Aspire Ventures pitted its adaptive artificial intelligence platform, A2I, against some of Europe's best diabetes specialists in an observational trial and the A2I won.
A diabetes management system built on a new artificial intelligence platform proved it could offer people with diabetes a less invasive and more personalized solution for managing their blood glucose levels.
Diabeter, a Netherlands-based diabetes clinic and research center that Medtronic bought in 2015, is known for routinely achieving some of the best results in the world in terms of managing diabetes, but a new artificial intelligence-based system could potentially make the clinic's diabetes management results even better. That was the conclusion of an observational study authored by Diabeter doctors who tested the Rhythm system developed by Tempo Health LLC, an Aspire Ventures portfolio company.
The closed-loop Rhythm system is built on Aspire's adaptive artificial intelligence platform, A2I. Diabeter presented the findings this week at the annual Advanced Technologies & Treatments for Diabetes conference in Paris, France. The clinic said it frequently participates in technological studies that could potentially improve the lives of people with diabetes.
Through the A2I platform, Tempo developed Rhythm to forecast and manage blood glucose levels of people with diabetes, based only on non-invasive biometric sensors (stickers) and artificial intelligence. By leveraging personalized blood glucose prediction models that adapted to each of the eight patients who participated in the observational study, researchers found that in seven of the eight patients, the Rhythm system alone would have been able to achieve a 20% increase in time in range, and a 9% reduction in lows, as compared to the actual results achieved by active control tower monitoring by focused and experienced doctors and their diabetes teams using patient-activated remote monitoring.
A2I uses a vast number of algorithms for self-optimization. The technology is designed to use any type of data, from text to video to biometrics, and draw from a library of analytical components to assemble, optimize, and combine components from multiple algorithms to build the best possible adaptive algorithm.
Mike Monteiro, chief data science and innovation officer, told Qmed the Rhythm system will be classified as an artificial pancreas technology, but he explained how the system is different from other artificial pancreas technologies. Other systems in the artificial pancreas category are designed to act sort of like thermometers for the body, Monteiro said, whereas "we're building a nest."
"Not everyone is using the same predictive algorithm," Monteiro said. "We're automatically selecting the best individualized algorithm customized to each patient's biometrics."
So the Rhythm system, using the A2I platform, is designed to listen to the patient's biorhythms and learn their behavioral patterns in order to figure out what their blood sugar needs to be and what the patient needs to do in order to keep their blood sugar level in that ideal range.
Dick Mul, a pediatric endocrinologist for Diabeter, said the trial results were encouraging, and offered a positive outlook for potentially improving diabetes treatment for people worldwide. "The good news from the trial results is that both in range increased and time in hypoglycemia decreased," Mul said. "This can be achieved without the direct need for additional or constantly invasive continuous glucose monitoring devices, and might help to reduce the need for active manual remote monitoring by a clinician. This is important, as currently not all our patients will yet be able to use sophisticated technological sensor-augmented insulin pump systems."
Monteiro said he was actually surprised at how well-received the system was among the Diabeter doctors. He anticipated more resistance from the specialists, and a mentality of "how can this do my job better than I can?"
"Pretty much all doctors, at the end of the day, really just care about outcomes for their patients," Monteiro said. He added that the doctors who participated in the study also expressed a sense of relief at not having to do all of the data processing themselves in order to help their patients achieve better outcomes.
"Doctors are doctors," he said. "They're not data processors."
By using technology like the Rhythm system, doctors can potentially spend more time focusing on patient care and less time analyzing data from a control tower.
Monteiro said the next step is to carry out a larger clinical trial an pursue FDA approval. The plan, he said, is to strip the functionality of the system into a couple different pieces in order to get through the regulatory process faster, but the company will also pursue approval in parallel of the full system.
Big Data has been big news for years now, but increasingly it’s taking a back seat to its more sophisticated sidekick: smart analytics.
“I believe that there will be many more devices and software that incorporate smart analytics that make decision making easier for both providers and patients,” predicted Mary Beth Privitera, principal, human factors engineering and research at HS Design.
Take, for example, the movement in radiology toward advanced image processing.
“These devices, such as IBM’s Medical Sieve Project, target the identification of lesions, therefore enabling radiologists to focus on more difficult cases,” Privitera said.
Smart analytics are taking hold in other areas, too. Consider Medtronic’s partnership with IBM, which this year brought us Sugar.IQ, an app that pairs real-time glucose and insulin data from Medtronic sensors and pumps with Watson’s cognitive computing power to help people with diabetes better manage their disease.
Virtual and Augmented Reality
Not just for gamers anymore, virtual reality (VR) and augmented reality (AR) applications are making their way into medtech.
“Mixed reality—the application of virtual and augmented reality—will change the way surgeons are trained and medical products are designed, developed, and marketed,” predicted Derek Mathers, director of advanced applications development at Minneapolis design firm Worrell.
He said his firm is already seeing medtech clients embracing VR and AR in the areas of product development, clinical education, and end-use healthcare applications. That’s likely only to ramp up as virtual and augmented reality gain a bigger hold in the consumer electronics realm.
“Healthcare will be intimately affected because displays can now appear anywhere, even super-imposing a patients’ own anatomy on top of their body during surgery. Virtual reality will be able to take patients out of their hospital beds and into almost any situation imaginable.”
As VR and AR technologies become more mainstream, “more unforeseen needs will be identified and developed for,” Mathers said. Companies he recommended keeping an eye on include Boston-based OssoVR and the UK’s Medical Realities, which are developing VR- and AR-based platforms for training surgeons.
In the past, many in medtech pooh-poohed wearables as a passing fad, but more and more, it looks like body-worn technologies are here to stay.
“Wearable diagnostic devices are likely to be significant in 2017,” predicted Nick Rollings, principal engineer for the Medical Technology Division at Cambridge Consultants. “Rather than just measuring footsteps and heart rate, the latest wearables under development are significantly more ‘invasive’ in that samples such as sweat can be analyzed for richer insight into the patient’s physiology.”
Rollings cited technical developments in the wearables themselves as well as tech companies’ efforts to provide platforms to aggregate and analyze the data—such as Apple’s Research Kit and CareKit (shown)—as reasons why wearables will be a technology to watch in 2017. Next year, he predicts a major tech company will collaborate with or acquire a startup developing an advanced wearable measuring something more invasive than footsteps or heartrate.
“A development of this nature would confirm the huge potential possible when advanced wearables are combined with large-scale data collection and aggregation means,” he said
Neurostimulation has been around at least as long as the pacemaker, but today this old technology is being used to do new tricks.
“We’re seeing applications on almost a monthly basis that are looking at new ways to utilize this technology,”said Bill Betten, director of business solutions at Eden Prairie, MN-based product development and engineering firm Devicx.
New applications range from pain management (such as Nevro’s Senza system, shown above), to alleviating Parkinson’s symptoms, to treatment of mental health disorders such as depression.
“I think there’s a new interest in how to apply and utilize this technology, and there’s also the availability of programmable generators and sensors and electrodes,” Betten said. “So, it’s kind of a confluence of capability being merged with the interest in how do we apply this technology in new places in the body.”
Players in the field include giants like Medtronic and Boston Scientific, but Betten said some of the novel neurostimulation application are coming from startups. He expects 2017 to bring a number of exciting clinical trials in the space.
We asked industry experts to weigh in on what medical technologies will be big in 2017.
From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017.
FGH Systems and Teknor Apex have developed material, equipment, tooling and mold technologies for high-volume extrusion blow molding of thermoplastic elastomers (TPEs), making possible a more efficient and lower-cost alternative to latex and nitrile butadiene rubber (NBR).
As the global market forbiosensingtechnologies continues to grow, these innovative medicalbiosensortechnologies could have the biggest impact inmedtech.
The global market for medicalbiosensortechnologies continues to see significant growth as demand for new technologies soars. Recent estimates have shown that the global market forbiosensingtechnologies could top $22 billion by 2020, according to a report fromPersistence Market Research, thanks in large part to an increasing demand for point-of-care technologies, as well as a rise in chronic diseases and overall health awareness.
Asbiosensingtechnologies advance and become more ubiquitous, they have begun to carve out more specialized areas within the medical device realm. From virus and disease detection to rehab and drug dosing, medicalbiosensorsare doing more with each passing year. The following are some of thebiosensorapplications that could have a significant impact in the medical realm.
Biosensing technologies could be quite the difference maker for patients suffering from diabetes in the coming years as researchers look to develop wearablebiosensorsthat can monitor a patient’s glucose levels through perspiration on the skin. The University of Texas at Dallas has developed a sensor roughly the size of a quarter than can detect cortisolin perspiration, providing real-time data from ambient sweat (shown).
Similarly, a team of researchers from the Hong Kong Polytechnic University andZhejiangUniversity in China are working to develop a fiber optic glucose sensor that can be integrated into amicrofluidicchip, creating a cheap and portable device that can measure glucose levels. Recently we’ve seen a variety of different technologies that aim to provide a less invasive means for glucose monitoring, evensensingtechnologiesin tattoo form — all in effort to bring an end to finger pricking. With these new technologies, that reality could be closer than ever.
Detecting DNA Mutations
A new electrical graphene biosensor chip could be the first of its kind to be used as a biomedical implant that can read and detect DNA mutations in real time. Researchers from the Jacobs School of Engineering at UC San Diego are working on the development of an inexpensive biosensor technology that can detect human gene mutations at high resolution, and transmit the data wirelessly to a mobile device.
The technology could lead to a whole new generation of diagnostic methods and personalized treatment, as the biosensor chip could be used to conduct biopsies and detailed DNA sequencing. Since the chip is attached to a graphene transistor, it enables the chip to run electronically — making it the first of its kind to combine dynamic DNA nanotechnology with high resolution electronic sensing.
Researchers from the National Nanotechnology Laboratory in Brazil have developed a new biosensor that is capable of detecting specific molecules associated with neurodegenerative diseases, as well as a few different types of cancer. The device was designed to react when it comes into contact with the enzyme glutathione S-transferase, an enzyme linked with Parkinson’s, Alzheimer’s, breast cancer, and other diseases.
The device is an organic nanometer-scale transistor on a glass slide, and can be deployed to diagnose complex diseases quickly and safely using nanometer-scale systems to identify specific molecules. The portability and low cost of the device makes it ideal for virtually any setting, and it can be adapted to detect other substances or molecules linked to different diseases. The team eventually plans to create a paper-based biosensor with just as much capability to further improve portability and cost.
When it comes to diagnostics,biosensingtechnologies could play a significant role in virus detection. Researchers from the Hong Kong Polytechnic University in China have created a novelnanobiosensorthat can be used to detect a variety of different viruses in as little as two to three hours.
Traditional testing methods can take anywhere from one to three days to complete, however this newbiosensoraims to useupconversionluminescence resonance energy transfer (LRET) forultrasensitivevirus detection in a liquid phase system. The design and operation of the technology is simple, and does not require any expensive equipment or specialized skill to use. The technology was also designed to identify virtually any virus one the genetic sequence of the targeted virus is known. In time, the technology could even be adapted to recognize multiple flu viruses on a single testing platform.
A newbiosensingchip could lead to the development of new personalized therapies with precision medicine, thanks to the efforts of researchers from theLuasanneResearch Institute in Switzerland. This one-centimeter square device contains a circuit, a control unit, and a radio transmission module that allows it to read and react to a wide range of compounds once implanted into the body.
The chip will allow doctors to monitor the real-time effect of drugs on the metabolism, an achievement that could lead to a whole new generation of personalized treatment and precision therapies. The group says thisbiosensingchip will be the first that can measure pH, temperature, and metabolism-related molecules like glucose and cholesterol. So far, the device has only been tested in vivo on mice, but the results have been promising. The technology could be used in human trials by 2020.
Brain Injury Detection
Brain injuries have become a significant issue in the world of medicine, specifically in the world of sports medicine, as researchers look for newways to diagnose brain trauma. Cardiology experts and engineers from Johns Hopkins have looked tobiosensingtechnologies to help alert doctors when serious brain injury occurs, specifically during heart surgery. The two teamed up to develop a fingernail-sizedbiosensorthat can detect a specific protein associated with brain injuries.
Children can often times develop issues with neurological development as a consequence of heart surgery, with recent studies showing that as many as 40% of infant patients who undergo heart surgery have brain abnormalities that show up in MRI scans. This new sensor platform is designed to recognize a specific protein that is abiomarkerfor brain injury, and could eventually be used outside the operating room to quickly detect and diagnose brain injuries among athletes and accident victims.
Monitoring for Rehab Patients
A collection of universities in the UK are partnering up to design and develop cheap, unobtrusivebiosensingtechnologies that can be used with rehab patients who use wheelchairs or prosthetics. Researchers plan to conduct a variety of different studies that utilizebiosensingtechnologies in the form of temporary tattoos and smart watches to collect data and monitor the effects of specific rehab equipment and exercises.
The study will observe how patients respond use and respond to rehab equipment and exercises at home, in an effort to develop software that can usebiosensorinformation to support patients with rehab in their own home. The aim of the study is to use the information supplied from these technologies to improve patient therapies as well as improve the design and functionality of in-home rehab equipment.
We’ve asked industry experts to name the most game-changing medical technologies making news this year.
From using gene-editing therapy in human beings to device-delivered pain management to biodegradable brain sensors, there are many promising medical device technologies to point to so far this year.
Here are 10 that especially stuck out to medtech experts.
New Gene Editing Tool Moves to Human Trial
A U.S. federal biosafety and ethics committee has unanimously approved the world’s first human study on the powers of the genome-editing technology CRISPR/Cas9, according to media reports. The study, proposed by University of Pennsylvania researchers, aims to use CRISPR to create genetically-altered immune cells to attack cancer.
David Albert, MD, former chief clinical scientist at GE Healthcare and and presently founder and chief medical officer at smartphone-based electrocardiogram device maker AliveCor, believes the new CRISPR technology could be transformative when it comes to editing out harmful genetic defects.
“CRISPR presents the opportunity to repair specific genetic defects, which could be revolutionary,” Albert says.
Efforts to develop immune-related cancer therapies are getting a boost through the $250 million Sean Parker (of Napster and Facebook fame) is providing for his Parker Institute for Cancer Immunotherapy, which includes UCSF, Memorial Sloan Kettering Cancer Center, Stanford Medicine, UCLA, the University of Pennsylvania, and The University of Texas MD Anderson Cancer Center. There is also Vice President Joe Biden’s National Cancer Moonshot Initiative.
Tiny sensors made out of thin sheets of silicon are able to monitor temperature and pressure inside the skull, then melt away after they've done their job, according to researchers led by John Rogers at the University of Illinois at Urbana-Champaign and Wilson Ray at the Washington University School of Medicine in St. Louis.
The advantage of the implantable rice-grain-sized sensors is that they can remain functional during a healing and recovery period—then dissolve and disappear, eliminating the need for a secondary surgical extraction, Rogers says.
Rogers is not sure when the sensors will be available in humans, though he thinks his upcoming move to Northwestern University will facilitate the work needed to get the technology into actual people.
Using Devices Instead of Drugs to Manage Pain
Neuroelectrics, a startup in Cambridge, MA, is developing technologies that use electroencephalogram (EEG) and transcranial current stimulation to help diagnose and improve brain function in patients with various conditions, such as those suffering from chronic pain or recovering from a stroke.
“Neuroelectrics' technology is used to wirelessly stimulate the brain for healing purposes but also for pain management, especially important as there is a worldwide push to limit pharmaceutical pain killers,” said Tom Sommer, president of MassMEDIC. Neuroelectrics will will be presenting at MassMEDIC’s Annual MedTech Showcase in October.
DARPA in the U.S. has also has been working on an Electrical Prescriptions (ElectRx) system to prevent and treat inflammation, chronic pain, and post-traumatic stress disorder. Instead of using pills or injections, ElectRx deploys electrical stimulation to get the nervous system working right. It artificially modulates the body’s essential peripheral nerves, prompting them to do their job of monitoring our health and initiating healing.
A Potentially Revolutionary Heart Failure Treatment
There are estimated to be more than 2 million patients with chronic heart failure who are no longer served well by their drug regimen, yet aren’t considered sick enough for an invasive surgery to receive a transplant or left ventricular assist device (LVAD). Procyrion, a Houston, TX, company that won MD+DI’s 2016 Medtech Startup Showdown is developing the Aortix device for these patients. The tiny pump will be delivered via transfemoral catheter to sit in the patient’s descending thoracic aorta—a location that reduces the risk of valve damage, blood flow issues within the heart, and thrombotic stroke—and will employ fluid entrainment to accelerate blood flow, increasing the heart’s efficiency. Patients are expected to be able to walk around while implanted with the Aortix, a feature that may help recovery and reduce comorbidities.
Surgical Sensors and Robots Evolve
Surgery is increasingly becoming digital amid new robotic surgery entrants, and those systems rely on novel technologies such as Chicago-based Briteseed's Safesnips, says Craig Scherer, senior partner at Insight Product Development and director of the Insight Accelerator Labs. (Briteseed is a Insight Accelerator Labs charter member.) Briteseed's low-cost optical sensors integrate directly into the jaws of surgical dissectors and energy tools, providing real-time information back to surgeons. Such information could make surgeons more efficient and limit poor surgical outcomes.
"This trend of providing 'insurance' to minimize negative outcomes has enormous potential to lower overall cost of care," Scherer says.
At the recent IATIBIOMED 2016 in Israel, Devicix's Bill Betten noticed that there were companies with robotic systems very different from the large and expensive systems exemplified by Intuitive Surgical’s daVinci robits. Such systems—ranging from snake-like robotic systems to instruments that assisted in instrument placement and alignment to systems that enabled surgeries that might previously have proven difficult or impossible to perform—seemed to be in the "middle ground of assisted surgery with a distinctly practical feel from the perspective of utility, cost, and practicality." The Mazor Robotics Renaissance Guidance System, for example, is meant to improve outcomes in such spine procedures as degenerative repair, pedicle screw fixation for complex spinal deformity, and vertebral augmentation.
"If daVinci represents the first generation and perhaps a system that is toward the high end, perhaps the next generation is the next logical stage of the evolution, demonstrating a migration to the smaller scale, more affordable robotic-assisted surgeries," says Betten, who is director of business solutions at Devicix (Eden Prairie, MN).
Leadless Pacemakers Become Widespread
FDA's approval earlier this year of Medtronic's Micra pacemaker is just the beginning, says Paul Iaizzo, PhD, professor of surgery, integrative biology and physiology at the University of Minnesota.
"I think the leadless pacemaker technology will be huge globally," Iaizzo says. "There are not enough trained cardiac electrophysiologists worldwide to put in systems with leads.The leadless could open up this, where interventionalists and radiologists could put them in. The Medtronic Micra was FDA approved several months ago. Now to come dual chamber andbiV systems."
A Connected Hearing Aid Going Beyond Basic Hearing Function
Hearing aids are usually not the first product that come to mind when medtech innovation is discussed. But hearing aid company Oticon has developed the Oticon Opn, a hearing aid that incorporates Internet of Things (IoT) into its functions using the If This Then That (IFTTT) network. This means users can link their hearing aid to their household alarms, lights, and doorbells, notes Yuhgo Yamaguchi, principal design strategist at Continuum (Boston).
“IoT is a pretty common idea at this point, but I love how Oticon has leveraged IFTTT as the platform/mechanism to enable this hearing aid to alert the wearer when an IoT doorbell rings, or if an IoT smoke detector alarms. By using an existing, familiar rules engine like IFTTT, they’ve enabled a hearing aid to be helpful in many contexts of use," Yamaguchi says.
Traumatic Brain Injury Detection Enabled by Software
The medical, military, sports, and other communities have rallied together to detect traumatic brain injuries (TBI) sooner. One problem is that the expensive, complex medical equipment used to diagnose TBIs—like CT or MRI scanners—is not easily accessible in many situations. Researchers at the University of Aberdeen have used funding from the United Kingdom’s Defence Science and Technology Laboratory’s Centre for Defence Enterprise to develop software that can be used with more common, portable ultrasound equipment to gather accurate brain scans. The software is designed to make conducting the scan user-friendly and the resulting 3-D image can be sent to an expert for diagnosis and treatment advice.
“This can enable TBI to be detected on the battlefield, remote areas, and playing field sidelines. An elegant expansion of the capabilities of existing medical equipment provides better care at lower cost—a win-win for everyone," says Yuhgo Yamaguchi, principal design strategist at Continuum (Boston).
A New Bio-Ink for Bioprinting Innovation
University of Bristol researchers say they were able to engineer 3-D printed tissue structures including a full-size tracheal cartilage ring over five weeks. How did they do this? The secret was a special bio-ink formulation, infused with stem cells and created after an arduous trial and error process.
Printing with living cells to create human tissue has been a major medical technology goal, but has been a complex challenge to solve as researchers struggle to get cells to create complex structures. So the British researchers’ innovation could prove to be an important development.
It might be possible someday to "breed" robots, allowing the robots themselves to select out what traits are most "attractive" in environments with unanticipated challenges. That is the tantalizing idea presented by a research team at VU Amsterdam, who say they have demonstrated a rudimentary proof of concept.
Self-reproducing medical nano robots inside the body could one day act as a "personal virus scanner" to fight germs and cancer cells, according to Guszti Eiben, an artificial intelligence professor at VU Amsterdam who led the team. Eiben, though, acknowledges that the concept, while technically a no-brainer, is ethically problematic: "Some people are OK with self-reproducing and evolving robots on Mars, but not with such things in the human body."