Both of the founders of Medical Device Pros, LLC did engineering to bring this combination product to market. Dr. Back's drug & polymer coating process development, and Michele Gardill's manufacturing process improvements were 2 key aspects of this project.
Crisis was brewing: a 510k submission was stalled when a company realized its data analysis capabilities were insufficient. Medical Device Pros, LLC provided the engineering statistics needed. The submission went forward & no more data was needed.
Silicone was combined with functional ingredients to provide custom properties for medical devices. Think thermal properties, antimicrobial properties, etc. Who had the engineering experience? Medical Device Pros, LLC.
A world-renown cardiology consulting group tapped into Medical Device Pros, LLC
engineering expertise to help put together a thorough FDA submission. This new Class III product is on iits way to FDA approval.
From patent applications to engineering development to manufacturing, Dr. Dwight Back provided technical leadership. We are proud that this superior, revolutionary breast implant has FDA approval & is on the market.
Dr. Dwight Back formulated reactive topical skin protectants, resulting in patented lotions that resist toxins. This engineering was done in record time.
How do you keep organ donations at the proper temperature during transport? Dr. Dwight Back formulated new phase change fluids & endothermic reactions for this critical application.
A breast implant client hired us to devise, build, and conduct unique test methods. Existing ASTM methods were insufficient. Our test methods--now patent-pending-- confirmed the new implant's superiority over competitors' implants.
A portable autoclave was needed for a remote area, where medical instruments could be steam sterilized without electricity. We devised a sterilizer using only a water/chemical exothermic reaction.
Clients needing lightweight, high-strength Class II and Class III implants benefited from our engineering experience with Carbon nanotube composites. These new materials offer advanced properties.
"Medical device development is a journey. Experienced guides can make all the difference."
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