Regulatory Submissions

Coatings and Surface Modifications

IV Catheters

Syringes

Drug Delivery Devices

Implant Materials

  PHIL TRIOLO & ASSOCIATES  LC

   148 South 1200 East,    Salt Lake City, UT 84102 

(801) 328 1996 / (801) 328 2399 fax

Biography

Phil Triolo has over 18 years of hands-on industrial experience in the design, development, evaluation, and approval of medical products.  He is co-inventor of 8 design patents for medical products ranging from bioluminescent detectors to drug delivery catheters, demonstrating an ability to make significant, original  contributions to the development of a wide array of  medical devices and diagnostic products.

Medical product development is a regulated process requiring proactive planning.  Phil has efficiently integrated documentation and submission requirements in product development activities to assure early submissions, short review times, and accelerated market introductions.  All of the regulatory submissions he has authored have been cleared in times shorter than FDA review averages.

The vast majority of Phil's work has been performed for entrepreneurial start-up companies.  He has met the challenges of tight budgets and compressed time lines by implementing practical, workable solutions to pressing technical problems while meeting regulatory obligations.

Certified (RAC) by the Regulatory Affairs Professional Society (RAPS) in FDA drug, device, and biologics regulations, Phil is a member of the Society for Biomaterials,  American Society for Quality (ASQ), Association for the Advancement of Medical Instrumentation (AAMI), Tau Beta Pi (Engineering Honor Society), and is President-elect of the Intermountain Biomedical Association.

Phil holds M.S. and Ph.D. Degrees in Bioengineering from the University of Utah where he was a Research Fellow, and a B.S. Degree in Biomedical Engineering awarded cum laude from Rensselaer Polytechnic Institute.  His master's thesis, Surface Modification and Characterization of Commonly Used Catheter Materials was conducted under the direction of Prof. Joe Andrade, and his doctoral dissertation, Release of Albumin from Biodegradable Poly(l-lactic acid) Matrices under the direction of Profs. Sung Wan Kim in the United States and Jan Feijen in the Netherlands.

Phil Triolo and Associates keeps current with the rapidly changing technical and regulatory environment by participating in seminars and conferences offered by nationally and internationally recognized organizations.