In 2002 David Makanani and Steve Ford, saw an opportunity to use their over 60+ years of combined experience in medical device development, to help companies successfully create products, move swiftly and accurately through the regulatory process and achieve market introduction in the shortest amount of time. OMEDtech was founded in that year to provide a resource with a proven track record of success to assist your company in meeting its product development goals.
- 29 years of medical device experience focusing primarily in management and development of medical devices through Engineering, Operations, and Quality.
- 10 years experience in aerospace and commercial aviation focused on engineering and manufacturing.
- President of OMEDtech, a medical device advisory providing assistance to the medical device community
- Chief Operating Officer for Soundtec, a medical device startup with a unique implantable hearing system
- VP of Manufacturing for Cyberonics, a medical device startup developing the first neurostimulation device for the treatment of epilepsy.
- Director of Manufacturing, for Quest Medical, a medical device startup introducing a new drug infusion technology and continued that role with the acquirer, McGaw
Mr. Ford is a graduate of Texas Tech University and the University of Texas at Arlington
- 36 years of healthcare experience focusing primarily in management and development of medical devices through the
Regulatory, Quality and Clinical processes.
- 10 years of this experience was with the FDA specializing in Medical Device requirements.
- Senior Vice President for Clinical and Regulatory Affairs for Soundtec, a medical device startup with a unique implantable hearing system.
- VP Clinical & Regulatory for Sulzer Intermedics, Inc. and Biotronik, Inc. manufacturers of implantable defibrillators and pacemakers,
- VP Clinical & Regulatory for Sulzer CarboMedics, a manufacturer of implantable prosthetic heart valves
- VP Clinical & Regulatory for Amnion, a manufacturer of blood recovery systems.
Mr. Makanani is a graduate of the University of Oklahoma