Iyo abagabuzi batangiye gushakisha uruganda rwa OEM orthopedic, mubisanzwe batangirana nishakisha rya Google, urutonde rwibibazo, nurutonde rwibitekerezo. ISO 13485 - kugenzura. FDA 510 (k) - kugenzura. Igiciro cyo gupiganwa - kugenzura.
Mugihe bamenye ko idakora, baramaze gufungwa. Birashoboka ko ari ukwezi kwa munani kandi baracyategereje koherezwa. Ahari uruganda rwafashe icyemezo cyo guhagarika umusaruro kugirango rukore amasezerano manini y'ibitaro byo murugo. Cyangwa birashoboka ko babonye igenzura ryambere ryubuyobozi hanyuma bavumbura ibyakozwe nuwabikoze ni impanuka.
Ibi ntabwo ari ukugenzura ibyemezo. Nijyanye no gusobanukirwa nukuri mubyukuri ubufatanye bwawe mumyaka 3 kugeza 5 iri imbere - nibibazo abakwirakwiza benshi bibagirwa kubaza.
Itandukaniro nyaryo hagati yuwatanze isoko nabafatanyabikorwa ba OEM
Ubwa mbere, ibisobanuro bifite akamaro kurenza uko byakagombye: guhamagara umuntu 'OEM ukora ' ntabwo bivuze ko akora mubyukuri. Bamwe mu batanga ibicuruzwa mu Bushinwa bagura ibicuruzwa biva mu ruganda rumwe, bagakubita ikirango cyawe ku bipfunyika, bakabohereza. Ibyo ni ugusubiramo. Nibirango byihariye. Nibihendutse, byihuse, ariko ntabwo OEM.
Umufatanyabikorwa nyawe wa OEM akora igishushanyo mbonera. Bakorana nibisobanuro byawe - waba ubasaba guhindura sisitemu iriho cyangwa guteza imbere ikintu gishya. Babika amadosiye agenga izina ryabo, mwizina ryawe. Batanga ibyiciro hamwe nibirango byawe. Bahagarara inyuma yibicuruzwa binyuze mu kugenzura nyuma yisoko.
Impamvu iri tandukaniro rifite akamaro ni inshingano. Niba umugabuzi wihariye-ibirango yatewe kuva rebrander, kandi harikintu kitagenda neza mumurima, uwagabanije ashinzwe gukosora. Rebrander yamaze gufata ibyo bagabanije. Umufatanyabikorwa wa OEM, kubwamasezerano, asangira inshingano nziza - bivuze ko bitaye cyane kubitsinzi byawe.
Ikibazo cya mbere rero mbere yo kuvugana numuntu wese: Mubyukuri barakora, cyangwa baragurisha ikirango cyawe?
Ikibazo cyo Kwemeza Ikibazo kiragoye kuruta uko gisa
Buri ruganda rusaba ISO 13485. Ikibazo ni urugero. Uruganda rushobora kuba ISO 13485 rwemeza ibyapa byihungabana ariko ntabwo ari sisitemu yumugongo. Canke barashobora gufata CE kuranga Uburaya ariko zeru FDA zeru kuri Amerika. Cyangwa bemejwe kubicuruzwa bisanzwe ariko ntabwo kubishushanyo mbonera.
Twabonye abadandaza basinyana amasezerano nababikora basa nkabizewe kumpapuro, gusa kugirango bagere ku ntambwe yambere yo kugenzura no kuvumbura imikorere yibikorwa byuruganda bidahuye nicyemezo. Abagenzuzi ntibitaye kubyo icyemezo kivuga - bitaye kubiri muri dosiye nyirizina. Niba kandi uruganda rwarimo gukata inguni kumyandiko kugirango ubike umwanya, ibyo byerekana byihuse.
Icyangombwa mubyukuri: Baza kureba icyemezo
cyurugero rwumugereka - inyandiko yerekana neza ibicuruzwa nibikorwa byemewe. Baza ibihugu byiyandikishije kugurisha ibicuruzwa, hanyuma usabe nimero zabo. Niba badashobora kubyara ibi mumasaha 48, komeza.
Baza kandi: Ubugenzuzi bwawe bwa nyuma ryari? Ni ibiki byagaragaye? Benshi ntibazitanga kubisubizo byubugenzuzi bubi, ariko nibabona kwirwanaho kubibazo, icyo ni ikimenyetso.
Ku bakora inganda zishingiye ku Bushinwa, hari ikindi cyemezo kimwe cyingenzi niba ugurisha muri Amerika: MDSAP (Porogaramu ishinzwe Ubuvuzi Igikoresho kimwe). Iki cyemezo kimwe gikubiyemo FDA, Kanada, Ubuyapani, na Berezile. Kubona bihenze kandi bitwara igihe. Niba uruganda rwabashinwa rufite, bashoye amafaranga akomeye mubikorwa remezo byubahirizwa. Ntabwo ari garanti, ariko ni ikimenyetso gikomeye kuruta ISO 13485 wenyine.
Ikibazo nuko ibyiciro byibicuruzwa bitandukanye bisaba ibyemezo bitandukanye. Umurongo wa plaque yawe ushobora guhanagurwa FDA mugihe sisitemu yumugongo ikiri mumasoko ya CE gusa. Mugihe usuzuma ababikora, reba niba bashobora gukwirakwiza ibyiciro byibicuruzwa uteganya gukwirakwiza - urashobora kubisubiramo sisitemu yo guhahamuka kandi umugongo ushiramo ibicuruzwa kumurongo kugirango wumve uburyo icyemezo gihuza nibicuruzwa bifatika.
Inkuru yo Gutanga Bakubwira na Gutanga Uzabona Mubyukuri
Buri ruganda ruvuga ko bafite ibicuruzwa byihuse. 'Iminsi 3 kubintu, iminsi 30 yo gutumiza ibicuruzwa. ' Ariko mubyukuri bivuze iki?
Iminsi itatu uhereye ryari? Kuva igihe bakiriye ibicuruzwa byawe byo kugura no kwishyura bisobanutse? Cyangwa guhera igihe ibyoherejwe biva mu kigo cyabo? Kandi 'ibintu byimigabane ' - bivuze ko ibintu babitse mububiko, cyangwa ibintu bashobora gukora vuba? Aya ni amagambo adasobanutse nkana.
Dore ibyo twabonye: ababikora bafite ibicuruzwa byihuse bitanga ibicuruzwa byinshi (mubisanzwe 80% + bya kataloge ya SKU mububiko). Ibyo bibatwara amafaranga nububiko bwububiko, kubwibyo babikora ari uko bahisemo ko aribwo buryo bwubucuruzi. Inganda zisaba guhinduka byihuse ariko zifite ibarura rito zirabeshya cyangwa zizasubiza inyuma ibyo wateguye mugihe umukiriya munini aje.
Ikibazo cya kabiri cyo gutanga ni itumanaho. Uruganda rushobora kohereza ku gihe ariko ntirukubwire igihe rwoherejwe. Wiga ukurikirana numero nyuma y'ibyumweru bitatu. Iyo habaye gutinda, ntacyo wumva kugeza ubirukanye. Ibi bifite akamaro kuko ibitaro byawe birategereje. Niba udashobora kubwira umukiriya wawe igihe abaterwa bazagera, nikibazo cyubucuruzi.
Baza konti zerekana. Hamagara umwe mubandi bakwirakwiza hanyuma ubaze: 'Mugihe utegereje koherezwa, uruganda rukubwira ivugurura ryimiterere, cyangwa ugomba kubaza? ' Uziga byinshi kubisubizo.
Baza kandi igipimo cyo gutanga ku gihe cyamezi 12 ashize. Uruganda ruvugisha ukuri ruzavuga ikintu nka 92%. Niba bavuga 100%, baba ari shyashya cyangwa bakubwira ibyo ushaka kumva.
Ubwiza bwibintu no gukurikiranwa - Aho igitutu cyigiciro kiboneka
Aha niho imipaka iri hagati ya 'nziza ihagije ' na 'mubyukuri umutekano ' ihinduka urujijo, kandi aho igitutu cyibiciro gisunika ababikora mu mfuruka.
Orthopedic yatewe ikozwe muri titanium, ibyuma bitagira umwanda, cyangwa cobalt-chromium. Ibikoresho byingenzi bifite akamaro: ASTM F136 (titanium idasanzwe-yo munsi) igura amafaranga arenze ASTM F67 (titanium yubucuruzi), ariko ifite imbaraga zo kurwanya umunaniro. Uruganda rwiyemeje ubuziranenge rukoresha icyerekezo gikwiye kuri porogaramu. Uruganda rukora igitutu cyigiciro rukoresha igenzura ryose.
Ariko dore ikibazo gikomeye: Nigute ushobora kugenzura ubuziranenge bwibintu? Impapuro zemeza ibyemezo biva mubikoresho bitanga ibikoresho ntibihagije. Ukeneye raporo yikizamini cya mashini - gupima umunaniro, imbaraga zingana, gukomera - kuri byinshi. Kandi ukeneye kubikwa byibuze imyaka 3 mugihe ibicuruzwa byananiranye mumurima kandi ukeneye amakuru yubucamanza.
Baza uwabikoze: 'Ufite laboratoire yo gupima murugo? ' Niba igisubizo ari oya, bohereza ingero kubandi bantu. Ibyo biratinda kandi bihenze kuri bo, bivuze ko ibyiciro bike bipimwa. Niba bavuze yego, baza ibikoresho bafite. Imashini ya Instron yo gupima tensile, imashini ya TA yo gupima umunaniro, CMM yo kugenzura ibipimo - aya ni $ 100K + buri umwe. Niba uruganda rwarashoramari cyane mugupima, bafatana uburemere ubuziranenge.
Baza kandi ibijyanye no gukurikirana. Bashobora gukurikirana buri kintu cyose cyatewe mugice cyacyo kibisi? Buri cyuma kigomba kugira nomero yerekana urutonde. Iyo ukuye umugozi mububiko bwamezi atandatu uhereye none, barashobora gukora raporo yikizamini cya mashini uhereye mugice cyavuyemo? Niba atari byo, ufite ikibazo cyubuyobozi niba hari ikinaniwe.
Niba ukeneye gusuzuma ibicuruzwa byihariye nibisobanuro bifatika, ababikora batanga ibisobanuro bya tekiniki mubisanzwe bakuramo ibicuruzwa nibisobanuro bya tekiniki - ubu ni inzira ifatika yo gusuzuma niba sisitemu zabo zikurikirana zujuje ibisabwa ku isoko.
Igiciro Cyihishe cya OEM Guhinduka
Abacuruzi benshi batekereza ko gukora OEM bivuze ko bashobora gusaba guhindura ibicuruzwa igihe cyose babishakiye. Inguni zitandukanye ku isahani. Ibara ritandukanye ryo gushiraho ikimenyetso. Agasanduku gashusho gahuye nibirango byabo.
Dore ikibazo: Buri gihinduka gisaba kwemeza igishushanyo, kuvugurura inyandiko zigezweho, hamwe nigiciro gishya cyibikoresho. Ababikora benshi bazishimira gufata ibyemezo byawe kugirango bahindure ibicuruzwa - kuri 3x igiciro cyibicuruzwa bisanzwe, hamwe niminsi 90 yo kuyobora. Uwatanze ibicuruzwa yiteze gushyira ahagaragara ibicuruzwa bishya byigenga kandi akavumbura ko biyemeje $ 50K mugukoresha ibikoresho nigihe ntarengwa cyamezi atandatu.
Niyo mpamvu ugomba gusobanura neza icyo 'OEM ' bivuze mumasezerano yawe. Niba ushaka igishushanyo mbonera, ukeneye:
- Amagambo asobanutse kubyerekeye impinduka ni ubuntu (kwisiga: gupakira, kuranga)
- Nibihe bihinduka bisaba ikiguzi cyinyongera nigihe ntarengwa (igishushanyo mbonera: inguni, ibipimo)
- Ninde ufite igishushanyo kimaze gutezwa imbere (wowe cyangwa nabo?)
- Bigenda bite niba ushaka kujyana igishushanyo kubandi bakora nyuma
Baza kandi: Nibihe ntarengwa byateganijwe kubishushanyo mbonera? Inganda zimwe zisaba ibice 1.000 mbere yo gukora igikoresho cyabigenewe. Bamwe bazakora 200. Itandukaniro ningirakamaro kubagabura bagifite kwemeza umurongo mushya wibicuruzwa.
Ikibazo IP Ntamuntu Wifuza Kuvuga
Gukorana nu ruganda rwabashinwa bitera impungenge IP zemewe. Ntabwo ari ukubera ko inganda zUbushinwa zisanzwe zizewe, ariko kubera ko imiterere ishimishije itandukanye. Niba umufatanyabikorwa wawe OEM adashobora guhangana nawe mumasoko yawe, ntibagerwaho no guca inguni cyangwa guhiga ibishushanyo byawe.
Amasezerano agomba kuba akubiyemo:
- NDA isobanutse - ikorwa mbere yuko dosiye zose zishushanya cyangwa ibisobanuro bisangiwe
- Ingingo ya nyirubwite - itangazo ryerekana ko ibishushanyo mbonera byateguwe kubisobanuro byawe bikomeza kuba IP yawe
- Ibidahiganwa - kubuza uwabikoze gutanga ibishushanyo bisa bya OEM kubanywanyi bawe bataziguye mubutaka bwawe bwanditse
- Uburenganzira bwo kugenzura - uburenganzira bwo kugenzura inyandiko zerekana umusaruro hamwe ninyandiko nziza
Kwiyemeza mu magambo kuri izi ngingo ntacyo bimaze. Niba uwabikoze adashaka gushyira imvugo yo kurinda IP mumasezerano, ibyo kwanga biratanga amakuru.
Niki Isano Mubyukuri isa nyuma yo gusinya
Amasezerano amaze gusinywa, umubano usobanurwa nibintu bitatu:
Inshuro y'itumanaho. Ababikora bamwe bakora ivugurura rya buri cyumweru. Bamwe baraceceka keretse ubirukanye. Shiraho ibiteganijwe imbere: Ni kangahe uzabona ibyemezo byoherejwe? Niki gihe cyo gusubiza kubibazo byihutirwa? Bafite umuyobozi wa konti yabigenewe cyangwa uri itike kumurongo?
Guhindura amabwiriza. Urashobora guhagarika itegeko ryo kugura nyuma yo gushyirwaho? Urashobora kugabanya umubare mugihe amasezerano yibitaro byawe ahindutse? Urashobora kongera ubwinshi niba ibisabwa byihuta? Shaka ibi mu nyandiko. Itandukaniro riri hagati ya 'urashobora guhagarika iminsi 14 mbere yo koherezwa ' na 'nta guhagarika ' ntacyo bitwaye.
Gukemura ibibazo. Bigenda bite iyo itsinda rihageze ugasanga ibibazo bifite ireme? Barayisimbuza ako kanya cyangwa bagusaba kohereza ingero kugirango ugerageze? Bikubiyemo ubwikorezi? Hariho idirishya ryiminsi 30 yo kumenyesha inenge cyangwa ni ubuzima bwose? Na none, ibi biri mumasezerano, ariko abagabuzi akenshi basiba kubisoma bitonze.
Igenzura ryoroshye
Mbere yo gusinya ikintu icyo ari cyo cyose, ibaze ubwawe: Niba narahagaritse gutumiza muriyi nganda ejo, bari kwitaba umuhamagaro wanjye? Cyangwa barabyitayeho gusa kuko nshyizeho amategeko?
Umubano w'abafatanyabikorwa bivuze ko bashaka kuguma mu bucuruzi nawe. Umubano wabatanga bivuze ko bashaka gahunda yawe yubu. Itandukaniro ryerekana mugihe ukeneye inkunga kandi uruganda ruhuze na konti nini.
Baza konti yerekana - undi mutanga asanzwe uyikoresha. Hamagara uwo ukwirakwiza hanyuma ubaze: 'Mugihe ufite ikibazo, bakwitabira bate? ' Uzabona igisubizo cyukuri. Abadandaza benshi bishimiye kuvuga kubabatanga, cyane cyane niba hari undi muntu ukora umwete.
Iyo Witeguye Kwimukira Imbere
Niba usuzuma abakora OEM, birashoboka ko ushaka kwagura umurongo wibicuruzwa cyangwa uhinduranya nuwabitanze bitakiri ibyiringiro. Umugabane nukuri - urimo gukora ibarura, imbaraga zubuyobozi, nicyubahiro cyamavuriro kubufatanye.
Tangira ufite ubushobozi bwa tekiniki: Bashobora rwose gukora ibyo ukeneye? Bashobora gukemura ibyo usabwa? Bashobora gupima gukura kwawe? Gusa nyuma yibyo byemejwe ugomba kuganira kubiciro.
Noneho nimwimuke mubikorwa: Bazohereza muburyo bwizewe? Bazashyikirana? Bazagukemura ibibazo mugihe ibintu bitagenda neza?
Niba utekereza cyane mubufatanye bwa OEM bushingiye mubushinwa, intambwe ifatika ikurikira ni ugusuzuma icyitegererezo cyakazi no gusobanukirwa inzira zabo zo gukemura umubare muto wambere. Abadandaza benshi bibwira ko ubufatanye bwa OEM busaba imihigo nini imbere - ariko abayikora neza basobanukiwe ko ugomba kwemeza ibikwiye, ibyangombwa, hamwe n’amavuriro mbere yo gupima ibarura. Mugihe witeguye kuganira kubicuruzwa byihariye nibiteganijwe kugihe, urashobora gutangira ikiganiro ninzobere ya OEM kugirango wumve uko ubufatanye busa mubyiciro byawe byo gukura.
Amagambo yamasezerano afite akamaro, ariko ubushobozi bwimibanire burahambaye. Ntabwo ugura ibicuruzwa. Urimo kugura uburyo bwo gufatanya ninganda musangiye ibyo wiyemeje kubungabunga umutekano wabaganga no gutsinda ibitaro.
Urashaka gusuzuma amahitamo ya OEM? Saba ingero, saba konti zerekana, kandi ugire ikiganiro kijyanye nubufatanye busa.
Ibibazo bikunze kubazwa
Ni irihe tandukaniro riri hagati ya OEM na ODM?
OEM bivuze ko uwabikoze akora ibimera mubisobanuro byawe - igishushanyo cyawe, ikirango cyawe. ODM bivuze ko batanga igishushanyo cyabo gisanzwe ushobora gutanga uruhushya na label-label munsi yikimenyetso cyawe. ODM irihuta kandi ifite ibyago bike; OEM irakwiriye mugihe ufite ibishushanyo mbonera byihariye cyangwa ibicuruzwa biriho IP kurinda.
Bifata igihe kingana iki kugirango ubone OEM orthopedic ibicuruzwa ku isoko?
Kuri ODM ifite ibishushanyo byemewe byemewe, amezi 3-6 arukuri kumasoko hamwe na CE cyangwa FDA yakuweho ibyangombwa bimaze kuba. Kuri OEM yuzuye ifite igishushanyo mbonera, bije amezi 12-18 yo kubara ibishushanyo mbonera, gutanga amabwiriza, no kwiyandikisha. Amasoko afite ibyangombwa birebire byo kwiyandikisha (urugero, Burezili ANVISA, Ubushinwa NMPA) yongeraho igihe.
Ni izihe mpamyabumenyi uruganda rukora amagufwa rwa OEM rukorera mu Bushinwa rugomba gufata?
Nibura: ISO 13485 hamwe nurwego rukubiyemo ibyiciro byibicuruzwa byihariye. Ikimenyetso cya CE kirakenewe kumasoko yuburayi; FDA 510 (k) kwemerera Amerika; MDSAP irakenewe cyane muri Kanada, Burezili, Ositaraliya, n'Ubuyapani. Ntugatekereze ko icyemezo kimwe gikubiyemo imirongo yose y'ibicuruzwa - saba umugereka w'urugero kuri buri cyemezo.
Niki MOQ yumvikana kubantu-label orthopedic yatewe?
MOQs iratandukanye cyane nababikora nicyiciro cyibicuruzwa. Kubakwirakwiza kubaka umurongo mushya wihariye-label, reba abatanga isoko batanga SKU-urwego MOQs murwego rwa 20-50 kubitumenyetso byambere, hamwe nibiciro bishingiye kubiciro kugirango usubiremo ibicuruzwa. Witondere kubakora ibicuruzwa bisaba ubwitange buke muri sisitemu yose mbere yuko wemeza ivuriro ryisoko ryawe.
Nigute narinda IP yanjye mugihe nkorana nu ruganda rukora amagufwa?
Kora NDA mbere yo gusangira ibishushanyo mbonera, amakuru yisoko, cyangwa amakuru yabakiriya. Amasezerano ya OEM ubwayo agomba kuba akubiyemo ingingo ya IP itomoye (ibishushanyo byabigenewe ni ibyawe), kubuza guhatanira kubutaka bwawe bwanditse, n'uburenganzira bwo kugenzura. Andika ibirango byawe mubushinwa mbere yuko umusaruro utangira - Amategeko yubucuruzi yubushinwa niyambere-dosiye, ntabwo ari ubwa mbere-gukoresha.
Uruganda rwa OEM rushobora gutanga ibyangombwa byokwiyandikisha byaho?
Umufatanyabikorwa ushoboye wa OEM agomba kuba ashobora gutanga dosiye ya tekiniki, Itangazo ryujuje ubuziranenge, raporo yisuzuma ryamavuriro, hamwe nibimenyetso byanditse bikenewe mubiyandikisha byinshi ku isoko. Emeza neza amasoko itsinda ryabo rishinzwe uburambe rifite uburambe - gushyigikira ibyifuzo bya EU MDR bitandukanye no gutegura dossier ya ANVISA, kandi ntabwo ababikora bose bafite ubushobozi bungana byombi.
