Wearable Tech’s Material Edge

Wearable medical technology, ranging from diagnostic and monitoring devices to drug delivery patches, is transforming healthcare and driving medical care innovation. Selecting the right materials is essential to ensure optimal performance and durability of these devices. By leveraging Boyd’s extensive fabrication services and industry-leading materials, medical device manufacturers enhance product quality, streamline production processes, improve patient safety and treatment, and accelerate time to market.

Material Selection for Optimal Wearable Device Performance

Boyd plays a crucial role in advancing various types of wearable medical devices, including continuous glucose monitors (CGMs), biosensors, ECG monitors, blood pressure monitors, drug delivery devices, and transdermal patches. Selecting materials for each device layer is critical for these devices to perform optimally and to enhance patient comfort. Starting from the outermost decorative protective layer to the innermost skin contact layer, Boyd ensures every component is meticulously engineered to meet the specific needs of the device while maximizing patient safety.

Decorative Protective Layer: Sealing, Aesthetics, and Branding

Cushioning Layer: Impact Protection and Comfort

Skin Contact Layer: Adhesion, Comfort, and Safety

Enhanced Patient Outcomes with Boyd’s Material Solutions

With the combined expertise of Boyd’s engineers and material specialists, we expertly guide medical material selection and optimize wearable device design. Our comprehensive solutions address every aspect of wearable medical devices, from housing layers that protect internal components to cushioning layers that provide impact protection and user comfort, printed flex circuit layers for electronic connectivity, skin contact layers for patient safety, and delivery liners for efficient application. These innovations ensure reliable device performance, improved patient treatment and safety, and accelerated time to market. Choose Boyd for your material selection needs in medical wearables to benefit from our expertise. Contact us today to discuss your project or schedule a consultation with our experts.

Wearable Innovations: Transformative Impact in Healthcare

Social Impact

The integration of health apps and preventative care wearables is revolutionizing healthcare, with an expected annual reduction of nearly $7 billion in system costs, and enhances health quality and cost-effective treatment. Pioneering this transformation, top companies in digital health technologies drive development of new generations of medical wearable devices that prioritize affordability, safety, and user-friendliness. These devices feature digitally connected capabilities and reliable body sensors, setting a new standard in healthcare technology and promising a profound social impact on the accessibility and effectiveness of healthcare services.

Environmental Impact

The healthcare industry prioritizes sustainability in wearable medical device production, emphasizing eco-friendly materials. Companies are engaged in active research on biodegradable plastics, recycled materials, and low-impact manufacturing to reduce the total environmental footprint. Wearable devices are meticulously engineered for energy efficiency, resulting in extended battery life and a decreased replacement rate. With optimized power consumption and rechargeable batteries, this industry actively promotes energy conservation and reduces electronic waste.

Boyd Leads the Charge in Sustainable Medical Wearables

Boyd takes the lead in medical wearable innovation, championing social and environmental responsibility through streamlined manufacturing and strategic material partnerships. From product inception to launch, we offer expert design and material selection support, ensuring each component is chosen for optimal performance and cost efficiency. Our efficient assembly process produces FDA-compliant wearable devices that prioritize patient comfort and healthcare provider efficiency with unwavering reliability and comprehensive cost management. We aim to inspire industry-wide adoption of similar practices for a more sustainable future.

Learn more about Boyd’s Environmental Responsibility and our commitment to Sustainability.

For our latest Ask an Expert blog, we invited people to submit any questions they had about Medical Wearables. We received questions spanning a breadth of topics, so we had one of our wearable device experts, Steve Baker, answer them.

What components typically make up a medical wearable?

The components in a medical wearable depend on the type, but transmitting wearables with on-board electronics usually include a cover film, thermoformed foam cover, printed flex electrode, printed circuit board assembly (or a printed assembly circuit with a battery), a stick-to-skin adhesive, conductive hydrogels, and a delivery/release liner. For wearables without on-board electronics, they can use a snap connector (or printed flexible electrode with connector), adhesive layer, stick-to-skin foam layer, conductive hydrogels, and a delivery/release liner.

We recently made a video that explains these different medical wearable components in detail.

What are some challenges unique to medical wearable design?

The biggest challenge to medical wearable design is usually deciding how long the adhesive needs to stick to the patient’s skin. What we see from the industry right now is typically seven to twelve days, but there are a few adhesives out there that can be worn for up to twenty. The release factor then becomes a concern; does it irritate the skin based on the aggressiveness of the adhesive? We’re always working with adhesive manufacturers to source new, highly engineered options that enable longer adhesion and more patient comfort.

The other unique wearable challenge is the flexibility and breathability of all the materials in the stack-up. Does the device flex well? Is it comfortable for the patient? Factoring in both challenges into cost structure is always important.

What is something people tend to overlook when designing medical wearables?

Simplicity. It’s counterintuitive, but wearable designers can overestimate their needs with adhesives and layers. Thinking that you need extremely tight tolerances, additional spacers, or the longest-lasting stick-to-skin adhesive sounds great, but it can increase cost and isn’t always necessary. Boyd relies on our years of knowledge and history creating wearable devices to say, that layer isn’t really necessary, this spacer will give you enough of a gap for the hydrogel this adhesive is less expensive and will hold up to the outdoor environment. And if there is a unique use case for a wearable that requires highly engineered materials, we can help work those in, too.

How do you decide on a stick-to-skin adhesive?

Adhesion is the critical factor, which comes down to how long it needs to be worn and the wear conditions. If you go too aggressive with the adhesive, it may cause skin irritation. If you don’t go with an aggressive enough adhesive, it may not stick based on the wear condition. We work with most medical adhesive manufacturers and compounders to meet different requirements. It’s best to reach out to Boyd’s team with your specific project requirements so we can suggest the right adhesive.

What is the tightest tolerance you can achieve on a wearable?

We frequently work with medical wearables that require extremely tight tolerances. It ranges a lot depending on the component, material, complexity, and geometry, but it can get down to +/- 0.05mm for complex, multilayered parts. We’re always happy to look at specific designs and suggest suitable fabrication methods for tolerance requirements.

How can you make wearables more durable?

It’s often moisture ingress that shortens life and decreases performance of a wearable, so the biggest factor is ensuring that you have the right adhesives that seal properly. Adhesives that not only stick to skin, but also between the different layers of the device. This all depends on the use of the wearable and the materials used in the different layers in the stack-up.

What is one of the most exciting medical wearable applications that you have worked on?

We recently worked on a continuous glucose monitor that had unique challenges. It required a very small footprint and included electronics for constant monitoring, so it had to be comfortable and long-lasting, even with all the design parameters involved. It’s always exciting to use our expertise to push the envelope on a solution like this.

That said, I don’t want to downplay simpler wearables, like ECG or EKG sensors. They’re high-volume and cost sensitive, but still have multiple layers and interesting design aspects. It’s also exciting to bring a high-volume, competitive, disposable device to the marketplace.

What do you think is the future of medical wearables?

Wearables are already a multi-billion-dollar market, and it’s growing rapidly. Improvements in battery life technology, stretchable conductive inks, and enhancements to near-field communication (NFC) and Bluetooth are coming. It’ll make the wearable industry much stronger, offering continuous remote patient monitoring outside of doctor’s’ offices and hospitals. It’ll be fully remote, and that’ll really change the medical wearable industry.

We’d like to thank everyone who submitted questions! To learn more about our Medical Wearable capabilities or inquire about your specific requirements, visit our Medical Wearables page or schedule a consultation with our experts.

Streamlining Medical Wearable Device Design for Performance & Total Cost Optimization – Part 2

We sat down with one of our Field Application Engineers to discuss how to optimize and streamline Medical Wearable Device design. Boyd is an expert in streamlining innovative design, manufacturing, and assembly of medical wearables to help product designers and medical device companies design for excellence (DFx). We help designers consider patient comfort & safety, manufacturing efficiency, product lifecycle, and total cost while navigating complex regulatory processes, providing global agility, assuring business continuity, and accelerating time to market.

Here are common questions we get as we work through Medical Wearable Device design projects with leading medical device design and manufacturing clients:

How do you incorporate electronics and functionality into extremely thin medical wearable devices?

Medical Wearable Device designers are tasked with packing a lot of sensitive and critically important electronics into very thin, streamlined wearables. There are all different types of sensor technology used because as sensors get smaller and less expensive, they’re being integrated into more devices and enabling new medical technology.

Types of Sensors Used in Wearable Devices

Electrocardiogram (ECG) monitoring devices, as an example, sense electrical stimulations based on the location of conductive electrodes worn on the chest. These patches are used to sense things like heart rate, respiratory rate, and arrhythmias. Product designers are also learning how to adapt acoustic sensors to collect heart metrics in different locations like the wrist.

Medical Wearable Devices also sense skin or body temperature with thermistors or thermocouples. Optical sensors on a wearable can measure oxygen saturation. Accelerometers and Gyroscopes can measure the wearer’s activity, movement, and positioning and can measure things like posture and fall detection.

Sharing Medical Wearable Device Data

Each sensor collects data that connects to either an embedded circuit board sandwiched within the wearable patch, or through electrical snap connectors to an external, reusable electronic module affixed to the wearable. Most of these wearable devices are using a Wi-Fi or Bluetooth transmitter to broadcast data to a secure cloud storage source accessed remotely by patients and doctors. Sensors and electronics must also be powered by a small battery which must be considered in the assembly process.

Assembling Medical Wearable Device Components Together

Medical Wearable Devices feature a large amount of very small, precise components. Due to their slim designs, there isn’t much room to accommodate all these components and there is certainly no room for misalignment. Meaning design for manufacturing and assembly accuracy are exceptionally important. Boyd has a lot of complex rotary converting processes that we leverage to cut and assemble with tight tolerance control and registration accuracy in highly automated processes. However, many medical wearable designs cannot be fully converted “on-press” in one continuous process utilizing the efficiency of traditional reel-to-reel converting methods. Because of complexity of the components used like the insertion of an electrical assembly or the attachment of snap connectors or the addition of a molded plastic housing, separate assembly steps are often required. This presents special assembly challenges that require creative process flow and innovative assembly fixture design to achieve efficient throughput and reduced labor costs.

Balancing Volume and Assembly Cost for Medical Wearable Devices

Newer medical wearable designers face special challenges as start-up companies who are trying to introduce a new technology into the market, facing long product development cycles due to regulatory / compliance requirements, and a slow ramp up due to long time of adoption. This means the economics for a fully automated assembly process are typically not feasible given the high NRE investment. Often it comes down to an efficient manual or semi-automated assembly process to help minimize these non-recurring expenses to give your wearable the best chance to succeed in the market. This is where Boyd excels in determining how best to assemble a complicated design in an efficient manner, leveraging the best of our diverse processes to assure trusted quality control. Blending the best of high precision converting with innovative assembly techniques under a highly documented, and process-controlled quality system.

Streamlining Medical Wearable Device Design for Performance & Total Cost Optimization – Part 1

We sat down with one of our Field Application Engineers to discuss how to optimize and streamline Medical Wearable Device design. Boyd is an expert in streamlining innovative design, manufacturing, and assembly of medical wearables to help product designers and medical device companies design for excellence (DFx). We help designers consider patient comfort & safety, manufacturing efficiency, product lifecycle, and total cost while navigating complex regulatory processes, providing global agility, assuring business continuity, and accelerating time to market.

Here are common questions we get as we work through Medical Wearable Device design projects with leading medical device design and manufacturing clients:

What are the best and safest ways to attach Medical Wearable Devices to the skin?

There are two important factors to consider regarding the attachment of the medical wearable: The attachment of the device itself to the skin and the style of conductive electrode used. All devices that attach to the skin must be highly tested and regulated to assure patient comfort and safety. Wearable devices must reliably attach to the patient for intended wear times without irritation while still being removable without damaging patient skin.

Wearable Device Adhesive Considerations

Selecting the right medical grade adhesive for wearable devices are selected based on:

• Required adhesion level (for example higher adhesion is necessary for longer wear times),
• Breathability: water against the skin needs to escape to help promote better wear time
• Ease of Removability,
• Wearer Comfort Level,
• Repositionability or Re-application (if required), and
• other application considerations.

Medical Wearable Design and Use Conditions

The shape and type of the skin contact layer may also be influenced by whether the wearable device needs to protect hydrogel electrodes or sensitive electrical components sandwiched within the patch from outside water ingress. In some unique applications when wear time is short, water ingress is not a factor, and repositionability of the wearable is desired, the adhesive skin contact layer can be foregone and rely on hydrogel components to provide the desired level of adhesion. We collaborate with many global raw material suppliers that are the world’s leading innovators in skin contact comfort and performance to help recommend materials to customers based on these factors to improve product comfort, care, and safety.

Medical Wearable Device Electrode Components

As for the electrode component, one traditional type of material used is open cell, medical grade foam pad saturated with a conductive gel as the electrically conducting medium. This style electrode can be more difficult to handle as a raw material and can impact manufacturing efficiency and cost. We have been steering customers towards hydrogel-based electrodes. Hydrogels present some cutting challenges, but our proprietary converting methods can offer a better option: they’re available in roll form and solid means a component easier to cut, handle, and place with greater quality control. There are several different global hydrogel raw material manufacturers available that offer responsive support and supply chain stability, enabling us to secure dual sources that can be compliant with regulatory and certification controls. Many material formulations to choose from, means we can typically find the right hydrogel to fit the specific electrical and application requirements.

We’ll continue our interview with our Medical Wearable Device FAE in an upcoming post!

For functional printing that requires tight tolerances and specifications, technical printing techniques are the perfect solution.

This blog is the first in our new series on technical printing. Throughout this series, we will describe the procedures involved in creating technical printing solutions, from start to finish. To begin, we’ll focus on defining technical printing and what it’s used for.

Introduction to Technical Printing

Technical printing is a generic term used for functional printing projects that fall outside industry standards, materials, processes, and specifications. These projects require extremely tight tolerances and critical product specifications, typically belonging to highly regulated industries, such as the medical industry. The processes follow current Good Manufacturing Practices (cGMP), which are regulations enforced by the FDA to ensure products consistently meet the required quality standards. Technical printing and functional printing are both used for similar applications, such as for membrane switches. Functional printing has more forgiving specifications while technical printing has much tighter requirements.

Examples of Technical Printing Projects

A common example of technically printed parts is printed electrodes, which are strips manufactured for electrochemical analysis. This involves technical printing because they are typically used in the highly regulated medical field, in applications such as diabetic test strips. When manufacturing printed electrodes, conductive lines are intricately printed on polyester, typically using conductive inks including carbons, silvers, and silver-silver chlorides.

With technical printing, applying a conductive ink to a surface is similar to the process of applying frosting to a cake. When you squeeze a bag of frosting, a controlled amount comes out of an opening at the end. This same process is how conductive inks are applied as circuit lines on polyester substrates during technical printing.

Technical Printing for the Medical Industry

Boyd frequently manufactures electrodes for electrochemical test strips and devices, such as diabetic test strips or quick diagnostic labs. Boyd prints electrodes with silver, carbon, or various conductive inks to measure a current or other signal. Our customers will then apply a reagent on top of the electrodes. When those reagents are exposed to bodily fluids such as blood, a chemical reaction takes place and the electrodes will detect that reaction and send the signal to the device it is powered to. This is done on a tiny scale and the readings of signals must be completely accurate, which is why this part requires technical printing with a high degree of scrutiny. Large variances in the circuit alter results and can cause the test strips to fail, so tighter tolerances of technical printing are necessary.

Many variables go into technical printing projects, such as the curing times and quality of inks, as well as the substrates and thicknesses used. These variables are closely controlled, especially when making electrodes for medical equipment. These parts go on critical equipment and could mean life or death in certain situations, such as buttons for a medicine administration device used in hospitals or printed electrodes used in diagnostic labs for diseases. Boyd is a trusted manufacturer for technical printing projects with years of experience in the medical industry and other highly regulated industries.

In our next blog in this series, we’ll be going over how technical printing projects go from development to production.

Biocompatibility:

Power Management:

Flexibility and Stretchability:

Sealing: