OEM Orthopaedic Implant Manufacturer: Jagokɛlaw ka kan ka fɛn minnu lajɛ sani u ka kɛ

A ka c’a la, sugandili OEM kolotugudaw dilannikɛla bɛ daminɛ ni ɲininkali nɔgɔman ye: yala nin feerekɛla in bɛ se ka fura in dilan sɔngɔ bɛnnen na wa?

O ɲininkali nafa ka bon, nka a man teli ka kɛ ɲininkali ye min bɛ a latigɛ ni jɛɲɔgɔnya bɛ baara kɛ. Kolotugudaw la, a ka c’a la, gɛlɛyaw bɛ bɔ kɔfɛ — mɔgɔ tɔgɔ sɛbɛnni waati, dɔgɔtɔrɔso jateminɛ waati, komandi seginni waati, walima ni jatebɔla dɔ ye gafesɛbɛn bɔ kaban ani ka feerekɛlaw dege.

Unit sɔngɔ min ka dɔgɔn, o bɛ se ka tunun joona ni seereyaw hakɛ ma jɛya, ni fɛɛrɛbɔ dosiye ma dafa, walima ni ciden dɔ ma se tender finɛtiri la. O de y’a to jatebɔlaw minnu bɛ se kosɛbɛ, olu ka teli ka tɛmɛn quotation sɛbɛn kan. U b’a ɲininka cogo min na a dilabaga bɛ sɛbɛnw, u nɔfɛtaama, u bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, u bɛ fɛnw mara cogo min na, ani u bɛ kunkanbaaraw ɲɛnabɔ ni fɛn dɔ ma taa i n’a fɔ a tun labɛnna cogo min na tigitigi.

Fɛn minnu bɛ duguma, olu ye yɔrɔw ye minnu ka kan ka lajɛ sani bɛnkansɛbɛn ka bolonɔ bila. U tɛ teoriw ye. U ye OEM jɛɲɔgɔnya yɔrɔw ye minnu ka teli ka kɛ sɔngɔ gɛlɛn ye n’u tora u ma jɛya.

1. Aw bɛ a daminɛ ni seereyaw hakɛ ye, aw kana daminɛ ni seereyaw taamasiyɛn ye

Dilanbaga fanba bɛ se ka seere dɔ jira. Mɔgɔ damadɔw bɛ se k’a ɲɛfɔ o seere bɛ min ɲɛfɔ o yɔrɔnin bɛɛ.

Jagokɛla fɛ, o danfara in nafa ka bon. ISO 13485 seere min bɛ siti kan, o kɔrɔ tɛ a yɛrɛma ko fɛn donta suguya bɛɛ, fɛn dilanni yɔrɔ bɛɛ, ani jagokɛyɔrɔ bɛɛ bɛ datugu. Sɛbɛn ɲumanw bɛ se ka sɔrɔ furakɛlikɛla dɔ fɛ joginda platiw kan nka sɛbɛnfura barikama bɛ se ka sɔrɔ kɔkolow la. Dɔ wɛrɛ bɛ se ka kɛ ni CE sɛbɛn barikamaw ye, nka dɔnniya danmadɔ bɛ a la ka dɛmɛ don mɔgɔ tɔgɔ sɛbɛnni na suguw la minnu bɛ sigida dosiye wɛrɛw wajibiya.

Sani aw ka sɔngɔw suma ɲɔgɔn na, aw bɛ seereyaw hakɛ bɛɛ ɲini ani a ni o ɲɔgɔnna farankanw. Seginkanni ka kan k’a jira ni a dilabaga bɛ se ka dɛmɛ don fɛn dilannenw denbaya tigitigi ma i b’a fɛ ka min tɔgɔ sɛbɛn, a kana kɛ dɔrɔn ni sosiyete ka jogoɲumanya seere caman bɛ a bolo.

Dugukolo kan koloci tilabaga fanba fɛ, a ka c’a la, sɛbɛnw lajɛ bɛ daminɛ ni ninnu ye:

• ISO 13485 — ka fɛn dilannenw suguyaw ni fɛn dilanni baara minnu kofɔlen don skɔpi kɔnɔ, olu lajɛ
• CE Mark — a jira ni fɛn dilannenw denbaya bɛ a kɔnɔ ani ni sɛbɛnw bɛ i ka EU walima suguya min bɛ tali kɛ o la, o dɛmɛ
• FDA 510(k) — min bɛ tali kɛ ni Ameriki sugu ye labɛn dɔ ye
• MDSAP — nafa ka bon jatebɔlaw ma minnu bɛ baara kɛ ni Kanada, Berezili, Ɔsitarali, Japon, walima sugu wɛrɛw ye, MDSAP bɛ se ka nɔ bila yɔrɔ minnu na sɛbɛnni na

Nin fana ye waati ɲuman ye walasa ka feerekɛla ka sariyasunba kumaɲɔgɔnya kɔrɔbɔ. OEM jɛɲɔgɔn setigi ka kan ka lafiya ka baro kɛ a bonya kan, fɛɛrɛko dosiyew, taamasiyɛnw, ani sugu sɛbɛnni wajibiyalenw kan cogo kɛrɛnkɛrɛnnenw na. Ni jaabi bɛɛ tora fɛn bɛɛ lajɛlen na, o ye lasɔmini taamasyɛn ye.

Walasa ka kunnafoni caman sɔrɔ jogoɲumanya-sigida jigiyaw kan, aw ye XC Medico ta lajɛ ISO 13485 ka seereyaw kolotugudaw dilanni seko ɲɛ.

2. Ka 'OEM' kɔrɔ ɲɛfɔ tiɲɛ na nin porozɛ in kɔnɔ

OEM daɲɛ bɛ baara kɛ ni lafiya ye kosɛbɛ kolotugudaw feereli sugu la.

Tuma dɔw la, o kɔrɔ ye fura dilanni lakika ye: feerekɛla bɛ na ni wajibi dɔ ye, dilancogo hakilina dɔ, walima kɛnɛyaso ka fɛɛrɛ dɔ, wa a dilannikɛla bɛ dɛmɛ don k’a tigɛli kɛ fɛn ye min bɛ se ka dilan. Tuma wɛrɛw la, o kɔrɔ dɔrɔn ye logo taamasiyɛn ye katalogu fɛn dɔ kan min bɛ yen. O modɛli filanan bɛ se ka nafa sɔrɔ hali bi, nka a surunyalen don mɔgɔ kelen-kelen ka labeli la ka tɛmɛ OEM dafalen dilanni kan.

Jagokɛlaw ka danfara bɛ ye. Danfara min bɛ sariyaw ni sariya siratigɛ la, o nafa ka bon ka tɛmɛ o kan.

Ni porozɛ in bɛ tali kɛ mɔgɔw ladamuni lakika la, a dilabaga ka kan ka se k’a ɲɛfɔ cogo min na ɛntɛrinɛti lajɛ, misali dilanni, dilancogo sɛgɛsɛgɛli, taamasiyɛnw, ani sɛbɛnw bɛna ɲɛnabɔ. Ni porozɛ in ye mɔgɔ kelen-kelen ka taamasiyɛn ye kosɛbɛ, feerekɛla ka kan ka jɛya a la, fɛn min bɛ se ka Changé ani min tɛ se ka Changé, k’a sɔrɔ a ma nɔ bila validation pake kɔrɔ la.

Foyi tɛ kojugu ye n’i y’a daminɛ ni dilancogo ye min sɛgɛsɛgɛra, ka porogaramu dɔ jɔ min bɛ wele ko privé-label (kɛrɛnkɛrɛnnenya la) a lamini na. Jagokɛla caman fɛ, o de ye sira ye min ka telin ani farati ka dɔgɔn. Gɛlɛya ye ni fan fila bɛɛ bɛ porozɛ wele 'OEM' nka jigiya tɛ kelen ye tigiya, ladamuni, sɛbɛnni, ani kunkanbaaraw ko la.

3. Traceability (Traceability) ye yɔrɔ ye, yɔrɔ min na, fɛn sɔngɔ gɛlɛnw bɛ kɛ sɔngɔ gɛlɛn ye tuma caman na

Don o don kumaɲɔgɔnyaw la, tugu-tugu-ɲɔgɔn kɔ bɛ se ka kɛ i n’a fɔ jogoɲumanya baarakɛyɔrɔ barokun. Jatebɔ baara lakika la, a ye feereli ni faratiw barokun ye fana.

Dɔgɔtɔrɔsow ni sariyasunba bɛ se k’a ɲininka o fɛn bɔra yɔrɔ min na, a tun bɛ kulu jumɛn na, ni sɛgɛsɛgɛli sɛbɛnw bɛ bɛn ni cikan ye, ani ni o fɛn donta bɛ se ka sɔrɔ ka tɛmɛn fɛn dilanni cakɛda fɛ. Ni fɛn dilannikɛla tɛ se k’o ɲininkaliw jaabi ka ɲɛ, a feerela bɛ to k’a ɲini ka fɛn dɔ ɲɛfɔ a ma min dilan.

Ni kolotugudaw doncogo don, o fɛn filen man kan ka jate i n’a fɔ a kɛcogo. Sɛbɛn lakikaw bɛ misaliw ɲini, feerekɛla bɛ minnu di ni u cilen don walima u cilen kɔfɛ. Dilanbaga ŋana ka kan ka se k’a jira cogo min na fɛn dilannenw ka seere, sɛgɛsɛgɛli sɛbɛn min bɛ baara la, sɛgɛsɛgɛli laban, ani laser taamasiyɛn bɛ ɲɔgɔn sɔrɔ cogo min na.

Fɛn koloma minnu ka kan ka segin u kan, olu dɔw ye:

• Fɛnɲɛnɛmafagalanw ka seereyaw — misali la, titaniyɔmu sɔgɔlen sɛbɛnw i n’a fɔ ASTM F136 / Ti-6Al-4V ELI walima a ɲɔgɔnna sariyaw ni o bɛ se ka kɛ
• Sɛgɛsɛgɛli sɛbɛnw minnu bɛ baara kɔnɔ — hakɛw sɛgɛsɛgɛli, dugukolo sanfɛla sɛgɛsɛgɛli sɛbɛnw, ani sɛgɛsɛgɛli sɛbɛnw
• Masina sɛgɛsɛgɛli rapɔɔriw — kɛrɛnkɛrɛnnenya la doni-ta-minɛnw na, sɛgɛn walima fanga kunnafoniw bɛ se ka kɛ yɔrɔ minnu na; ɲininkali kɛ ni sɛgɛn sɛgɛsɛgɛli bɛ se ka kɛ ka kɛɲɛ ni ISO 12189 ye walima fɛɛrɛ minnu bɛ bɛn o ma
• Laser taamasiyɛn ni batch traceability — fɛn kelen-kelen bɛɛ ka kan ka tugu ɲɔgɔn kɔ ka kɛɲɛ ni a dilanni batch ye

Ni farati ka bon farikolo doncogo suguyaw la, sɛgɛsɛgɛli seko nafa ka bon ka lajɛ ka ɲɛ. XC Medico ka jogoɲumanya siratigɛ bɛ dɛmɛ sɔrɔ laboratuwari dɔ fɛ min lakodɔnnen don CNAS fɛ, ni minɛnw ye i n’a fɔ Instron sɛgɛn sɛgɛsɛgɛli masinw, CMM sɛgɛsɛgɛli minɛnw, ani 3D topidiya sumanikɛminɛnw. Jagokɛlaw fɛ, o nafa ka bon bawo sɛgɛsɛgɛli rapɔɔriw ni sɛgɛsɛgɛli sɛbɛnw tɛ izini kɔnɔna dosiyew dɔrɔn ye; tuma caman na, u bɛ kɛ daliluw dɔ ye minnu bɛ kɛ furaw sɛbɛnni waati, dɔgɔtɔrɔso jateminɛ waati, ani suguba kɔfɛ jogoɲini waati.

4. MOQ tɛ sanni nimɔrɔ dɔrɔn ye

MOQ bɛ i n’a fɔ jagokɛla fitinin dɔ fo ka se a tilabaga dɔ ma k’a ɲini ka fɛnw doncogo kura daminɛ.

MOQ belebele bɛ se ka sɔn fura kɔgɔlen ma min ka dɔgɔtɔrɔso ɲinini sabatilen don. A ka gɛlɛn kosɛbɛ ka jo di ni a tilabaga bɛ ka operelikɛla ka sɔnni sɛgɛsɛgɛ hali bi, ka minɛnw jɔ, ka mɔgɔ tɔgɔ sɛbɛnni labɛn, walima ka don mara kura kɔnɔ. O waati la, MOQ jugu bɛ se ka wari siri SKUw kɔnɔ minnu bɛ taa dɔɔnin dɔɔnin sanni sugu k’a yɛrɛ jira.

O de kama MOQ ka kan ka baro kɛ ɲɔgɔn fɛ ni daminɛ bolodalen ye, a man kan ka kɛ danfara la. A ka c’a la, fɛn dilannikɛla min bɛ jatebɔlaw ka sɔrɔko faamuya, a ka c’a la, o bɛna da wuli ka komandi kɛ dakunw na: misaliw fɔlɔ, o kɔfɛ, komandi fɔlɔ danma, o kɔfɛ, hakɛ sɔngɔko ni a tali bɛ bonya.

Sani aw ka layidu ta, aw bɛ a ɲɛfɔ:

• MOQ per SKU ka ɲɛsin fɛnw ma minnu bɛ wele ko standard privé-label
• Yala OEM/ODM komandi minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, olu bɛ se ka daminɛ 1 set , kɛrɛnkɛrɛnnenya la sugu sɛgɛsɛgɛli waati
• MOQ ka ɲɛsin fɛnw doncogo, minɛnw, pakew, ani taamasiyɛnw ma minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, tiɲɛni fɔlɔ kɔfɛ
• Misali kumasenw ka kɔn sɛnɛko yamaruya fɔlɔ ɲɛ
• Waati min bɛ kɛ ka ɲɛsin komandi fɔlɔ ma ni yamaruya seginni ye
• Yala sɔngɔko bɛ se ka ɲɛ ni san hakɛ ye, o bɛ jɛya ka taa a fɛ

Fɛn dilanbaga min bɛ gɛlɛya fɔlɔ dɔrɔn de gɛlɛya, o bɛ se ka kɛ ka izini bɔli ɲɛnabɔ sanni i ka don sugu la. OEM jɛɲɔgɔn ɲuman bɛ jagokɛla dɛmɛ ka dɔ bɔ laseli farati la k’a sɔrɔ a bɛ sira da hali bi ka taa sɛgɛsɛgɛli la. Tiɲɛ na, komandi minnu bɛ daminɛ ni seti 1 ye, olu bɛ dilanbaga ka so di u ma walasa a ka se ka fɛn dilannenw bɛncogo sɛgɛsɛgɛ, ka sɛbɛnw dafa, ka sigida tɔgɔsɛbɛnni labɛn, ani ka gɛrɛ dɔgɔtɔrɔsow la k’a sɔrɔ u ma wari datugu sistɛmu dafalen kɔnɔ joona kojugu.

Walasa ka jateminɛ wɛrɛw kɛ feerekɛlaw sugandili kan, aw bɛ se ka XC Medico ka gafe fana kalan min kan kolotugudaw dilannikɛla ɲumanw sugandili feerekɛlaw ye.

5. Aw bɛ IP sariyaw bila sɛbɛn kɔnɔ sani ja fɔlɔ ka ci

IP lakanani bɛ kuma tuma caman na kɔfɛ kojugu.

A daminɛ na, fan fila bɛɛ bɛ se k’a miiri ko o jɛɲɔgɔnya ye teriya ye ani ko a tilennen don. Jagokɛla b’a fɛ ka quotation teliya. A dilabaga b’a fɛ ka seko jira. Jaw, kiliyanw kunnafoniw, pakew hakilinaw, ani suguya labɛnw bɛ daminɛ ka taa ɲɛfɛ ka segin sanni bɛnkansɛbɛn kan ka labɛn.

O tɛ delinako ɲuman ye.

Sani aw ka dosiye sɛgɛsɛgɛlenw tila ɲɔgɔn na, sariya jɔnjɔnw ka kan ka sɛbɛn kaban. O man kan ka gɛlɛya, nka a ka kan ka kɛ k’a jɛya. Bɛɛnkansɛbɛn ka kan k’a jira jɔn ye fɛn dilannenw ye minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, kunnafoniw gundo bɛ minɛ cogo min na, ani ni a dilabaga balilen don ka fɛn dilannenw dilancogo kelenw di ɲɔgɔndankɛlaw ma minnu bɛ dilanbaga ka yɔrɔ lakananen na.

A dɔgɔyalenba la, baro kɛ nin hakilinaw kan:

• NDA — bolonɔ bilalen bɛ sanni dilan dosiyew, kiliyanw ka kunnafoniw, walima sugu labɛnw ka tila ɲɔgɔn na
• Design ownership — kɛrɛnkɛrɛnnenya la fɛnw kama minnu dilannen don ka bɔ jatebɔla ka fɛn dilannenw na
• Jamana lakanani — ni a bɛnnen don, i k’a ɲɛfɔ ni OEM cogoya kelenw bɛ se ka feere ɲɔgɔndan ɲɛmɔgɔw ma
• Jateminɛ ni sɛbɛnni josariyaw — ka ɲɛfɔli kɛ jogo ni fɛn dilanni sɛbɛnw minnu bɛ se ka lajɛ

Kɛlɛ fanba tɛ daminɛ bawo fan dɔ tun bɛ gɛlɛya makɔnɔ. U bɛ daminɛ bawo daɲɛ nafamaw tun bɛ miiri sanni u ka sɛbɛn.

6. Jiginni dannaya de nafa ka bon kosɛbɛ komandi fɔlɔ kɔfɛ

Tuma caman na, ci fɔlɔ de bɛ jateminɛ sɔrɔ kosɛbɛ. Misaliw bɛ labɛn ka ɲɛ, kumaɲɔgɔnya bɛ teliya, wa fan fila bɛɛ b’a fɛ porozɛ ka taa ɲɛ.

Kɔrɔbɔli min ka fisa, o ye min bɛ kɛ jagokɛla ye feereli daminɛ kɔfɛ.

Yala fɛn dilannikɛla bɛ se ka fɛnw mara minnu bɛ kɛ ka kɛɲɛ ni sariya ye wa? Yala segin-ka-bɔnyew bɛ se ka kɛ ka kɔrɔ wa? Yala furakɛlikɛla bɛ se ka dɔgɔtɔrɔso ɲinini kɔrɔtɔlenw faranfasi ka bɔ fɛnw falennicogo nɔgɔman na wa? Ni fɛnw doncogo dɔ bɛ minɛnw de wajibiya, yala o minɛnw bɛ sɔrɔ ni fɛnw donna fɛnw na wa?

O kunnafoniw nafa ka bon bawo feerekɛlaw tɛ fɛnw feere dɔrɔn. U bɛ dannaya feere fana operelikɛlaw, dɔgɔtɔrɔsow ani sannikɛlaw ma. Porogaramu min bɛ kɛ mɔgɔ kelen-kelen bɛɛ fɛ, n’a bɛ iko nafa bɛ a la papiye kan, o bɛ se ka gɛlɛya ka lafasa ni stockouts bɛ to ka kɛ walima ni lead times bɛ Changé k’a sɔrɔ i ma lasɔmi.

Sani i ka i bolonɔ bila OEM bɛnkansɛbɛn na, i ka a ɲini:

• Waati min bɛ kɛ ka caya ka ɲɛsin katalogu fɛnw ma minnu bɛ kɛ ka kɛɲɛ ni sariya ye
• Waati ɲɛminɛni ka ɲɛsin sɛnɛfɛnw dilanni bolicogo ma min bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye
• Inventory coverage for the product familys i b’a fɛ ka minnu lase mɔgɔw ma
• Waati lasecogo kɛcogo ka bɔ kɔsa in na jatebɔlaw ka komandiw la
• Sɛnɛfɛnw dilanni seko ani baarakɛcogo min bɛ kɛ sisan

Laɲini tɛ ka feerekɛla dɔ sɔrɔ min bɛ layidu ta fɛn bɛɛ la. Laɲini ye ka mɔgɔ sɔrɔ min ka layidu kɛrɛnkɛrɛnnenw bɛ se ka labɛn kɛ a lamini na.

Seginkanni nafama min bɛ kɛ ka kɔn bɛnkansɛbɛn ɲɛ

Sani ka bɔ quotation la ka taa kontra la, o bɛ dɛmɛ ka baara sumaya ani ka yɔrɔw lajɛ minnu ka teli ka gɛlɛyaw lase kɔfɛ:

• Seereyaw hakɛ bɛ bɛn fɛn dilannenw suguyaw ma ani sugu laɲinitaw ma
• OEM/ODM modɛli ɲɛfɔlen don ka jɛya sanni sɔngɔko ka ban
• Misali traceability sɛbɛnw bɛ lajɛ, layidu tɛ dɔrɔn
• MOQ bɛ dɛmɛ don jatebɔla daminɛcogo lakika la, o la, ni 1-set daminɛ yamaruyaw bɛ sɔrɔ
• NDA, dilancogo tigiyali, ani waajulikɛyɔrɔ sariyaw sɛbɛnnen bɛ bɛnkansɛbɛn kɔnɔ
• Waati minnu bɛ kɛ ka taa ni u ye ani fɛnw jatebɔsɛbɛnw dafalen don, olu kɛrɛnkɛrɛnnen don dɔgɔtɔrɔso ka fɛnw labɛnni na

Baara kɛli ni OEM jɛɲɔgɔn ɲuman ye

OEM kolotugudaw dilannikɛla ɲuman tɛ tɛmɛ kolotugudaw dilanni dɔrɔn kan. A bɛ feerekɛla dɛmɛ ka dɔ bɔ dannayabaliya la sani furaw ka se dɔgɔtɔrɔsow la.

O kɔrɔ ye sɛbɛnni jɛlenw ye, sɛnɛfɛnw dilanni bolodacogo lakika, jogoɲini sabatili, ani jagokɛcogo min bɛ bɛn jatebɔlaw ka bonya cogo ma tiɲɛ na. Tuma caman na, jɛɲɔgɔn min ka fisa, o tɛ mɔgɔ ye min ka fɔta fɔlɔ ka dɔgɔ. O de bɛ mɔgɔ tɔgɔ sɛbɛnni, a daminɛ, a falenni, ani dɛmɛ kuntaalajan ɲɛnabɔli nɔgɔya.

XC Medico bɛ OEM ni ODM porogaramuw dɛmɛ kɔkolo, joginda, kolotugudaw, ani CMF suguyaw bɛɛ la, ni fɛn dilanni ye, ni misali labɛnni ye, ka sariyasɛbɛnw dɛmɛ, ani ni fɛn dilanni ye min bɛ kɛ ka caya, ka ɲɛsin porozɛw ma minnu ɲɛmɔgɔya bɛ jagokɛlaw bolo. OEM/ODM komandiw kama minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, porogaramu bɛ se ka daminɛ ni 1 set MOQ ye , o b’a to jatebɔlaw bɛ se ka layini kɔrɔbɔ sanni u k’u yɛrɛ bila sistɛmu bɛɛ lajɛlen ka fɛnmarayɔrɔbaw la.

Sɛgɛsɛgɛli kɛ kɔkolo doncogo dilannikɛla ani trauma implants supplier ka fɛn dilannenw siraw, walima fɛn dilannenw ɲɛfɔcogo ni fɛɛrɛ sɛbɛnw telesarse sani i ka i ka feerekɛlaw ka seginnkanni daminɛ.