New hydrophilic coatings offer convenience, durability, and economic benefits.
|Glass simulated use models used to evaluate coating integrity for neurovascular catheters, sheaths, and guidewires (left), and peripheral PTA catheters (right).|
Hydrophilic coatings are unmatched in their ability to impart a high degree of lubricity to medical devices, and have made a significant contribution to vascular access and patient care.1
By reducing the force required to manipulate intravascular medical devices during vascular interventional procedures, hydrophilic coatings reduce risk of damage to blood vessel walls and prevent vasospasm.2, 3 Because they allow catheters to navigate tortuous vascular pathways and lesions inaccessible to uncoated devices, hydrophilic coatings have also expanded the range of treatment sites for procedures such as balloon catheter angioplasty, neurological interventions, lesion crossing, or site-delivered drug delivery, and have been shown to reduce thrombogenicity.1,4 Reduced friction between therapy and support catheters is also associated with improved outcomes, and reduced procedure time and cost.5
Hydrophilic coatings can decrease the frictional force between devices 10- to 100-fold.1But the properties that make hydrophilic coatings so lubricious—the ability to imbibe and exude water—have also made them susceptible to mechanical degradation, resulting in the generation of particulates.6 Hydrophilic coatings introduced in the 1990s—many of which are still used today—are a case in point. The durability of even historically best-in-class coatings could only be improved through an increased level of crosslinking, but this led to reduced water uptake, which reduced lubricity.
For manufacturers, the result was an unwelcome trade-off: to increase the lubricity of hydrophilic coatings, they had to accept a corresponding reduction in coating durability and higher coating particulate generation.
Example of a Class III medical device seal that contains a hair that is undetectable to the human eye. Image courtesy DWFritz Automation Inc.
For sterile medical devices, it’s critical that the seal on the package be completely intact to maintain product sterility. Seal defects can include voids, wrinkles, dust, random particles, or hair—all of which threaten the integrity of the seal. Inspecting seals after they’ve been formed has traditionally been a manual, visual process, done on a sample basis. Destructive package integrity testing may also be used, but this results in the package being discarded and the contents being rehandled on the production line for repackaging.
SFDI Images of melanin, total hemoglobin (Hb) and oxygen saturation (O2 sat.) of the treated breast of a 49 y.o. subject, at baseline and at the end of the radiation treatment (52 Gy out of 60 Gy total). The right panels show the percent change from baseline of the melanin (top), and total Hemoglobin and oxygen saturation (bottom) for all the study time-points (Credit: Anaïs Leproux, Beckman Laser Institute and Medical Clinic)
To eradicate any cancer cells that may potentially remain after surgery or chemotherapy, many breast cancer patients also undergo radiation therapy. All patients experience unfortunate side effects including skin irritation, and sometimes peeling and blistering. Patients can also develop permanent discoloration of the skin and thickening of the breast tissue months, or even years, after treatment. There is currently no method to predict the severity of these acute and late effects, and even current evaluation of these effects are based on subjective scoring.
Internet of Things-enabled medical devices have great potential, but it's important for device developers to have a strong understanding of value creation in IoT-enabled medical products.
This is a story you may be able to relate to. A medical device organization saw the potential of its medical-grade, in-hospital wearable device for a broader consumer audience. Certainly, changes were needed, the most significant of which included adding smartphone connectivity to allow for ongoing service and data collection. The engineering was not difficult. Even marketing the device through consumer pharmacy chains proved easier than expected; pharmacy technicians could easily explain the device and its intended use. It sold well. In fact, it sold better than expected.
Then the problems started.
Surgical robotics systems stole the show at this year's annual meeting of the American Academy of Orthopaedic Surgeons, but analysts are struggling to assess what the rate of adoption and peak penetration will be for these robots.
Zimmer Biomet said it plans to launch its Rosa total knee application within 18 months.
Silicon technology is one of the most promising solutions for low-cost, sensitive, and specific measurements of a large number of biomarkers.
Chip technology has given us ever-faster and smarter computers, smartphones, sensors and will keep on doing this in the future. We will need further scaling of chip building blocks for faster and better data communication, computation, and storage in large server plants. Finally, chip technology will enable a revolution in healthcare.
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.