Simplifying the 510K Process for qualifying Medical Adhesives: Your Path to FDA Clearance with The Tape Lab

Blue and white FDA cleared 510k seal.

Introduction: Welcome to The Tape Lab’s official blog, where we share valuable insights and expertise to empower biotech companies in navigating the intricate world of medical device regulations as it pertains to medical adhesives and converting. Today, we delve into the critical topic of 510K medical adhesive consulting and how our team can guide you through the FDA clearance process with confidence and ease.

Unlocking the Potential of Your Innovation: As a biotech company, your primary focus is on creating revolutionary technologies that can transform healthcare. However, understanding the complex landscape of FDA regulations and compliance requirements can be overwhelming, especially when you are primarily driven by data scientists and electrical engineers. This is where The Tape Lab steps in as your trusted partner, offering unrivaled expertise in adhesive solutions and regulatory compliance.

Collaborative Consulting for Seamless Compliance: At The Tape Lab, we firmly believe in bridging the gap between innovation and compliance. Our team of experts collaborates closely with your company to gain a deep understanding of your unique medical device and its intended application. By asking the right questions and conducting meticulous analyses, we help you develop a robust plan that ensures your device meets the rigorous standards set by the FDA.

Refining Design, Materials, and Manufacturing: Our consulting journey begins by evaluating and refining your device’s design, materials, and manufacturing processes. We consider both short-term and long-term factors, ensuring scalability, prototyping, and the selection of biocompatible materials. Our goal is to optimize your device for success, addressing crucial aspects such as functionality, performance, and adherence to regulatory standards.

Prototyping for Precision and Performance: Prototyping plays a pivotal role in our consulting process. Leveraging our state-of-the-art facilities and expertise, we create accurate prototypes that bring your vision to life. These prototypes serve as tangible representations of your device, enabling us to assess functionality, performance, and compliance with regulatory standards. Through iterative rounds of prototyping, we refine and enhance your device, moving it closer to regulatory clearance.

Strategic Collaborations for Manufacturing Excellence: To ensure a seamless transition from prototype to production, we facilitate strategic collaborations with trusted medical converters. These partnerships connect you with qualified manufacturers who possess the capabilities to produce your device’s components. By involving converters early in the process, we ensure seamless integration between design and manufacturing, optimizing layout and addressing any complexities that may arise.

Comprehensive Testing and Documentation: At The Tape Lab, we leave no stone unturned when it comes to testing and documentation. We develop rigorous testing protocols to evaluate your device’s adhesive performance and compliance requirements. Through our extensive network of accredited testing laboratories, we identify the most suitable sources for comprehensive testing. We meticulously analyze the results, making necessary design, adhesive, and liner adjustments to meet the highest safety and performance standards.

Navigating the FDA Approval Process: Once your device and its adhesive components are ready, we assist in compiling the proper documentation, ensuring that all materials touching the skin meet FDA standards. We work diligently to identify predicate devices using similar materials, leveraging prior use cases to strengthen your 510K application. Throughout the FDA clearance process, we stand by your side, representing your interests in meetings with the FDA. Our expertise in adhesive solutions and biocompatibility testing protocols ensures that your device receives the attention it deserves.

A Partner in Your Success: At The Tape Lab, we understand that the FDA approval process is both intricate and dynamic. While the exact timeline for approval may vary, our commitment to your success remains unwavering. We keep you informed throughout the process, providing updates on progress, results, and any necessary adjustments required to achieve compliance.

Conclusion: Simplifying the 510K process is our mission at The Tape Lab. We offer unrivaled expertise, collaborative consulting, and a customer-centric approach to ensure your journey to FDA clearance is smooth and successful. Choose us as your trusted partner, and together, we can revolutionize the healthcare industry with confidence. Contact us today to embark on your path to FDA clearance and bring your transformative medical device to the world.

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.

How Innovative Adhesive Solutions Are Transforming Continuous Health Monitoring & Wearable Medical Tech

Medical Wearables

We may not realize it, but the use of continuous health monitors is quite common – especially within the Global healthcare systems. As of 2020, over 23 million patients in the US alone utilized some form of continuous and remote health monitoring and this number is expected to hit 30 million by the year 2024.

Let’s dig a bit deeper and see how far the modern continuous monitoring tech has come and its impact on how we approach medical care. We will also shed light on how material converting and production partners are helping to bring continuous enhancements within the wearable med tech space.

What Exactly Is A Continuous Health Monitors (CHM)?

As the name implies, it is a medical device that monitors a patient continuously. The goal is to gather data on the patient’s primary health indicators and relay the information to concerned medical caregivers. In most cases, these are wearable devices that the patient can stick onto their body while carrying out their usual daily activities including working out or taking a shower.

Why It Matters?

While the technology may still be young; we’re already seeing its tremendous potential in simplifying healthcare. For starters, it can significantly reduce the time patients spend commuting to their doctor’s office or the hospital and then waiting there for the physician.

During a 2015 study, Harvard Medical School discovered patients on average spend 2 hours on a hospital visit. Continuous health monitors can minimize or almost eliminate these visits in many instances. For example, someone with a chronic heart issue can leverage it to share their data on vital health indicators and get instant feedback from their consultant rather than making the long commute.

Not only is it convenient but such devices may also help manage medical emergencies much better. The constant flow of primary health data enables doctors to take immediate action. Moreover, by minimizing patient visits, these gadgets can significantly improve the efficiency of medical facilities by reducing patient pressure.

The Role of Reliable Adhesive Solutions in Quality Wearable Devices to the Market

Depending on the patients’ needs, they may choose to wear such a device for up to 3 weeks. This means the device must be able to withstand the rigors of daily life without fail. A reliable adhesive solution ensures that the device stays securely attached to the patient’s body for the intended period. Let’s take a closer look at how advanced medical adhesive solutions add to the utility of these devices:

  • Makes It Suitable For An Active Lifestyle: Just because a patient needs to be continuously monitored shouldn’t mean that they cannot commit to normal daily activities such as school, runs, working out or a hike on the weekend. This, however, means that the device must deal with sweat, moisture, and an occasional bump. A reliable adhesive ensures that the device stays put and performs well under normal push and pull of the human body.
  • Ergonomics & Comfort: Let’s be honest. The idea of something continuously sticking to your body is not very appealing. That said, certain health conditions such as diabetes may require patients to wear glucose monitoring devices for weeks. A well-designed adhesive system guarantees that the patient can wear the device comfortably for extended periods without the risk of skin rashes or irritation.

The Importance Of A Reliable Converting & Production Partner

Unquestionable credibility is the backbone of any enterprise that provides healthcare services and related products. This means your production and converting 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:

  • Trusted By Global Wearable Medical Tech Brands: 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 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.
  • 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 Global, and Dermamed. 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.
  • Unrivaled Adhesive Engineering & Production Expertise: 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 packaging. We’re equally proficient in the design, manufacturing, and packaging of stick-to-skin wearables. Moreover, each tape component is manufactured in our ISO-8 certified clean rooms.

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.

References

  1. https://blog.prevounce.com/27-remote-patient-monitoring-statistics-every-practice-should-know#:~:text=Consumer%2FPatient%20Statistics&text=A%20survey%20conducted%20by%20Insider,services%20and%20tools%20in%202020
  2. https://aabme.asme.org/posts/innovations-in-continuous-health-monitoring

Charting The Way Forward For The Stick-To-Skin Industry – Jason Zajac (President, The Tape Lab) Addresses PSTC

Charting The Way Forward For The Stick-To-Skin Industry

During the first week of May (May 2-5), the Pressure Sensitive Tape Council (PSTC) held the inaugural PSTC Tape Week in Lake Buena Vista, Florida.

PSTC Tape Week is a lot more than a traditional networking exercise. The primary objective is to unite the Tape Manufacturers with the adhesive makers and engineers of the pressure-sensitive adhesive (PSA) industry under one roof. The focus is to enable niche-specific knowledge sharing and to provide segmented learning and growth opportunities for PSA professionals.

Our President, Jason Zajac had the honor to speak on the medical stick to skin pressure-sensitive adhesives (PSAs) and what trends will shape the medical market, more specifically the wearables space in the near to medium-term future.

Let’s explore further.

PSTC – Shaping The American Tape Manufacturing Industry

For the past 60 years, the Pressure Sensitive Tape Council (PSTC) has dedicated its resources to developing a thriving tape manufacturing sector within the United States. It strives to create an enabling environment for North American tape manufacturers and affiliate suppliers, thereby, helping them produce quality pressure-sensitive adhesive tape products in the global marketplace.

Jason Sketches A Thorough Overview Of The Medical Stick-to-Skin Industry

After touching upon common stick-to-skin adhesive applications, Jason elaborated on the core deciding factors while choosing the right PSA and ended by shedding light on the importance of choosing the right converting partner. Let’s dive a bit deeper into each section:

  1. Common Stick-To-Skin Applications: Wearable stick-to-skin products 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. More importantly, they offer numerous application options from head to toe including CGM/insulin delivery, ECG/EKG, wearable devices/patient monitors, pulse oximeters​, wound dressings​, wound closures​, adhesive bras​, cosmetic products​, and transdermal patches.
  2. ​Factors For Determining What PSA To Use: The factors that dictate which medical PSA should be chosen include:
    1. Wear Time: Depending on the patient’s needs, stick-to-skin products can be worn anywhere for a couple of days to several weeks. For short-term usage, the core adhesive components are silicones, rubbers, hydrogels​, and hydrocolloids. And the backing should be foams, TPE​, PE film​, and PET.​ Stick-to-product intended for long-term use should have adhesives made from solvent acrylics and UV cured acrylics. And the backings should either be PU film​ or non-woven PET/ PU.​ ​
    2. 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. For enhanced absorption hydrocolloids and absorbent foams should be utilized. And when it comes to breathability, materials such as PU film backings, non-woven backings, and perforated PSAs​ have consistently delivered the desired results. ​ ​
    3. Skin Irritation: The slightest irritation can compel the wearer to abandon the device, thereby, defeating its entire purpose. Factors such as the wearer’s age, local climate, daily activity volume, device placement on the body and product wear time all equally impact the irritation level. Adhesive materials such as acrylic, rubber, silicone, and hydrogels offer the right balance for eliminating irritation. For the backing, the preferred material choices are PU/ PET/ PE film, on-wovens​, PE Foams​ , and cloth​. ​
    4. Clarity of backing Material & PSA​: Backing is the carrier to which the PSA layer is laminated. Moreover, it dictates the way the tape behaves and ensures that the skin has breathability. Applications include wound dressings, NPWT, cover tapes, and shower tapes. Materials such as PU film, PET film​, and PE films are used for an optically clear backing.
    5. Material Availability & Strong Supplier Partnerships: What sets The Tape Lab apart is its 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.
  3. The Right Conversion Partner: No business, healthcare, or otherwise can survive without undisputed integrity. The easiest way to ensure that is by choosing a seasoned material converting partner that brings to the table extensive research and development capabilities. The Tape Lab checks all of these boxes:
    1. Unquestionable Credibility & Extensive Adhesive-Specific Experience: The Tape Lab has over 18 years of research & manufacturing experience in the stick-to-skin medical tech space. Some of the largest names in the industry have entrusted us with developing adhesive solutions for their flagship continuous health monitors. 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: 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.

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.

How Stick-To-Skin Mouth Tapes Are Transforming Sleep Apnea Treatment

Mouth Tape

Medical tape is not exactly the first thing that pops up when you think of the usual medical supplies. Even though not as common as a stethoscope or a disposable syringe but stick-to-skin tapes can be incredibly handy and can be used in a variety of healthcare situations such as Wound dressings, , wearable patient monitors as well as athletic injury prevention, chafing prevention, and more.

Sleep apnea is a sleep disorder characterized by inconsistent breathing during sleep, loud snoring, and feeling fatigued after a full night’s sleep. We’ll examine today how stick-to-skin mouth tapes are enabling people to tackle sleep apnea more effectively.

Innovations In Sleep Apnea Treatment

For over 25 years, healthcare experts have been advising continuous positive airway pressure as a primary treatment for obstructive sleep apnea (OSA).

However, lack of patient tolerance and their inability to stick with it long-term presents a major challenge and has prompted the search for a more reliable treatment to counter sleep apnea. Surprisingly stick-to-skin mouth tape has emerged as one of the most effective ways to counter sleep apnea. Not to mention, it is the cheapest of all available options. Moreover, taping the mouth can help minimize snoring.

A 2015 study was carried out in Taiwan with subjects having mild sleep apnea. It revealed that wearing a porous stick-to-skin patch over the mouth enabled the subjects to breathe through their nose and altered the angle of the palate and the tongue. This resulted in significant breathing improvement and brought about a measurable reduction in snoring.

As its efficacy become apparent, healthcare experts are now increasingly advising patients to use stick-to-skin mouth tapes. And several well-known direct-to-consumer medical and cosmetic brands are offering various mouth tape variations.

The Tape Lab’s Proven History Of Stick-To-Skin Tape Manufacturing

The Tape Lab specializes in engineering stick-to-skin medical devices and solutions.. Armed with the industry’s best practices and over 18 years of experience, our product engineers bring to the table an unparalleled knowledge of stick-to-skin tape converting and manufacturing.

What makes us stand out as a product development partner is our strong relationship with several 3M Preferred Converters. This gives us uninterrupted access to some of the most sought-after materials in the industry. This means The Tape Lab can design and manufacture your stick-to-skin products such as mouth tapes much quicker, cheaper, and without any deviations from your design specifications.

Then it comes to stick-to-skin applications from mouth tapes for sleep enhancement to CBD adhesive patches and breast lift tapes, we can help you envision, design, produce and package a stick-to-skin solution for any possible use.

We also offer clean room manufacturing and converting services to ensure compliance with all relevant industry standards. Our certified ISO Class 8 clean rooms contain state-of-the-art converting and slitting equipment and operate in a temperature- and humidity-controlled environment to ensure successful manufacturing processes free of contamination.

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.

References

https://pubmed.ncbi.nlm.nih.gov/25450408/

Why upfront engineering of stick-to-skin medical devices is so important

Doctor reviewing patient's medical records.

The medical device industry has always been focused on progress and change that benefits patient outcomes. Lately the pace of that change seems to be accelerating. New wearable health monitors and other stick-to-skin medical devices are quickly replacing old techniques both in clinical settings and for outpatient treatment. To keep up with the rest of the industry, manufacturers need to streamline product development and production processes wherever possible. That’s where the right tape converter can provide significant value. With both engineering and manufacturing expertise, a converter like The Tape Lab can provide the upfront engineering you need to create successful stick-to-skin medical devices.

Upfront engineering yields efficiency

Engineers face an uphill battle in trying to bring new, unique stick-to-skin medical devices to market. Product design teams routinely find themselves asking questions like:

  • How will my materials and stick-to-skin adhesives hold up under various sterilization techniques?
  • Which materials are best suited for my intended application?
  • How can I ensure patient comfort and avoid damaging the user’s skin while still maintaining adequate device performance?
  • How does my intended wear time impact my options for adhesives?
  • How can I ensure the device will be effective for all types of skin and under a range of conditions?

The best way to overcome these challenges is to anticipate them as early as possible in the product development cycle. Otherwise, you could end up wasting time, materials and resources building and testing devices that don’t meet application requirements. Spending more time and energy on the front end will ultimately yield greater efficiency throughout the rest of the development and production processes.

The right partner can also help drive efficiency by augmenting your internal team to provide the upfront engineering and adhesives expertise necessary to streamline product development. An experienced converter like The Tape Lab can truncate upfront design time by helping you select the appropriate adhesives and materials for your application. We work with your engineers to fully understand product requirements and can help guide decisions for stick-to-skin adhesives, carrier materials, wearable device tapes and more. This can significantly reduce wasted time and materials while also helping you design for scalability.

A full-service tape converter can then provide the manufacturing processes — like die cutting, slitting, laminating, sheeting and even packaging — to streamline your manufacturing process. This can help get products into market faster and ultimately help you create more successful stick-to-skin medical devices.

For more in-depth insights on what it takes to bring stick-to-skin products to market, download our ebook, Designing and Producing Wearable Stick-to-Skin Products.

A proven history of stick-to-skin medical device engineering

At The Tape Lab, we truly believe our experience engineering stick-to-skin medical devices separates us from any other converter out there. Our staff has worked for tape companies like Avery Dennison as well as run successful converters in the medical die cutting space which has given us a true competitive advantage in the engineering realm. We know what it takes to create successful stick-to-skin products and can use that knowledge and experience to help you avoid common problems that can delay product development. We also have strong relationships with multiple 3M Preferred Converters, giving us unique access to some of the most sought-after materials in the industry. This gives our clients greater flexibility in product design with fewer tradeoffs.

We also offer clean room manufacturing and converting services to ensure compliance with all relevant industry standards. Our certified ISO Class 8 clean rooms contain state-of-the-art converting and slitting equipment and operate in a temperature- and humidity-controlled environment to ensure successful manufacturing processes free of contamination.

Position your organization for success

Stick-to-skin medical devices represent a significant opportunity not only for patients, but for manufacturers as well. To get those products into market quickly, it pays to invest in upfront engineering that helps avoid common pitfalls. By working with an experienced partner that can offer expert guidance, you can streamline product development and help ensure a successful product launch.

If you’re looking to develop new stick-to-skin medical devices, connect with The Tape Lab today and we can help you accelerate product development and streamline your manufacturing process.