Innovative NZ medical invention destined for US
Click for big version
(Left to right) : Adrian Whiteman (New Zealand Trade and Enterprise Sector Manager for Specialised Manufacturing), Dr Michael East (surgeon and inventor) and Paul Morrison (manufacturer) with the Manipuseal, a high-tech medical device invented and developed in New Zealand and now destined for the US market.
Innovative New Zealand medical invention destined for America
31 October 2005: A New Zealand invention that had its origins in a surgical rubber gloves is set to launch in to the lucrative American market.
The Manipuseal, a high tech, innovative medical device, designed and developed by Christchurch surgeon, Dr Michael East, and specialist manufacturing company, Insitu Systems Ltd, was recently given approval for its use in the United States by the Federal Drug Administration.
Adrian Whiteman, a Sector Manager for Specialised Manufacturing with New Zealand Trade and Enterprise says getting the FDA approval is a huge step for the small company. "This opens up significant export opportunities as the US currently forms the largest single market for health products."
The Manipuseal is a disposable product designed to be used in Laparoscopic Assisted Vaginal Hysterectomies (LAVH). Employing the Manipuseal makes the key-hole surgery simpler and quicker for surgeons.
Insitu Systems Ltd Product Manager, Ross Bayer, says LAVH procedures are becoming increasingly popular over traditional abdominal or vaginal hysterectomies as they are less traumatic on the patient.
"One of the reasons LAVH procedures are still not widely used," says Bayer, "is they require a greater degree of surgical skill than the alternatives."
"The Manipuseal is designed to make the process easier for surgeons and thereby reduces the risks for the patient, as well as the time it takes to perform the surgery. The procedures allow better visibility and also results in a shorter stay in hospital for the patient."
Insitu Systems Ltd believe the resulting cost savings and patient benefits will be an important selling point in the American market which is struggling against escalating health costs and the growing pressure to perform more and more LAVH procedures.
"Currently about 10 per cent of all hysterectomies performed globally are LAVH procedures and this figure is tracking upwards by at least one per cent a year," says Bayer. "In the US this is about 60,000 patients."
Although the device has been proven and is in use in New Zealand, the costs of entering the American market have proved prohibitive for Insitu Systems Ltd.
"We approached NZTE," says Bayer, "and they stepped in with Growth Services Funding that made it possible for us to go ahead with the FDA application."
Whiteman says that for NZTE getting the device into the US market is an opportunity to showcase an innovative product in a highly specialised market. "The Manipuseal is a brilliant example of New Zealand's capacity for design excellence especially in niche areas such as the health market."
Insitu Systems Ltd chose to work with US-based medical device consultants, MDCI, on the application for the FDA approval.
"They understood the process totally so could help us get the product to a stage where it would pass the requirements. It was vital for us to have that expertise," says Bayer.
"Fortunately, Dr East had eight years of rigorous clinical research data so that in the end the FDA required only a few minor adjustments before giving us approval."
NZTE will continue to help Insitu Systems Ltd by providing Market Development Funding to assist in developing sales of the device in the US.
The company will manufacture and distribute the Manipuseal device from its Christchurch base at Enztec Manufacturing.