Engineering the Future of Drug Delivery: A Multi-Layer Adhesive Breakthrough

Engineering the Future of Drug Delivery: A Multi-Layer Adhesive Breakthrough

How advanced adhesive technology is transforming pharmaceutical delivery systems

Introduction

The pharmaceutical industry is undergoing a quiet revolution in drug delivery. While oral medications and injections remain common, transdermal delivery systems—which administer medication through the skin—are emerging as game-changers for patient compliance, consistent dosing, and reduced side effects.

At the heart of this innovation lies an often-overlooked component: the adhesive system that makes it all possible.

At The Tape Lab, we recently partnered with a pharmaceutical developer to engineer a multi-layer adhesive system that fundamentally reimagines how medications interact with the body. This breakthrough demonstrates how sophisticated adhesive engineering is not just supporting medical innovation—it’s actively driving it.

The Challenge: Beyond Simple Adhesion

When our pharmaceutical partner approached us, they outlined multiple complex requirements that far exceeded conventional adhesive functionality:

  1. Directional Drug Delivery: The system needed to ensure medication moved downward into the skin, not laterally or outward 
  2. Temperature-Activated Release: The medication needed to be released only when in contact with body temperature (98.6°F) 
  3. Moisture Balance: The adhesive needed to maintain an appropriate moisture environment for effective drug absorption 
  4. Extended Wear Performance: The system needed to remain adhered for the full therapeutic duration while remaining waterproof 
  5. Biocompatibility: All materials needed to meet stringent biocompatibility standards for prolonged skin contact 

Creating a solution that addressed all these requirements simultaneously required rethinking the fundamental structure of transdermal delivery systems.

The Solution: A Purpose-Built Layered System

Rather than approaching this as a simple adhesive application, we engineered a comprehensive multi-layer system where each component serves a specific therapeutic purpose:

Layer 1: Waterproof Barrier

The outermost layer utilizes our TTL 6840 long-term wear tape technology, a specialized breathable but waterproof barrier that protects the entire system from external moisture while allowing natural skin transpiration. This material maintains its protective properties during showering, exercise, and daily activities, ensuring consistent drug delivery regardless of conditions.

Layer 2: Drug Reservoir

The middle layer features a custom-engineered absorbent matrix designed to hold the pharmaceutical agent in suspension until activation. This layer was specifically calibrated to work with our partner’s proprietary medication formulation, ensuring compatibility and stability throughout the product’s shelf life.

Layer 3: Hydrophilic Directional Interface

The innovation that truly transformed this system was the development of a specialized hydrophilic material that creates a one-way pressure differential. When activated by body heat at precisely 98.6°F, this layer undergoes a controlled phase change that generates downward pressure, directing the medication into the skin rather than allowing lateral diffusion.

This directional pressure ensures maximum therapeutic efficiency by focusing medication delivery exactly where it’s needed—into the underlying tissue rather than spreading across the skin surface.

Technical Execution: Material Science Meets Pharma Necessity

Developing this solution required pushing the boundaries of adhesive material science:

Temperature-Sensitive Polymer Development

The temperature-activation mechanism was achieved through a specialized polymer blend that undergoes a precisely calibrated phase change at body temperature. This required extensive testing across different environmental conditions to ensure that premature activation wouldn’t occur during storage or transport, while guaranteeing consistent activation when applied to the skin.

Hydrophilic Engineering

The directional flow characteristic was achieved by creating a gradient of hydrophilic properties within the adhesive matrix itself. This required precise control of material porosity and surface chemistry to establish the necessary pressure differential that drives medication downward.

Biocompatibility Optimization

Throughout development, each material component underwent rigorous biocompatibility testing according to ISO 10993 standards. This involved iterative reformulation to eliminate potential irritants while maintaining the critical functional properties of the system.

Results: Performance Beyond Expectations

The final system delivered exceptional performance across all requirements:

  • Directional Efficiency: Testing showed a 68% improvement in drug penetration compared to conventional transdermal systems
  • Consistent Release Profile: Medication release maintained ±4% consistency throughout the wear period
  • Waterproof Performance: The system maintained full functionality through water exposure testing equivalent to daily showering
  • Extended Wear Time: Reliable adhesion for the full 7-day therapeutic duration with minimal degradation
  • Patient Comfort: Reduced skin irritation by 72% compared to previous transdermal solutions

Implications for the Future of Drug Delivery

This technological breakthrough has implications extending far beyond this single application:

Expanding the Range of Transdermal Medications

Many medications previously unsuitable for transdermal delivery due to diffusion limitations can now be reconsidered with this directional delivery technology. This has the potential to transform treatment regimens for conditions ranging from chronic pain management to hormone replacement therapy.

Personalized Medicine Applications

The precision control offered by this system opens possibilities for more personalized medication delivery, with potential for custom formulations tailored to individual patient needs and metabolism rates.

Combination Therapy Possibilities

The multi-layer structure creates opportunities for delivering multiple therapeutic agents with different release profiles from a single application, potentially simplifying complex treatment regimens.

From Innovation to Implementation

The journey from concept to commercial application required close collaboration between our adhesive engineering team and our pharmaceutical partner’s medical specialists. This interdisciplinary approach was crucial in bridging the gap between adhesive technology and therapeutic requirements.

Key elements of this successful partnership included:

  • Iterative Prototyping: More than 14 prototype iterations were developed and tested
  • Real-World Simulation Testing: Performance evaluation under various environmental conditions and activity levels
  • Regulatory Pathway Planning: Proactive design considerations to support FDA approval processes

Conclusion: Adhesive Innovation as Medical Advancement

This case demonstrates how advanced adhesive technology is not merely a component of medical innovation but often the enabling factor that makes breakthrough treatments possible. By approaching adhesive development as a fundamental therapeutic challenge rather than simply a means of attachment, we’ve helped create a system that significantly advances the possibilities for transdermal drug delivery.

For medical device engineers and pharmaceutical developers, this underscores the importance of considering adhesive technology as an integral part of the therapeutic solution rather than an afterthought.

The future of drug delivery will increasingly rely on sophisticated adhesive systems that do far more than simply stick—they will actively participate in the therapeutic process, improving efficacy, patient compliance, and treatment outcomes.

At The Tape Lab, we specialize in developing custom adhesive solutions for the most challenging medical applications. To learn more about our capabilities in pharmaceutical and medical device adhesives, download our free “Adhesives 101 for Wearable Devices” guide or contact our engineering team for a consultation.

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Navigating FDA 510(k) Approval for Wearable Devices with Skin Adhesives

Navigating FDA 510(k) Approval for Wearable Devices with Skin Adhesives

In the rapidly evolving world of medical technology, wearable devices that adhere to the skin are revolutionizing patient care and monitoring. However, bringing these innovative products to market requires navigating the complex FDA 510(k) approval process. This guide will walk you through the key steps, challenges, and best practices for obtaining FDA 510(k) approval for wearable devices that use adhesive tape to stick to the skin.

Understanding Wearable Medical Devices in the Context of FDA Regulations

Wearable medical devices are transforming healthcare by providing continuous, real-time patient data and enabling remote monitoring. These devices, which often use adhesive technology to attach to the skin, present unique regulatory challenges. The FDA classifies most wearable devices under the 510(k) premarket notification pathway, requiring manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device.

The market for wearable medical devices is rapidly expanding, with innovations in skin-adhesive technologies pushing the boundaries of patient monitoring and treatment. As these devices become more sophisticated, understanding the regulatory landscape is crucial for successful market entry.

The FDA 510(k) Approval Process: An Overview

Obtaining FDA 510(k) approval for wearable devices requires a thorough understanding of both the regulatory process and the unique challenges posed by skin-adhesive technologies. The process involves several key steps:

  1. Device Classification: Determine the device’s risk level and corresponding regulatory controls.
  2. Predicate Device Identification: Find a legally marketed device with similar intended use and technological characteristics.
  3. Performance Testing: Conduct necessary tests to demonstrate safety and effectiveness.
  4. Submission Preparation: Compile all required documentation and test results.
  5. FDA Review: Submit the 510(k) application for FDA evaluation.
  6. Clearance Decision: Receive FDA decision on substantial equivalence.

FDA Cleared vs Approved: Key Differences for Wearable Device Manufacturers

Understanding the distinction between FDA cleared vs approved is crucial for wearable device manufacturers navigating the regulatory landscape. While both terms indicate FDA authorization for marketing, they have different implications:

  • FDA Cleared: Applies to most 510(k) submissions. It means the device is substantially equivalent to a predicate device in terms of safety and effectiveness.
  • FDA Approved: Typically used for higher-risk devices that go through the Premarket Approval (PMA) process, requiring more rigorous clinical testing.

For wearable devices using skin adhesives, FDA clearance through the 510(k) process is the most common pathway. However, novel technologies or high-risk applications might require the more stringent PMA process.

Unique Considerations for Wearable Devices with Skin Adhesives

Wearable devices that use tape to adhere to the skin present specific challenges in the 510(k) approval process:

Biocompatibility and Material Testing

The FDA requires rigorous testing to ensure the safety of materials in direct contact with the skin. Key considerations include:

  • Cytotoxicity Testing: Evaluating potential toxic effects on cells.
  • Sensitization Assessment: Checking for allergic reactions.
  • Irritation Studies: Determining if the adhesive causes skin irritation.
  • Long-term Wear Testing: Assessing the effects of prolonged skin contact.

Adhesive Performance and Durability

Manufacturers must demonstrate that the adhesive maintains its integrity and performance over the intended wear time. This includes:

  • Adhesion Strength Testing: Measuring the force required to remove the device.
  • Moisture Resistance: Evaluating performance in various humidity conditions.
  • Skin Flexibility Compatibility: Ensuring the device moves naturally with the skin.

Overcoming Common Challenges in 510(k) Approval

Navigating the FDA 510k approval timeline for wearable devices can be complex, but understanding common hurdles can help streamline the process:

  1. Data Quality and Quantity: Ensure comprehensive and well-organized test data.
  2. Predicate Device Selection: Choose an appropriate predicate to demonstrate substantial equivalence.
  3. Regulatory Strategy: Develop a clear strategy aligned with FDA expectations.
  4. Documentation Clarity: Provide clear, concise, and complete documentation.

Best Practices for a Successful Application

To increase the chances of a smooth approval process:

  1. Early FDA Engagement: Utilize the Pre-Submission Program for feedback on your testing plan.
  2. Comprehensive Testing Protocol: Develop a robust testing plan that addresses all potential safety and effectiveness concerns.
  3. Clear Substantial Equivalence Argument: Articulate how your device compares to the predicate device in terms of intended use and technological characteristics.
  4. Thorough Risk Analysis: Conduct a detailed risk assessment and mitigation strategy.
  5. Stay Updated on Regulations: Keeping abreast of FDA wearable device regulations is essential for companies developing skin-adhesive technologies.

Future Trends and Regulatory Evolution

As wearable technology continues to advance, staying up-to-date with FDA wearable device regulations is essential for companies developing skin-adhesive technologies. Future trends likely to impact the regulatory landscape include:

  1. Increased Focus on Real-World Data: The FDA is showing growing interest in real-world performance data to support regulatory decisions.
  2. Enhanced Cybersecurity Requirements: As wearable devices become more connected, expect stricter security and data protection standards.
  3. Streamlined Processes for Digital Health Technologies: The FDA is working on new frameworks to expedite the review of digital health products.
  4. Greater Emphasis on User Experience: Usability and human factors engineering will play an increasingly important role in the approval process.

Conclusion

Navigating the FDA 510(k) approval process for wearable devices with skin adhesives requires a thorough understanding of regulatory requirements, meticulous planning, and a commitment to safety and effectiveness. By focusing on biocompatibility, adhesive performance, and comprehensive testing, manufacturers can increase their chances of successful clearance.

Remember, the journey doesn’t end with FDA clearance. Ongoing compliance, post-market surveillance, and continuous improvement are crucial for long-term success in the dynamic wearable medical device market. By staying informed about regulatory trends and maintaining open communication with the FDA, you can position your innovative wearable devices for success in this exciting and rapidly evolving field.

Revolutionizing Medical Tapes for Wearable Devices: The Tape Lab’s Engineering Approach

In the rapidly evolving world of wearable medical technology, the unsung hero often lies in the smallest details – specifically, the tape that holds these innovative devices securely and comfortably to the human body. At The Tape Lab, we’ve made it our mission to engineer these critical components with precision and care. Our expertise in medical tapes for wearable devices goes beyond simple adhesion; we’re crafting solutions that enhance device performance, ensure patient comfort, and meet the rigorous demands of the healthcare industry.

The Evolution of Medical Tapes in Wearable Technology

The landscape of wearable medical devices has transformed dramatically in recent years, driven by advancements in telehealth and remote patient monitoring. This evolution has placed new demands on the humble medical tape, requiring it to do more than ever before. The Tape Lab specializes in engineering medical tapes that meet the unique demands of wearable devices, from ensuring long-term adhesion to accommodating the flexibility needed for patient comfort.

As wearable technology becomes more sophisticated, so too must the tapes that secure these devices to the skin. We’re not just talking about simple bandages anymore; modern medical tapes must contend with challenges like:

  • Varying skin types and conditions
  • Extended wear times
  • Exposure to moisture and temperature fluctuations
  • The need for breathability to maintain skin health
  • Compatibility with device electronics and sensors

Our engineering process takes all these factors into account, resulting in tape solutions that are as advanced as the devices they support.

Engineering Precision: The Science Behind Medical Adhesive Tape

At The Tape Lab, we understand that the success of a wearable medical device often hinges on the quality and specificity of its adhesive components. Our expertise in medical adhesive tape engineering ensures optimal performance and patient comfort in wearable applications. But what sets our approach apart?

  1. Material Selection: We work with a variety of backing materials, including polyurethane, polyester, and polyethylene, each chosen for its unique properties that match specific device requirements.
  2. Adhesive Formulation: While we don’t create the adhesives ourselves, we partner with industry leaders like 3M, Avery Medical, and Berry Plastics to source the perfect adhesive for each application.
  3. Custom Converting: Our state-of-the-art converting services, including die cutting, laminating, and printing, allow us to create tape solutions that fit precise specifications.
  4. Clean Room Manufacturing: Our ISO 8 clean room ensures that every tape product meets the highest standards of cleanliness and quality control.

This combination of material expertise, strategic partnerships, and advanced manufacturing capabilities allows us to engineer medical adhesive tapes that stand up to the rigorous demands of wearable devices.

Optimizing Medical Device Wearables with Custom-Engineered Tapes

The world of medical device wearables is incredibly diverse, ranging from simple activity trackers to complex drug delivery systems. Each device presents its own set of challenges when it comes to adhesion, and that’s where our custom engineering approach shines.

We collaborate with leading manufacturers to create custom tape solutions for cutting-edge medical device wearables. Our process involves:

  1. Consultation: We work closely with device manufacturers to understand the specific requirements of their product.
  2. Design: Our engineering team develops custom tape designs that address the unique challenges of each device.
  3. Prototyping: We create and test prototypes to ensure the tape solution meets all performance criteria.
  4. Production: Once approved, we manufacture the custom tape solution in our clean room facility.

This tailored approach ensures that each wearable device benefits from a tape solution that’s optimized for its specific use case, whether it’s a long-term wear cardiac monitor or a disposable glucose sensor.

Challenges and Solutions in Tape Engineering for Wearable Medical Devices

The success of wearable medical devices often hinges on the quality and specificity of their adhesive components. Some of the key challenges we address include:

  • Skin Sensitivity: We select materials that minimize the risk of irritation, even with prolonged wear.
  • Moisture Management: Our engineered tapes often incorporate breathable materials that allow moisture to escape while maintaining a secure bond.
  • Flexibility: We design tapes that move with the body, ensuring comfort without compromising adhesion.
  • Electronics Integration: For devices with onboard electronics, we engineer tapes that accommodate components like batteries and sensors without interfering with their function.

By addressing these challenges head-on, we help our clients create wearable devices that are not only effective but also comfortable and reliable for patients.

The Importance of Medical Grade Adhesive Tape in Device Performance

When it comes to wearable medical devices, not just any tape will do. Our medical grade adhesive tape undergoes rigorous testing to ensure biocompatibility and long-term reliability. This level of quality is crucial for several reasons:

  • Patient Safety: Medical grade tapes are designed to minimize the risk of skin irritation or allergic reactions.
  • Regulatory Compliance: Our tapes meet stringent industry standards, helping device manufacturers navigate the complex landscape of medical device regulations.
  • Device Longevity: High-quality medical grade tapes ensure that devices stay in place for their intended wear time, improving data collection and treatment efficacy.

By focusing on medical grade adhesive tapes, we help our clients create devices that not only perform well but also meet the high standards expected in the healthcare industry.

The Future of Medical Tape Engineering

As wearable technology continues to advance, so too will the demands placed on medical tapes. At The Tape Lab, we’re always looking ahead, anticipating the needs of tomorrow’s medical devices. Some areas we’re exploring include:

  • Smart Adhesives: Tapes that can respond to changes in the wearer’s skin condition or environment.
  • Biodegradable Options: Environmentally friendly tapes for short-term use devices.
  • Enhanced Sensor Integration: Tapes designed to work seamlessly with next-generation biometric sensors.

Our commitment to innovation ensures that we’ll continue to provide cutting-edge tape solutions as the wearable medical device market evolves.

Partnering with The Tape Lab for Your Wearable Device Needs

In the world of wearable medical devices, the right tape can make all the difference. At The Tape Lab, we bring together material science, engineering expertise, and a deep understanding of the medical device industry to create tape solutions that enhance device performance and patient experience.

Whether you’re developing a new wearable device or looking to improve an existing one, we’re here to help. Our team of experts is ready to work with you to engineer the perfect tape solution for your unique needs.

Ready to take your wearable medical device to the next level? Contact The Tape Lab today to learn how our custom-engineered medical tapes can enhance your product’s performance and user experience.

Navigating FDA Requirements: A Guide to Adhesive Compliance in Medical and Wellness Products

FDA Approval Process

Understanding regulatory requirements for adhesive components can mean the difference between a successful product launch and costly delays. Whether you’re developing a medical device or a nutraceutical delivery system, knowing your regulatory pathway is crucial.

Understanding Your Product Category

Different products face different regulatory challenges:

– Medical Devices: Full FDA compliance pathway

– Nutraceutical Delivery Systems: Dietary supplement regulations

– Cosmetic Applications: Cosmetic regulatory framework

– Wellness Products: General product safety requirements

Each category requires specific documentation and testing protocols.

Biocompatibility Testing: What You Need to Know

Even for non-medical applications, skin safety is paramount:

– ISO 10993 testing considerations

– Cytotoxicity evaluation

– Sensitization testing

– Irritation assessment

– Wear time validation

Understanding these requirements early prevents costly retesting.

Documentation Best Practices

Successful compliance requires robust documentation:

– Material specifications

– Manufacturing protocols

– Quality control procedures

– Testing data

– Supplier certifications

Our experience shows that organized documentation can accelerate your timeline.

Common Submission Pitfalls

Avoid these frequent compliance challenges:

– Incomplete testing data

– Insufficient material documentation

– Inadequate manufacturing controls

– Missing biocompatibility assessments

– Poor change control procedures

Early planning helps navigate these potential obstacles.

Timeline Optimization Strategies

Smart strategies can accelerate your compliance process:

– Early regulatory pathway determination

– Parallel testing protocols

– Strategic material selection

– Proactive documentation preparation

– Expert consultation utilization

Success Case Study

A recent wellness product launch demonstrates effective compliance navigation:

– Challenge: Complex adhesive requirements for skin contact

– Solution: Strategic material selection and testing plan

– Result: Successful launch with complete documentation

– Timeline: 40% faster than industry average

Expert Support Available

Understanding and navigating these requirements doesn’t have to be overwhelming. Our team of experts can guide you through the process, ensuring compliance while optimizing your development timeline.

Visit us at MD&M West Booth 2246 for a personalized consultation on your regulatory pathway. Our experts will help you develop a strategic plan for compliance success.

Click Here to Book Your Regulatory Consultation at MD&M West

5 Critical Adhesive Decisions That Make or Break Medical Device Development

The success of a wearable medical device often hinges on decisions made in the earliest stages of development. Among these, adhesive selection stands out as a critical factor that can determine your project’s timeline, budget, and ultimate success. Research shows that over 70% of medical device development delays stem from adhesive-related challenges discovered too late in the process.

Material Compatibility Considerations

Your device’s housing material directly impacts adhesive performance. Consider this ripple effect:

– Choosing a low surface energy plastic? Your adhesive options become limited

– Using flexible materials? Your adhesive must match that flexibility

– Working with sensitive electronics? Adhesive chemistry must prevent corrosion

The key is evaluating material compatibility before finalizing your device design. Early testing with multiple material combinations can prevent costly redesigns later.

Wear Time Requirements

The duration your device needs to stay adhered dramatically influences adhesive selection:

– Short-term wear (1-3 days) allows for simpler adhesive formulations

– Medium-term wear (3-7 days) requires balanced adhesion and breathability

– Long-term wear (7+ days) demands advanced moisture management and skin protection

Remember: Extended wear time isn’t just about stronger adhesion. It’s about maintaining consistent performance while protecting skin health.

Skin Sensitivity Factors

Medical adhesives must balance security with skin safety:

– Consider your target population’s skin types

– Account for movement and flexibility needs

– Factor in environmental conditions (moisture, temperature)

– Plan for atraumatic removal

Biocompatibility testing should begin early, as reformulations can add months to your timeline.

Regulatory Pathway Planning

Your adhesive choice impacts your regulatory strategy:

– Different adhesive classifications require different testing protocols

– Some adhesives have existing FDA master files, simplifying approval

– Novel adhesive formulations may require additional documentation

– Consider global regulations if planning international distribution

Early regulatory planning can save months in your approval timeline.

Cost Optimization Strategies

Smart adhesive decisions impact your bottom line:

– Material selection affects manufacturing efficiency

– Die design optimization reduces waste

– Roll format choices influence production speed

– Inventory management considerations

– Scale-up implications

Consider total cost of ownership, not just material costs.

Making the Right Choice

Each of these decisions interplays with the others, creating a complex web of considerations. The key to success? Making informed decisions early with expert guidance.

Visiting MD&M West? Stop by Booth [X] for a personalized assessment of your adhesive strategy. Our experts will help you navigate these critical decisions and optimize your development timeline.

Click Here To Schedule Your Personalized Assessment at MD&M West  

Exploring Medical Device Adhesives: Materials & Applications

wearable medical device tape

In the realm of medical devices, adhesives are the unsung heroes, ensuring that devices adhere securely to the skin, wounds heal effectively, and components stay in place during medical procedures.  From wound care to wearable sensors, the right medical adhesive according to the specific application is crucial for proper functionality, security, and patient comfort. Let’s dive into the diverse world of adhesives used in medical devices, exploring the different adhesive materials, applications, and key considerations. 

Acrylic Adhesives

Acrylic adhesives are versatile and known for their durability and resistance to environmental factors.

  • Applications: Used in medical tape, wound dressings, and long-term wearables.
  • Features: Offers strong bonding and long-term adhesion.

Rubber Adhesives

Rubber adhesives are versatile and known for their quick stick properties and adherence to low surface energy materials, as well as skin.

  • Applications: Used in medical tape, wound dressings, and short-term wearables, tie layers in wearable devices.
  • Features: Offers strong bonding and shorter-term adhesion on skin.

Silicone Adhesives

Silicone adhesives are biocompatible and flexible, making them suitable for skin contact applications.

  • Applications: Commonly used in wound dressings, medical tapes, and devices requiring gentle skin adhesion.
  • Features: Provides a comfortable and effective bonding solution for sensitive skin.

Hydrocolloid Adhesives

Hydrocolloid adhesives create a moist environment for wound healing and are commonly used in wound care applications.

  • Applications: Found in wound dressings, bandages, and patches for managing exudate.
  • Features: Promotes healing and provides a barrier against external contaminants.

Polyurethane Adhesives

Polyurethane adhesives offer high strength and flexibility, making them suitable for medical tubing and catheters.

  • Applications: Used in medical devices that require a strong yet conformable bond.
  • Features: Resistant to water and chemicals, ensuring stability in various medical environments.

Water-Resistant Adhesives

Water-resistant adhesives are crucial for wearable health technology intended for activities like swimming or intense workouts.

  • Applications: Used in waterproof fitness trackers, smartwatches, and other wearables exposed to moisture.
  • Features: Maintains adhesion even in wet conditions.

Cloth & Fabric Adhesives

Fabric adhesives provide comfort and breathability, making them suitable for wearables requiring continuous skin contact.

  • Applications: Used in health monitoring patches and devices where user comfort is a priority.
  • Features: Skin-friendly, allows air circulation.

Double-Sided Adhesives

Some wearables require adhesives on both sides for increased stability.

  • Applications: Used in wearables that need to adhere to both the skin and the device surface simultaneously.
  • Features: Ensures a secure attachment, preventing device shifting.

Transparent Adhesives

Transparent adhesives are ideal for wearables where aesthetics and discreteness are important.

  • Applications: Used in wearables that need to blend seamlessly with the user’s skin.
  • Features: Allows for easy monitoring of the skin under the adhesive.

Get Customized Adhesives for Your Medical Device

As technology advances and patient needs evolve, the development of specialized adhesives continues to contribute significantly to the field of medical innovation. The careful selection of the right adhesive is paramount, considering factors such as biocompatibility, strength, and intended application, to ensure the seamless integration of medical devices into patient care. 

Contact us to learn more about how we can help support your creation of the next medical device.

Stick-To-Skin Adhesives – A Key Disruptor in Modern Healthcare

Transdermal patch on arm

Wearable stick-to-skin medical devices give doctors the freedom to become time and location-independent. Healthcare providers can effortlessly gather vital patient information and take appropriate action from virtually anywhere. Plus, the patient doesn’t have to spend hours on a long commute. CGM (Continuous Glucose Monitor) is a good example, which allows doctors to remotely monitor diabetics.

However, the core component that is crucial to the effectiveness of such devices is a stick-to-skin adhesive. It ensures that the device stays attached to the patient’s body for the desired period without disrupting their usual routine. Let’s take a closer look at stick-to-skin adhesives and the importance of a reliable conversion partner.

On The Cusp Of A Growth Boom

Wearable technology; a once farfetched idea, is becoming a norm in modern medicine. It would be fair to conclude that it is rewriting the way healthcare is delivered. We are used to receiving medical attention within a typical clinical establishment; however, most patients face a medical situation at home, on travel, or at work. A moment’s delay in such a state could be catastrophic.

This has given an exponential boost to the demand for wearable tech for remote patient monitoring. According to an industrial analysis Mordor Intelligence, the wearable adhesive market, which was valued at $294.21 million in 2020, is on its way to more than doubling to $617.43 million by 2026. From medical devices and patient monitors to wound closure and sports tapes, this presents a sizeable growth opportunity in every market segment.

Considerations For Designing A Winning Stick-To-Skin Product

While the patient benefits from the device itself, however, a reliable stick-to-skin adhesive is what enables the device to do its job. Let’s explore the factors that must be considered to ensure that the product meets the expected standards:

Material Considerations:
  1. Moisture Management: Stick-to-skin devices are designed to be compatible with the user’s daily lifestyle. That means it must stand up to sweat, bodily fluids, and external moisture. To counter this, adhesive materials employ the following two methods:
    1. Fluid absorption – The adhesive takes on the moisture and holds it away from the skin to prevent irritation.
    2. Moisture-vapor transmission – Tiny holes in the adhesive and carrier material allow moisture to evaporate.
    3. Getting the layer right: Designing an effective stick-to-skin product is a complicated endeavor. Several layers of materials must come together before a product starts to take shape. The designers and manufacturers must get this delicate balance just right for the product to function correctly. For example, if an adhesive used in the skin contact layer is breathable but the outer layer does not allow moisture-vapor transmission, the product won’t perform as intended.
  2. Regulatory Considerations: Bringing a medical-grade product to the market requires the manufactories to adhere to strict regulatory standards. Even a small oversight can cause significant losses – both monetary and in terms of time to the market. Here’s what to look out for.
    1. Relevant ISO Certification & Documentation: Your design, manufacturing, and supply partners must be ISO 13485 certified and compliant.
    2. Safety Tests: To ensure that the adhesives meet the required safety standards, your suppliers must be able to conduct tests such as primary skin irritation (PSI) testing, cytotoxicity screening, biocompatibility, and safety testing, and guinea pig sensitization
  3. The Right Converting Partners: Unquestionable credibility is the backbone of any enterprise that provides healthcare services and related products. This means your production and conversion partner must have extensive experience along with outstanding research and development capabilities. The Tape Lab checks all of these boxes. Let’s take a closer look:
    1. Unquestionable Credibility & Extensive Adhesive-Specific Experience: The Tape Lab brings to the table over 18 years of research & manufacturing experience in the stick-to-skin medical tech space. Some of the largest names in the industry such as Avery Dennison have entrusted us with developing adhesive solutions for their flagship continuous health monitor. We’re supremely confident we can meet and exceed your expectations as well.
    2. A Wide Range OF Stick-To-Skin Products: The Tape Lab currently offers 11 individual categories for stick-to-skin products and 6 categories for wearable medical products. Our range includes but is not limited to adhesive bras, boob tape, CBD adhesive patches, fashion tape, wearable device tape, and diagnostic tape. You can explore our full product range over here. No matter what you have in mind, you’ll find it under one roof with The Tape Lab.
    3. The Ability To Customize & Unrivaled Engineering Expertise: Do you have an idea for a unique stick-to-skin product? We can help you bring it to life. The Tape Lab excels in every facet of medical adhesive design and manufacturing. Our core competencies include designing the tapes, die-cutting the patches, layer lamination, customizing the liner releases, and full-service OEM assembly. This gives us the scale and production capacity that will empower you to bring your product to market quicker and cheaper than your competition.
    4. Strong Supplier Partnerships: What sets us apart is our rock solid supply chain. We enjoy strong relationships with leading material manufacturers in the medical adhesive space. Our partners include 3M, Avery Dennison, Berry Plastics, Adhesive Applications and Polymer Science. This ensures immediate material access and enables us to design and produce customized medical adhesive solutions far quicker and cheaper than most of our competitors.

Next Step – Book A Free Consultation

Looking for a full-service tape converter and adhesives specialist? Contact The Tape Lab today. Our experts will schedule an obligation-free call and explain how we can put our full suite of converting services to work for you.

Transdermal Topical Patches – Will They Redefine The Way Vitamins and Supplements are Delivered?

medical device adhesive

It certainly seems that way. It wasn’t long ago that transdermal patches were viewed as a novel way to cope with chronic smoking. However, as their acceptance increased over the years, they are now being utilized to deliver vitamins, supplements, as well as give consumers remedies for, pain relief, sleep, hangovers and recovery, relaxation- or any combination of all the above via a topical patch.

Let’s explore further and take a closer look at the considerations for manufacturing quality transdermal topical patches.

What Is A Transdermal Patch & Its Various Types

In essence, these are small stick-to-skin patches to administer carefully determined plant based botanicals and vitamin doses through the patient’s skin. Patients find them convenient, non-invasive, and pain-free. Moreover, the patches enable delivery in a controlled manner, therefore, eliminating sharp peaks and valleys in vitamin and supplement administration.

Transdermal topical patches usually have 5 core components i.e. backing, ingredients (vitamins and supplements), membrane, adhesive, and the liner. They can be broadly categorized into 5 groups:

The Importance Of Choosing The Right Adhesive Converter For Transdermal Patches

The adhesive plays a critical role in ensuring that the patch stays securely pasted to the user’s skin and delivers the vitamins and supplements as intended. Let’s take a closer look at the criteria the patch adhesive must meet:

  1. Seamless Skin Adherence & Removal: It should be strong enough that the patch stays put and securely adhereed to the user’s skin for the required period. However, the adhesive must be balanced enough that the user can easily remove it without any discomfort.
  2. No Residue: No one likes to scrape sticky residue off their skin. When the patch is removed, it must not leave any adhesive residue on the skin.
  3. Comfortable: The adhesive must not cause any irritation, rashes, or trigger sensitivity.
  4. Skin- Adhesive Compatibility: It should seamlessly blend the adhesive with the ingredients without causing any physical or chemical clashes.
  5. Permeation: It should not interfere with the way or the speed at which the vitamins or supplement is supposed to be transferred to the patient.

Why An Experienced Adhesive Converter Matters

Transdermal Topical patch manufacturing is a complicated process and an experienced converter can help you stay competitive by eliminating unnecessary costs and significantly shortening the time to market.

  1. End-To-End Patch Design & Development: A knowledgeable converter can help you with any phase of the design and manufacturing process. E.g. it can help you design the required delivery system patch. What you’ll get is a well-made transdermal topical patch perfectly sized and designed to function seamlessly with the intended area of the body.
  2. Selection Of The Correct Pressure-Sensitive Adhesive: A reliable adhesive converter will ensure that the patch stays pasted to the user for the intended period and can stand up to sweat, dirt, and daily activity without causing any discomfort or skin damage.
  3. Consistent Patch Quality: A seasoned convertor will ensure that patch is made to deliver a consistent dosage.
  4. Regulatory Compliance: You will never have to worry about any compliance issues if you work with a converter that is cGMP certified.
  5. Desired Patch Shape & Size: Transdermal Topical patches have various uses, which may require the patch to be of a certain shape or size. An experienced converter brings to the table with numerous die-cutting, slitting, and sheeting capabilities, therefore, giving you the freedom to design and manufacture the patch in any shape or size. Moreover, an expert converter will eliminate material waste and help further reduce your per unit cost.
  6. Continuous Access To Critical Patch Making Materials: Experienced convertors have ties to major suppliers and can help you source the premium materials to make quality patch products that stand out in the marketplace.

What Sets The Tape Lab apart

That is indeed a relevant question. Let’s see how The Tape Lab can help bring your transdermal topical patch products to the market quicker and cheaper.

  1. A Wide Range Of Transdermal Topical Patches: No matter what type of transdermal topical patch you have in mind, we can bring it to life. And we aren’t just limited to patches. The Tape Lab offers an extensive range of stick-to-skin products such as adhesive bras, boob tape, fashion tape, wearable device tape, and diagnostic tape. You can explore our full product range over here.
  2. Unquestionable Credibility & Extensive Adhesive-Specific Experience: The Tape Lab brings to the table over 18 years of research & manufacturing experience in the stick-to-skin medical tech space. Some of the largest names in the industry such as Avery Dennison have entrusted us with developing adhesive solutions for their products. We’re supremely confident we can meet and exceed your expectations as well.
  3. Strong Supplier Partnerships: What sets us apart is our rock solid supply chain. We enjoy strong relationships with leading material manufacturers in the medical adhesive space. Our partners include 3M, Avery Dennison, Berry Plastics, Adhesive Applications and Polymer Science. This ensures immediate material access and enables us to design and produce customized adhesive solutions a lot quicker and cheaper than most of our competitors.

Next Step – Book A Free Consultation

Looking for a full-service tape converter and adhesives specialist? Contact The Tape Lab today. Our experts will schedule an obligation-free call and explain how we can put our full suite of converting services to work for you.