Medical Device

Medical Device

Medical device clinical development and trials differ from that of drug development in many ways

Below are just a few of the differences between medical devices and their development cycle versus pharmaceutical products and their development cycle:

Medical Devices:

  • Work physically
  • Invented
  • Therapeutic or diagnostic
  • Can be changed/improved during development
  • Can have short life cycle
  • Approved through PMA process
  • Approved by CDRH or CBER

Pharmaceutical Products:

  • Work chemically or biologically
  • Discovered
  • Therapeutic
  • Cannot change during development
  • Usually have long life cycle
  • Approved through NDA process
  • Approved by CDER or CBER

Due to the different landscape of the medical devices trial and approval process, it’s important to have ProTrials, an experienced partner, work with you to ensure all steps and nuances are completed.  With over 37% of our staff having experience with medical device trials, you can be assured that we have the appropriate support for your study needs.

37%

of all staff with Medical Device Experience

Includes Regional Monitoring, Project Management, and Clinical Trial Assistance

  1. 35+

    studies conducted to date

    • Multiple medical specialties and indications, Class II & III
  1. 18+

    Indications

  2. Top Areas:
    • Reproductive/Genitourinary
    • Spinal/Disc/Interbody Fusion
    • Cardiovascular

Indications

  • Arterial Closure
  • Biologic Implants
  • Cardiovascular Device
  • Contraception
  • Corneal Cross-linking
  • Intravitreal Implant
  • Orthodontic
  • Orthopedic
  • Pain Management
  • Peripheral Vein Graft Stent
  • Radiographic Imaging
  • Respiratory
  • Spinal Implant
  • Tissue Expansion
  • Tubal Ligation
  • Vascular Access Ports
  • Vascular Imaging
  • Vascular Stent