Imakethe yomhlaba wonke yeizingxenye zepulasitiki zezokwelapha ngokwezifiso ifinyelele ku-$8.5 billion ngo-2024, igqugquzelwa izitayela zemithi yomuntu siqu kanye nokuhlinzwa okungatheni. Naphezu kwalokhu kukhula, bendabukoukukhiqiza izabalaza nobunzima bokuklama nokuhambisana nokulawula (i-FDA 2024). Leli phepha lihlola ukuthi izindlela zokukhiqiza eziyingxubevange zihlangana kanjani isivinini, ukunemba, kanye nokuqina ukuze kuhlangatshezwane nezidingo ezintsha zokunakekelwa kwezempilo ngenkathi kulandelwa ISO 13485 izindinganiso.
Indlela yokwenza
1.Umklamo Wocwaningo
Kusetshenziswe indlela exubile:
● Ukuhlaziywa komthamo wedatha yokukhiqiza evela kubakhiqizi bemishini yezokwelapha abangama-42
● Izibonelo zezifundo ezivela kuma-OEM angu-6 asebenzisa izinkundla zokuklama ezisizwa yi-AI
2.I-Technical Framework
●Isoftware:Yenza i-Mimics® ibe yimodeli ye-anatomical
●Izinqubo:Ukubumba komjovo omncane (i-Arburg Allrounder 570A) nokuphrinta kwe-SLS 3D (EOS P396)
● Izinto:I-PEEK yebanga lezokwelapha, i-PE-UHMW, nenhlanganisela ye-silicone (iqinisekisiwe i-ISO 10993-1)
3.Amamethrikhi okusebenza
● Ukunemba kobukhulu (nge-ASTM D638 ngayinye)
● Isikhathi sokuhola sokukhiqiza
● Imiphumela yokuqinisekisa i-Biocompatibility
Imiphumela kanye nokuhlaziya
1.Ukuphumelela Okuphumelelayo
Ukukhiqizwa kwengxenye yangokwezifiso usebenzisa ukuhamba komsebenzi kwedijithali kuncishisiwe:
● Isikhathi sokuklama-kuya-isibonelo sisuka ezinsukwini ezingama-21 kuye kwezingu-6
● Imfucuza yezinto ezibonakalayo ngo-44% uma iqhathaniswa nemishini ye-CNC
2.Imiphumela Yomtholampilo
● Iziqondiso zokuhlinza eziqondene nesiguli zithuthukise ukunemba kokusebenza ngo-32%
● Izimila ze-orthopedic eziphrinte i-3D zibonise ukuhlanganiswa kwe-osseo 98% phakathi nezinyanga ezingu-6
Ingxoxo
1.Abashayeli Bezobuchwepheshe
● Amathuluzi omklamo okhiqizayo anikeze amandla amajiyometri ayinkimbinkimbi ukuze angafezeki ngezindlela ezikhiphayo
● Ukulawulwa kwekhwalithi esemgqeni (isb, amasistimu okuhlola umbono) kwehlise izinga lokulahlwa laba ngu-<0.5%
2.Izithiyo Zokutholwa
● I-CAPEX yokuqala ephezulu yemishini enembayo
●Izimfuneko eziqinile zokuqinisekisa i-FDA/EU MDR zelula isikhathi sokuya emakethe
3.Imithelela Yezimboni
● Izibhedlela ezisungula izindawo zokukhiqiza zangaphakathi (isb, Ilebhu Yokuphrinta Ye-3D ye-Mayo Clinic)
●Shintshela ekukhiqizweni ngobuningi uye ekukhiqizeni okusatshalaliswa okudingeka kakhulu
Isiphetho
Ubuchwepheshe bokukhiqiza idijithali buvumela ukukhiqizwa okusheshayo, okungabizi kwezingxenye zepulasitiki zezokwelapha ngenkathi kugcinwa ukusebenza kahle komtholampilo. Ukutholwa kwesikhathi esizayo kuncike kulokhu:
● Ukulinganisa izimiso zokuqinisekisa zokufakwa kwezakhi ezengeziwe
● Ukuthuthukisa amaketanga okunikezela agugile okukhiqiza amaqebelengwane amancane
Isikhathi sokuthumela: Sep-04-2025
