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Enztec originally made a wide range of surgical instruments when it launched 25 years ago, but when the Baby Boomer growth market became obvious, the company narrowed its focus to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