Isoko ryisi yoseibice bya pulasitiki byubuvuzi yageze kuri miliyari 8.5 z'amadolari mu 2024, yatewe inkunga n’ubuvuzi bwihariye ndetse no kubaga byibasiye. Nubwo iri terambere, gakondoinganda urugamba rwo gushushanya no kubahiriza amabwiriza (FDA 2024). Uru rupapuro rusuzuma uburyo uburyo bwo gukora ibivangavanga bihuza umuvuduko, neza, hamwe nubunini kugirango byuzuze ibyifuzo bishya byubuzima mugihe byubahiriza ISO 13485 ibipimo.
Uburyo
1.Ubushakashatsi
Uburyo buvanze-uburyo bwakoreshejwe:
Analysis Isesengura ryinshi ryamakuru yakozwe kuva 42 bakora ibikoresho byubuvuzi
Inyigo zakozwe kuva 6 OEM zishyira mubikorwa bya AI bifashishije ibishushanyo mbonera
2.Ubuhanga bwa tekiniki
●Porogaramu:Koresha Mimics® yo kwerekana imiterere
●Inzira:Gushushanya Micro-inshinge (Arburg Allrounder 570A) hamwe no gucapa 3D SLS (EOS P396)
● Ibikoresho:Urwego rwubuvuzi PEEK, PE-UHMW, hamwe na silicone (ISO 10993-1 yemejwe)
3.Ibipimo by'imikorere
Ect Ibipimo nyabyo (kuri ASTM D638)
● Umusaruro uyobora igihe
Oc Ibisubizo byemewe bya biocompatibilité
Ibisubizo n'isesengura
1.Ingirakamaro
Umusaruro wigice ukoresheje ibikoresho bya digitale byagabanutse:
● Igishushanyo-kuri-prototype igihe kuva 21 kugeza 6
Waste Imyanda y'ibikoresho kuri 44% ugereranije no gutunganya CNC
2.Ibisubizo bya Clinique
Guide Ubuyobozi bwihariye bwo kubaga abarwayi bwongereye imikorere ya 32%
● 3D-icapishijwe orthopedic yatewe yerekanaga 98% osseointegration mumezi 6
Ikiganiro
1.Abashoferi b'ikoranabuhanga
Tools Ibikoresho byo gushushanya byafashaga geometrike igoye itagerwaho hamwe nuburyo bwo gukuramo
Control Kugenzura ubuziranenge kumurongo (urugero, sisitemu yo kugenzura iyerekwa) yagabanije ibiciro byo kwangwa kugeza kuri <0.5%
2. Inzitizi zo kwakirwa
Intangiriro yambere CAPEX kumashini isobanutse
Ibisabwa FDA / EU MDR ibisabwa byo kwemeza byongerera igihe-isoko
3.Ingaruka zinganda
Ibitaro bishyiraho amazu yo gukoreramo mu nzu (urugero, Laboratwari ya 3D ya Mayo Clinic)
Kuvana mubikorwa rusange ukajya kubisabwa bikwirakwizwa
Umwanzuro
Ikorana buhanga rya digitale rituma umusaruro wihuse, uhenze cyane wibikoresho bya pulasitiki byubuvuzi bikomeza gukora neza. Kurera ejo hazaza biterwa na:
Kuringaniza protocole yo kwemeza ibyongeweho byakozwe
Gutezimbere urunigi rwogutanga umusaruro muke muto
Igihe cyo kohereza: Nzeri-04-2025
