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Adhesives are a foundational element in wearable medical devices, yet they come with their own set of challenges — from regulatory approval to patient comfort. During a recent interview with UC Liu, Head of Regulatory Affairs atBioIntelliSense, we explored the essential considerations when developing adhesives for medical devices, including the 510(k) process and post-market surveillance.

The Importance of Adhesives in Medical Devices:

Adhesives in wearables need to balance strong adhesion with skin safety.BioIntelliSense, a leader in wearable sensor technology, uses adhesives to attach their devices to patients for continuous monitoring of vital signs. But getting these adhesives approved by the FDA isn’t as simple as it sounds. UC Liu shared that one of the biggest challenges is biocompatibility testing, which ensures that adhesives do not irritate or harm the skin.

Navigating the 510(k) Process for Adhesives:

The FDA’s 510(k) submission process requires extensive validation of adhesives, particularly around performance and biocompatibility. As UC explained, adhesives must undergo cytotoxicity, sensitization, and irritation testing to ensure they are safe for prolonged use. These tests often take months, but working with accredited labs can streamline the process.

Common Regulatory Pitfalls and How to Avoid Them:

UC stressed the importance of choosing the right predicate device when submitting your adhesive for approval. If the FDA perceives an adhesive to be too novel, they may require more extensive testing, moving your submission out of the 510(k) pathway into a more complex approval process. Pre-submission meetings with the FDA can help mitigate these risks.

Post-Market Surveillance: What to Watch For:

Even after FDA approval, adhesives often face post-market challenges. Complaints about skin irritation or adhesion failure are common, making up about 20% of all reported issues. UC recommends setting up a robust post-market surveillance system to monitor these complaints and report them to the FDA if necessary.

Conclusion:

Developing adhesives for medical devices is a complex process that requires careful planning, testing, and ongoing monitoring. By involving adhesive experts early in the process, companies can avoid many of the common pitfalls and ensure their products are safe, effective, and compliant with regulatory standards.

As medical technology advances, the need for high-performance, flexible, and biocompatible materials becomes increasingly important. Henkel Printed Electronics is at the forefront of this transformation, providing innovative solutions that enable next-generation medical devices. In a recent presentation, Pia, from Henkel’s Business Development team, shared insights into how printed electronics are driving change in the healthcare sector.

1.The Growing Demand for Advanced Materials in Medical Devices

Medical wearables and diagnostic tools are rapidly evolving. Devices like glucose monitors, ECG patches, and continuous glucose monitors (CGMs) require materials that offer flexibility, stretchability, and long-term skin adhesion. Henkel addresses these needs with a portfolio of conductive inks, dielectrics, and adhesives that are biocompatible and meet ISO 10993 standards.

2.Printed Sensors for Diagnostics and Wearables

One of Henkel’s key innovations is its printed sensors, used in a variety of medical applications:

Point-of-Care Diagnostics: Henkel’s conductive silver and carbon inks are used in glucose monitors and other diagnostic sensors, offering high conductivity and durability.

Moisture Sensors: Henkel’s high-speed printable carbon inks are revolutionizing applications like moisture sensors in diapers, improving detection and accuracy.

Regulatory and Compliance Landscape

One of the standout elements of alio’s strategy has been their forward-thinking regulatory approach. By focusing on a long-term roadmap, they ensured that their initial hardware could serve as the platform for future upgrades, allowing for seamless software updates rather than new clearances. This modular approach not only saves time but also reassures customers that they will continue to receive cutting-edge solutions.

3.Flexible Heaters for Medical Devices

Henkel’s foil heaters are another breakthrough technology. Integrated into medical devices such as heating blankets, surgical equipment, and even personal protective gear, these heaters use Positive Temperature Coefficient (PTC) technology. This allows them to self-regulate, reducing the risk of overheating and ensuring safe, efficient operation.

4.Stretchability and Biocompatibility: Key for Medical Wearables

Medical wearables, from ECG monitors to bioimpedance sensors, need materials that can conform to the body while maintaining functionality. Henkel’s stretchable conductive inks, combined with flexible substrates like TPU, ensure that wearables can meet the growing demand for comfort, durability, and long-term use. The company’s expertise in adhesive technologies also ensures these devices stay securely attached without causing skin irritation.

Conclusion:

Henkel Printed Electronics is leading the charge in medical device innovation. With a focus on flexible, stretchable, and biocompatible materials, their solutions are empowering the next generation of smart medical wearables and diagnostic devices. As the healthcare industry continues to advance, Henkel’s printed electronics solutions will play a critical role in shaping the future of medical technology.

Wearable technology has transformed patient care, especially in chronic disease management. During our recent summit, we had the privilege to speak with Dave from alio, who shared how their innovative approach to non-invasive wearables is pushing the boundaries of remote monitoring. In this blog post, we’ll dive deep into alio’s journey, the challenges they overcame, and how they are shaping the future of healthcare technology.

Body:

alio’s Origins and Mission

alio’s story began when Dave, while in medical school, recognized a gap in patient care for those with chronic diseases. From that point, the company aimed to create a non-invasive wearable capable of monitoring vital signs and beyond — not only providing data but clinically actionable insights for healthcare providers. Today, alio is a leader in wearable health tech, capable of monitoring complex metrics such as potassium and hemoglobin, with FDA clearance and expansion plans across markets like kidney disease and cardiology.

Key Innovations and Technological Challenges

Developing the world’s most advanced non-invasive wearables didn’t come without hurdles. alio’s journey was marked by significant technical challenges, particularly in achieving reliable skin adhesion for prolonged wear without sacrificing comfort — a critical factor for patients with fragile skin, like those suffering from chronic kidney disease. Dave explained how they developed a unique approach to using blood vessels for data collection, enhancing accuracy while ensuring the wearability of their device.

Regulatory and Compliance Landscape

One of the standout elements of alio’s strategy has been their forward-thinking regulatory approach. By focusing on a long-term roadmap, they ensured that their initial hardware could serve as the platform for future upgrades, allowing for seamless software updates rather than new clearances. This modular approach not only saves time but also reassures customers that they will continue to receive cutting-edge solutions.

Future Innovations and Impact on the Market

alio’s wearable technology continues to evolve, with future expansions planned for more advanced metrics such as blood pressure. By working closely with regulatory bodies and clinical teams, alio is poised to further disrupt the healthcare wearables market. Their technology is already making waves in markets like Saudi Arabia, and the potential for global reach is immense.

Conclusion:

alio is setting the bar high for the next generation of wearable technology. With their commitment to innovation, patient-centric design, and a robust regulatory strategy, they are not only revolutionizing the way we monitor chronic conditions but also setting the stage for a healthier future.

In the fast-evolving world of medical wearables, adhesives are playing a pivotal role in device success. From patient comfort to device performance and long-term wearability, the right adhesive can make or break a wearable medical device. I recently had the opportunity to speak with Mary Picotta from Berry Global, one of the leaders in adhesive innovation, about how they’re pushing the boundaries in the healthcare sector.

1.The Importance of Patient Comfort:

According to Mary, patient comfort is at the forefront of adhesive design. “If the adhesive isn’t comfortable, patients won’t use the device,” she explained. This presents a challenge when designing adhesives that need to stick to the skin for extended periods without causing discomfort, irritation, or skin damage.

Berry Global focuses on creating adhesives that balance strong adhesion with comfort, ensuring that patients can wear medical devices without any adverse reactions. These adhesives are designed to perform optimally, even during long-term wear, making them a crucial component of any wearable medical device.

2.Integration with Medical Devices:

In the world of wearable devices, integration is key. Modern devices now feature multiple sensors and components that must work together seamlessly. Mary emphasized that adhesives must not interfere with device performance, including signal processing and sensor accuracy.

Berry Global works closely with device manufacturers to ensure their adhesives fit into the device ecosystem. “Collaboration early in the development process helps us understand the bigger picture and ensure our adhesives complement the entire device,” she noted.

3.Challenges of Extended Wear:

As wearables become more sophisticated, the demand for long-term wear adhesives is increasing. Mary explained that designing adhesives for extended wear comes with its own set of challenges. Skin health and the skin’s natural turnover cycle must be considered alongside the adhesive’s ability to stay in place.

Berry Global is developing breathable adhesives that promote skin health while maintaining the strength needed for long wear times. This is particularly important for devices that must stay in place for weeks at a time, such as continuous glucose monitors or heart rate sensors.

4.Sustainability in Adhesives:

Sustainability is a growing concern in the healthcare industry. While recycling may not be feasible for medical adhesives due to hygiene concerns, Berry Global is focusing on reducing waste through longer wear times and exploring renewable materials.

Mary shared that Berry Global is actively working on biodegradable adhesives and other sustainable innovations that align with the unique needs of the medical sector. “Sustainability in healthcare is about reducing waste, not just recycling,” she explained.

Conclusion:

Adhesives may not be the most visible component of a medical device, but they are essential to its success. From ensuring patient comfort to improving device performance, the innovation happening at companies like Berry Global is revolutionizing how we think about adhesives in healthcare. By focusing on collaboration, sustainability, and long-term wear solutions, Berry Global is helping to drive the future of medical technology.

The medical device industry has long relied on hydrogel electrodes, but this technology has inherent limitations: it dries out, requires costly packaging, and can cause skin irritation. Enter FLEXcon’s OmniWave—a dry electrode that is redefining what’s possible for medical wearables. Recently, we had the opportunity to speak with Amit Roy, Business Development Manager at FLEXcon, about the development and benefits of OmniWave.

1.What is OmniWave?

OmniWave is a dry adhesive electrode that solves many of the challenges associated with hydrogel technology. “Hydrogel requires expensive barrier packaging because it’s water-based and needs to stay wet. With OmniWave, we’ve eliminated the need for any packaging, drastically reducing costs and waste,” explained Amit.

2.Clinical Performance and Patient Comfort:

In a clinical trial conducted at UMass Memorial Hospital, patients overwhelmingly preferred OmniWave over traditional hydrogel electrodes. One key reason? Comfort. “Hydrogel electrodes can cause irritation, and at least 8% of patients are allergic to them. OmniWave showed no signs of such irritation,” Amit shared.

This breakthrough in comfort is critical, especially as medical devices become more integrated into patients’ everyday lives, requiring long-term wearability without discomfort.

3.Increased Efficiency for Manufacturers:

One of the standout benefits of OmniWave is its impact on manufacturing efficiency. Hydrogel rolls are typically around 300 feet long, but OmniWave can be produced in rolls up to 3,000 feet—ten times the length. This drastically reduces downtime in production. “You don’t have to stop and start as frequently, and there’s no need for specialized storage like freezing,” Amit explained.

Additionally, OmniWave can be laser-cut, which is impossible with hydrogel. This flexibility makes it a more versatile option for manufacturers.

4.Diverse Applications for OmniWave:

Although OmniWave was initially developed for ECG applications, its potential goes far beyond. “We’ve seen it used in everything from diagnostic devices to EDA (electrodermal activity) monitoring and muscle health assessments,” Amit noted. Other groundbreaking applications include detecting internal bleeding post-surgery and even shrinking tumors through electrical stimulation..

5.Regulatory Compliance and Safety:

OmniWave meets the highest standards for safety and regulatory compliance. It has passed ISO 10993 for sensitization and irritation and complies with the AAMI EC12 standards for disposable electrodes. FLEXcon already has customers using OmniWave in FDA 510(k) approved devices, with more on the way.

Conclusion:

FLEXcon’s OmniWave is poised to be a disruptive force in the medical wearables market. By addressing the limitations of hydrogel, OmniWave offers superior performance, comfort, and cost savings. As more medical device manufacturers adopt this technology, it’s only a matter of time before OmniWave becomes the new standard for dry electrode applications.

As the medical device industry advances, the need for high-performance, skin-friendly adhesives becomes more crucial than ever. Wacker Corporation, a global leader in silicone adhesives, is driving innovation in this space. In a recent discussion, Stephen Mancosi and Kyle Gaines from Wacker shared insights into the benefits of silicone adhesives for wound care, prosthetics, and medical wearables.

1.The Key Benefits of Silicone Adhesives

Silicone adhesives offer several advantages over traditional materials like acrylic and rubber:

Breathability: Unlike many other adhesive technologies, silicone allows the skin to breathe. This prevents moisture buildup and maceration, making silicone adhesives ideal for long-term use, especially in wound care and orthotics.

Atraumatic Removal: Silicone adhesives provide gentle removal, reducing the risk of skin tears or damage. This is particularly important for elderly patients and newborns with delicate skin.

2.Biocompatibility and Comfort

Silicone is inherently biocompatible, which makes it an excellent choice for long-term skin contact applications. Unlike some other adhesives, silicones don’t cause skin irritation or contact dermatitis, and they maintain comfort for the duration of wear. Their ability to remain gentle while still holding firmly is why silicone adhesives are often the top choice for advanced wound care and wearable medical devices.

3.Innovations in Long-Term Wear and Extreme Conditions

While silicones have traditionally been known for shorter-term wear applications, Wacker is pushing the boundaries with new developments that allow silicone adhesives to maintain their hold for extended periods, even in high-moisture or active conditions. These advancements make silicone adhesives a viable solution for athletic wearables, patient monitors, and more.

Wacker is also addressing challenges with sterilization, ensuring that their silicone adhesives can be gamma sterilized, opening up new possibilities for their use in sterile environments.

4.The Future of Medical Devices with Silicone Adhesives

The healthcare industry is moving toward remote patient monitoring and wearable devices, particularly in the geriatric and neonatal markets. Silicone adhesives play a pivotal role in making these devices both effective and comfortable for long-term wear. Wacker’s focus on innovation, combined with its expertise in polymer chemistry, ensures that silicone adhesives will continue to set new standards for patient comfort and device performance.

Conclusion:

Wacker Corporation’s innovations in silicone adhesive technology are set to revolutionize medical devices. From atraumatic removal to improved long-term wear, these adhesives offer the performance and comfort that healthcare providers need to improve patient outcomes.

The healthcare industry is undergoing a dramatic transformation, fueled by innovations in AI, wearable technology, and remote patient monitoring. As we move from hospital-based care to at-home solutions, these technologies are not only improving patient outcomes but also changing how healthcare is delivered. In our recent Tape Lab Summit, I had the pleasure of discussing these shifts with Robin Farmanfarmaian, a healthcare entrepreneur and expert in medical innovation.

1.The Shift from Hospital to Home

Healthcare is no longer confined to hospital walls. Major players like United Healthcare and Humana are investing billions into home-based care solutions, acquiring companies that provide remote patient monitoring and even hospitalizations at home. This shift is making healthcare more accessible, allowing patients to receive treatments like dialysis and IV medications in the comfort of their homes.

As Robin highlighted, this is not just about telemedicine—it’s about a full-scale transition to home-based medical care, driven by healthcare giants and supported by FDA approvals and Medicare reimbursements.

2.The Rise of Remote Patient Monitoring

Wearable technology is at the forefront of this revolution. Devices like BioBeat are using advanced technology such as PPG (photo-plethysmography) to monitor vital signs continuously. These small, adhesive patches collect millions of data points daily, tracking everything from blood pressure to heart rate variability. The ability to monitor patients in real-time is leading to proactive care and early interventions.

For patients, this means fewer hospital visits and better health management, while doctors gain access to valuable, real-time data to make informed decisions.

3.AI and Predictive Analytics in Healthcare

One of the most exciting developments in healthcare is the use of AI for predictive analytics. Companies like Hythe AI are utilizing AI to monitor patient behaviors, such as cough patterns, and predict hospitalizations up to three days in advance. By analyzing data from wearable devices and other sources, AI is shifting healthcare from reactive to predictive care, allowing for timely interventions that improve patient outcomes and reduce hospital stays.

4.Generative AI and Automation Generative AI

is transforming the administrative side of healthcare as well. Robin’s own company is working on automating medical transcriptions and filling out qualified medical exams, drastically reducing the time healthcare providers spend on paperwork. This automation is streamlining the process, cutting down the 13 million hours spent annually on prior authorizations to just minutes.

As this technology continues to evolve, we can expect AI to take over more of the routine tasks in healthcare, freeing up providers to focus on patient care.

Conclusion:

The future of healthcare is here, driven by AI, wearable technology, and the shift to home-based care. These innovations are not only making healthcare more efficient but also empowering patients to take control of their health in ways never before possible. At the Tape Lab, we are excited to be a part of this revolution, providing the adhesive technology that makes many of these wearable devices possible.

Want to learn more about how AI and wearables are changing healthcare? Let’s connect.

When designing wearable medical devices, the focus often falls on the hardware. However, there is another critical component that is often overlooked—the adhesive. Adhesives are what hold these devices in place, ensuring they stay on the body and function as intended. In our recent Tape Lab Summit, I had the pleasure of speaking with Mike Muchen from Avery Dennison, who shared his extensive knowledge on the subject.

1.The Role of Adhesives in Medical Devices

Adhesives are more than just the “sticky stuff” that holds a device in place. They are integral to the device’s performance, comfort, and wearability. As Mike explained, “Without the right tape, the device simply doesn’t work as intended.” This is especially true in medical applications where devices need to stay in place for extended periods, often while the patient is moving, sweating, or showering.

2.The Challenge of Sticking to Skin

One of the most unique challenges in designing adhesives for medical devices is the nature of the substrate—human skin. Unlike other surfaces, skin varies greatly from person to person. Factors like skin type, oil production, moisture, and even hair can affect how well an adhesive bonds. This variability makes it essential for device designers to test adhesives on real people early in the process.

Mike highlighted that “testing prototypes on a small cross-section of people can provide invaluable insights,” allowing designers to understand how their device will perform in the real world.

3.Early Testing is Key

Waiting until the later stages of development to test adhesives can lead to costly delays. That’s why Mike emphasized the importance of early testing. Even a small group of five to ten people can reveal issues that might not show up in a lab environment.

“We get so hung up on full-blown clinical studies,” Mike shared. “But early prototype testing can help avoid larger problems down the road.”

4.Choosing the Right Adhesive

There are many different types of adhesives used in medical devices, each with its own benefits and drawbacks. Acrylic adhesives are the most commonly used because they offer a good balance of cost and performance. Silicone adhesives are also popular for their gentleness on the skin, but they may not offer the same durability for long-term wear.

Mike noted, “It’s all about compromise. No adhesive is perfect. It’s about finding the right balance between adhesion strength, comfort, and wear time.”

Conclusion:

In the world of wearable medical devices, adhesives play a far more critical role than many realize. By involving adhesive experts early in the design process and conducting thorough real-world testing, device manufacturers can avoid common pitfalls and ensure their products perform as expected. At Avery Dennison, we are proud to support this critical aspect of device design, helping to bring innovative, life-saving technologies to market.

#WearableTech #AdhesivesInHealthcare #MedicalDeviceDesign #HealthcareInnovation

In the fast-evolving world of wearable healthcare technology, few companies are making waves like Nanoware. With its revolutionary cloth nanotechnology sensors, Nanoware is enabling home-based digital diagnostics that are transforming how we monitor and treat cardiopulmonary conditions. During a recent conversation with Venk Varadhan, CEO of Nanoware, we got an inside look at the technology driving these breakthroughs.

1.What is Cloth Nanotechnology?

At the heart of Nanoware’s innovation is its FDA-approved textile sensor. Unlike traditional sensors, Nanoware’s fabric-based sensors use billions of nanosensors to capture high-fidelity signals from the human body. These sensors are soft, non-corrosive, and able to detect tiny fluctuations in electromechanical signals without being affected by motion artifacts or environmental factors like sweat.

As Venk Varadhan explains:

“Our cloth nanotechnology provides exponentially higher signal fidelity compared to other on-body sensors, making it the first textile sensor approved by the FDA for capturing and transmitting essential performance biomarkers.”

2.Addressing Cardiopulmonary Disease at Home

One of the primary applications for Nanoware’s sensors is in cardiopulmonary diagnostics. Nanoware’s platform enables patients to self-administer diagnostic tests at home, providing real-time data that helps clinicians monitor chronic conditions like hypertension, heart failure, and coronary artery disease. This not only reduces the need for frequent in-clinic visits but also provides real-world evidence that can improve patient outcomes.

According to Varadhan:

“Patients on a multi-year journey with cardiovascular disease need recurring assessments. Our technology allows these assessments to happen at home, giving clinicians the data they need to make informed decisions.”

3.A New Approach to FDA Approval

Developing such a novel product wasn’t without its challenges. Without a predicate device to guide the FDA approval process, Nanoware had to work closely with the agency to create new safety protocols and testing procedures. This included unique biocompatibility testing to ensure the sensors were safe for long-term skin contact.

“We met with the FDA frequently to create novel protocols. We had to inject nanosensor tips into the bloodstream of test animals to ensure the sensors were safe—something that had never been done before,” Varadhan shares.

4.A Vision for Global Access

While Nanoware’s technology is already making waves in the U.S., the company has a broader, global vision. As Varadhan explains, they aim to make this life-saving diagnostic technology accessible to underserved regions where access to cardiologists and healthcare facilities is limited. With the rise of smartphone technology, even patients in remote areas could benefit from Nanoware’s self-administered diagnostics.

“We envision a world where people in remote villages can access cardiopulmonary diagnostics through their smartphones—making healthcare more equitable and accessible globally.”

Conclusion:

Nanoware’s innovative cloth nanotechnology sensors are poised to transform the landscape of cardiopulmonary diagnostics. By offering a user-friendly, accurate, and self-administered platform, Nanoware is not only making it easier for patients to manage chronic conditions but also opening doors for global healthcare access.

With this first-of-its-kind technology, the future of healthcare looks brighter than ever.

#WearableTech #MedicalDevices #DigitalHealth #HealthcareInnovation #CardiovascularCare