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Medegen
medical products company

  • Case_Study-Medegen
  • Case_Study-Medegen3

Challenge

Our Client wished to expand beyond their current healthcare product space into the IV (intravenous) securement segment. There are many competitors in this space with many patented technologies and the new product must also be developed under strict protocols, since it is classified as a Class I Medical Device by the FDA.

Solution

We started with an exhaustive Patent Mapping of Issued and Published patents in the U.S. followed by several focus groups with nurses who used IV securement devices. We were then able to design an innovative, new flexible type IV securement device that was also very practical and easy to use. With the Design Dossier almost complete, the materials sourced and the patent application filed, a converter was selected and the new product was qualified under a PQ, after the appropriate IQ, OQ was performed on the equipment.

Things we did

  • Formulation
  • Prototyping
  • Regulatory
Launch website

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