Nusiwo Nàdi le OEM Ƒumeŋuɖui ƒe Ƒumeŋuɖui Dɔwɔƒe

Ne ƒumelãwo mamalawo dze OEM ƒumeŋutinunyala didi gɔme la, zi geɖe la, wodzea egɔme kple Google didi, nyabiasewo ƒe xexlẽdzesi, kple susu me dzodzro ƒe xexlẽdzesi. ISO 13485 — dzro eme. FDA 510(k) — dzro eme. Ga home hoʋiʋli — kpɔ ɖa.

Kaka woakpɔe be mele dɔ wɔm o la, wotu wo ɖe eme xoxo Ðewohĩ ɣleti enyiliae nye ema eye wogale lalam be woaɖoe ɖe yewo si ƒe ŋugbe wodo. Ðewohĩ dɔwɔƒea ɖoe be yeatɔ te ewɔwɔ be yeatsɔ awɔ kɔdzi ƒe nubabla si lolo wu le dukɔa me. Alo ɖewohĩ woxɔ woƒe sedziwɔwɔ ƒe agbalẽdzikpɔkpɔ gbãtɔ eye wokpɔe be adzɔnuwɔƒea ƒe nuŋlɔɖiwo nye afɔku.

Menye ɖaseɖigbalẽwo me toto ŋue nya sia ku ɖo o. Eku ɖe nusi tututu trɔa asi le wò hadomeɖoɖoa ŋu na ƒe 3 va ɖo 5 siwo gbɔna gɔmesese ŋu — kple nyabiase siwo mama akpa gãtɔ ŋlɔna be be yewoabia.

Vovototo Vavãtɔ Si Le Nudzrala Kple OEM Dɔwɔhati Dome

Gbã la, numekɔkɔ si le vevie wu alesi wòle be wòanɔ: yɔyɔ be ame aɖe be 'OEM wɔla' mefia be wowɔa nu ŋutɔŋutɔ o. Chinatɔwo ƒe nudzrala aɖewo ƒlea nusiwo wotsɔ dea ame ƒe ŋutilã me le dɔwɔƒe ɖeka, tsɔa wò dzesidenu ƒoa nuawo ɖe agbaa dzi, eye woɖoa wo ɖe wò. Ema nye rebranding. Enye ame ŋutɔ ƒe ŋkɔ dede ame ŋu. Eƒe asi bɔbɔ wu, ewɔa dɔ kabakaba wu, gake menye OEM ye o.

OEM hadɔwɔla ŋutɔŋutɔ kpɔa aɖaŋuwɔwɔ ƒe nyawo gbɔ. Wowɔa dɔ kple wò nɔnɔmewo — eɖanye be èle biabiam tso wo si be woatrɔ asi le ɖoɖo aɖe si li xoxo ŋu alo woawɔ nu yeye aɖe o. Woléa sewo ŋuti nyatakakawo ɖe asi le woƒe ŋkɔ me, ɖe tawò. Woɖea batch records ɖe go kple wò branding. Wotsia tre ɖe adzɔnua megbe to ŋkuléle ɖe eŋu le asitsatsa megbe me.

Nusita vovototo sia le vevie ɖoe nye agbanɔamedzi. Ne numamãla aɖe tsɔ ŋkɔ na nusiwo wotsɔ dea ame me le eɖokui si tso rebrander gbɔ, eye nane gblẽ le agblea dzi la, emama ƒe agbanɔamedzie wònye be wòaɖɔe ɖo. Rebrander la xɔ woƒe lãɖeɖe xoxo. OEM hadɔwɔla, to nubabla me, ma nyonyome ƒe agbanɔamedzia — si fia be wotsɔ ɖe le wò dzidzedzekpɔkpɔ me wu.

Eyata bia gbã hafi nàƒo nu kple ame aɖeke: Ðe wole adzɔnuwo wɔm ŋutɔŋutɔa, alo ɖe wole nu dzram ake kple wò ŋkɔ si woŋlɔ ɖe edzia?

Ðaseɖigbalẽ ƒe Nyabiasea Sesẽ Wu Alesi Wòdzena

Adzɔha ɖesiaɖe gblɔna be ISO 13485. Kuxiae nye kekeme. Dɔwɔƒe aɖe ate ŋu axɔ ISO 13485 ƒe ɖaseɖigbalẽ na nuveviwɔame ƒe agbalẽviwo gake menye na aklã ƒe dɔwɔwɔ o. Alo woate ŋu axɔ CE dzesi na Europa gake FDA ƒe mɔɖeɖe zero na United States. Alo woɖo kpe wo dzi na nusiwo wowɔna ɖaa gake womeɖo kpe wo dzi na atsyã siwo wowɔ ɖe ɖoɖo nu o.

Míekpɔe be numãlawo de asi nubabla te kple adzɔnuwɔƒe siwo dze abe ɖe woate ŋu aka ɖe wo dzi le pepa dzi ene, gake wova ɖo sedede ƒe nu vevi gbãtɔ dzi eye wokpɔe be dɔwɔƒea ƒe nuŋlɔɖiwo wɔwɔ ƒe nuwɔnawo mesɔ kple ɖaseɖigbalẽa o. Agbalẽdzikpɔlawo metsɔ ɖeke le nusi ɖaseɖigbalẽa gblɔ me o — wotsɔ ɖe le nusi le faɛl ŋutɔŋutɔwo me me. Eye ne dɔwɔƒea nɔ dzogoewo lãm le nuŋlɔɖiwo ŋu be wòaɖe ɣeyiɣi dzi akpɔtɔ la, ema dzena kabakaba.

Bia hã be: Ɣekaɣie nye wò agbalẽdzikpɔkpɔ mamlɛtɔ? Nukawoe nye nusiwo ŋu woke ɖo? Ame akpa gãtɔ matsɔ wo ɖokui ana be yewoatsɔ agbalẽdzikpɔkpɔ me tsonu manyomanyowo ana o, gake ne wova ʋli wo ɖokui ta le nyabiasea ŋu la, esia nye dzesi.

Le China-dɔwɔƒewo gome la, ɖaseɖigbalẽ ɖeka gali si le vevie ne èle nu dzram yi United States: MDSAP (Medical Device Single Audit Program). Ðaseɖigbalẽ ɖeka sia ku ɖe FDA, Canada, Japan, kple Brazil ŋu. Exɔ asi eye wòxɔa ɣeyiɣi geɖe be woaxɔe. Ne Chinatɔwo ƒe dɔwɔƒe aɖe le esi la, ke wode ga vevie ɖe sedziwɔwɔ ƒe xɔtuɖoɖowo ŋu. Menye kakaɖedzie wònye o, gake enye dzesi si sesẽ wu ISO 13485 ɖeɖeko sã.

Kuxiae nye be zi geɖe la, adzɔnuwo ƒe hatsotso vovovowo hiãa ɖaseɖigbalẽ vovovowo. Ðewohĩ FDA akɔ wò trauma plate line la ŋu esime wò akɔta ƒe ɖoɖowo gakpɔtɔ le CE ɖeɖeko ƒe asiwo me. Ne èle adzɔnuwo wɔlawo me dzrom la, kpɔe ɖa be woate ŋu aƒo nu tso adzɔnuwo ƒe hatsotso tɔxɛ siwo nèle ɖoɖo wɔm be yeama ŋu hã — àte ŋu ato woƒe... trauma implant systems kple spine implant product lines be woase alesi ɖaseɖigbalẽ nana sɔ kple adzɔnuwo ƒe nutsyɔtsyɔ ŋutɔŋutɔ gɔme.

Delivery Story Si Wogblɔna Na Wò vs. Delivery Si Nàxɔ Le Nyateƒe

Adzɔha ɖesiaɖe gblɔ be yewotsɔa nu yina kabakaba. 'Ŋkeke 3 na nusiwo le nudzraɖoƒe, ŋkeke 30 na nudɔdɔ siwo wowɔ ɖe ɖoɖo nu.' Gake nuka tututue ema fia?

Ŋkeke etɔ̃ tso ɣekaɣi? Tso esime woxɔ wò nuƒle ƒe sedede kple fexexe ƒe kɔma? Alo tso esime nudɔdɔa dzo le woƒe dɔwɔƒea? Eye 'stock items' — ɖe ema fia nusiwo wodzrana ɖo ɖe nudzraɖoƒe, alo nusiwo woateŋu awɔ kabaa? Esiawo nye nya siwo woɖo koŋ be nya siwo me mekɔ o.

Nusi míede dzesii enye si: adzɔnuwɔƒe siwo si nudɔdɔ kabakaba ŋutɔŋutɔ le la léa nudzraɖoƒe ƒe kpekpeɖeŋu gã (zi geɖe la, woƒe SKU ƒe agbalẽdzraɖoƒe ƒe 80%+ le nudzraɖoƒe). Ema gblẽa ga kple nudzraɖoƒe teƒe na wo, eyata ne wotso nya me be asitsatsa ƒe kpɔɖeŋue nye ema ko hafi wowɔa esia. Dɔwɔƒe siwo gblɔna be tɔtrɔ kabakaba gake woƒe nudzraɖoƒewo mesɔ gbɔ o la da alakpa alo woatutu wò nudɔdɔa ɖe megbe ne asisi gãtɔ va.

Kuxi evelia si le vidzidzi ŋue nye kadodo. Ðewohĩ adzɔnuwɔƒe aɖe aɖoe ɖe game dzi gake magblɔ ɣeyiɣi si woɖoe ɖe wò gbeɖe o. Èsrɔ̃a nu to xexlẽdzesi yometiti me le kwasiɖa etɔ̃ megbe. Ne heheɖemegbe aɖe va la, mèsea naneke o vaseɖe esime nèti wo yome. Esia le vevie elabena miaƒe kɔdziwo le lalam. Ne màte ŋu agblɔ ɣeyiɣi si me nusiwo wotsɔ dea lãme na wò ava ɖo na wò asisi o la, ke asitsatsa me kuxie nye ema.

Bia numekugbalẽwo. Yɔ woƒe mamala bubuawo dometɔ ɖeka eye nàbia be: 'Ne èle nudɔdɔ lalam la, ɖe dɔwɔƒea gblɔa nɔnɔme yeyewo na wò, alo ɖe wòle be nàbia?' Àsrɔ̃ nu geɖe tso ŋuɖoɖoa me.

Bia woƒe nudɔdɔ ɖe game dzi ƒe agbɔsɔsɔme hã le ɣleti 12 mamlɛawo me. Adzɔnuwɔla anukwaretɔ agblɔ nya aɖe abe 92% ene. Ne wogblɔ be 100% la, ke wonye ame yeye ŋutɔ alo wole nusi nèdi be yease la gblɔm na wò.

Nusiwo Wozãna ƒe Nyonyome Kple Wo Didi — Afisi Gazazã ƒe Nyaƒoɖeamenu Va Va Nyateƒe Le

Afi siae liƒo si le 'nyui si sɔ' kple 'dedie ŋutɔŋutɔ' dome la me mekɔna o, eye afisi gazazã ƒe nyaƒoɖeamenu ƒoa nuwɔlawo ɖe dzogoewo dzi le.

Wotsɔa titanium-kpe, gakpo si mexɔ dzo o, alo cobalt-chromium wɔa ƒumeŋuɖui. Nusi wotsɔ wɔe ƒe spec le vevie: ASTM F136 (extra-low interstitial titanium) ƒe asi wu ASTM F67 (titanium dzadzɛ si wozãna le asitsatsa me), gake eƒe ɖeɖiteameŋu ƒe tsitretsitsi nyo wu. Adzɔha si tsɔ eɖokui na ɖe nyonyome ŋu zãa spec si sɔ na dɔa. Adzɔnuwɔƒe si le gazazã ƒe nyaƒoɖeamenu me zãa nusianu si to ŋkuléle ɖe eŋu me.

Gake biabia si sesẽ wue nye esi: Aleke nèwɔna ɖoa kpe nuwo ƒe nyonyome dzi ŋutɔŋutɔ? Ðaseɖigbalẽ siwo tso nu xoxowo dzrala gbɔ mesɔ gbɔ o. Èhiã mɔ̃ɖaŋu dodokpɔ ŋuti nyatakakawo — ɖeɖiteameŋu dodokpɔ, tensile strength, hardness — le lot ɖesiaɖe me. Eye èhiã be woadzra wo ɖo ƒe 3 ya teti nenye be adzɔnu aɖe do kpo nu le agblea dzi eye nèhiã ʋɔnudrɔ̃ƒe ŋuti nyatakakawo.

Bia adzɔnuwɔla aɖe be: 'Dodokpɔƒe le aƒea mea?' Ne ŋuɖoɖoa nye ao la, ke wole kpɔɖeŋuwo ɖom ɖe ame etɔ̃lia. Ema le blewu eye wòxɔ asi wu na wo, si fia be wodoa hatsotso ʋɛ aɖewo kpɔna. Ne wogblɔ be ɛ̃ la, bia dɔwɔnu kawoe le wo si. Instron mɔ̃ aɖe na tensile dodokpɔ, TA mɔ̃ na ɖeɖiteameŋu dodokpɔ, CMM na didime ƒe kpeɖodzi — esiawo nye $100K + ɖesiaɖe. Ne dɔwɔƒe aɖe de ga gbogbo ma gbegbe dodokpɔ me la, wobua nyonyome nu vevii.

Bia nu tso traceability hã ŋu. Ðe woate ŋu akpɔ nusi wotsɔ de lãme na ame ɖesiaɖe tso eƒe nu xoxowo ƒe hatsotso mea? Ele be xexlẽdzesi si wotsɔ laser de dzesii nanɔ gavi ɖesiaɖe ŋu. Ne èhe gavi aɖe tso nudzraɖoƒewo me le ɣleti ade megbe la, ɖe woate ŋu awɔ mɔ̃ɖaŋu dodokpɔ ŋuti nyatakakaa tso hatsotso si me wòtso mea? Ne menye nenema o la, ke ɖoɖowɔwɔ ƒe kuxi aɖe le ŋuwò ne nane do kpo nu.

Ne ehiã be nàda adzɔnuwo ƒe nɔnɔme tɔxɛwo kple nusiwo wotsɔ wɔe ƒe nuŋlɔɖiwo kpɔ la, zi geɖe la, adzɔnuwɔƒe siwo naa mɔ̃ɖaŋununya ŋuti nyatakakawo naa nusiwo woate ŋu awɔ kɔpi na adzɔnuwo ƒe nɔnɔmewo kple mɔ̃ɖaŋu ŋuti nuŋlɔɖiwo — esia nye mɔnu nyui aɖe si dzi nàto akpɔe ɖa be woƒe traceability systems ɖo wò asi ƒe nudidiwo gbɔ hã.

OEM ƒe asitɔtrɔ le nɔnɔmewo ŋu ƒe Gazazã Ɣaɣla

Mamãla geɖe susu be OEM wɔwɔ fia be yewoate ŋu abia be woawɔ tɔtrɔ siwo wowɔ ɖe ɖoɖo nu ɣesiaɣi si yewodi. Dzogoe siwo to vovo vie le agbaa dzi. Amadede si to vovo na dzesidede. Aɖaka ƒe nɔnɔme si sɔ kple woƒe dzesidenu.

Kuxiae nye esi: Tɔtrɔ ɖesiaɖe bia be woada asi ɖe aɖaŋuwɔwɔ dzi, woawɔ sedziwɔwɔ ŋuti nuŋlɔɖi yeyewo, eye woaxe dɔwɔnu yeyewo ƒe gazazãwo. Adzɔnuwɔƒe akpa gãtɔ atsɔ dzidzɔ axɔ wò nudɔdɔa hena tɔtrɔ siwo wowɔ ɖe ɖoɖo nu — le 3x ƒe asi si nye nusiwo wowɔna ɖaa, kple ŋkeke 90 ƒe ɣeyiɣi siwo woatsɔ awɔ dɔe. Mamãla la le mɔ kpɔm be yeaɖe adzɔnu yeye aɖe si ƒe ŋkɔ woŋlɔ na ame ŋutɔ la ɖe go eye wòkpɔe be yewotsɔ yewo ɖokui na be yewoawɔ $50K le dɔwɔnuwo ƒe gazazãwo kple ɣleti ade ƒe ɖoɖowɔɖi ƒe ɣeyiɣiɖoɖo me.

Esia tae wòle be nàgblɔ nusi 'OEM' fia le wò nubabla me tẽ. Ne èdi be yeate ŋu atrɔ asi le aɖaŋuwɔwɔ ŋu la, ke ahiã be:

• Nya si me kɔ tso tɔtrɔ siwo wowɔna femaxee ŋu (atsyɔ̃ɖonuwo: nubablɛwo, ŋkɔ dede wo dzi) .
• Tɔtrɔ kawoe bia gazazã kple ɣeyiɣi ƒe ɖoɖo bubuwo (trɔtrɔ le aɖaŋuwɔwɔ ŋu: dzogoewo, didimewo) .
• Ameka tɔe aɖaŋu si wowɔ zi ɖeka (wò loo alo woawo?) .
• Nukae adzɔ ne èdi be yeatsɔ aɖaŋua ayi na dɔwɔƒe bubu emegbe

Bia hã be: Nukae nye woƒe nudɔdɔ ƒe agbɔsɔsɔ suetɔ kekeake na atsyã siwo wowɔ ɖe ɖoɖo nu? Dɔwɔƒe aɖewo hiãa unit 1,000 hafi woawɔ dɔwɔnu si wowɔ ɖe ɖoɖo nu. Ame aɖewo awɔ 200. Vovototo ma ɖe dzesi ŋutɔ na numamãla si gakpɔtɔ le asi kpem ɖe adzɔnu yeye aɖe ŋu.

IP Nyabiase Si Ŋu Ame aɖeke Medi Be Yeaƒo Nu Tsoe O

Dɔwɔwɔ kple Chinatɔwo ƒe adzɔnuwɔƒe aɖe fɔa IP dzitsitsi siwo sɔ ɖe te. Menye esi Chinatɔwo ƒe dɔwɔƒewo nye esiwo dzi womate ŋu aka ɖo le dzɔdzɔme nu o tae o, ke boŋ esi dzideƒonamenuwo ƒe ɖoɖo to vovo tae. Ne wò OEM dɔwɔhati mate ŋu aʋli ho kpli wò le se nu le wò asiwo me o la, wometea wo kpɔna be yewoatso dzogoewo alo ada wò atsyãwo o.

Ele be nubabla la nanye:

• NDA si me kɔ — wowɔe hafi woama aɖaŋuɖoɖo ƒe faɛl alo nɔnɔme ɖesiaɖe
• Ownership clause — nya si wogblɔ tẽ be aɖaŋu tɔxɛ siwo wowɔ na wò nɔnɔmewo gakpɔtɔ nye wò IP
• Hoʋiʋli manɔmee ƒe ɖoɖowɔwɔ — mɔxexe ɖe adzɔnuwɔƒea nu be wòagatsɔ OEM ƒe ɖoɖo siwo sɔ ana wò hoʋlila tẽ siwo le wò anyigbamama si woŋlɔ ŋkɔ na me o
• Gomenɔamesiwo le agbalẽdzikpɔkpɔ me — gomenɔamesi be woalé ŋku ɖe nuwɔwɔ ŋuti nuŋlɔɖiwo kple nuŋlɔɖi nyuiwo ŋu

Viɖe aɖeke mele ŋugbedodo siwo wogblɔna kple nu le nya siawo ŋu o. Ne adzɔnuwɔƒe aɖe medi be yeade IP takpɔkpɔ gbegbɔgblɔ nubabla la me o la, didi ma nye nyatakaka.

Alesi Ƒomedodoa Le Nuteƒewɔwɔtɔe Le Asidede Agbalẽ Te Megbe

Ne wonya de asi nubabla la te ko la, nu etɔ̃e wotsɔ ɖea ƒomedodoa fiana:

Dzeɖoɖo edziedzi. Adzɔnuwɔƒe aɖewo wɔa nu yeyewo kwasiɖa sia kwasiɖa. Ame aɖewo zia ɖoɖoe negbe ɖe nèti wo yome hafi. Ðo mɔkpɔkpɔwo ɖi do ŋgɔ: Zi nenie nàxɔ kpeɖodzigbalẽ siwo ɖo kpe edzi be woɖoe ɖe wò? Nukae nye ɣeyiɣi si woatsɔ aɖo nyabiase siwo hiã kpata ŋu? Ðe gakɔntadzikpɔla tɔxɛ aɖe le wo si loo alo ɖe nènye tikiti si le fli mea?

Trɔtrɔ ɖe nɔnɔmewo ŋu le nudɔdɔwo me. Àte ŋu ate fli ɖe nuƒle ƒe nudɔdɔ aɖe me ne èwɔe vɔa? Ðe nàte ŋu aɖe agbɔsɔsɔ dzi akpɔtɔ ne wò kɔdzi ƒe nubablawo trɔa? Ðe nàte ŋu adzi agbɔsɔsɔ ɖe edzi ne nudidiwo dzi ɖe edzia? Na woŋlɔ esia ɖe agbalẽ me. Vovototo si le 'àteŋu ate fli ɖe eme vaseɖe ŋkeke 14 hafi aɖoe ɖa' kple 'teteɖeanyi aɖeke o' dome anɔ vevie.

Kuxiwo gbɔ kpɔkpɔ. Nukae dzɔna ne batch aɖe va ɖo eye nèkpɔ quality issues? Ðe woɖɔliae enumake loo alo bia tso asiwò be nàgbugbɔ aɖo eƒe kpɔɖeŋuwo ɖa be woadoe kpɔa? Ðe woxea fe ɖe meliɖoɖowo ta? Ðe ŋkeke 30 ƒe fesre aɖe li si dzi woato agblɔ nusiwo gblẽ loo alo ɖe wònye agbemeŋkekewo katãa? Le afisia hã la, esia le nubabla la me, gake zi geɖe la, emamãlawo doa kpo exlẽ nyuie.

Nyateƒenyawo Me Dzodzro Blewu aɖe

Hafi nàde asi nane te la, bia ɖokuiwò be: Ne medzudzɔ nudɔdɔ tso dɔwɔƒe sia gbɔ etsɔ la, ɖe woagaɖo nye kaƒoƒoawo ŋu kokokoa? Alo esi mele nudɔdɔwo wɔm ta koe wotsɔ ɖe le emea?

Srɔ̃tɔ ƒe ƒomedodo fia be wodi be yewoanɔ asitsadɔ me kpli wò. Nudzralawo dome ƒomedodo fia be wodi wò nudɔdɔ si nèbia fifia. Vovototoa dzena ne èhiã kpekpeɖeŋu eye dɔwɔƒea le vovom ɖe akɔnta si lolo wu ŋu.

Bia nufiame akɔnta — mamala bubu si le wo zãm xoxo. Yɔ mamala ma eye nàbia be: 'Ne kuxi aɖe do mo ɖa la, aleke wowɔa nui?' Àxɔ ŋuɖoɖo anukwaretɔe. Edzɔa dzi na numamãla akpa gãtɔ be yewoaƒo nu tso yewoƒe nudzralawo ŋu, vevietɔ ne ame bubu aɖe le veviedodonu si dze wɔm.

Ne Èle Dzadzraɖo Be Yeayi Ŋgɔ

Ne èle OEM wɔlawo me dzrom la, ɖewohĩ èle didim be yeakeke yeƒe adzɔnuwo ɖe enu alo èle tɔtrɔm tso dɔwɔƒe si dzi womate ŋu aka ɖo o gbɔ. Nusiwo le eme la nye nyateƒe — èle nudzraɖoƒewo, ɖoɖowɔwɔ ƒe agbagbadzedze, kple atikewɔƒe ƒe ŋkɔ nyui tsɔm na hadomeɖoɖo sia.

Dze egɔme kple mɔ̃ɖaŋununya ƒe ŋutete: Ðe woate ŋu awɔ nusiwo nèhiã ŋutɔŋutɔa? Ðe woate ŋu akpɔ wò sedziwɔwɔ ƒe nudidiwo gbɔa? Ðe woate ŋu adzi ɖe edzi kple wò tsitsia? Ne woɖo kpe esiawo dzi vɔ ko hafi wòle be nàwɔ ɖoɖo ɖe asixɔxɔ ŋu.

Emegbe nàʋu ayi dɔwɔwɔ dzi: Ðe woaɖo meliwo ɖe amewo kakaɖedzitɔea? Ðe woaɖo dze kpli woa? Ðe woakpɔ kuxiwo gbɔ kpli wò ne nuwo meva yi nyuie oa?

Ne èle China-dukɔ OEM hadɔwɔla aɖe ŋu bum vevie la, afɔɖeɖe si kplɔe ɖo si wɔa dɔe nye be nàda kpɔɖeŋu si le dɔ wɔm la kpɔ eye nàse woƒe ɖoɖo si wowɔna tsɔ kpɔa gbeɖiɖi siwo bɔbɔ le gɔmedzedzea me gbɔe gɔme. Mamãla geɖe tsɔe be OEM ƒe hadomeɖoɖowo bia ŋugbedodo gãwo do ŋgɔ — gake adzɔnuwɔƒe siwo ɖoa nya ŋu se egɔme be ele be nàda asi ɖe alesi wòsɔ, nuŋlɔɖiwo, kple dɔdaƒe ƒe lɔlɔ̃ ɖe edzi dzi hafi nàdzidze nudzraɖoƒewo. Ne èle klalo be yeadzro adzɔnuwo ƒe hatsotso tɔxɛwo kple ɣeyiɣi ƒe mɔkpɔkpɔwo me la, àte ŋu adze dzeɖoɖo gɔme kple OEM eŋutinunyala aɖe be nàse alesi hadomeɖoɖowɔwɔ le ŋutɔŋutɔ le wò tsitsi ƒe afɔɖeɖea me gɔme.

Nubabla me nyawo le vevie, gake ƒomedodo ƒe ŋutete ya le vevie wu. Menye adzɔnu aɖekee nèle ƒlem o. Èle mɔ ƒlem na adzɔnuwo wɔwɔ ƒe hadɔwɔla si hã tsɔe na amekolawo ƒe dedienɔnɔ kple kɔdzi dzidzedzekpɔkpɔ.

Nya Siwo Wobiana Enuenu

Vovototo kae le OEM kple ODM dome?

OEM fia be ewɔla wɔa nusiwo wotsɔ dea ame me ɖe wò nɔnɔmewo nu — wò atsyã, wò adzɔnu ƒe dzesi. ODM fia be wotsɔa woawo ŋutɔ ƒe atsyã si li xoxo si nàte ŋu ana mɔɖegbalẽe eye nàde dzesii le wò adzɔnu ƒe ŋkɔ te la naa. ODM wɔa dɔ kabakaba wu eye afɔku mele eme o; OEM sɔ ne aɖaŋuwɔwɔ ƒe nudidi siwo nye tɔwò alo adzɔnu ƒe IP si li xoxo le asiwò nàtsɔ akpɔ eta.

Ɣeyiɣi didi kae wòxɔna hafi woate ŋu atsɔ OEM ƒumeŋuɖui aɖe ava asi me?

Le ODM kple aɖaŋu siwo ŋu woda asi ɖo xoxo gome la, ɣleti 3–6 nye nu ŋutɔŋutɔ na asi siwo me CE alo FDA-kɔkɔe ƒe nuŋlɔɖiwo le xoxo. Le OEM blibo kple custom design, gazazã ƒe ɖoɖo ɣleti 12–18 be woabu akɔnta le design validation, sedede ɖoɖo ɖa, kple ŋkɔ ŋɔŋlɔ. Asi siwo me nutoa me ƒe ŋkɔ dede agbalẽ me ƒe nudidi didiwo le (le kpɔɖeŋu me, Brazil ANVISA, China NMPA) tsɔa ɣeyiɣi bubuwo kpena ɖe eŋu.

Ðaseɖigbalẽ kawoe wòle be OEM ƒumeŋuɖuiwɔƒe si le China naxɔ?

Ne mede ɖeke o la: ISO 13485 kple kekeme si axɔ wò adzɔnuwo ƒe hatsotso tɔxɛwo. Wobia be woade dzesi CE na Europa ƒe asiwo; FDA 510(k) ƒe mɔɖeɖe na U.S.; Wole MDSAP hiãm geɖe wu na Canada, Brazil, Australia, kple Japan. Mègatsɔe be ɖaseɖigbalẽ ɖeka koe ƒo nu tso adzɔnuwo ƒe hatsotsowo katã ŋu o — bia kekeme ƒe kpeɖeŋutɔ na ɖaseɖigbalẽ ɖesiaɖe.

Nukae nye MOQ si me susu le na ƒumeŋuɖui siwo wotsɔ dea ame ŋutɔ ƒe ŋkɔ me?

MOQs to vovo ŋutɔ le adzɔnuwɔƒe kple adzɔnuwo ƒe hatsotso nu. Le mamala si le ame ŋutɔ ƒe ŋkɔ ƒe fli yeye tum gome la, di nudzrala siwo naa SKU-level MOQs le 20–50 units dome na nudɔdɔ gbãtɔwo, kple asixɔxɔ ƒe ɖoɖo siwo wotu ɖe agbɔsɔsɔme dzi na nudɔdɔ siwo wogbugbɔ wɔ. Kpɔ nyuie le adzɔnuwo wɔlawo ƒe biabia be woawɔ blanket volume commitments le ɖoɖo blibo aɖe me hafi nàda asi ɖe dɔdaƒewo ƒe xɔxlɔ̃ dzi le wò asi me.

Aleke mawɔ akpɔ nye IP ta ne mele dɔ wɔm kple Chinatɔwo ƒe ƒumeŋuɖuiwɔƒe aɖe?

Wɔ NDA hafi nàma aɖaŋu ɖesiaɖe si nye ame ŋutɔ tɔ, asitsatsa ŋuti nyatakaka, alo asisiwo ŋuti nyatakaka. Ele be OEM ƒe nubabla la ŋutɔ nanye IP ƒe amesinɔnɔ ƒe nya si me kɔ (wò ŋutɔ tɔ ƒe nɔnɔmetata siwo wowɔ ɖe ɖoɖo nu), mɔxexe ɖe hoʋiʋli manɔsenu nu na wò anyigbamama si woŋlɔ ŋkɔ na, ​​kple agbalẽdzikpɔkpɔ ƒe gomenɔamesiwo. Ŋlɔ wò asitsadzesiwo ɖe China hafi woadze ewɔwɔ gɔme — Chinatɔwo ƒe asitsadzesiwo ƒe se nye gbãtɔ si woatsɔ ade agbalẽ me, ke menye gbãtɔ si woazã o.

Ðe OEM-dɔwɔƒe aɖe ate ŋu ana sedziwɔwɔ ŋuti nuŋlɔɖiwo na nye nutoa me ƒe ŋkɔ dede agbalẽ mea?

Ele be OEM ƒe hadɔwɔla bibi nate ŋu ana mɔ̃ɖaŋununya ƒe faɛl, Ðekawɔwɔ ƒe Nyatakaka, dɔdaƒe ƒe numekuku ŋuti nyatakaka, kple dzesidegbalẽvi siwo hiã na asitsatsa ƒe ŋkɔ ŋɔŋlɔ akpa gãtɔ. Kpe asi ɖe asi siwo ŋu woƒe ɖoɖowɔha si si nuteƒekpɔkpɔ le koŋ dzi — kpekpeɖeŋunana EU MDR ƒe nyatakakawo ɖoɖo ɖa to vovo tso ANVISA ƒe agbalẽwo dzadzraɖo gbɔ, eye menye adzɔnuwɔlawo katã ƒe ŋutete sɔ le wo ame evea siaa me o.