How to know when a soft goods solution is appropriate for your wearable.

This article was originally published on Medical Design & Outsourcing on July 25, 2024.

Wearable medical device developers are offering products similar in form and function to a FitBit, Whoop or a number of other wrist-worn devices.

However, a growing number of wearable technologies require placement on other parts of the body, with a great example being Avation Medical’s noninvasive ankle garment for treating overactive bladder by stimulating the tibial nerve.

One challenge of these alternate placement requirements is attaching a wearable device to the body in a way that facilitates ease of use, while enabling the technology to live up to its full potential. Here are three factors to determine if a soft goods solution is appropriate for your wearable, and three key considerations during development.

Three wearable factors that call for a soft goods solution

1. When the device must be highly configurable

Whether your device has a wide range of wearing options, it’s worn somewhere other than the wrist like the neck, ankle, or torso, or it needs to fit 5%-95% of the population, a soft goods solution can go where traditional hard goods cannot.

Materials such as elastics, knit materials and stretch laminates are excellent for making comfortable, highly configurable devices. Apart from stretch and comfort, soft goods options include tens of thousands of off-the-shelf fabrics, buckles, d-rings and hook and loop parts.

These materials allow variable attachment methods to accommodate a wide range of body sizes and shapes. They also address problems around disposability and multi-patient use.

2. When close contact with the skin is a requirement

Close contact with the skin is a key functional requirement for many wearable technologies, but it can render adhesives or hard plastics inappropriate due to compromised skin or challenging locations like near a patient’s sacrum.

In a perfect world, you would be able to peel and stick the device directly to the skin and have it stay in place without any discomfort or skin irritation. When working with the infinite variability of placing a hard object on a soft human form, it becomes clear we do not live in such a perfect world.

Thankfully, soft goods provide unique strengths in these situations. Fabric has an unmatched ability to conform to a contoured form, allowing it to move and adapt to a body’s movement and provide comfort even with tight-fitting items.

Cleanability is a chief concern with any device in a clinical setting, and cleanable, durable textiles are important options as industry leaders look for opportunities to transition from disposables . While there is a spectrum of cleanability and durability, the ability to create custom textiles and narrow goods to target specific functionalities and requirements puts textile-based solutions in a class of their own.

3. When cost is a concern

Soft goods manufacturing is historically one of the more cost-effective ways to produce a product. It is not without its own unique challenges (more on that soon), but simple items like straps, harnesses and covers are excellent places to consider soft goods.

Many manufacturing facilities even have a wide range of line items that are customizable, allowing you to bypass development costs. Depending on the certifications needed for your device, you can expect a wide range of cost estimates and manufacturing lead times. Balancing a manufacturer’s skill with cost is an important consideration when evaluating potential MFG partners.

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