Medizone International, Inc. announces that it has entered into a final product development and production agreement for the manufacture of its AsepticSure Advanced Oxidative Sterilization Processes, with ADA Innovations of Toronto, Canada.
Edwin Marshall, CEO of Medizone, comments, "Purely from a corporate perspective, ADA is a 'new kid on the block,' but what the development team behind it brings to the table for the future of AsepticSure, exceeds all of our expectations."
ADA founders and directors Mark Costa and Hao Chen bring more than 20 years of high-level experience to this project from the top echelons of industry both in the engineering and medical device sectors.
"After short-listing five potential manufacturing partners each with impressive backgrounds in medical device development ADA stood out as a logical choice for us, for two reasons: They were the only group who boasted a depth of knowledge in ozone-based technologies and experience in medical device design, building and product launch," Marshall says.
Dr. Michael Shannon, Medizone's director of medical affairs, adds, "The dual qualifications that ADA brings to this collaborative venture are not only unique in the medical device industry, but are also essential to the achievement of our end goalÂ -- the mass production of a device that satisfies all design and operational requirements pertaining to any relevant market sector, anywhere on the planet."
"From a compliance point of view," Marshall says, "our relationship with ADA ensures that the design, content and manufacturing standards of the production units will be regulatory-compliant, not only in North America, but also in the lucrative UK and EU markets. Given that the stringent green regulations applicable to these two regions are some of the toughest in the world, it's reassuring that ADA can seamlessly tailor location-specific unit designs to meet and comply with local regulatory standards."
The AsepticSure final-phase development program, already underway, can be broken down into four primary steps: Completion of final commercial design and verification, regional regulatory compliance, soft product launch involving small scale manufacturing output, and multi-sector market penetration supported by up-scaled output and the ability to outsource macro manufacturing capacity at the appropriate time.
"While the transition from beta to production equipment has taken significantly longer than anticipated a year ago, the wait has been well worth it," Marshall says. "We're now more confident than ever that our AsepticSure product line will far surpass any other form of sterilization technology on the market not only in terms of its clinically proven antimicrobial efficacy, but also in its functionality, mobility and cost-effectiveness."