Otago Daily Times

Cer­ti­fi­ca­tion of­fers Enztec ad­van­tage

- JANE PHARE Business · Greater Auckland · Christchurch · European Union · New Zealand · North America · United States of America · United Kingdom · Australia · Asia · Beijing · Singapore · South Korea · Japan · Boomer, North Carolina

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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