Safety Issues With Lithium-Ion Batteries

There are several ways lithium-ion batteries can catastrophically fail, raising four major safety concerns.

Fires

Thermal runaway happens when lithium-ion batteries generate more heat than they can release. A chemical decomposition process results in self-oxygenation, accelerating and sustaining the reaction. The uncontrollable heat and pressure cause rapid degradation, leading to ignition. Medical devices will seemingly randomly burst into flames.

Leaks

Batteries contain corrosive, toxic chemicals that can cause irritation, burns, blindness and death. For example, regarding hydrofluoric acid, concentrated exposure to as little as 2.5% of the body can be deadly. Due to the sheer size and weight of commercial-sized power banks, leaking medical devices can cause tremendous damage.

Fumes

Off-gassing occurs when a lithium-ion battery releases combustible hydrocarbons like methane, acetylene, hydrogen and propane. These fumes can also contain toxic chemicals like hydrogen cyanide, carbon monoxide and hydrogen fluoride. Hospitals’ commercial-grade power banks can produce enough smoke to force a wing-wide evacuation.

Blasts

Explosions can result from thermal runaway because lithium-ion batteries are highly combustible. While they often cause fires, the burst does enough unique damage to be classified as its own safety concern. The consequences are severe — especially when the reaction happens to someone with an implantable medical device.

Examples of Lithium-Ion Battery Failure in Medical Devices

Unfortunately, safety concerns surrounding lithium-ion batteries are based on real-world events. There have been countless cases of these cells igniting, combusting, leaking or smoking. Usually, the United States Food and Drug Administration (FDA) removes high-risk models from the market as quickly as possible.

For instance, the agency recalled an Abbott glucose monitoring system in 2023 after discovering it could catch fire if users didn’t use the manufacturer-provided charging cable and power adapter. Over 4.2 million devices were affected since the recall came seven years after the initial distribution date.

Some recalls come too late. In May 2022, Muhammedou Tarawally received Abbott’s HeartMate 3 Left Ventricular Assist System. The device — which the FDA has since recalled — failed less than one year after implantation. The battery pack’s cells shorted out internally due to an alleged manufacturing defect, causing an explosion.

While Tarawally likely passed away from the blast, his 3-year-old son died as a result of the subsequent fire, leaving Fatou Nguda Secka, his spouse, as the family’s sole survivor. Cases like this illustrate how serious the safety issues surrounding lithium-ion cells are — critical injuries and fatalities are real possibilities.

Even in cases where no one is hurt, malfunctioning power sources can cause unplanned downtime and impede patient care. In 2023, a children’s hospital in Tampa, Florida, caught fire and 80 people had to be evacuated after a commercial power bank began off-gassing. Two of the 30 lithium-ion batteries — weighing approximately 100 pounds each — had ruptured.

Why Do Medical Devices Still Use Lithium-Ion?

The safety concerns surrounding this power source seem serious enough to necessitate a switch to an alternative. However, as batteries go, lithium-ion is actually relatively safe. Although failures are almost always catastrophic, they are rare as long as users follow the manufacturer’s instructions and best practices.

Besides, these batteries are incredibly long-lasting compared to similar alternatives. A standard model can last 1,000 to 2,000 charge-discharge cycles on average. Lithium-ion batteries retain capacity surprisingly well despite consistent use, making them ideal for powering medical technologies and implantable devices.

These power cells are also one of the most affordable options on the market. Their cost has decreased by about 97% since entering the market. Standardization has driven research and development, resulting in unparalleled levels of optimization. Further, the chemicals and rare earth minerals required for production are relatively common.

How to Address These Safety Issues

While health care IT professionals may not have as much power as original equipment manufacturers, they can still address safety concerns in multiple ways.

1.    Validate Suppliers

When designed for medical applications, lithium-ion power sources must comply with IEC 60086-4 — a standard from the International Electrotechnical Commission — to ensure chemical, electrical and mechanical safety standards are met. IT teams should verify that their equipment supply comes from reputable, compliant providers.

2.    Replace Batteries

There are multiple signs a battery may soon ignite, combust, leak or smoke. If it swells, is hot to the touch or experiences a drastic capacity change, the IT team should replace it immediately. They cannot put it in the garbage — they must dispose of it at a hazardous waste collection point to prevent it from catching fire or smoking in transit.

3.    Have a Plan

Catastrophic issues often happen when least expected. Professionals may be unable to prevent every failure, but they can safeguard patients and providers. Having a plan for a sudden combustion reaction or off-gassing event is essential. They should keep the proper tools — like a chemical extinguisher for a Class B fire — on hand.

4.    Post Guidelines

Not everyone knows how lithium-ion batteries should be used, charged and stored. Even fewer know they can produce toxic fumes and are highly combustible. The IT team should post guidelines for patients, providers and team members to ensure everyone works together to follow best practices, preventing failure.

Making Medical Device Batteries Safe to Use

Lithium-ion batteries are necessary parts of medical devices. However, they can be dangerous. Health care professionals can protect their institution by knowing the signs of an impending failure and how to address hazardous situations. Their quick thinking could save their colleagues and patients.

By Zac Amos, ReHack

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The assay from global health technology provider Mindray allows clinical teams to measure cardiac troponin I proteins that are released into the blood during heart attacks, and when the heart is damaged.

Found to be highly precise and sensitive for both men and women, the cardiac troponin I assay has been the focus of a new study carried out by world-renowned cardiac biomarker specialists at Hennepin Healthcare’s Hennepin County Medical Center in Minneapolis, Minnesota. Early evidence has shown significant potential for clinical applications in helping to reduce pressure on busy emergency departments.

Opportunity for Clinical Diagnosis of Heart Attack Risk

Researchers found that the test not only performed as well, if not better, than those already available in the market, but that it also had the potential to help clinical teams rule out many patients with symptoms suggestive of a heart attack at an early stage.

Focussing on more than 1,500 patients who presented to the inner-city hospital’s emergency department with symptoms such as chest pain, arm pain, or jaw pain, the study found that 15% of early presenters could be ruled out for a heart attack based on a single blood test on arrival at hospital.

Typically for most assays of this kind, an initial blood examination would serve as a baseline measurement for early presenters, with a further test required to detect cardiac troponin I two hours later.

Combining this approach and applying a second blood sample to the Mindray assay after two hours, researchers also found that an additional 30-40% of remaining participants could also be safely ruled out with less than a 1% probability of an adverse event within 30 days.

Unusually precise measurements of cardiac troponin I made possible using the Mindray assay, meant additional individuals could also be ruled out. In total, across all cardiac troponin I measures, researchers were able to identify 60% of patients presenting to the emergency department with heart attack like symptoms, who could be safely sent home.

Opportunities for Cardiac Troponin Assay

Professor Fred Apple, the study’s principal investigator, a medical director in laboratory medicine at Hennepin Healthcare, professor at the University of Minnesota, and a former committee chair of the International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Application of Cardiac Bio-markers, said: “Patients who comes in to an emergency department with chest pain or arm pain, symptoms suggestive of a heart attack, would rather spend the night at their home with a surety that they aren’t going to have a heart attack, versus a bed in the hospital. But sometimes it can be difficult for a clinician to determine whether or not that pain is related to the heart.

“Our preliminary findings around Mindray’s high-sensitivity troponin I test are exciting for emergency medicine – with multiple ways this could be built into algorithmic clinical practice to help avoid overcrowding and enhance triage safety.

“Cardiac troponin alone doesn’t determine if you have had a heart attack, but it can tell the clinician if the heart has been injured, and when measurements are normal that it is safe to send a patient home.

“In 40 years of cardiac biomarker research, this assay is as good, if not better than any cardiac troponin assay I’ve worked with in my career. That it is so incredibly precise and analytically very sensitive to measure low cardiac troponin concentrations, opens new and unique possibilities when patients present early to an emergency department, so that clinicians can make informed decisions to send people home, without concern.”

In addition to ruling individuals out, findings also demonstrate that the assay can help to determine with high probability when patients are having a heart attack, with a high positive predictive value of approximately 70%. Researchers believe this could assist clinical decisions to immediately admit patients.

The Institutional Review Board approved study (MERITnI) was conducted alongside existing tests as patients presented to the hospital. Standard hospital procedures were used in the triage and care of patients, and the same blood samples drawn for routine clinical practice were also applied to the Mindray high sensitivity cardiac troponin I assay for research purposes, in order to evaluate the assay. The Mindray assay used in research was not used for patient care decisions during the study.

The assays were produced by Mindray after it acquired the Finnish company HyTest in 2021, where Professor Apple previously served on the board.

Preliminary findings are now undergoing peer review, but already additional possibilities are being explored. Future work in examining high sensitivity cardiac troponin I and high sensitivity cardiac troponin T assays are expected to inform applications that might help clinicians to better understand if myocardial injuries are chronic or acute – and help them to determine the best treatments and therapies for patients.

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By creating virtual avatars of hospitals, medical devices, and even parts of the human body, researchers are trying to see how to use them to address real-world challenges of healthcare. For instance, neurological conditions are a major cause of disability and the reason behind 140,000 deaths annually in the UK. Millions continue living with such a condition. Now, technology is being used to create a virtual brain on which complex procedures and treatment methods can be modelled.

This is being done with digital twin technology, which creates virtual replicas of physical entities and simulates countless scenarios. This helps customize treatments for individual patients, predict the progress of their ailment, and test out possible interventions on the virtual replica rather than the actual patient, thus diminishing the risk factor.

In recent years, digital twins have helped providers find a way to maintain high-quality patient care while responding quickly.

Transforming the future of healthcare

Although still in the early stage of adoption, the use of digital twins in healthcare is advancing quickly, promising to transform how we diagnose and treat patients, and improve outcomes by realigning incentives. Increasingly, wearable sensors are being used to collect vital data in real time. These can be transferred and fed continuously to a remote server holding the user’s digital twin. Sensors can also help care providers remotely monitor vital signs, exercise routines and other useful data of patients who are less mobile and require constant supervision.

Digital twins can also be pivotal in providing performance prediction for a new product or process launch. Modern drug development necessitates the testing of a great number of possibilities in a highly controlled environment. These facilities are automated and prioritized using a digital twin of the lab. Researchers can modify drugs and test the attributes and applications of a medical device in a virtual environment before taking it to production, thus reducing costs of failure and improving the performance of the final product.

Here are just a few of the most compelling applications of digital twins in healthcare.

A digital twin of the human body can model organs, single cells, or an individual’s genetic makeup, physiological characteristics, and lifestyle habits to create personalized medicine and treatment plans. Doctors can use customized simulations to track the reactions of each patient to different treatments, which increases the accuracy of the overall treatment plan. This capability can transform the management of chronic diseases.

The treatment approach can be modified by observing a virtual avatar of a potentially problematic organ. Multiple research teams across Europe and the US are trying to build a virtual heart so that treatment can be personalised and tailored to individual patient needs. At the same time, the technology helps track the progression of diseases over time and understand their response to new drugs, treatments, or surgical interventions. Digital twins can also be used to optimize drug dosage for people with chronic pain, using data relating to age, lifestyle, etc. to predict the effects of pain medication.

Medical devices such as automated insulin pumps, pacemakers, and even novel brain treatments need constant monitoring and optimization, which is another area that digital twins can help with. Here a patient-specific digital twin is generated from lab tests, ultrasound, imaging devices, genetic tests and other data sources. A regulatory framework is being defined by the FDA to allow companies to formalize this offering.

Digital twins can monitor usage, performance, and upcoming repair of medical devices in real-time, which is crucial in asset-intensive facilities where these devices need to be available always.

While digital twin technology is demonstrating success in increasing the efficiency of healthcare, the adoption of data analytics and machine learning, telemedicine and remote patient monitoring further drive its adoption. The use of automation and robotics in other sectors is also expected to amplify demand for digital twin technology.

Overcoming hurdles to adoption

These use cases show how digital twin technology can make healthcare more effective, and demonstrate its potential to save countless lives while reducing the burden on healthcare professionals.

However, the rising cost of healthcare means only institutions with sound financial capabilities can realistically afford digital twin technology. The most advanced treatments may not be available to those who need them the most. Also, poor-quality data can affect the reliability of digital twin models used in diagnosis and treatment, possibly doing more harm than good.

An industry-wide collaborative effort is essential for the successful deployment of digital twins that will fast-track us into the next era of healthcare. Strategic alliances will drive innovative product launches and value-based care. In addition, healthcare providers must look out for new technologies and processes that will drive better patient outcomes without cutting corners on data quality, security, and privacy aspects.

By Venky Ananth, EVP and Global Head of Healthcare, Infosys

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The long-term health effects when medical devices fail are highlighted in the IMMDS report First Do No Harm. This includes the thousands of women injured by pelvic mesh implants who have experienced life-changing complications, many of whom lost their mobility, relationships and jobs.

New medical device regulations designed to protect patients from incidents like these are due to come into force in 2025 and should be very much welcomed.

However, whilst strengthening the regulation of medical devices is an important step towards protecting patients, a tighter regulatory framework – if not constructed correctly – could unintentionally have the opposite result.

If it is too expensive or time-consuming to generate the amount of data required to meet the new regulations, patients may indirectly suffer. There is a risk that it could hinder the innovation of new products or reduce the availability of legacy devices.

Medical registries will play a pivotal role in striking a fine balance in this regard. Registries hold the key to essential information about the performance of devices and their impact on patient outcomes. This data will be critical in helping mitigate against the risk of the new regulations stifling innovation and reducing the availability of successful legacy devices.

The UK is well-placed in this respect as we already have arguably the best Joint Registry in the world, the NJR or National Joint Registry. And earlier this year, a registry for all implants was launched, the ORP, Outcomes and Registries Programme, delivered by NHS England.  This is currently being rolled out across all hospitals.

Registry data, along with other sources, is already used to benchmark all orthopaedic joint replacements through ODEP (the Orthopaedic Data Evaluation Panel). An independent panel of voluntary experts interpret the data to provide objective ratings on the performance of joint replacements. This helps hospitals and surgeons choose the very best and safest implants for patients.

The challenges of new medical device regulations

So while we strive to extend the scope of regulations to promote patient safety, we need to be careful not to discourage manufacturers from bringing ground-breaking new products to market. Or perhaps even see long successful products be withdrawn.

What we don’t want to see as an unintended consequence of the new framework, are fewer specialist options for clinicians. This could happen if the new MRHA regulations require greater volumes of data over much longer timescales.

If this is the case, manufacturers might find it difficult to secure approval for their smaller volume devices such as specialist joint replacements which could be removed from the market altogether.

In this case we may see patients not receiving the most appropriate implant, compromising the final functional outcome and with life-changing implications for the patient.

Take a specialist hip replacement that’s been available for 15 years for example. Under the new regulations manufacturers are likely to be required to collect extensive clinical data to ensure its continued availability to surgeons. But if they must pay vast sums to collect this data, it could result in the implant being withdrawn or becoming more expensive.

We then face a learning curve while surgeons learn how to use a new device, if the one they have previously performed many successful operations with, is no longer available.

It is a question of balance, as Tim Wilton, orthopaedic surgeon and Medical Director of the National Joint Registry explains. “Many of the steps to tighten the regulatory framework should be welcomed. However, it may be necessary to find a way to allow existing devices that work well to stay on the market, even when their usage may not be high enough to allow the manufacturer to justify the expense involved in going through the entire process repeatedly.”

Keeping the door open to innovation

If the regulations become too demanding, they may deter manufacturers from operating in the UK and lead them to focus on other countries instead. This would risk diminishing the UK’s status as an MedTech innovation hub.

Since we don’t want to close the door on innovation there is a tightrope to be walked.

Registries will be an instrumental part of that balancing act as they can provide the evidence needed for regulators within the new legislative landscape.

This is because, unlike a database which is simply a repository for data, a registry is a system which collects and monitors data contemporaneously that is then analysed regularly by medical professionals to evaluate outcomes.

In principle, a registry can collect data on every medical procedure. Each time a surgeon places a new device in a patient, those details are recorded.

Whilst nobody disputes the reliability of controlled clinical trials, registries are generally cheaper and more comprehensive. They nearly always provide reliable information more quickly, as the cohorts of patients are often so much bigger. Data is collected from all surgeons using the device and not just the design surgeon as is often the case with a trial.

Registries are much more cost effective for manufacturers to contribute to, rather than commission their own trials, which will encourage innovation as well as keeping successful devices in the market.

Consultant orthopaedic surgeon, John Skinner, explains why this is important. “We will always need manufacturers to develop new implants to solve complex individual situations such as when, a patient’s anatomy has changed from the standard situation, or has been damaged and needs complicated revision surgery.”

As the UK navigates the new medica device regulations and regulatory framework, it is crucial we prioritise both patient safety and the best treatment options. Withdrawing successful products from the market, or stifling innovation, is not the way to improve patient care.

Medical registries will play a pivotal role in getting this right, providing evidence for both new and established devices. By leveraging the data and insights from registries, the UK can offer the best treatment options available and continue to be a hub of medical innovation. This way, we can improve patient outcomes without compromising on safety.

About the author

Mr Keith Tucker FRCS is Chairman of the Orthopaedic Data Evaluation Panel (ODEP) and the Beyond Compliance Advisory Group. He explores these views further in ‘Medical device regulations: a step forward for patient safety or a step backwards for innovation?’

The post Due Care and Attention: Why New Medical Device Regulations need to Balance Protecting Both Patients and Innovation appeared first on .

The Burden of Chronic Wounds

The prevalence of chronic wounds, including leg ulcers, has reached epidemic proportions. Between one and three percent of adults above the age of 60 suffer from chronic leg ulcers, rising to over five percent in adults above 80 years old. Chronic wounds, like venous leg ulcers (VLU), are notoriously complex, slow to heal and difficult to treat, with many patients experiencing recurrences within a year of healing. This poses a significant physical and emotional burden to patients, and a wider financial burden on healthcare systems, costing the NHS approximately £2bn to treat every year.

As a result of chronic wounds, many patients experience discomfort, shame and social isolation, impacting their ability to take on everyday tasks. Perhaps the most debilitating result of chronic wounds is the ongoing pain patients live with due to the nature of chronic wounds and the treatment provided.

Leg Ulcers and Pain Management

Pain is the most reported symptom in VLU patients. In terms of pain intensity, up to 35 percent of patients with chronic VLUs suffer a pain intensity recorded at ≥5 out of 10 (10 being unbearable pain). However, managing persistent wound pain with opioid and non-opioid analgesics often proves inadequate, with patients struggling to access the right treatment or reporting it ineffective. Living with this pain negatively impacts the quality of life of wound patients and those who care for them. When combined with a lack of mobility and sleep, this can lead to a deterioration in mental health and have further consequences on patients’ physical health.

There are a number of direct factors that impact the experience of pain, including the severity of the injury and its management. Wounds UK revealed that negative emotions, such as anxiety, stress, depression, and a lack of control can all contribute to increased pain, indicating that psychological variables and pain management need to be recognised across wound care to improve healing outcomes.

Pain and Patient Adherence

The current standard of care for treating wounds like VLUs is compression therapy, which can come in the form of two or four-layer bandaging, wraps, or hosiery dressings. Compression therapy improves venous circulation and reduces swelling by squeezing the leg to promote blood flow back to the heart, accelerating wound healing and helping prevent infections.

However, overall patient adherence to compression therapy is low, estimated between 12 and 52%. Low adherence to compression therapy is often a result of patients being unable to tolerate the pain and discomfort caused by the pressure applied. At times, this can trigger patients to form a negative relationship with compression therapy, causing them to be less receptive to treatment, and delaying healing progress significantly.

Improving Pain Relief

According to the International Wound Journal, an estimated 50-60 percent of patients experience persistent wound pain, often as a result of failure to heal or lack of concordance with treatment. In some instances, patients may request lighter levels of compression to reduce pain, causing healing progress to slow or stop altogether, causing patients to experience wound pain for longer. However, by prioritising pain reduction, patients gain more trust in their treatment, fostering a more receptive attitude and speeding up the healing process significantly.

As the experience of pain is central for the wound patient, it should be for the healthcare professional also. To manage their ongoing pain, patients need to feel empowered to take control of their condition. Indeed, Wounds UK further revealed how the more control patients have in managing their condition, the less likely they could be to suffer from pain.

The Promise of MedTech

Fortunately, innovations in medical technology (MedTech), are providing adjunctive solutions to wound care that can be used alongside compression therapy to improve healing outcomes. For example, a small, non-invasive wearable device that promotes blood flow increase can be worn by patients with compression therapy. This results in enhanced oxygen and nutrient delivery to the wound bed and edge, clinically proven to reduce pain and accelerate wound healing.

This enhanced blood flow, provided by both compression therapy and a wearable medical device, puts less reliance on compression therapy alone. Combined, they successfully drive up adherence to standard of care, ensuring better patient outcomes.

With MedTech used in combination with compression therapy, patients can benefit from reduced pain, which subsequently gives them more confidence in their treatment and hope that their condition will improve. This positive outcome plays a huge role in patient adherence and improving the quality of life.  By addressing pain and the emotional and physical impacts of chronic wounds on patients, MedTech promotes greater freedom, mobility and independence. This is especially true for devices that facilitate self-management, empowering patients to take ownership of elements of their care.

Investing in The Future

To improve patient adherence, healthcare systems are more than ever acknowledging that pain management is a crucial step of the wound-healing journey. The impact of deploying MedTech can be equally profound. Faster healing of wounds means less complications and fewer resources needed to deliver wound care. Within health systems, this results in substantially reduced costs, including a reduction in the requirements for home visits from community and remote nursing teams. By breaking the cycle of hard-to-heal chronic wounds, the growing use of medical devices represents a potential step-change in pain management and wound healing outcomes for patients everywhere who are affected by this complex, common – and increasingly prevalent – condition.

By Bernard Ross, CEO of Sky Medical Technology

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Wearable devices support patient self-care, but they are also becoming essential tools for healthcare professionals to perform health monitoring and early detection of medical conditions. As a result, the healthcare industry is embracing wearable devices on a collective mission to usher in a new era for preventative health and provide more personalised patient care. Global demand for wearable medical devices is expected to grow at an impressive 27.4% compound annual growth rate (CAGR) from a market size of $29 billion in 2022 to $325.7 billion by 2032, according to Research and Markets.

However, as these devices and their components become smaller and more powerful, testing and validation become increasingly complex in the design phase. Many factors must be tested during the development cycle to ensure that wearable healthcare devices can operate reliably, effectively, and securely in the real world. Here is a closer look at the top three factors for designing wearable healthcare devices that users can depend on.

Reliability of wearable healthcare devices

The development cycle requires rigorous testing and validation processes to ensure that wearable healthcare devices remain trustworthy. The devices must consistently provide reliable performance and accurate data, but that can be challenging due to the diversity of applications. Devices such as smart rings, blood pressure-monitoring bracelets, and brainwave-reading headbands leverage advances in biofeedback to track physical and even emotional responses, including stress, alertness, and drowsiness through eye movement.

The reliability of wearable medical devices also requires batteries that can stand the test of time. Advanced battery test and emulation software is being used to create profiles of actual batteries, which can then be applied in repeated tests without having to use actual batteries. It’s also important to measure how a connected device consumes a charge over time through battery drain analysis, and then uncover new ways to optimise battery life through event-based power analysis.

Wireless connectivity is another important concern. Testing is needed to analyse 5G signals and Bluetooth transmissions to make sure that connected medical devices can co-exist in noisy wireless hospital environments. In addition, AI-driven test automation can be used to help evaluate the user experience. Software-based solutions explore all potential paths through complex applications by testing all possible user journeys. Automation delivers results significantly faster than traditional testing and it automatically focuses more attention on testing areas where defects are prevalent, ensuring that manufacturers can deliver effective and safe devices on time.

Interoperability

The ability for different devices and systems to communicate and share data, while complying with standards, is vital for delivering early disease detection and developing more promising treatment options. Developers will need to collaborate across a sound, interoperable ecosystem. In this way, real-time integration between electronic health records (EHR) can lead to more personalised patient care by allowing physicians to monitor patients remotely, collect data, and reduce the time and costs associated with treatments.

The healthcare industry’s push towards digitalisation has produced a growing need for software quality assurance in EHR systems. Automated software testing can help improve the interconnectivity of system components, while greatly surpassing the capabilities of manual testing.

Security

Devices such as electrocardiogram (ECG) monitors and other clinical sensors enable healthcare professionals to monitor a variety of health metrics. However, many connected devices in use today have not been designed with adequate security, making them targeted points of entry for bad actors.

Proper security measures include encryption, secure data transmission, and compliance with regulatory requirements such as the Health Insurance Portability and Accountability Act (HIPAA). To ensure that devices comply with regulatory standards, manufacturers may need to obtain approval from the FDA, depending on the wearable device’s application and intended use.

Cyberattacks risk patient safety, block access to electronic health systems, and threaten highly sensitive confidential patient records. Ransom payments, downtime, and recovery efforts can be extremely costly, but healthcare organisations are fighting back to reduce vulnerabilities, get in front of potential attacks, and improve their mitigation strategies in case of attacks.

Internet-enabled medical equipment and devices are becoming more mainstream for diagnosing, treating, and monitoring patients. For this reason, wearable healthcare devices must be made dependable to achieve widespread adoption and enhance the quality of healthcare. While these technologies are improving the standard of care, they have introduced new challenges for healthcare practitioners, administrators, and patients. The good news is that many of these concerns can be mitigated or even eliminated through rigorous testing in the engineering and design phase.

By Marie Hattar, SVP, Keysight Technologies

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“The global nanoparticle technology market size is worth US$ 9.20 million in 2022. The market is projected to witness a CAGR of 5.5% over the forecast period, to reach a market valuation of US$ 17.49 Mn by 2032,” states Sudip Saha from Future Market Insights. Corporations from all over the world are keen to leverage this growth for the advancement and increased application of this sector, particularly the Medical Field.

Nanotechnology in Medicine

Nanotechnology in medicine uses tiny components and tools to transform medical practice. By utilizing nanoparticles and nanodevices for focused therapy and diagnosis, it provides accurate drug delivery, sophisticated illness detection, and cutting-edge treatments. Using lab-on-a-chip technology and biosensors, nanotechnology in medicine has also made it possible to diagnose diseases more quickly. Antimicrobial nanomaterials, such as nano-silver, have the ability to combat antibiotic resistance. Clinical trials are being conducted on gold nanoparticle-based cancer treatments. Nanotechnology makes it possible for the medical fraternity to reach areas it has never gone to before. Widespread research and development is leading to newer techniques and technologies which help in the advancement of the medical sector.

The use of nanotechnology in medicine and healthcare is known as nanomedicine. It entails the use of nanoscale tools and materials for tissue regeneration, medication delivery, and other therapeutic purposes. The distinct physical, chemical, and biological characteristics of nanoscale materials enable innovative medicinal applications. Nano-devices provide less invasive operations, ultrasensitive biosensors, and point-of-care diagnostics. These cutting-edge technologies make it possible to provide individualized medical care. Nanotechnology is being adopted by more and more doctors worldwide to achieve faster and more accurate results. Hospitals are using researched equipment to diagnose and treat patients which is showing good results over time. Though nanotechnology in medicine is in its nascent stage, it has shown promising growth in multiple prospects.

Medical diagnostics can be greatly enhanced by nanotechnologies. “Smart pills” are a prime illustration of this since they are more affordable and convenient, as they allow patients and physicians to monitor a large array of illnesses. A majority of the healthcare problems can be solved if an illness is detected before its occurrence in a patient. The illness that a smart pill is intended to treat or diagnose will determine how it functions. Smart tablets use nanoscale sensors, which are intended to identify disease long before a patient may notice any symptoms. This can help doctors and patients take preventive steps to avoid the disease. Medications can be prescribed, therapies and diets can be administered to minimize the problem leading to the illness.

Nanorobots

Nanorobots—small motors that are able to navigate to specific body regions are a progressive innovation in nanotechnology. Nanorobots can be injected or swallowed, and they can travel to the location of the illness, take images, and communicate them to the patient or physician. Nanotechnologies are also shown to be very beneficial in the treatment of illnesses requiring close adherence to a specified medication schedule. The majority of patients with chronic illnesses don’t take their medications as directed. However, this issue can be solved by employing nanotechnologies that are designed to release medications on their own.

An origami nanorobot is made up of a synthetic DNA sheet that is flat, covered in an enzyme that clots blood, and can be folded into a variety of shapes. After being injected into the bloodstream, the nanosized DNA sheet is designed to find tumor cells, adhere to their surface, and inject them with the blood-clotting enzyme, depriving the tumor cell of the blood necessary for survival. One of the most difficult issues in cancer treatment is destroying cancer cells without endangering neighboring healthy tissue. This nanoscale robot helps solve the challenge.

Nanofibers

Nanofibers are used for application in tissue engineering, artificial organ components, implants, wound dressings, and surgical fabrics. Researchers are trying to create “smart bandages,” which, when applied, will dissolve into the surrounding tissue as the area heals. These smart bandages may include sensors to identify infection symptoms in addition to clotting agents and antibiotics embedded in nanofibres.

Another promising area of nanotechnology research for disease prevention is wearables. Smart bandages that incorporate growth hormones, blood-clotting agent nanoparticles, or sensors that can identify infections and deliver antibiotics are using nanotechnologies to help avoid infectious wounds. These bandages are often composed of biodegradable materials, which enable them to be applied to wounds and left there until they decompose.

Advancement of nanotechnology in medicine

Science is a dynamic field. The development of nanotechnology is fascinating and intriguing while it only still touching the tip of the iceberg. Medical institutions that utilize this cutting-edge knowledge, particularly those in the healthcare sector, will produce solutions that are easily attainable and contribute to a better world.

In the field of nanomedicine, there is still much to learn and explore. Engineers, biologists, and doctors are working together as a collaborative force to advance this field of study. The development of nanomaterials for cancer and vaccinations in clinical trials will guarantee progress. Comprehensive bench-side investigations of the behavior of these materials within the body offer a foundational framework for nanoparticle engineering. The advancement of nanomedicine for societal benefit will depend on these combined insights and future prospects.

There are still many obstacles to be overcome before nanotechnology is completely adopted into healthcare. The long-term effects of nanotechnology and its influence on the environment are a topic to debate. Authorities and regulatory bodies must establish more precise rules about nanotech-based devices and possible health hazards. Sometimes, the expensive cost of many nanotech-based gadgets prevents their mass production. These gadgets’ accessible production options will contribute to the widespread adoption of this technology. On the other hand, there’s growing hope that the application of nanotechnology in medicine will result in major advancements in illness prevention, diagnosis, and treatment. The multiple uses of nanotechnology in medicine and its potential to lead the sector into a new phase of growth make it a sector to keep a watch on.

The post The Marriage of Nanotechnology and Medicine lead to Groundbreaking Advancements appeared first on .

Managing rising demands in healthcare

From the aftershocks of the pandemic and a growing ageing population with chronic diseases, rising costs and ongoing recruitment challenges, healthcare providers need to find new ways to efficiently care for large and diverse patient populations, while also encouraging individuals to manage their own care. Recent studies reveal that just under 50% of UK citizens live with long-standing health problems or chronic diseases, while The Institute for Public Policy Research estimates long-term illnesses costs the economy £43 billion a year.

Connected health is on the rise

Thankfully, an increase in connected health can address the majority of these issues. Whether it’s calculating steps on fitness trackers, FaceTiming, or asking Alexa for something, it’s easy to take for granted the ways in which technology makes our lives easier and shapes our habits. When it comes to health, we also rely on products like glucose monitoring systems, wearable vital sign monitors and sleep support devices.

These products have one thing in common: their intuitive design and human machine interface makes them easy or sometimes automatic to operate, which makes them “stickier” with end users. This needs to be a guiding principle when designing medical devices. They should make our lives simpler, healthier, and more efficient without more steps or complexity. To support consumer demand and market trends, healthcare companies must make sure that at the design phase, HMI and the overall user experience is considered. By anticipating both the opportunities and the challenges of a more connected world and ensuring devices fit seamlessly into the end user’s life, medical device manufacturers can gain a competitive edge while still delivering an improved patient experience.

For an ageing population

When designing smart devices, the elderly population is not often seen as the target audience. Older users can struggle with newer technologies, especially if the information is seen as too technical or complicated for them to follow. This makes effective HMI more vital, because designing for the average consumer — not just the most tech-savvy one — means devices are more likely to be used in the way they were designed.

There is a big opportunity to improve care for the older generation through more intuitive medical devices with an easy, intuitive HMI, especially according to The Journal of Public Health who suggest that age (along with other factors such as gender and working status) correlate with non-adherence with very-elderly people being some of the worst affected which is expected to cost the NHS over £900 million a year. Helping the elderly interface with medical equipment can help in addressing care gaps, boost patient education and improve overall healthcare quality.

Tackling chronic illnesses directly

The rise of chronic illnesses and the associated financial implications is something of a concern. The NHS defines a chronic disease as a “health problem that requires ongoing management over a period of years or decades and is one that cannot currently be cured but can be controlled with the use of medication and/or therapies.” These can be attributed to both the older population as well as key risk behaviours like tobacco use, bad nutrition, physical inactivity and excessive alcohol consumption. Additionally, some people who contracted COVID-19 are experiencing long-term effects.

These patients need fast, easy, and reliable access to quality care so that they can manage ongoing health conditions and mitigate adverse outcomes.

Innovative medical devices can also improve quality of life. For example, a soft robotic wearable that can assist upper arm and shoulder movement in people with ALS. Though the product is not yet available commercially, its intuitive human machine interface — where participants learned to operate the device in less than 15 minutes — will allow it to integrate into a patient’s everyday life with little disruption.

Alleviating recruitment issues

Another challenge for the healthcare industry is ongoing challenges with staffing. COVID-19 disrupted more than just global supply chains, and in many cases the pandemic interrupted the education and training for those embarking on a medical career. Many also decided against remaining in the medical field due to burnout from stressful work environments.

As the healthcare industry addresses these ongoing staffing challenges, they need to implement both short and long-term strategies. For healthcare systems, strategies could include recruitment, training, and retention initiatives, while medical device manufacturers could look into how they can improve product design to make devices error-proof so that they can be operated by a newer, less experienced or part-time workforce. Improving human machine interface for telemedicine solutions can alleviate the demands on the system, allowing patients in underserved or remote areas the chance to access quality care even when there are staffing shortages.

The need for HMI in medical device development can’t be overstated. As the world becomes more digitised and connected, medical device manufacturers are responsible for making sure that products are innovative, efficient and of course user-friendly. By focusing on the needs and experience of all demographics of end users and making HMI a priority in the device’s design, we can improve patient care, enhance the user experience and ultimately save lives.

By Jennifer Samproni, Chief Technology Officer, Health Solutions, Flex

The post Human Machine Interface Innovation: Non-negotiable in Medical Device Development appeared first on .

Medical Devices: Examples and Definition

The FDA defines medical devices as anything that helps diagnose, treat, cure or prevent diseases. The definition also includes anything that physically alters bodily functions without using chemical action. A medical device can be used internally or externally, and either a patient or a doctor can control the device. It must serve a medical — rather than cosmetic — function.

Therefore, examples of medical devices include pacemakers, artificial hips, tongue depressors, continuous glucose monitors and prosthetic arms. Even needles count as medical devices under the FDA’s definition. Analysts predict that in 2023, the global medical device market will be worth $470.6 billion, with cardiology devices generating 14% of the total revenue.

Explaining Electromagnetic Compatibility

Electromagnetic compatibility (EMC) is the ability of electronics to function near other electronic devices. For example, a pacemaker doesn’t react to the presence of a cell phone, nor does wearing a pacemaker affect a patient’s ability to talk on the phone. Although both devices use electrical circuits to function, they don’t interfere with each other.

Thorough EMC testing ensures electronic devices do not emit electromagnetic interference (EMI) or receive it in such a quantity that they behave differently. Meeting EMC medical standards is crucial when designing, testing and marketing medical devices. That’s because device failure could strongly impact a patient’s quality of life.

Examples of medical devices subject to rigorous EMC testing include glucose monitors, hearing aids, defibrillators and diagnostic equipment. Researchers test them for three main qualities — emissions, immunity and susceptibility:

• Emissions: How much energy a device releases into its environment
• Immunity: How well it can function in the presence of EMI
• Susceptibility: How likely it is to fail in the presence of other electronics

Testing looks for surge immunity, harmonic performance, radiated emissions and flickers, among other behaviors.

The 2022 FDA Guidelines

The Electromagnetic Compatibility (EMC) of Medical Devices replaces the 2016 document on the same subject. It refers to electrically-powered medical devices or those which have functions or sensors using electronic circuitry.

The 20-page document tells manufacturers to outline the level of care patients must take and which types of electromagnetic disturbances can occur in particular environments. The guidelines help manufacturers meet the IEC 60601/80601 series of standards, which refers to any medical devices that directly apply or transfer energy to a person. The document also helps manufacturers meet the IEC 61010-1 standard, which applies to electrical laboratory equipment.

The guidelines recommend manufacturers use observable, quantitative, device-specific EMC pass/fail criteria. The FDA document cites this as fundamental to assessing the validity of EMC testing and determining product safety.

The FDA requires manufacturers to affix warning labels to medical devices if they are unsafe to use in an MRI machine. The guidelines point out that in addition to MRI machines, devices may be exposed to cell phones and tablets, so manufacturers should test them around these everyday household items.

Electromagnetic Compatibility (EMC) of Medical Devices makes several recommendations for manufacturers about listing device characteristics, including:

• A description of the power supply, including if patients can use the device while it charges.
• A description of any wireless technology.
• An overview of the device, including block diagrams, functions, modes, relevant accessories, cables and device interoperability.
• Photographs of the device and accessories.
• Whether the device contains any intentional radiofrequency emitters that could cause electromagnetic interference.

The document also tells manufacturers to specify which environment the device should be used in — is it intended for use in a professional health care facility, home setting or special environment? It gives examples of medical devices’ potential locations.

For the professional health care facility environment, it lists surgical centers, laboratories, clinics, dental offices, nursing homes and hospital facilities, among others. In addition to houses, the home health care environment includes restaurants, stores, schools, outdoor environments and any other public place. Special environments include health care facilities with MRI machines or other high-powered medical equipment, military areas, heavy industrial plants and aircraft environments. Devices rated for these areas must not interfere with planes, helicopters, submarines, radar installations or weapons control systems.

EMC in Medical Devices Is Crucial

Electromagnetic compatibility ensures electronics don’t fail when exposed to energy-emitting devices. Medical EMC testing is especially important because patients’ lives are on the line. Thanks to the FDA’s new 2022 guidelines, medical devices are subject to rigorous testing for EMC, protecting patients against electromagnetic interference that could cause device failure.

By Shannon Flynn, ReHack

The post Medical Devices Improved By Electromagnetic Compatibility (EMC) appeared first on .

To broaden that application – or to make the personalisation in healthcare more widespread – the sector requires software that makes designing 3D printed devices simple, even for people who don’t have technical knowledge of 3D printing, like clinicians who are not trained in this area.

Additive manufacturing may still be in a critical phase of development but its life-changing impact on the sector is being felt on a wide scale, from guiding future innovation right through to its promise of aiding the completion of complicated surgeries today.

As a result, forecasts believe that medical device additive manufacturing could grow to as much as $9.8 billion by 2031. Meanwhile, new estimations also show that 90% of the top 50 medical device companies worldwide currently use 3D printing to create accurate prototypes and medical devices.

With its influence continuing to grow, I analyse the many ways software for additive manufacturing is making a tangible difference in people’s lives.

Precise, painless, and personalised experiences are becoming the norm

Romans Ferrari Medical Centre is a paediatric rehabilitation institution based in Lyon, France. It is renowned for working with children suffering from burn injuries and recently turned to 3D printing in order to deliver a pain-free approach to fabricating facial orthoses.

Historically, the process of creating custom-made face masks has been anything but painless. It requires taking an impression of the patient’s face with plaster strips, which is incredibly discomforting because of the direct contact with the flesh. Up to now, it’s been a necessity for the purpose of fabricating materials that massage the impacted area of the skin and stimulate healing.

It is the traumatic nature of conventional manufacturing methods that has led many caregivers around the world to explore better alternatives.

Romans Ferrari Medical Centre is one of those caregivers. In 2021, it piloted a new painless treatment for children suffering from burns which involves 3D printing. The treatment was developed by 3DZ, a specialist reseller of additive manufacturing software and hardware.

How was it done?

In order to get a highly-accurate image of a child’s face, 3DZ substituted the traditional plaster strips with a 3D scanner, with data captured by the scanner serving as a negative image when creating a perfectly-fitting mask. The digital model of the face was 3D printed on a Formlabs Fuse1 and a polypropylene sheet is thermoformed on top of the model to create the orthosis.

For the modelling, 3DZ works with Geomagic Freeform, Oqton’s 3D design and sculpting software, which creates products that precisely fit the human body. The software was used in conjunction with a haptic device that allowed the team to quickly and easily mark the treatment area on the 3D digital model.

Romans Ferrari’s pilot project was completed in early 2022 and proved to be a major success, with the approach not only being economically feasible but also providing a stress-free experience for young patients. The institution has since permanently replaced the old plaster cast and milling method with 3D scanning and printing.

3D prostheses are making anything possible

On the other side of the Atlantic, there is a surge of people rapidly embracing additively manufactured prosthetics as they prove to be comfortable in both routine activities and high-impact conditions like sports.

Richard Blalock is just one fine example of this. An engineer with a lifelong passion for running, Richard traverses up to 2,000 miles (3,219 km) a year. An impressive feat. Even more, considering his right foot was amputated in 2009.

Initially, he turned to traditionally-fabricated prostheses. However, Richard was left in pain and blisters every time he took up running. In his search to find a pain-free alternative, he opted to trial custom-made 3D-printed prostheses, created by Brent Wright. He hasn’t looked back since.

He said: “The weight-savings are a big plus for me and comfort is right up there with that. We can also adapt the design to accommodate leg changes. Residual limbs will change over time, and, with 3D printing, you can change the model of the limb on the computer and print the new leg. That makes a night and day difference. It can be done in hours instead of days or weeks.”

His original prosthesis was made from carbon fibre and was substantially heavier. “Carbon fibre is quite light, but between the inner socket and the outer socket frame, my 3D-printed leg is about a pound lighter. When I’m running 26 miles [42 km] this makes a huge difference.

“The frame I have currently that Brent 3D-printed is very sturdy – we could run over it with a truck and it’s not going to break. But I feel confident we could lower the weight even more.”

3D printing is revolutionising patient care

Patient care is always more effective if treatment can be tailored to a particular patient, especially if the treatment requires a device or instrument that fits the patient, like a prosthetic socket or a plate to hold bones together whilst healing.

Patient specific devices will always fit better, be more comfortable, and typically function better than a generic device manufactured using standard sizing models.

Historically, producing patient-specific devices has been difficult as traditional manufacturing techniques are relatively slow and expensive, requiring highly skilled technicians. These limitations often meant a patient-specific device was either too expensive or, in the case of an emergency, could not be manufactured in time.

There has been a quiet revolution happening for the past 15 and more years in the treatment using patient specific devices. Digital technology and healthcare 3D printing have improved vastly to make them an everyday reality, one available to many more patients than was ever possible before.

Scanners are now available to create a digital twin of the patient at a lower cost, more accurately, more reliably, and easier, than ever before.

Even when the digital twin existed inside the computer, planning and design software used to be only really effective with mechanical shapes and forms (think of a car engine), not the organic forms of the human body.

But now, effective design software for additive manufacturing makes it easier to manufacture the more complex forms of the body. Lastly, manufacturing patient-specific devices using 3D printers is now easier and more available than ever before as printers become mainstream with lower costs and better materials.

It is this confluence of design software and 3D printing technology, that is now making patient-specific devices an everyday reality across healthcare. All resulting in patients living a better life.

By Kevin Atkins, Healthcare Product Manager at Oqton

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