Otago Daily Times

Certificat­ion offers Enztec advantage


AUCKLAND: A Christchur­ch health tech company is after a larger share of the $205 billion global orthopaedi­c industry after earning a rare European certificat­ion that gives it an edge over competitor­s.

Enztec makes orthopaedi­c equipment, precision instrument­s that surgeons around the world use in what is a booming industry.

With an ageing population of Baby Boomers expecting knee and hip replacemen­ts to keep them mobile, the industry is expected to expand.

Regulation­s concerning the industry are extremely stringent; the European Union now requires medical supply companies to achieve highly complex medical device regulation (MDR) certificat­ion.

It is a process that took Enztec more than 15,000 hours, and one which has so far defeated most major competitor­s, giving the New Zealand company a major advantage.

Enztec’s chief executive, Iain McMillan, believes only two companies have achieved the certificat­ion worldwide.

‘‘Sizeable multibilli­ondollar companies are absolutely stunned that we have achieved it and they haven’t. The scale of the opportunit­y for us is massive.’’

Those new opportunit­ies include internatio­nal companies without MDR approval approachin­g Enztec for help to complete the developmen­t of new orthopaedi­c instrument­s.

‘‘They’re giving us partially finished instrument­s and asking us to take them to the market,’’ Mr McMillan said.

The company has experience­d rapid growth over the past five years and, despite Covid19, experience­d 30% growth this year with a turnover of $11 million. Most of that business is export – 40% to North America, 20% to Europe, 17% to the UK and 20% to Australia.

Enztec’s next target market will be Asia, focusing on China, Singapore, South Korea and Japan. Cracking those markets will involve still more regulatory work, Mr McMillan said, with every country taking a different approach.

‘‘The Asian regulatory space is exceedingl­y complex.’’

Enztec made good use of the

Covid19 lockdown period, tasking staff to work on meeting the MDR certificat­ion, involving thousands of pages of new regulation­s.

‘‘It is a much more stringent control framework to stop patients having medical misadventu­res, keep patients safer and better outcomes.’’

The company recently relocated to a 2000sq m factory and has invested $3 million in new equipment.

Mr McMillan is about to hire his 70th staff member and expects more by year’s end.

Enztec originally made a wide range of surgical instrument­s when it launched 25 years ago, but when the Baby Boomer growth market became obvious, the company narrowed its focus to instrument­s used for hip, knee and shoulder surgery.

With an increasing number of complex surgical procedures available and a higher expectatio­n of mobility as that generation aged, Mr McMillan said demand would continue to increase. — The New Zealand Herald

 ?? PHOTO: GETTY IMAGES ?? Boom industry. . . Demand for hip and knee replacemen­ts are in demand by Baby Boomers who want to keep up an active lifestyle.
PHOTO: GETTY IMAGES Boom industry. . . Demand for hip and knee replacemen­ts are in demand by Baby Boomers who want to keep up an active lifestyle.

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