![Blueprint-to-implant]()
Kukhazikitsa mzere wa mafupa achinsinsi omwe amagwiritsidwa ntchito kutanthauza chimodzi mwazosankha ziwiri zoyipa: perekani kuyitanitsa yayikulu (ndikupemphera kuti mutha kusuntha zinthu), kapena kukhala miyezi ingapo chifukwa mulibe zojambula, mafayilo oyika, kapena dongosolo lomveka bwino lotsatira.
Woyendetsa wa MOQ wotsika amasintha masamu. M'malo mobetcha pa voliyumu, mumatsimikizira wogulitsa, zolemba, ndi zomwe mukufuna pamsika ndikuyendetsa koyamba.
Chotengera chofunikira : Chitani '10 sets MOQ' ngati kuyesa kwa msika , osati njira yachidule. Kusuntha kopambana ndikuphatikiza voliyumu yotsika ndi kuwongolera kwakukulu: ziyeneretso za ogulitsa, umwini wa zolemba, kulemba zilembo / kukonzekera UDI, ndikusintha kusintha.
Zofunikira zofunika
MOQ yotsika imachepetsa chiwopsezo cha zinthu - koma ngati zolemba zanu ndi zolemba zanu zili zokonzeka. MOQ ndi za mtengo wokhazikika wa wopanga, osati njira yanu yogulitsira. (Onani tanthauzo la SeaComp la minimal order quantity (MOQ).)
Kupambana pamalebulo achinsinsi nthawi zambiri kumakhala 'mapu a umwini.' Muyenera kumveka bwino za omwe ali ndi zilembo, UDI, kasamalidwe ka madandaulo, kusintha kosintha, ndi mafayilo owongolera.
Kwa mbale zowopsa / zokomera, kugulitsa kwanu koyamba si kuyikapo - ndi chidaliro. Zipatala ndi maopaleshoni amafuna kutsatiridwa, kupanga kosasintha, komanso zida zodziwikiratu.
Kupaka ndi kutsekereza kumatha kukhala vuto lanu losalankhula. Konzani zovomerezeka ndi nthawi yotsogolera koyambirira; musatenge kulongedza katundu ngati sitepe yomaliza.
Gawo 0: Mvetsetsani zomwe '10 seti MOQ' imakugulirani
MOQ imatanthawuza kuchuluka kwa madongosolo ocheperako - njira yaying'ono yomwe wopanga angavomereze chifukwa imakhudzabe nthawi yokhazikitsira, zida, ndandanda, ndi mtundu wazomwe zimapangidwira. Ndichifukwa chake mafakitale apamwamba a MOQ amakonda kukankhira ma seti 500+: akuteteza chuma chawo.
MOQ yokhala ndi 10-set ndi yofunika chifukwa imakulolani:
Tsimikizirani zokonda za ochita opaleshoni ndi mayendedwe a tray ndi ogwiritsa ntchito enieni
Yendetsani kutsegulira koyendetsedwa m'gawo lodziwika
Tsimikizirani zolembera, UDI, ndi zolemba zikuyenda musanawonjezere
Pewani kusunga nyumba yosungiramo katundu yodzaza ndi makulidwe omwe simunagulitsebe
Msampha: MOQ yotsika imatha kuyesa magulu kuti alumphe 'ntchito yotopetsa' (kugawanika, kulemba, kufufuza). Ntchito yotopetsa ndiyomwe imapangitsa kuti mtundu wanu ukhale wamoyo.
Gawo 1: Lembani 'mapu audindo' musanasankhe wopanga
Musanalankhule za magiredi a titaniyamu kapena nthawi yotsogolera, mvetsetsani bwino kuti ndani amene adzayankhe pa zomwe mukupanga ma lebulo achinsinsi.
Ku US, a FDA amalamula zolembetsa zolembetsa ndi kuyika zida zomwe zimakhala pansi pa 21 CFR Gawo 807 (kulembetsa kwa FDA ndi mndandanda wa zida). Kugwiritsa ntchito kwenikweni kumadalira udindo wanu (wopanga motsutsana ndi relabeler motsutsana ndi wogawa), koma zotengera zomwe ogawa ndizosavuta:
Muyenera kumveka bwino kuti ndi gulu liti lomwe likuchita ngati 'cholembera,' ndi zomwe ziyenera kulembedwa / kulembetsa
Muyenera kupewa chilankhulo chomwe chimatanthawuza kulembetsa/mindandanda yofanana ndi FDA 'kuvomerezeka'
Zomwe mungalembe (zochepera):
Kukula kwa chipangizo (dongosolo lenileni, kukula kwake, zida)
Kusintha kowongolera: ndi zosintha ziti zomwe zimafuna kuti muvomereze zolembedwa?
Madandaulo + CAPA: ndani amafufuza, ndani amatseka, ndani akupereka malipoti?
Kulemba + umwini wa IFU (kuphatikiza zomasulira)
Kupanga UDI ndi maudindo a database
Maudindo opaka/kutsekereza ndi njira zovomerezera
Ufulu wa Audit ndi nthawi yoperekera zolemba
Pro nsonga : Chitani izi ngati chiwongolero chamgwirizano wa Supplier Quality Agreement. Ngati fakitale sidzasaina mawu omveka bwino oletsa kusintha ndi kuyankha madandaulo, 'mtundu' wanu ndi chizindikiro chabe pandandanda ya munthu wina.
Khwerero 2: Sankhani kuchuluka kwa SKU komwe chipatala chingathe kuyesa (mndandanda wotsegulira mtundu wa mafupa)
Kwa mbale zovulala ndi zomangira, njira yofulumira kwambiri yopita ku mayankho enieni ndi zida zoyambira zocheperako , zomwe dokotala wa opaleshoni angamvetse komanso wopereka chithandizo.
Mulingo woyeserera wothandiza nthawi zambiri umatanthauza:
Njira imodzi yoyang'ana (mwachitsanzo, distal volar plating kapena kagawo kakang'ono)
Kuthamanga kocheperako (kokwanira kuphimba ma anatomy wamba, osati mitundu yonse)
Zida zomwe zimagwirizana ndi implant system (madalaivala, owongolera, zobowola, zoyezera kuya)
Cholinga chanu sikungofuna kuchita chidwi kwambiri. Cholinga chanu ndikuchepetsa kukangana:
zigawo zochepa zomwe zikusowa
zochepa 'zadongosolo lapadera'.
maphunziro osavuta a reps
Gawo 3: Tsimikizirani kuthekera kopanga momwe zipatala zimachitira: zolemba-choyamba
Otsatsa nthawi zambiri amakakamira pazokambirana zapadera pomwe otsekereza enieni amakhala mipata yolemba. Makasitomala anu akuchipatala (ndi owongolera anu) adzafunsa umboni wodziwikiratu.
Yambani ndi paketi yofunsira zikalata:
Satifiketi ya ISO 13485 (pakali pano, yotsimikizika)
Zikalata zakuthupi (za titaniyamu / PEEK / chitsulo chomwe mukufuna kugulitsa)
Njira yotsatirira (zowongolera zambiri / magulu ndi zolemba)
Njira yotsekera ndi kuyika (ngati mungagulitse wosabala)
Zitsanzo zoyendera ndi malipoti a mayeso
Ngati muli kale ndi mndandanda waufupi wa fakitale, gwiritsani ntchito cheke chowunikira ndikuchiyendetsa mosalekeza. Ngati mukufuna dongosolo lokonzekera kugawa, onani Momwe Mungakhalire Vet Othandizira Mafupa: Mndandanda wa Ogula a US.
Khwerero 4: Pangani reverse-engineering chinthu-osati chiwopsezo
Ogawa ambiri samayamba ndi zojambula zonse za uinjiniya—makamaka ngati 'poyambira' ndi zitsanzo, geometry yosankhidwa ndi dotolo, kapena makina opikisana nawo omwe mukuyesa.
Ngati wopanga wanu akupereka uinjiniya wosinthika, funsani kayendedwe komwe kafotokozedwe:
Mtundu wolowetsa (zitsanzo, chithunzi, jambulani data)
Zotulutsa (zojambula za 2D + 3D CAD + kulolerana)
Unikaninso njira (omwe asayina, momwe kuwongolera kumayendetsedwa)
Dongosolo lotsimikizira (ndimiyeso yotani yomwe imatsimikizira kufanana?)
Patsamba lofikira la XC Medico la OEM/ODM, amayika chithunzi/chitsanzo-kujambula chothandizira pambali pakupanga makiyi ndi malo oyambira 10 achinsinsi (onani XC Medico OEM/ODM ntchito (10-set MOQ ndi makiyi otembenukira) .
Gwiritsani ntchito lusoli mosamala: ukadaulo wosinthira ndi mwayi ngati mbiri yokonzanso ndikutsimikizira zikuwongoleredwa.
Khwerero 5: Pangani zolemba zanu + UDI pulani molawirira (chifukwa dzina lanu lili pamenepo)
Malamulo awiri a thumb:
Zolembazo ziyenera kuwonetsa bwino yemwe anachita. Malamulo a FDA olembera pazida zopakidwa amanena kuti cholembedwacho chiyenera kusonyeza dzina/malo abizinesi, ndipo ngati wotchulidwayo sanapange chipangizocho, ubalewo uyenera kukhala woyenerera (mwachitsanzo, 'Wopangidwa ndi' kapena 'Wogawidwa ndi') pa 21 CFR § 801.1 zofunika zolembera pazipangizo zamankhwala zopakidwa.
UDI sichosankha pochita ma tenda akuluakulu. A FDA akufotokoza mu FDA UDI Basics (DI, PI, ndi GUDID) kuti UDI nthawi zambiri imakhala ndi Chizindikiritso cha Chipangizo (DI) ndi Identifier Yopanga (PI), ndipo dongosololi limathandizira kuzindikira ndi kufufuza kuchokera pakupanga mpaka kugawa mpaka kugwiritsidwa ntchito kwa odwala.
Zomwe mungasankhe poyendetsa ndege:
Kapangidwe ka zilembo zanu (dzina lachidziwitso, bungwe lovomerezeka, adilesi)
Mwini wanu wa IFU (olemba, omwe amavomereza zosinthidwa)
Kuyenda kwanu kwa data ya UDI (yemwe amapanga DI/PI, momwe imajambulidwa mu ERP yanu)
Lamulo lanu lowongolera kusintha (ndi liti pamene chizindikiro/IFU kukonzanso kumayambitsa kutsimikiziranso?)
Khwerero 6: Osalola kulongedza/kutsekereza kukhala kuchedwa kwanu kodzidzimutsa
Ngati pulogalamu yanu yazidziwitso zachinsinsi ili ndi zinthu zosabala, nthawi yanu yotsegulira nthawi zambiri imakhala yokonzekera kulongedza.
Pamlingo wapamwamba, kutsimikizika kwapakedwe ka mafupa nthawi zambiri kumatsimikizira mayeso monga kukalamba kofulumira (ASTM F1980), kulimba kwa chisindikizo (ASTM F88), komanso kuyesa kugawa (mwachitsanzo, ASTM D4169/D642), monga tafotokozera mwachidule za ODT pakuyika kwa mafupa ndi kutsekereza kubereka (ASTM)
Simufunikanso kukhala mainjiniya onyamula - koma mufunika dongosolo:
Kodi zipatala zanu zingavomereze mtundu wanji wazolongedza?
Ndani yemwe ali ndi machunidwe ovomerezeka a paketi?
Kodi UDI idzagwiritsidwa ntchito bwanji (label + AIDC)?
Kodi nthawi yoyamba yolongedza zinthu ndi malo otsekera ndi iti?
⚠️ Chenjezo : Chitani zinthu zonyamula katundu ngati gawo loyendetsedwa ndi zinthu zanu. Mukamaliza kuyika mochedwa, mutha 'kumaliza kupanga' koma muphonyebe tsiku lanu loyambitsa.
Khwerero 7: Yendetsani oyendetsa 10-seti ngati kuyesa koyendetsedwa
Woyendetsa ndege wa MOQ wotsika amagwira ntchito mukamafotokozera kupambana ndi kulephera musanagulitse seti yoyamba.
Sankhani ma metric 3-5 ofunika:
Kuchita pa nthawi yobereka
Kukwanira kwa zida (zinthu zomwe zikusowa pamlandu uliwonse)
Label/UDI scan yachita bwino pamayendetsedwe enieni a ntchito
Madandaulo ndi nthawi yoyankha
Ndemanga za Opaleshoni: ergonomics, kukula, malingaliro a tray
Kenako ikani chisankho chosavuta:
Sinkhani pamene zolembedwa + mayendedwe ali okhazikika ndipo kuyitanitsanso ndikudziwikiratu
Bwerezaninso pamene implant ili yovomerezeka koma kachitidwe kantchito/kapangidwe kake kakufunika kukonzedwanso
Imani pamene kufufuza, kusintha kuwongolera, kapena kuyankha kwalephera
Ngati mukufuna mndandanda wazomwe zimaperekedwa ndi omwe akukhudzidwa ndi zoopsa, izi zikukwaniritsa njira yoyeserera: Mafunso 10 kwa Vet Trauma Implant Suppliers (US Distributors).
Khwerero 8: Sankhani mosamala: onjezani ma SKU motsatizana zipatala zimvetsetse
Njira yachangu kwambiri yochotsera mtundu wachinyamata ndikuwonjezera ma SKU mwachangu kuposa momwe zolemba zanu komanso mtundu wowonjezera ungathandizire.
Njira yokulirapo yotetezeka:
Wonjezerani m'magulu amtundu womwewo (makulidwe ochulukirapo, kenako zisonyezo zoyandikana)
Onjezani kukhathamiritsa kwa zida (chepetsani kulemera kwa thireyi, chepetsani masitepe)
Onjezani dongosolo lachiwiri lopwetekedwa mtima pokhapokha woyamba ali ndi kukonzanso kokhazikika
Izi zimathandiza ma reps anu kukhala odalirika komanso kuchepetsa chiopsezo cha kusalinganika kwa katundu.
Zolakwitsa zofala poyambitsa mzere wapayekha wa mafupa a mafupa
Kuchitira MOQ ngati njira. MOQ ndi nthawi yogula; njira yanu ndi qualification + controlled rollout.
Kudumpha zosintha zolembedwa. Ngati geometry, zipangizo, mapeto a pamwamba, kapena zoikamo zingasinthe popanda chilolezo chanu, simukulamulira mtundu wanu.
Kuchepetsa kulembera / nthawi ya UDI. 'Tidzakonza zolemba pambuyo pake' ndi momwe zotsegulira zimakakamira.
Kungoganiza zida zida ndizosavuta. Mu zoopsa, kupanga zida ndi kukwanira kumasankha chidaliro cha dokotala.
Kulonjeza mopitilira muyeso wamalamulo. Khalani olondola; samatanthawuza kuti 'FDA idavomerezedwa' chifukwa chakuti china chake chalembetsedwa / chalembedwa.
Poyambira kothandiza (ngati mukufuna kuyambitsa ndi ma seti 10)
Ngati cholinga chanu ndikuyambitsa ma trauma plates/screw achinsinsi okhala ndi chiwopsezo chochepa, yambani ndi zolonjeza zitatu:
Mapu a udindo ndi malamulo olembedwa owongolera kusintha
Paketi yofunsira zolemba zomwe zimagwirizana ndi momwe zipatala zimagulira
Khadi lazigoli loyendetsa lomwe mugwiritse ntchito posankha masikelo ndi iterate
Mtundu wa OEM/ODM wa XC Medico umamangidwa mozungulira kuyezetsa misika yotsika kwambiri (maseti 10) kuphatikiza uinjiniya wobwerera kumbuyo ndikuyenda kwa ma turnkey (onani tsamba la OEM/ODM lomwe lalumikizidwa kale).
Gawo lotsatira
Ngati mukufuna, tumizani kuchuluka kwa zomwe mukufuna kuchita (njira, kukula kwake, komanso ngati mukufuna zoyikapo zosabala). Tiwonanso zotheka ndikutchula woyendetsa wa seti 10 wokhala ndi zolemba ndi zolemba zomwe zikugwirizana kuyambira tsiku loyamba.
Funsani mtengo / yambani ntchito ya OEM / ODM: Lumikizanani ndi XC Medico
