Key Considerations in the Converting Process for Wearable Devices

?Q&A with Rebecca Taylor, Sr. Program Manager and Thomas Lackey, Engineering Manager at Scapa Healthcare, Knoxville, TN.

?What is the role of converting in the process of working with customers to bring products from concept to commercialization, and why is it an essential piece of the puzzle?

When discussing “concept to commercialization,” it is imperative to emphasize the concept aspect. Many of our customers bring the Scapa team on early in the product development process so that we can partner with them along the way.

One of the critical value-adds that Scapa provides is ensuring the end design is something that can be manufactured. For instance, while a customer may bring us a product with incredible features and benefits in the wearable device space, our role in the partnership is to bring our team’s extensive experience and expertise to ensure it can be efficiently and cost-effectively manufactured. Converting is one of the critical phases in that process.

What type of unique converting techniques separates Scapa from other converters?

Scapa prides itself on using high-tech equipment. Our unique converting techniques include ultrasonic capabilities and inline automated visual inspection systems. These machine features are unique because they were either custom-made for Scapa or modified to expand our capabilities and the product types we can service.?

The ultrasonic system capabilities allow us to make smaller perforations than a traditional die-based cutting system typically can. This capability is significant when developing wearable devices that require extended wear time as the perforations are designed to enhance the skin breathability, helping the device stay on longer.

Automated visual inspection capabilities incorporate a validated system that takes the subjectivity out of determining whether a part is dimensionally good or bad. This helps make inspections more accurate and efficient because it reduces the amount of labor that goes into the process.

What are the latest converting manufacturing capabilities that customers are asking for?

Our customers are constantly asking for end-user ease of use features, ease of assembly on the customer device (addition of alignment features for the assembly), and how to combine multiple parts into the product to reduce assembly time.

What material considerations need to be kept in mind to maximize the manufacturing of converted products?

When it comes to materials, it boils down to end-user needs and how the skin contact interface will work with a device’s electronic components. Some general material considerations that should be considered to maximize the manufacturing of converted products include the release of the material off the liner, elongation of material, and material variability. These properties influence how easily and consistently the final device is processed as the web tension must be closely monitored.

Elongation, in particular, can have some significant processing because it is difficult to maintain physical tolerances and device flatness or, in the case of roll goods, tunneling and wrinkling where the liner and adhesive layer release from each other and the adhesive is exposed to the elements.

Can you explain the key aspects of converting wearable devices? What is involved in the process, and what benefits does it provide to the wearable device?

Converting for the wearable device market involves taking rolls of raw adhesive materials and liners through different lamination stages, die-cutting, and ultimately producing finished parts.

A tremendous amount of R&D work goes into making the specific adhesive for a wearable device. As a result, one of Scapa's benefits is a high-speed, consistent, stable manufacturing process. That consistency from roll to roll also helps make a financially viable product while ensuring that the process is repeatable.

That is where the expertise of the Knoxville team comes into play. Our team has decades of converting knowledge, so when looking at the product, we have the unparalleled expertise to determine the best process to produce it. For example, do we need to add a heat process to the line, or are ultrasonic capabilities needed?

With the converting process, we focus on rotary die-cutting and how the layers of materials work together to provide a product that meets all the customers’ requirements. So ultimately, the services that Scapa provides help create the best device at the best price.

What role does packaging play when developing the manufacturing process of converted products?

Packaging is certainly a big part of the manufacturing process for converted products. Most wound dressings are packaged on the line without having any human interaction. Products that will end up being sterilized will be packaged on our equipment that can do Mylar and Tyvek-type packaging. We also do secondary and tertiary packaging for some devices that will go directly to the consumer.

What are the differences in converting wound dressings versus wearable devices?

The difference is really in the die profile in terms of what is being cut. For example, wound dressings traditionally have absorbent materials attached to some type of barrier with an adhesive. Therefore, when converting wound dressings, there is more focus on cutting thick materials, foams, and fibers.

Medical wearable devices, including components like continuous glucose monitoring or pulse oximetry, are often multi-layer; products can range from one single layer up to 7-9 layers. Our expertise is needed to ensure the accuracy of the thick materials.

Can you talk about some of the key applications you are converting for?

Some of the key applications we are working with include pulse oximetry, diabetes care, foot care, silicone and non-silicone advanced wound care, Catheter fixation, and more. Customers often have a concept part and come to the Scapa team to figure out how to make the production of that product feasible and create a speed-to-market advantage.

Why is Scapa’s method the optimal choice for these applications?

We excel in implementing creative solutions to produce complicated parts.

For example, a diabetes care product we manufacture consists of many different materials with tight tolerances. Our team came up with a creative combination of skill sets, dies, and laminations to repeatedly assemble everything in the right way.

We also have expertise with regulatory bodies and can help our customers navigate the complex regulations the FDA and other groups put forth.

How has the market grown or evolved since you began working with wearable devices? What are some key trends you see in the market, and how are they leading to growth in Scapa's services?

One of the most significant evolutions has been the overarching trend of technology that was previously only available in a healthcare setting, becoming available for consumers in their homes. For example, with COVID-19, the demand for pulse oximetry products skyrocketed. Beyond that, patients can now have medications like insulin administered at home, work, or almost anywhere. This rapidly advancing technology has led to substantial growth in the demand for our services.

What innovations are you expecting to see in the market going forward?

We will see many technological advances in vital signal monitoring, incorporating telemetry-type applications with printed adhesive solutions versus having chips and additional equipment.

We expect to see an increasing shift in some of the materials used to create these skin contact medical solutions. For example, because of skin sensitivity, the medical device industry has been moving toward more skin-friendly adhesives and designs. We also expect growth in products that promote skin and wound wellness overall.

What differentiates Scapa from other converters in the market? What are the company’s strengths from a technical perspective?

One of the first things that set the Scapa team apart is that we are very customer focused. We have a lot of creativity and experience that we continuously utilize to meet our customers’ unique requirements. As previously mentioned, we can take a project from a concept to commercialization; Scapa has the expertise on the front end with development engineers and the engineering resources that can help them convert those initial development ideas to something that can be efficiently, cost-effectively, and repeatedly manufactured.

Another thing that differentiates us from other converters in the market is the breadth of offerings. We have state-of-the-art equipment (including six of the most modern, top-of-the-line converting machines), processes, and knowledge. This also gives Scapa a lot of flexibility regarding what products we can make and how they're made. A further advantage is our speed- in terms of the ability to react quickly to market changes and get a product to market quickly.

What capabilities should OEMs consider when choosing a converting partner for wearable devices?

Most importantly, OEMs should look for a professional relationship where the converting partner and their development team can work together to develop the very best manufacturing solution. Our team’s experience in manufacturing can be built in early enough to help make the end product better for our customers. This focus on customers and depth of experience will continue to set Scapa apart for years to come.

About Scapa Healthcare

Scapa Healthcare provides full support for the design, development, and manufacturing of wearable fixation devices. Our highly qualified team offers fully integrated project management services from concept to commercialization, including proof of concept and feasibility testing, validation and commercialization, and regulatory support.

If you are creating a ground-breaking new product and need an experienced converting services partner, Scapa Healthcare can help. Scapa Healthcare offers a fully integrated range of skin contact converting and assembly solutions to develop and manufacture simple to complex multi-layer wearable medical devices. Our engineering teams can design precision converting solutions?using advanced laminators with high-precision cutting– rotatory, flatbed, laser, and punch press format– with high speed and tight tolerance. To learn more about Scapa Healthcare’s converting services, contact us directly at?[email protected].