Device Designs FDA
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                Device Designs FDA is a full service medical device
                consulting company. Why go to several companies
                when Device Designs FDA can do your job under 
                one roof!

                                                               OUR MOTTO: Time is money. Even a small delay in a product
                                                           release can cost thousands of dollars from lost sales, lost marketing
                                                           edge, frustrated customers! We are committed to saving your valuable
                                                           time, maximizing the use of your resources, helping you win!

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We have had a long, successful career in the field of infection prevention, having started such efforts in 1978, giving us a major leg up on the competition now that nosocomial and home care patient born infections and resulting injuries have reached, if you will, a fever pitch internationally.

The following is a sampling of our range of abilities - our comprehensive and outstanding experience bring forth a large treasure trove of techniques:


  • Non-drug surface treatments that prevent biofilm build-up on internal blood contact and external fluid flow device components
  • Surface treatment with drugs for biostasis where the effort is to prevent growth on an implant without infusing drugs into the surrounding tissue
  • Surface treatments that include polymer coatings, composite coatings, interlayer coatings that can release an antimicrobial either rapidly or time released
  • Material impregnations with interstitially bound slow-released drugs
  • Material impregnations with an overlay that releases different drugs at different rates
  • Both device and OTC applications with drugs, biologics and non-drug materials that act synergistically to rapidly kill a broad base of microbes, including MRSA, VRSA, VRE, GRSA, Acinetobacter, fungi, yeasts
  • Treatments for short-term (a few hours to a few days), intermediate-term (up to a few weeks) and long-term (from 31 days to several months) applications
  • Coatings and treatments on stainless steel, titanium, silicone rubber, Teflon(R), woven and non-woven materials including Nylon (R), Dacron(R) and cotton, and most plastics and ceramics
  • Broad spectrum treatment OTC soaps, alcohol-based scrubs and gels, alcohol-free scrubs and gels
  • Our broad experience even extends to antimicrobial and antiseptic soaps, scrubs and gels for the OTC (Over The Counter) market for selling into the institutional as well as residential markets.
Here is summary of patents and applications:
U.S Patent 8,932,624; Co-inventor; Bio-film resistant surfaces
Patent Application 20090029961; Bio-Film resistant Surfaces
Patent Application 20140178447; Reduction of Biofilms on Medical devices
Patent Application 20150118275; Bio-Film Resistant Surfaces
Patent Application 20170368234; Bio-Film Resistant Surfaces


​We like to think that with our other talents in engineering and regulatory, this array of technologies for infection mitigation makes our company a powerful one-stop location for most of your device needs.


TELEPHONE: 610-916-2949

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