Medical Wearable Device Design - Part 1 - Attaching to the Skin

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Adhesive Medical Wearable Devices need reliable materials to not only withstand use, but be gentle enough of the skin. 

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.

 

 

Medical Grade Adhesives for Medical Wearable Devices

 

Stick-to-skin materials are a special class of medical grade adhesives that can be acrylic, silicone, or hydrocolloid based that are skin friendly with little to no skin irritation or sensitivity as well as non-cytotoxic to meet ISO 10993 biocompatibility testing standards. 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 optiontheyre available in roll form and solid means a component easier to cut, handle, and place with greater quality controlThere 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!