First Dedicated Pediatric and Neonatal Acute Dialysis Machine Released U.S.

Medtronic is releasing in the United States the industry’s first and only dedicated pediatric and neonatal acute dialysis machine.

The Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) has been in development for about a decade and the first in-human use was announced back in 2014. Having now received FDA marketing authorization, Medtronic is now making it available to hospitals around the country. Cincinnati Children’s Hospital Medical Center already has these installed and in use.

The continuous renal replacement therapy (CRRT) device is indicated for patients between 2.5 and 10 kilograms (5.5 to 22 pounds) with acute kidney injury, or that are fluid overloaded, and requiring hemodialysis or hemofiltration therapy.

Fluid overload is a common occurrence in children that undergo cardiac surgeries and acute kidney injuries can happen due to a variety of reasons. Typically, CRRT machines designed for adults are used off-label to treat neonates and young children, and the Carpediem device overcomes some of the limitations and risks associated with that approach.

“CRRT procedures performed for critically ill infants using previously available technology are not optimal largely because dialysis machines available in the U.S. are not designed to treat these small, fragile patients, and can potentially expose them to many risks,” said Stuart L. Goldstein, M.D., professor of pediatrics and director, Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, in a Medtronic press release. “This new system is designed specifically for these patients which enables increased precision of neonatal CRRT treatment and, potentially, reduces these risks. We are grateful to be the first site in the U.S. with this technology to help the children in our care.”

Related: CA.R.PE.DI.E.M. (Cardio-Renal Pediatric Dialysis Emergency Machine): evolution of continuous renal replacement therapies in infants. A personal journey; Continuous renal replacement therapy in neonates and small infants: development and first-in-human use of a miniaturised machine (CARPEDIEM)

Via: Medtronic
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ivWatch Monitors IV Placement Sites for Leakage, Now Cleared by FDA

ivWatch, a company based in Newport News, Virginia, won FDA clearance for its SmartTouch sensor that detects peripheral IV infiltration and extravasation events. Though somewhat rare, these can be difficult to notice and a late response can lead to grave consequences. The SmartTouch sensor can warn physicians that something is wrong, sometimes hours before a clinician would notice any visual or tactile changes on the patient’s body.

The sensor, which is already cleared in Europe, is a single-use disposable device that can be used on patients of any age, including those in the neonatal intensive care unit. Thanks to the SmartTouch, clinicians can take advantage of additional options in terms of where to place the IV, which is especially important for neonates, to choose longer dwell times, and to keep an eye on active patients that may be ambulatory at times.

The device, which uses visible and near-infrared light to penetrate the skin, can be used alongside the ivWatch Patient Monitor that algorithmically analyzes the optical signatures of tissue around the IV site while compensating for patient movements. The system can detect changes as small as .2 mL of IV fluid, with an average detection volume of 2.02 mL, according to ivWatch. Any adverse events are immediately relayed to the clinical team for a quick response.

The adhesive on the back side of the sensor is breathable, leading to minimal irritation and compatibility with existing IV dressings.

More from ivWatch regarding the tested efficacy of the SmartTouch:

A series of seven IRB-approved studies were conducted to test the efficacy and safety of the SmartTouch Sensor. Five verification studies were conducted to understand the performance and optimize ivWatch’s proprietary algorithm to maximize sensitivity to infiltrated tissues, while limiting the number of false notifications issued. Two validation studies were conducted to investigate device sensitivity and false notification rates.

Clinical data shows that the SmartTouch Sensor issued notifications for 99.0%* of early stage infiltrations in less than 10 mL of infused IV fluid. Results also showed less than one false notification was issued every six days, therefore having minimal contribution to clinician alarm fatigue.[3],[4],[5] The majority of the non-infiltration notifications were attributed to a force applied to the IV site, which may beneficially notify clinicians of conditions that could place the peripheral IV site at a greater risk for complications. ivWatch also has a proven record of detecting IV infiltrations an average of 15 hours before the clinician.[2]

Flashbacks: ivWatch Detects IV Infiltrations and Extravasations: Interview with Gary Warren, President and CEO; ivWatch Monitors IV Placement Sites for Leakage Outside Veins; ivWatch IV Infiltration Detection Device Cleared in Europe; ivWatch Detects Leaks Near IV Placement Sites;

Product page: SmartTouch Sensor

Via: ivWatch
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Nanoparticles for Large Gene Therapy to Cure Common Eye Diseases

Wet age-related macular degeneration and a number of other eye diseases, including congenital conditions, are related to mutated genes that result in blood vessel abnormalities. These can be treated with gene therapy, but delivering genetic material has proven to be difficult when dealing with large gene sequences that are common in retinal conditions.

Viruses have been the go-to vectors for delivering genes into the eye, but the immune system wants to fight them. Too often this results in poor efficacy on follow-up treatments. Moreover, they are not good at carrying large genetic payloads and there’s also a risk of cancer.

Now, researchers at Johns Hopkins University have devised a way to tightly pack long chains of DNA into nanoparticles and deliver those into the eye. Once inside the cells of the retina, the DNA bundles are released to promote the production of a therapeutic protein without worrying about any viral side-effects.

To make this possible, the team created a novel large polymer molecule to compress the DNA bundles very tightly. This molecule is biodegradable and leaves the eye and the body once its job is done. The compact vessel of the DNA and the polymer is small enough to enter living cells without causing damage.

Initially, the scientists delivered genetic material for a fluorescent protein into the eyes of mice to see whether it gets into the cells and produces the protein. Even months later, the eyes of the mice continued to glow. Once it was confirmed that the approach works and does so for a long time, the researchers delivered a gene that produces a protein (vascular endothelial growth factor (VEGF)) that leads to abnormal blood vessel growth into a group of rats. These animals developed blood-vessel growth similar to that seen in people with wet macular degeneration.

The last experiment was essentially the opposite, delivering gene therapy that generates a protein that deactivates VEGF. This is the same therapy as that already available but in the form of a nanoparticle that produces long-term effects and doesn’t require frequent eye injections. The results showed that after the nanoparticle injections, the animals had a 60% reduction in abnormal blood vessels compared with the controls, and the effect lasted for over a month.

“These results are extremely promising,” said Jordan Green, Ph.D., professor of biomedical engineering at the Johns Hopkins University School of Medicine, in a press release. “We have the ability to reach the cells most significantly affected by degenerative eye disease with non-viral treatments that can allow the eye to create its own sustained therapies.”

Full study in Science Advances: Suprachoroidal gene transfer with nonviral nanoparticles

Via: Johns Hopkins
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Micro-LEDs and Solar Panels Wirelessly Power Medical Implants

Researchers at the Gwangju Institute of Science and Technology in South Korea have developed a method to wirelessly power implanted devices using light. The technique involves a micro-LED patch to transmit light through the skin and a photovoltaic system on implanted devices that can turn this light into electricity. This technology could help researchers to develop devices that do not need batteries, avoiding the need to remove and replace them when the batteries are depleted.

Implantable electronic medical devices have had a significant impact on healthcare, particularly on the long-term management of chronic conditions. Such devices include old favorites, including the pacemaker, and those in development, such as the artificial pancreas. However, a common stumbling block for these devices, particularly those intended for long-term implantation, is their supply of power.

“One of the greatest demands in biomedical electronic implants is to provide a sustainable electrical power for extended healthy life without battery replacement surgeries,” says Jongho Lee, a researcher involved in the study. “Currently, a lack of a reliable source of power limits the functionality and performance of implant devices. If we can secure enough electrical power in our body, new types of medical implants with diverse functions and high performance can be developed.”

At present, electronic implants must either be powered through external wires, which penetrate the skin and pose an infection risk, or through an internal battery. There are some wireless techniques already in use, such as inductive coupling, but they are generally only safe at lower power levels. Internal batteries can have a significant life-span, on the other hand, but will eventually become depleted, requiring a surgical procedure to replace them. This is inconvenient for patients, and also comes with risks such as infection and other complications.

To address these limitations, the Korean researchers have developed a method to wirelessly power implanted devices, using the implantable equivalent of solar panels. The technique, described in the Proceedings of the National Academy of Sciences, relies on an externally applied light source in the form of a micro-LED patch that is stuck to the skin above where an implanted device resides.

The patch exploits the translucent nature of tissue, which allows light penetration to some extent – think of the glow that happens when light from a flashlight, that is pressed against your fingers, passes through your skin.

The second component is a photovoltaic system that is attached to an implanted device, which uses the light transmitted through the skin to generate electricity. So far, the researchers have tested the system in mice and demonstrated that it can successfully power an implanted device.

“These results enable the long-term use of currently available implants, in addition to accelerating emerging types of electrical implants that require higher power to provide diverse, convenient diagnostic and therapeutic functions in human bodies,” said Lee.

Study in Proceedings of the National Academy of Sciences: Active photonic wireless power transfer into live tissues

Via: Gwangju Institute of Science and Technology
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Revolutionizing IV Access With TournIQ: Interview With Jonathan Ilicki, Co-Founder of Ortrud Medical

IV access is one of the most common clinical procedures in healthcare, with over 300 million hospitalized patients in the United States receiving a peripheral venous catheter every year. However, as many have painfully experienced, catheter insertion isn’t always successful on the first attempt. Often times, we place the blame on dehydration, our deep veins, or the healthcare worker’s lack of skill.

Surprisingly, the humble tourniquet plays a very significant role in whether or not IV access is successful on the first poke. To maximize the chances of success, and to spare our arms the additional pain, Stockholm-based Ortrud Medical has designed TournIQ, a tourniquet that helps the user apply optimal pressure on the arm to increase vein visibility, palpability, and size when gaining IV access.

TournIQ is unique in that it features “Kiri-Tech” which are mechanical features built into the tourniquet that allow it to stretch to indicate when optimal pressure has been reached. Moreover, TournIQ is single-use, but made from recyclable paper-like Tyvek, which uses 6 times less material than other single-use tourniquets, and helps allay concerns about hygiene compliance and environmental impact.

We wanted to learn more about why re-innovating the tourniquet is so important right now, so we sat down with Ortrud Medical’s co-founder and board member, Dr. Jonathan Ilicki, to share more about TournIQ.

Scott Jung, Medgadget: Tourniquets have reliably been around for many years with little innovation. What are some of their problems, and how does TournIQ address them?

Dr. Jonathan Ilicki, Ortrud Medical: Several studies have shown that reusable tourniquets can spread drug resistant bacteria. Single-use tourniquets address this, but these disposable tourniquets often apply the wrong pressure on the arm, which causes poor venous dilation. This is one of the reasons why up to every third IV attempt fails.

TournIQ combines the hygienical aspects of single use tourniquets with a unique pressure indicator that guides the user to apply pressure that gives the quickest and largest venous dilation. Bigger veins mean more successful IV attempts. As IV access is performed so often, and is so critical, this can really help patients and reduce complications and costs for healthcare providers.

Medgadget: Why is TournIQ particularly important during COVID-19?

Dr. Ilicki: Disposable tourniquets have been used in the US for some time but adoption has been slow in Europe and the rest of the world. COVID-19 has made many European health care providers rapidly shift to disposable tourniquets. However, this shift has often met resistance as disposable tourniquets often are less user friendly and apply a lower pressure, and nurses get frustrated over the sudden difficulty of having to place IVs in small veins. We designed TournIQ to specifically address this: being hygienical as well as simplifying IV access through correct pressure, and is why several larger providers have shifted to using it following our market launch in Sweden only 6 months ago.

Medgadget: What’s the story behind TournIQ’s creation and development?

Dr. Ilicki: A few years ago the co-founders and I participated in a Clinical Innovation Fellowship, . The program matched me, an MD with a business degree, with Patrik Nilsson, MSc in Industrial Design, and Caroline Dahl, phD in Biomechanics, with the aim to solve a big problem in healthcare. We spent weeks observing clinical needs and quickly zoomed in IV access. At the end of the fellowship, we realized that we had come up with a simple and groundbreaking innovation – and that we could create a new global standard for safe IV access. TournIQ was created and Ortrud Medical was founded.

Medgadget: What was your process in evaluating different materials and ultimately choosing Tyvek for TournIQ?

Dr. Ilicki: We were looking for a material that was resilient, comfortable for patients, and most importantly recyclable and as environmentally friendly as possible. TournIQ’s low weight and recyclable material mean a smaller carbon footprint and a more sustainable product life cycle than other tourniquets.

Medgadget: Can you share some of the successes you’ve had with your customers who are using TournIQ?

Dr. Ilicki: There are many interesting stories! One example is a leading private surgical clinic that gave TournIQ a trial run, but they liked it so much that the whole clinic shifted from reusable tourniquets to TournIQ. We’ve done several follow up studies and see that users love TournIQ. In one study 90% of nurses stated that TournIQ gives better venous dilation. Another study showed that users got an average increase in venous dilation of 70% – which makes IV access a lot easier!

Another example is an emergency department that previously had shifted from reusable tourniquets to a market-leading disposable tourniquet in order to improve hygiene. However, due to poor usability and poor venous dilation, the staff refused to use the disposable and went back to reusable tourniquets. The department then tried TournIQ, loved it, and have now shifted to only using TournIQ at their emergency department.

During the past months, covid-19 has catalyzed the interest in TournIQ – and it’s now being used in half of Sweden’s 21 regions! Distributors have also contacted us and the tourniquet will within short be used in other parts of the world.

Medgadget: Lastly, where does the name “Ortrud” come from?

Dr. Ilicki: During the fellowship, we did a deep dive into IV access and the role of tourniquets. We were tutored by a senior nurse named Ortrud Kasche who had been placing IVs ever since when they were made of metal instead of flexible plastic! She emphasized the role of optimizing the core factors in order to succeed with IV access, such as applying correct pressure to get proper venous dilation. We decided to name the company after Ortrud as a tribute to really understanding IV access and getting the basics right – which we feel she personifies.

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Robotic Transcranial Doppler for Stroke Detection and Risk Assessment in COVID: Interview with Diane Bryant, Neural Analytics

Emerging evidence suggests that COVID-19 patients are at a higher risk of stroke and promptly diagnosing and treating such patients is a priority in hospitals across the world. Moreover, identifying which COVID-19 patients are at increased risk of developing a stroke is also important, and may help with preemptive treatment and monitoring.

The Lucid Robotic System, developed by LA-based Neural Analytics, is a transcranial doppler system that allows clinicians to identify clots and changes in blood flow in the brain in real time, without needing a specialized technician. The device is robotically assisted and automatically optimizes placement of the ultrasound probe, which can help to minimize clinician exposure when assessing COVID-19 patients.

Positioning the probe and patient takes less than five minutes, and the procedure can be performed at the bedside. Crucially, the device allows clinicians to rapidly identify blood clots in COVID-19 patients, and then implement timely treatment.

The system has already been used in COVID-19 patients, and may help clinicians to identify which patients are at higher risk of vascular complications. Neural Analytics has begun shipping units specifically to support the COVID-19 response. For instance, a unit sent to a hospital in New York was used to scan COVID-19 patients in the ICU the same day that it was delivered and installed.

See a video about the technology below:

Medgadget had the opportunity to talk to Diane Bryant, Chairman and CEO of Neural Analytics, about the technology.

Conn Hastings, Medgadget: Please give us an overview of the Lucid Robotic System.

Diane Bryant, Neural Analytics: Our founder, Dr. Robert Hamilton, developed the Lucid Robotic System as a means to monitor and assess the blood flow to the brain. It is the only fully automated, real-time method to non-invasively display the intensity and direction of intracranial blood flow. These data enable rapid identification of blood clots and other neurological abnormalities. Robert succeeded in his mission by combining long-established ultrasound technology with state-of-the art robotics and artificial intelligence. Brain illnesses, such as stroke, require immediate intervention to avoid life-long disability or death. The Lucid Robotics System uniquely provides precise insight into blood flow velocity, the existence of clots or other deposits, and the narrowing or widening of the blood vessels.

Brain derived illnesses have touched all our lives, whether personally or through someone close to us. Stroke, dementia, Alzheimer’s, traumatic brain injury, Parkinson’s disease – all manifest themselves in the brain. I personally find it distressing that in our annual physical check-ups our general practitioner informs us of the health of our heart and lungs but provides no insight into the health of our brain, an organ clearly as critical. At Neural Analytics, we strive to become the fifth vital sign.

Medgadget: How is the Lucid Robotic System being used in COVID-19 patients?

Diane Bryant: In mid-April we were contacted by three renowned medical institutions. Their message was consistent: emerging evidence showed COVID-19 patients are entering a hypercoagulable state leading to blood clotting in multiple organs including the lungs and brain. The medical community is faced with an alarming 700% increase in stroke for COVID patients under the age of 50 compared to historical norms. Patients of COVID-19 are emerging from ventilation with impaired speech, immobility, loss of memory and in some cases they do not survive.

The medical community requested the use of our Lucid Robotics System to continuously monitor the blood flow of COVID-19 patients. Once a patient is sedated and ventilated there is no other means to assess brain function. The clinical teams also face the issue of infection, necessitating limited exposure to the COVID-19 patient. The Lucid Robotics System allows them to maintain strict infectious disease protocols by robotically monitoring the patient from outside the room.

Medgadget: How long does it take to scan someone? How does the system avoid the need for specialized technicians?

Diane Bryant: The time to set up the robotic system and lock on the arteries in the brain is less than five minutes. The physician may view the blood flow for minutes in the identification of existing abnormalities, or may use the system for hours to continuously monitor the brain through surgeries or monitor in the neuro-intensive care unit to alert for possible strokes.

When the ultrasound-based transcranial doppler system was invented in 1982 it pledged to be the stethoscope of the brain. The technology failed to meet its vision due to the difficulty in locating the thinnest part of skull, providing the necessary window into the brain. We have solved that problem using robotics and artificial intelligence.

Medgadget: Please give us an overview of how data from the system may help to increase our understanding about which COVID-19 patients are at greater risk of stroke, and how this could influence pre-emptive treatment.

Diane Bryant: The medical community’s understanding of the COVID-19 virus continues to evolve. It affects different people in different ways. Infected people have had a wide range of symptoms and the death rate is alarming. Initially believed to be a typical acute respiratory distress syndrome like the flu, it increasingly appears this is not the case. The Lucid Robotics System provides a unique view into the disease. Just this past week our system was confirmed by the FDA to cover COVID-19 patients. Although our system was initially developed for illness of the brain, we have realized through our work with medical institutions that insights into pulmonary diseases like COVID-19 can be obtainable through analysis of cerebral blood flow. The body is clearly interconnected.

Our clinical training team has been working side by side with critical care physicians, scanning all COVID-19 patients. A paper was published on May 5th in the New England Journal of Medicine connecting COVID-19 and stroke. Scans of five patients under the age of 50 were completed and the results were staggering. All five showed physical signs of large-vessel stroke. We are working with Mount Sinai and other medical institutions to improve the outcome of COVID-19 patients through assessment and monitoring of blood flow through the brain. Our mission is to contribute to a better understanding of the virus, have a positive impact on COVID-19 patients, and reduce the impact of the disease nationwide.

Product page: Lucid Robotic System…

Link: Neural Analytics homepage…

Flashbacks: Now Available: Neural Analytics’ Lucid Robotic Ultrasound System for Brain Blood Flow Assessment; Lucid M1 Ultrasound Brain Damage Assessment System Cleared by FDA; Lucid M1 Brain Damage Assessment Transcranial Doppler Ultrasound System Now Available; Lucid M1 Transcranial Ultrasound Cleared in Europe to Help Assess Brain Damage
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The Impact of COVID-19 on The Medical Device Industry

As of early May 2020, over 4.7 million people have been confirmed to be infected with the SARS-CoV-2 coronavirus[1], and governments are scrambling to contain its spread. The high R0 value (a measure of contagiousness- estimated to be between 2.0 and 3.02) of SARS-CoV-2 means that those infected copiously spread the virus and develop complications suddenly. As a result, health care systems are overwhelmed, and the effective delivery of medical care to all patients has become a challenge worldwide. Insufficient attention to early warning signs, inadequate stockpiling, lack of access to testing kits and personal protective equipment (PPE), and nationwide variability in the approaches to testing, distribution of PPE, and timing and degree of social distancing measures likely all affected the spread of the disease. Inadequate PPE, overcrowding, and difficulty protecting existing patients are key challenges the medical industry is grappling with[3].

Medical device manufacturers have not escaped the pandemic’s impact. Similar to pharmaceutical companies, medical device manufacturers rely heavily on healthcare facilities for their clinical trial data collection. Most medical device products must undergo clinical trials both pre- and post-market before manufacturers can obtain certificates for market approval. As the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty. Medical device professionals have the unenviable task of asking for a pause amid the panic. No matter how bad it is or how bad it might get, here’s the truth: heedless action will make it worse. Despite the adrenaline telling us to produce as fast as possible, this is the moment when quality matters more than anything else.

With a strategy that leverages exemptions, production procedures that innovate to fill needs and a communication plan that works across public and private entities, you can navigate the chaos and support public health. Announcements from governing bodies and conversations with key decision-makers and regulatory experts hold the key to the success of the medical device industry.

Overall, the implementation of several new regulations may be postponed allowing both companies and regulatory agencies time to react to the crisis. However, there is no evidence this will alter reporting deadlines for established legislation.

At present, this is what we know about specific regulatory impacts:

1. Impact of COVID-19 on regulatory approvals in EU

In the European Union (EU), the Medical Device Regulation (MDR) requires manufacturers to conduct Post Market Clinical Follow-Up (PMCF) studies to demonstrate the continued safety and performance of their devices, as well as capture any emerging risks these may carry. However, the COVID-19 pandemic has delayed clinical trials and disrupted processes. While certain trials such as Investigator-Initiated Studies (IIS) are necessary for the broad healthcare system to come to a consensus around the efficacy of certain therapeutic options, other clinical trials are initiated by sponsors to investigate the safety and clinical performance of devices to satisfy regulatory requirements.

Due to the COVID-19 pandemic, the European Commission recently adopted a proposal on April 3, 2020, to postpone the application date of the MDR for one year. “As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation,” the Commission wrote in a statement. Based on this proposal, the functionality of the European Database on Medical Devices (EUDAMED) will instead be announced by March 25, 2021, with reporting requirements beginning May 26, 2021. While reporting requirements have been delayed, companies should aim to have their supply chain data compiled and ready for submission by March of next year to give themselves adequate time and ensure they can make this deadline.

Among some of the biggest changes seen under EU MDR are:

  • Increased requirements for clinical evaluation
  • Digital and physical labeling
  • Postmarket surveillance (PMS), and
  • Total life cycle traceability.

There is no word yet on the In-vitro Diagnostic Medical Devices Regulation (IVDR), or the impact of this potential delay on European Notified Body audit activities.

The European Commission recently adopted revised harmonized standards to expedite the production of medical face masks, gloves, containers for intravenous injections, sterilization devices and disinfectants, and alter particular requirements for emergency and transport ventilators. In collaboration with the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), the European Commission has agreed to make a number of these harmonized standards freely available.

2. Impact of COVID-19 on regulatory approvals in the US

Emergency Use Authorizations

In the US, the FDA has issued Emergency Use Authorizations (EUA) for medical devices including IVD test kits to diagnose COVID-19 as well as PPE (including conservation of gloves, gowns, and masks) needed to protect healthcare providers interacting with patients. Under EUA declarations, the FDA has the authority to authorize rapid emergency use of specific devices via expedited premarket review during public health crises such as the COVID-19 pandemic. The EUA submission should include as much safety, effectiveness, and risk-related data as is available pertaining to the devices in question. Although obtaining an EUA designation provides expedited access to the US healthcare market, these authorizations last only as long as the public health emergency for which they are granted by the FDA.

Supply chain

The FDA is collaborating with manufacturers of ventilators, ventilator accessories, and other respiratory devices to better understand the current supply chain issues related to the COVID-19 outbreak and to help mitigate any widespread shortages of these devices.

Ventilator guidance

The FDA has issued final guidance on ventilator devices that facilitates EUA designations for these products to treat COVID-19 patients. Non-medical manufacturers (such as automotive and industrial manufacturers) have the opportunity to enter the medical device space during this unprecedented time but they need to be aware of the quality, safety and performance standards the FDA requires for the production and modification of ventilator hardware, software and materials.

3D-printed PPE

The FDA has also released a recent FAQ regarding 3D-printed PPE devices and components, cautioning healthcare providers that they may not provide the same level of protection as conventional products. Manufacturers should review the FDA’s final guidance on technical considerations for 3D-printing for a range of recommendations on medical device applications, including device design, software workflow, material controls, post-processing, and process validation.

3. Medical device shortage and exemptions for COVID-19 related devices

During this global pandemic, the medical device regulatory environment is quickly adapting to meet the challenge of supplying sufficient PPE to front-line healthcare providers and life-saving equipment to those people in medical need. Medical device manufacturers must also rise up to meet this challenge and embrace these opportunities to bring their device faster to the market and help us to come out safely on the other side of the COVID-19 curve. One industry that is majorly impacted by this global crisis is the ventilator industry. There’s currently thought to be a global shortage of thousands of ventilators as the world attempts to tackle the deadly pandemic. The US and the EU are still short of the ventilators they would need to treat burgeoning numbers of COVID-19 patients during the pandemic.

Both Prime Minister Boris Johnson and President Donald Trump, have called on the automotive, aerospace and other industries to help plug the shortage. Ford, GE, and Tesla are among those to have used heating, ventilation, and air conditioning factories to produce respirators in the US, while the VentilatorChallengeUK consortium has been established in Britain to produce 10,000 devices. Alongside seven UK-based Formula 1 teams, the UK consortium features manufacturers as diverse as Rolls-Royce, Airbus, Accenture, Dell Technologies, Siemens, and Unilever working to upscale production of ventilators by slightly modifying existing designs used by medical device manufacturers Smiths Group and Penlon. Dyson, the engineering innovator behind bagless vacuum cleaners and touchless hand dryers, designed a completely new ventilator design in just 10 days.

While most of these efforts involve using established ventilator designs, regulation remains a key consideration for manufacturers involved — many of which have little-to-no experience of medical devices.

If we take a little deep dive, ventilators are categorised as Class II devices in the US. This means they pose a moderate-to-high risk to patient safety and should be subject to rigorous, lengthy clinical trials and regulatory processes. FDA has 510(k) policy, which covers a range of devices including ventilators, allowing manufacturers to place an item on the market after far less extensive testing — providing they can prove it is substantially similar to a product already in use. From my personal experience of dealing with FDA, I can say in case of ventilators, there’s not necessarily need to conduct full clinical trials as ventilators are not new. So, even if there is no situation of pandemic such as COVID-19, they wouldn’t always require huge clinical trials. However, they need to exhibit some clinical evaluation with respect to the design of a new ventilator compared to previous ventilators, to know whether the clinical data utilised by the new ventilators can be assumed as the same.

In the UK regulation, ventilators are considered a Class 2b device by the EU, meaning they pose a medium-to-high risk to patients and must undergo extensive safety checks. However, because they have been around for decades, new models rarely require the one or two-year-long regulatory process associated with novel MedTech innovations.

While the FDA’s 510(k) notification is based around “substantial equivalence” — showing a new device to be sufficiently similar to a product already on the market — the EU’s version is known as a “demonstration of equivalence”, a system that’s slightly stricter but ostensibly the same as the US’.

Not only the US and the EU but the global regulatory landscape is currently in flux for all medical device companies. Regulatory frameworks are shifting around the world, and existing rules may be evolving. However, most of this depends on where a device is being sold and what type of device is being manufactured. Leveraging the right exemptions may lead to faster market entry.

Notable exemptions related to COVID-19 include:

  • China will expedite the registration process for medical protective clothing if they meet standards from Japan, the European Union, or the United States.
  • Singapore will exempt specific devices like particulate respirators, protective gear, surgical masks, and thermometers from registration requirements.
  • Australia issued an exemption for mechanisms involved in the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19.

4. Impact of COVID-19 on personal protective equipment (PPE)

The impact of COVID 19 on the PPE has exposed the unpreparedness of enterprises to cater to an unprecedented demand surge. In response to WHO’s sanitation guidelines and the requirement from healthcare professionals attending the infected patients, a range of PPE such as sanitizers, medical masks, gloves, ventilators are hitting the bottom of their repositories. This visible instance of supply chain disruption in the PPE market is getting worse with the rigidity of government policies pertaining to the import and exports of essential medical components. Levying of import tariffs and export restrictions are adding to the supply crisis in this market in the wake of the impact of COVID 19.

During my current involvement with a MedTech company based out of New York, USA, dealing in the PPE market, we are heavily reliant on the exported medical components from China which is one of the top exporters of PPE globally. While the government has exhibited its intent of relaxing import tariffs by announcing a 90-day deferral of certain duty payments of a range of medical products imported from China, it declined the request of rolling back Section 301 tariffs on a wider range of PPE imported from China. This will result in the procurement price hike for enterprises in the market that will induce them to cut short their imports.

To address the sudden surge in the demand for protective equipment, a majority of countries have risked a breach of the basic principle of the GATT 1947 agreement and have restricted the export of medical components and equipment. This has created major supply chain disruptions in the PPE markets across countries that are heavily reliant on the medical imports. Protective equipment and respirators are some of the protective equipment types that are currently restricted to be exported from some of the EU member states which are seen as an aftermath of the impact of COVID-19 on the civilization.

5. Impact of COVID-19 on medical device grant funding

Funding agencies across the world are working closely with the scientific research community and companies to bolster the national response to COVID-19. Organizations and individuals can now apply for grants specific to COVID-19 research.

COVID-19 grants in the EU

For example in the EU, the scope of the European Union Solidarity Fund (EUSF) has been extended to encompass major public health emergencies. This fund supports EU member states and accession countries that are hit by major natural disasters. Due to the current crisis, the European Commission proposed to extend the scope of the EUSF to allow financial assistance for those seriously affected by COVID- 19. Hence, in 2020, up to EUR 800 million are available to finance medical assistance, medical devices, laboratory analyses, PPE, special assistance to the population, health checks, sanitation of buildings and facilities, development of vaccines and medicines, and many more.

The European Commission had also created a strategic rescEU stockpile of medical equipment. The stockpile includes equipment such as ventilators and personal protective equipment to help EU countries in the context of the COVID-19 pandemic. The initial EU budget of the stockpile is EUR 50 million, of which EUR 40 million is subject to the approval of the budgetary authorities.

COVID-19 grants in the US

In the US, the National Science Foundation is funding dozens of research projects on COVID-19 to mobilize the scientific community to better understand and develop measures to respond to the virus. NSF’s Rapid Response Research (RAPID) funding mechanism enables the agency to quickly process and support research that addresses an urgent need. US congress has pumped up the national funding programs to fast-track COVID-19 research. Critics are arguing that the money the government will be spending on funding new research on medical devices and treatment options is a tiny slice of the $2 trillion stimulus package crafted by legislators to help the country deal with the unprecedented situation of COVID-19. The National Institutes of Health (NIH) has issued several funding opportunity announcements for researchers to submit competitive revisions or seek supplemental funding for existing projects, in order to redirect their research efforts to COVID-19. Other agencies that are typically less focused on health research have also sought to shift their R&D priorities on medical device development for COVID-19.

6. Impact on clinical trials and IRB reviews

The impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology. IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances. Clinical trial protocols are required to be changed to eliminate apparent immediate hazards to participants such as changing in-person visits to virtual visits, elimination of study visits/procedures that do not impact the integrity of the study or participant safety, incorporation of screening questions to identify potential COVID-19 exposure.

Other challenged posed by sponsors of clinical trials include:

  • Delays in study initiation activities resulting from the inability to perform site selection/initiation visits and/or clinical vendor qualification visits, and subsequent downstream delays in patient enrollment,
  • Protocol adherence issues arising from an inability to comply with visit schedules, study procedures, drug administration, and monitoring procedures,
  • Delays in clinical material distribution and import/export delays due to limited manufacturing and operations staff, limited or reprioritized hospitals staff, and travel bans,
  • In some cases, suspension of all patient activities for trials, sites, or studies that do not have active patients being treated,
  • Cancellation or postponement (indefinitely, in some cases) of major scientific and professional conferences and meetings, and KOL, investigator, and scientific advisory board meetings.

The FDA issued guidance in March 2020, Conduct of Clinical Trials of Medicinal Products During COVID-19 Pandemic4, which emphasises mitigation and precautionary strategies based on study-specific circumstances. It also provides recommendations on the management of procedural modifications, protocol amendments, and deviations (e.g., implementation, IRB approvals, FDA consultation), as well as preparedness, to describe the tactics and impact in the corresponding clinical study reports. Some of these recommendations are also highlighted in the Association of Clinical Research Organization’s (ACRO’s) Considerations to Support Clinical Trial Monitoring Oversight During COVID-195 and in the UK Medicines and Healthcare products Regulatory Agency’s Advice for Management of Clinical trials in relation to Coronavirus6.

Summary

In closing, I would like to reiterate that we’re in the midst of an unprecedented global health crisis. This crisis calls on the medical device industry to work closely with customers, patients, regulators, and public organizations for the sake of public health. The news will be fast-paced, and much of it will be disappointing, frustrating, and dispiriting.

The key, however, will be for companies to focus on how they can make the most effective contributions to control the spread of the virus and save lives.

Short term, that might mean ramping up production to new levels; long term, that might mean sticking closely to regulatory guidance to ensure that speed doesn’t destroy quality, creating even more problems in the future. No matter what, medical device professionals will have an essential role to play in the fight against COVID-19.

References

  1. Coronavirus Resource Center. COVID-19 map. Baltimore, MD: Johns Hopkins University; 2020. Available from: https://coronavirus.jhu.edu/map.html. Accessed 2020 May 17
  2. Carlos del Rio, Preeti N. Malani. COVID-19—New Insights on a Rapidly Changing Epidemic. JAMA. 2020;323(14):1339-1340.
  3. Jessop ZM, Dobbs TD, Ali SR, Combellack E, Clancy R, Ibrahim N, Jovic TH, Kaur AJ, Nijran A, O’Neill TB, Whitaker IS. Personal Protective Equipment (PPE) for Surgeons during COVID-19 Pandemic: A Systematic Review of Availability, Usage, and Rationing. Br J Surg. 2020 May 12.
  4. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency).
  5. Considerations to Support Clinical Trial Monitoring Oversight During COVID-19. ACRO. (https://www.acrohealth.org/wp-content/uploads/2020/03/ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20.pdf)
  6. MHRA, Advice for Management of Clinical trials in relation to Coronavirus. (https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/).

About the author

Shrinidh Joshi is a freelance medical writer at Kolabtree, the world’s largest freelance platform for scientists. Kolabtree helps medical device companies consult experts for help with medical writing, clinical trials and regulatory compliance. Shrinidh has over 10+ years of experience in pharmaceutical, clinical, regulatory and medical writing and has worked in companies like Sun Pharma, Virgilant, CannTrust and ThermoFisher Scientific.

 

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A Virtual Care Platform for Respiratory Illness: Interview with Stacie Ruth, CEO of AireHealth

AireHealth, a medtech company based in Orlando, Florida, currently offers a portable nebulizer and companion app for respiratory patients aged two and over. The small nebulizer can be charged using a micro USB charger and then placed in a bag or pocket for easy transport and use on the move. The companion app is geared toward increasing patient engagement and medication adherence, which is important in maximizing therapeutic outcomes among chronic respiratory patients.

Recently, AireHealth announced a merger with BreathResearch, a respiratory healthcare company based in Silicon Valley that specializes in detection and monitoring of respiratory diseases. The company has developed a portable spirometer that can be used to measure lung health. The technology involves analyzing breathing sounds and lung flow volumes using AI and machine learning to recognize changes in a respiratory condition.

This technology will be merged with that of AireHealth to form VitalBreath, a virtual care platform for respiratory illness. The system encompasses disease monitoring, including a lung health score based on 35 different biomarkers, drug delivery, and patient apps that aim to increase patient engagement and medication adherence.

The overall aim is to reduce the number of emergencies and hospitalizations that respiratory patients experience by monitoring lung health and promptly treating disease exacerbations. Another potential benefit is significant reductions in healthcare costs.

Medgadget had the opportunity to talk to Stacie Ruth, AireHealth Co-Founder and CEO, about this technology.

Conn Hastings, Medgadget: Please give us an overview of chronic respiratory illnesses and the burden they pose for patients and healthcare systems.

Stacie Ruth, AireHealth: Respiratory illness is a big and growing problem — the number of respiratory compromised people in the United States alone tops 100 million. This is made up of individuals with asthma, COPD, respiratory viruses such as COVID-19, pneumonia, and Cystic Fibrosis. These individuals have a staggering mortality rate of 50 deaths per 100,000. Most of this mortality rate is driven by delayed diagnosis, delayed treatment, poor adherence, and unnecessary hospitalization. These factors cost over $130 billion a year.

Medgadget: How has the COVID-19 pandemic affected patients with chronic respiratory diseases?

Stacie Ruth: The COVID-19 pandemic continues to affect those who are respiratory compromised, as they are a population considered at-risk by the CDC. Having access to their medication and being able to treat their respiratory conditions at home, before they escalate, is crucial.

Medgadget: How important is drug compliance in managing a chronic respiratory disease?

Stacie Ruth: At AireHealth we like to draw a distinction between Compliance to a prescribed therapy, which refers to how the clinical community evaluates whether a patient is following through on the instructions and actions they are given, and adherence to a therapy is how you describe it from the patient perspective. Adhering to a therapy, such as a medication, is critical in managing a chronic respiratory disease, but maybe even more important than the act of “complying” with your care plans is if you are better educated about why your therapy is necessary, how you are responding to it, and seeing your improvements and declines in health status as it happens. This is important as a delayed or slow response to changes in lung health are significant factors that lead not only to patient decline but also the increasing costs to both patients and healthcare systems.

Medgadget: How does AireHealth help patients to improve their drug compliance?

Stacie Ruth: AireHealth believes that increased adherence will ultimately lead to better outcomes for patients with lung conditions and will lower costs to the individual and the system. AireHealth’s virtual care platform, VitalBreath (coming late 2020), provides early detection of respiratory decline. Full visibility to therapy cycle is created by combining drug adherence and patient engagement with connected drug delivery, connected respiratory device, and patient-centric companion applications.

We see four different health statuses that AireHealth’s VitalBreath can assist a patient with at home:  1) proactive lung care, helping a respiratory compromised person keep track of their current health situation, 2) needing a second look, providing the person with access to telehealth services through our platform, 3) an acute episode, where the person needs an intervention from a clinical perspective – maybe even a hospital visit, and 4) post-acute care, where we increase the intensity of support for this patient after they have experienced an emergency.

All the while, the AireHealth connected devices such as the FDA cleared nebulizer and our soon to be released spirometer are helping promote adherence to the patient’s care plan as we bring the devices together with our software solutions that utilize 35 proprietary and IP protected biomarkers to look at different dimensions of lung health and processes them in our AI engine to categorize symptom severity. Then the VitalBreath solution detects and calls attention to anomalies and manages respiratory care. In addition, there is a remote patient monitoring (RPM) vital signs tool built in for in-home use and a phone camera-based warning system to assess patient decline.

By tracking symptoms, status, decline, interventions, and outcomes, AireHealth can build data sets for clinical benchmarks, improve early detection of respiratory diseases and reduce high costs. Helping achieve the quadruple aim, VitalBreath will provide value-based care and early detection of respiratory decline, saving patients’ lungs and lives.

Medgadget: Please give us an overview of the services and products offered by AireHealth.

Stacie Ruth: AireHealth currently has a portable nebulizer that is available for purchase on our website, and we are also in a pilot with AdventHealth where patients receive the nebulizer along with a companion application and provide feedback. Mobile apps are extremely helpful in creating awareness and a more proactive patient, especially when the person experiencing lung conditions is in a vulnerable population.

Medgadget: How has this latest merger increased the capabilities of AireHealth?

Stacie Ruth: Open innovation has always been at the core of AireHealth, and as a company we are always seeking innovative opportunities to improve the lives of people living with respiratory conditions. This merger also enables AireHealth to accelerate our roadmap and journey towards digital therapeutics by bringing an added level of machine learning and artificial intelligence to our existing respiratory care solution. We are taking the next step to saving lungs and lives.

Link: AireHealth…
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Noona Cloud Tool for Cancer Patients: Interview with Jani Ahonala, VP, Global Patient Outcomes, Varian Medical

Varian Medical Systems, based in Palo Alto, California, has announced that its Noona mobile service now has some new features, some of which are a direct response to the COVID-19 pandemic. Noona is a cloud-based system that allows cancer patients to connect with their clinicians and clinics. Patients can record their symptoms and proactively manage their conditions. The idea is that issues can be flagged early and the resulting preemptive action could enhance patient outcomes.

In light of the current COVID-19 pandemic, mobile solutions for patient care are now more important than ever. Sadly, the pandemic doesn’t just affect patients who contract COVID-19, but also makes it difficult for a variety of existig patients with chronic diseases to manage their conditions, receive appropriate treatment, and attend appointments at healthcare facilities for checkups. Avoiding potential exposure to the virus is important, but it can interfere with basic healthcare in certain circumstances.

Healthcare apps can help to fill this void, providing a virtual connection between patients and healthcare providers, and Noona is an example of such a system designed specifically for cancer patients. Recently, Varian has introduced some new features, including a questionnaire to screen for COVID-19 symptoms, patient access to medical records, and secure messaging.

Medgadget had the opportunity to talk to Jani Ahonala, Vice President, Global Patient Outcomes at Varian Medical Systems, about the technology.

Conn Hastings, Medgadget: Please give us an overview of Noona and its features.

Jani Ahonala, Noona: Noona is a smart cloud-based mobile service that connects cancer clinics with patients, captures patient-reported outcomes to improve the review of symptoms and determines the need for medical attention. Proactivity is increased, which positively impacts survival rates and helps preserve clinical resources. Noona also automates patient management workflows to enhance efficiency and ensure the delivery of more effective patient care.

Medgadget: What advantages does Noona offer patients in terms of keeping track of their condition and being more involved in managing it?

Jani Ahonala: With Noona, patients are given easy access to healthcare professionals, affording them ongoing communications around their symptoms which helps them feel less depressed and more connected, and granting them the opportunity to play a more active role in their own care. Patients know that their questions and concerns about symptoms will be addressed, providing them with much-needed support and peace of mind. They understand that this engagement will lead to better care.

Medgadget: How have staff responded to using Noona? Does it offer time savings for busy healthcare staff?

Jani Ahonala: Noona provides cancer care teams with significant time savings and improved clinical workflow through more efficient patient monitoring, and the response has been quite positive. Through Noona’s smart algorithms and patient-reported data, staff have the ability to identify and predict symptom changes, prioritize patients by severity and utilize a work queue to automate and track follow-up. This has been a huge time saver for clinicians, saving nurses up to an hour a day on the phone with patients and directing their attention to where it’s needed.

Medgadget: How does Noona help with clinical decision making and the early identification of symptoms?

Jani Ahonala: By equipping patients with a platform to easily participate in the discussion of their treatment, Noona facilitates the collection of key patient-reported data and, subsequently, the delivery of more informed patient care. Clinicians can use Noona to better monitor patient symptoms, predict future outcomes and address minor changes early, providing proactive adjustments to treatment before a patient ends up in the emergency room.

Medgadget: How has the COVID-19 pandemic increased the need for remote medical care?

Jani Ahonala: COVID-19 has really altered the delivery of care, and when you have a patient population that is already at risk with a compromised immune system and dealing with disease symptoms outside the clinic, that’s a big deal. Managing those symptoms and communicating remotely becomes paramount as visits to the hospital or hospitalizations could cause risky exposure to the virus. Having a remote platform that provides greater efficiency and automation is extremely important for clinicians right now, specifically triage nurses, who are otherwise inundated with an enormous increase in calls.

Tennessee Oncology is a great example of how remote capabilities improve clinical workflow. One of the nation’s largest community-based cancer care groups, the organization’s 600 care team members are able to manage about 10,000 patients directly through the Noona patient app and 31,000 patients through the telephone triage workflow automation in Noona. COVID-19 has made a major case-in-point for why Noona is so necessary, and we believe that keeping patients and clinicians remotely connected is going to become foundational as we see the long-term impacts of the pandemic.

Medgadget: Please tell us the new features you have added to Noona in response to the pandemic.

Jani Ahonala: In response to the pandemic, we’ve expanded Noona’s capabilities to support both patients and care teams as they grapple with the “new normal” in healthcare delivery. The Noona app now includes a COVID-19-specific questionnaire that helps identify patients whose symptoms may indicate a possible infection, allowing for swift action to be taken. With the urgent need for this tool, we also reinvented our implementation process to make it much quicker and entirely remote. This rapid deployment process allows us to get Noona into the hands of patients and staff in a matter of weeks without ever requiring in-person exposure.

Info page: Noona mobile service

Link: Varian Medical Systems

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Sweat Sensor Gathers Large Samples for Accurate Analysis

Sweat excreted by the skin contains important biomarkers for a number of diseases, as well as being a critical parameter in athletic performance, overall body function, and even an early warning indicator of an oncoming illness.

Measuring sweat output and its chemical composition, in an accurate and easily administered way, has been a challenge. Athletes and others would benefit from a wearable patch that can be stuck near sweat glands to continuously measure pH levels, glucose, salt content, and the overall amount of sweat produced. Making such patches has turned out to be harder than thought, even with existing microfluidic devices, because it’s hard to gather large samples and process them without substantial evaporation.

Now, a team of engineers at Penn State and Xiangtan University in China have developed a microfluidic device that overcomes important sample gathering issues for skin-based sweat sensors, hopefully leading to the introduction of such devices for wider use.

The new approach uses a single opening to collect a sweat sample into tiny channels inside a vial. The channels are hydrophilic, and so draw the sweat in, while the valve inside the inlet is made of hydrophobic components so that all the sweat passes through and into the channels. Because there is only a single open end of each channel, the sweat doesn’t have a chance to evaporate, resulting in substantially larger sample sizes for analysis.

“The two-valve device is more complicated and requires using a clean-room technique called photolithography. Our simpler one-valve device can be made without expensive equipment utilizing micromachining,” said Huanyu “Larry” Cheng, assistant professor of engineering science and mechanics at Penn State, in a press release

To analyze the sweat for certain parameters, a color-based analyte can be introduced into the sweat-holding chambers and a color change can be seen by the eye or, for particularly sensitive tests, with a smartphone that is more keen at detecting specific colors.

Study in Lab on a Chip: Skin-interfaced microfluidic devices with one-opening chambers and hydrophobic valves for sweat collection and analysis

Flashback: Stick-On Wearable Sweat Sensors to Monitor Exercise, Disease

Via: Penn State
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