drug testing to screen out chemical compounds that can compromise the structure of the intestine.
More towards on-the-spot diagnosis, Caltech researchers developed a rapid antimicrobial susceptibility test to identify the best antibiotics to prescribe to patients with urinary tract infections (UTIs). This rapid test provides a definitive answer about antibiotic resistance of bacteria in 30 minutes, and has comparable performance to the gold standard test that takes several hours.
In another example of on-the-spot diagnosis, Nevisense, a system developed by a Swedish firm called SciBase, helps dermatologists assess suspect cutaneous lesions that could be melanoma tumors. The system takes advantage of the fact that tumor skin transmits electricity differently than normal skin. It won FDA approval in the middle of the year.
It has been an incredible year for advances in diagnostics, but more importantly, there has been a strong push towards the development of cheap diagnostics for third world countries. Earlier this year, we wrote about Paperfuge, the low-cost power-free centrifuge developed by the same Stanford team that came up with the 50 cent foldable microscope a few years back. In 15 minutes, the paperfuge is capable of separating malaria parasites from infected blood, at a rate comparable to industrial centrifuges, paving the way for cheaper and faster diagnosis.
Students at Rice University also developed an easy to use device that rapidly detects jaundice from a drop of blood by measuring a protein called bilirubin within 2 minutes. The device, aptly named BiliSpec, has already proved to be comparable to standard lab equipment in a small trial with 68 patients in Malawi, with a larger trial coming next year.
In another advancement in point-of-care diagnostics, a $10 sensor was developed by researchers in Duke University that can transform any 2D ultrasound scanner into 3D reconstructions, allowing physicians to view these 3D models in a manner similar to MRI and CT scans.
A multidisciplinary team from Los Angeles and Sweden also built an inexpensive lens that snaps onto a Nokia Lumia phone for targeted DNA sequencing and mutation analysis of living tissues, providing a means of portable molecular analysis that has not been previously achieved.
Deep learning and machine learning were two buzzwords that were name-dropped by every major tech company in 2017, and healthcare was no different. In collaboration with IBM, a team of Canadian researchers developed an advanced software tool that analyzes functional magnetic resonance imaging scans for signs of schizophrenia in patient brains. The algorithm correctly predicted the disease in 74% of patients and was also able to determine how bad the symptoms were.
In a dermatological application of deep learning, a skin lesion diagnostic app called Derm Expert was developed by VisualDx. This app runs a picture of the patient’s skin lesion against a vast database of existing skin conditions, helping inform patients and general practitioners of the severity of the lesion and skin condition. We expect many more strides to be made in image analysis and diagnosis using deep learning algorithms in 2018.
Surgical innovations are geared towards reducing the cost and duration of surgery, and eliminating possible postop complications, such as infections and non-healing wounds. Cleancision, a Wound Retraction and Protection system developed by Prescient Surgical, won FDA’s de novo clearance for being a novel, first of a kind device. It is an expanding wheel-like device that opens and holds the wound in a retracted position for easy access. It also prevents hands or instruments from touching the incision, providing an irrigation system to deliver a sterile solution from a nearby fluid bag to the tissue, further helping to prevent infections. They won FDA marketing approval recently for the device.
A novel wound closure device named microMend was developed by KitoTech Medical, which works conceptually similar to a smart bandage, except through the use of micro-staples. The device, which lasts as long as the wound needs to heal, can be placed across a wound where the flexible micro-staples painlessly embed into the skin to close the wound.
We reported a surge in the use of augmented reality in healthcare at the end of 2016, with the trend continuing in 2017. Notably, Microsoft’s HoloLens was successfully used for spinal surgery applications by a surgical navigation company named Scopis. There are several advantages to this system including reduced radiation exposure of patients, improved screw placement accuracy, and decreased surgery times.
It has been an exciting year for healthcare with many advances in how diseases are diagnosed, treated, and cured. Medical devices are constantly becoming smaller, smarter, cheaper, more precise and user friendly, and with the growth of fields such as gene therapy, machine learning, nanotechnology, and 3D printing, we expect an exciting year ahead. Here is wishing you and yours the best of health and happiness as you celebrate the holidays and we hope you will join us in our journey as we report on the cutting-edge medical innovations of 2018!