CareWear's Medical Device Patch

INNOVATIVE COLLABORATION: HOW DURATECH ENHANCED CAREWEAR’S MICRO-LED MEDICAL DEVICES

Background

CareWear, a privately held manufacturer of Class II FDA Approved Medical Devices, specializes in innovative treatments using pulsed micro-LED technology. These patches, applied directly to the skin, are effective in treating various conditions such as physical pain, trauma-induced bruising, and muscle spasms by enhancing blood flow and promoting healing through increased oxygen delivery.

CareWear approached DuraTech to produce their light patch assembly. This crucial component requires precise application of coatings within microns of an inch. DuraTech’s R&D Printing Lab is responsible for applying a thin adhesive layer on one side to bond the flexible current distribution film to the light engine film. The other side features a phosphor screen-printed layer that shifts the LED’s energy value, allowing for deeper skin penetration and enhanced cellular effects.

Challenges Faced by CareWear

Before collaborating with DuraTech, CareWear encountered several challenges in maintaining new protocols for thin film wearables in Class II Medical Devices. These challenges included:

  • Thin Film Handling and Storage: Ensuring proper handling and storage of thin films, which are delicate and require specific conditions.
  • Static Control: Adhering to strict electrostatic discharge (ESD) protocols due to the high sensitivity of the micro-LEDs.
  • Precision Tolerances: Finding a contract manufacturer capable of handling multi-layer precision tolerance thin film assemblies.

Given these complexities, CareWear needed a manufacturing partner with expertise in producing high-precision, multi-layered medical device components.

Discovering DuraTech

One of DuraTech’s engineers had previously worked with CareWear on the development of their innovative products. Impressed with his expertise, CareWear sought his assistance, along with DuraTech’s capabilities, for their patches. Since DuraTech was able to fulfill CareWear’s project needs, CareWear decided to continue the relationship with DuraTech.

DuraTech’s Solution

The collaboration between CareWear and DuraTech was spearheaded by Michael LeFebvre, an engineer at DuraTech who had been instrumental in the design and development of the CareWear PhotoBioModulation Light Therapy System. Over three years, a small team worked diligently on prototyping various designs and testing them using custom methods and metrology. This rigorous development process allowed the team to produce high-volume solutions that met CareWear’s precise requirements.

Original Intimate Contact Test Fixture Designed by DuraTech

Original Intimate Contact Test Fixture Designed by DuraTech

Implementation and Results

DuraTech’s role in the manufacturing process involved assembling the product from high-volume runs, taking advantage of their expertise in precision application and quality control. The use of advanced R&D capabilities ensured that the light patch assemblies met all necessary specifications and performance standards.

Through this partnership, CareWear was able to overcome their manufacturing challenges, ensuring the successful production and functionality of their patches. The collaboration proves DuraTech’s capability to deliver complex, high-precision medical components, reinforcing their position as a trusted partner in the medical device industry.

Conclusion

The partnership between CareWear and DuraTech exemplifies a successful collaboration in the medical device manufacturing industry. With DuraTech’s expertise in printed electronics manufacturing and R&D, CareWear was able to bring an innovative product to market, addressing key challenges and ensuring the delivery of high-quality medical patches to their customers.

Looking for a custom graphics manufacturer with proven success developing in-mold decorating (IMD), in-mold electronics (IME) or in-mold structural electronics (IMSE) solutions? Request a quote or contact DuraTech today to learn how our experience and technology can add value to your business.