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Guard NPseal Negative Pressure Wound Therapy

Client: Guard Medical

Objective: Engineer and design an innovative, wearable surgical dressing with an integrated pump that establishes, and maintains negative pressure with a few pinches. The goal being, to use Negative Pressure Wound Therapy (NPWT) to improve healing and reduce Surgical Site Infections after surgery while providing savings to the healthcare system

Activities

Performed Design Development from alpha prototype to be ready for manufacturing
Design for joining of elastomeric components, manufacturability, cost
Designed testing plan, and executed Verification and Validation
Provided contract manufacturer management and support
Provided 3rd Party testing support for human factors, biocompatibility, sterilization, shelf life, and package integrity

Guard Medical engaged with Goddard to create, and test a simple, inexpensive negative pressure wound therapy system, with the aim to eventually seek FDA approval, and commercialization of the system in the United States. Our engineers were tasked with determining how to create this single pump that would reliably produce the same level of negative pressure every time it was deployed.

We began by refining the product’s core concept, and building intellectual property for Guard to submit multiple patents for the system, that IP also providing them value as a young startup. From there we turned our focus to the choice of, and best bonding method for the elastomeric components, as well as formulating engineering and design solutions for the pump component of the product.

After core engineering was complete, we conducted verification and validation testing, supported transfer to manufacturing, and assisted Guard Medical in its 510(k) submission to the FDA, from which clearance eventually be granted for this system.

Results

Product passed verification and validation without issue
Product is 1/100th the weight of the competitive system
Product is performing very well due to lack of any close competitive innovation on the market

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Guard NPseal Negative Pressure Wound Therapy

Client: Guard Medical

Objective: Engineer and design an innovative, wearable surgical dressing with an integrated pump that establishes and maintains negative pressure with a few pinches. The goal being, to use Negative Pressure Wound Therapy (NPWT) to improve healing and reduce Surgical Site Infections after surgery while providing savings to the healthcare system

Activities

Performed Design Development from alpha prototype to be ready for manufacturing
Design for joining of elastomeric components …

Click HERE to Learn More!

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