Nudɔdɔ aɖe kɔa dɔwɔƒea, toa ŋkuléle ɖe eŋu me, eye wòva ɖoa afisi woɖo tae — ɖeko woawɔe le dukɔmeviwo ƒe adzɔxedɔwɔƒe elabena ɖaseɖigbalẽ ɖeka mewɔ ɖeka kple nutoa me ƒe nudidi o. Le adzɔhawo kple mamalawo siwo dia atikewɔnuwo tso China gome la, esia menye nususugblɔ ƒe nɔnɔme o. Enye vodada siwo bɔ wu — eye wòxɔa ga geɖe wu — le atikewɔƒewo didi le atikewɔnuwo ƒe asitsatsa me le liƒowo dzi la dome.
Kuxi siawo ƒe akpa gãtɔ tso nyametsotso ɖeka gbɔ: nudzrala tiatia evɔ màɖo kpe eƒe ɖaseɖigbalẽwo, nyonyome ƒe ɖoɖowo, kple ŋutete si le esi be wòasubɔ wò asi tɔxɛwo dzi bliboe o. Nyati sia ma nusiwo woakpɔ, nusita wòle vevie le asitsatsa me, kple alesi adzɔnuwɔƒe si woɖo anyi abe Joytech Healthcare ene kpɔa nudidi siawo dometɔ ɖesiaɖe gbɔe.
Nuƒlela Siwoe Esia Le Vevie Wu
Stakes dzena vovovo le amesi le sourcing — gake hiahiã si le ete la nye ɖeka.
• Mamãla siwo tsɔa nu vaa asi siwo ŋu wowɔ ɖoɖo ɖo me hiã ɖaseɖigbalẽ siwo sɔ kple teƒe ɖesiaɖe ƒe sewo — masɔmasɔ ate ŋu atɔ te nudɔdɔ blibo aɖe le dukɔmeviwo ƒe adzɔxeƒewo.
• Adzɔnu ƒe adzɔnu ƒe aƒetɔ siwo le woƒe adzɔnu ƒe nɔnɔmetata ta kpɔm hiã na adzɔnuwɔƒe si ƒe nyonyome ƒe ɖoɖo si dzi woate ŋu aka ɖo — elabena adzɔnuwɔƒea tɔ ƒe ŋkɔe le adzɔnua dzi, ke menye adzɔnuwɔƒea tɔ o. Dzɔdzɔmeŋutete ƒe nya siwo ɖoa zãla mamlɛtɔ gbɔ la dina be yewoabu adzɔnu ƒe dzesidea ŋu, ke menye dɔwɔƒe si le megbe nɛ ŋu o.
• OEM/ODM nuƒlela siwo le dɔ wɔm na ɖoɖowɔɖi siwo wowɔ ɖe ɖoɖo nu la hiã hadɔwɔla si ate ŋu alé agbɔsɔsɔme kple nuŋlɔɖiwo ɖe te le ƒe geɖe ƒe ƒomedodo me, ke menye duƒuƒu ɖeka ko o.
Nu vovovo siwo wotsɔ ɖo nɔƒe gbãtɔ, gake le nɔnɔme nyuitɔ me la, wo katã wodzea egɔme tso teƒe ɖeka: ɖo kpe nudzrala aɖe ƒe ŋutete dzi hafi nàtsɔ wo ɖokui ana.
Nusitae Nudzralawo ƒe Ðaseɖigbalẽwo tsoa nya me le wò asi me yiyi ŋu
Hafi asixɔxɔ alo ɣeyiɣi si woatsɔ awɔe la, ɖo kpe edzi nenye be adzɔnuwɔƒe aɖe ƒe ɖaseɖigbalẽwo léa wo ɖe te ŋutɔŋutɔ. Mɔ̃ aɖe ƒe mɔ yi asi ɖesiaɖe me nɔ te ɖe ɖaseɖigbalẽ siwo metsɔna le wo ɖokui si o dzi — nusiwo kɔ nuto ɖeka me ate ŋu ahiã be woawɔ numekuku ɖe vovo le bubu me. Akpa etɔ̃e le vevie wu, eye wo dometɔ ɖesiaɖe ate ŋu akpɔ ŋusẽ ɖe wò nya vevitɔ dzi:
• Adzɔnuwo ƒe nyonyome si nɔa anyi ɖaa — kpena ɖe ame ŋu wokpɔa ga ƒe vovototowo ta eye wòɖea gakpɔkpɔ dzi kpɔtɔna. Adzɔnuwɔƒe si le dɔ wɔm le nyonyomedzikpɔkpɔ ƒe ɖoɖo abe ISO 13485 ene te kpɔa eƒe dɔwɔwɔwo dzi le dɔwɔƒea ƒe ɖoɖo nu, eyata nusiwo woawɔ la nɔa anyi si woate ŋu agblɔ ɖi le ewɔwɔ ƒe duƒuƒuwo katã me. Le nuƒlelawo gome la, ema ate ŋu akpe ɖe eŋu be woaɖe unit siwo gblẽ siwo ɖoa asisi mamlɛawo gbɔ dzi akpɔtɔ, aɖe nyatoƒoetoto ƒe agbɔsɔsɔ dzi akpɔtɔ, eye wòaɖo seɖoƒe na ga si wobu le gakpɔkpɔ me.
• Asi geɖe ƒe dzadzraɖo — gakpɔkpɔ ƒe mɔnu geɖe, ɣeyiɣi si woatsɔ aɖo agbalẽdzraɖoƒe kabakaba. Ðaseɖigbalẽ siwo ku ɖe asitsanyawo ŋu koŋue afia afisi woate ŋu adzra wò nuawo le le se nu. CE MDR ƒe ɖaseɖigbalẽ doa alɔ Europa ƒe asi me yiyi, gake FDA 510(k) ƒe mɔɖeɖe (na kpɔɖeŋu siwo sɔ) doa alɔ United States ƒe asi me yiyi. MDSAP naa agbalẽdzikpɔkpɔ ƒe ɖoɖo ɖeka si dzi sedzikpɔlawo da asi ɖo le ʋɔnudrɔ̃ƒe atɔ̃, si kpena ɖe adzɔnuwo wɔlawo ŋu be woawɔ ɖoɖo ɖe nyonyome dzikpɔkpɔ ŋu le asi geɖe me. Ne womexɔ ɖaseɖigbalẽ kple mɔɖeɖe siwo sɔ o la, woate ŋu ahe adzɔnuwo tsɔtsɔ va asi me ɖe megbe.
• Nusiwo ŋu kakaɖedzi le — kpena ɖe ame ŋu be agbalẽdzraɖoƒewo nanɔ nudzraɖoƒe eye asisiwo trɔna gbɔna. Adzɔnuwɔƒe si si nuwɔwɔ ƒe ŋutete, gomenɔamesiwo, kple mɔ̃ɖaŋununya ƒe goglome le be wòatsɔ ana ɣesiaɣi le ƒewo me — menye be wòawɔ nudɔdɔ ɖeka dzi ko o — ate ŋu ado alɔ ɣeyiɣi siwo woate ŋu agblɔ ɖi wu, akpe ɖe ŋuwò nàɖe nudzraɖoƒewo ƒe vɔvɔ dzi akpɔtɔ, eye wòana mɔnukpɔkpɔ geɖe wò dɔwɔƒea be wòatsi.
Joytech Healthcare le atikewɔnuwo wɔm tso ƒe 2002 me eye fifia wole wo ɖom ɖe dukɔ siwo wu 150 me. Eƒe atikewo dometɔ aɖewoe nye ʋu ƒe sisidzidzenuwo, no me pɔmpiwo, compressor nebulizers, asibidɛ ƒe nugbɔ ƒe ʋu ƒe sisi ƒe oximeters, kple dzoxɔxɔdzidzenu siwo wozãna le kɔdzi. Le nuƒlela siwo le atikewɔnuwo dim tso China gome la, ema fia be nudzrala si le ɖoƒe si akpɔ nuŋlɔɖiwo, ɖaseɖigbalẽwo, kple nuwɔwɔ ƒe ɖekawɔwɔ si asi geɖe me asitsatsa bia gbɔ.
• Ate ŋu akpe ɖe gakpɔkpɔ dzi ɖeɖe kpɔtɔ eye wòakpɔ ŋkɔ nyui si le adzɔnu ƒe ŋkɔ ŋu ta — Joytech wɔa dɔ le ISO 13485 ƒe nyonyome dzikpɔkpɔ ƒe ɖoɖo te le dɔwɔƒea ƒe ɖoɖo nu. Nuƒlelawo ateŋu abia eye woalé ŋku ɖe nuŋlɔɖi sia ŋu tẽ, aɖo kpe batch-to-batch ƒe ɖekawɔwɔ dzi hafi atsɔ wo ɖokui ana.
• Woɖoe be woado alɔ asi ƒe yiyi le nuto geɖe me — Joytech ƒe adzɔnuwo ƒe hatsotsowo tsɔa CE MDR na Europa asi, FDA 510(k) ƒe mɔɖeɖe na mɔ̃ tiatia aɖewo le United States, kple MDSAP ƒe ɖaseɖigbalẽ si ku ɖe sedede ƒe ʋɔnudrɔ̃ƒe atɔ̃ ŋu. Nuƒlelawo ate ŋu aɖo kpe nusiwo woatsɔ axe fe ɖe wo ta dzi le adzɔnuwo kple nuto siwo tututu woɖo be yewoasubɔ me.
• Wotue be woado alɔ ɣeyiɣi didi ƒe nuzazãwo ƒe hadomehabɔbɔwo — Esi wònye be eƒe nuwɔwɔ ƒe ŋutete si wu meta 260,000 sq, eƒe gomenɔamesi wu 100, kple numekuku ƒuƒoƒo si me eŋutinunyala siwo wu 100 le ta la, Joytech doa alɔ ƒe geɖe ƒe ɖoɖowo — si naa hadɔwɔlawo kpɔa mɔ na hatsotso geɖe to dzɔtsoƒe ɖeka si dze dzi.
• . Ʋu ƒe sisi dzikpɔlawo — kadodo ƒe tiatia geɖe (Bluetooth, Wi-Fi, 4G) na nuƒlelawo sɔ kple SKUwo ɖe nudzadzra ƒe mɔnu vovovowo kple asi ƒe nudidiwo nu.
• . No pɔmpiwo — wodo, elektrik, kple asi ƒe kpɔɖeŋuwo. Wotrɔ asi le dɔwɔwɔ si me ɖoɖoezizi le ŋutɔ le mɔ̃ veviwo katã me ŋu be wòakpe ɖe ame siwo zãa nuwuwu ƒe nyatoƒoetotowo kple tɔtrɔgbɔ ƒe agbɔsɔsɔme dzi ɖeɖe kpɔtɔ ŋu.
• . Compressor nebulizers — ame tsitsiwo kple ɖeviwo ƒe atsyãwo, si kpena ɖe nuƒlelawo ŋu be woasubɔ asisiwo ƒe hatsotso si keke ta wu kple SKU ʋɛ aɖewo.
Ðaseɖigbalẽ kawoe wòle be nuƒlelawo naɖo kpe edzi ne wole atikewɔnuwo dim tso China?
Ðaseɖigbalẽ veviwo dometɔ aɖewoe nye ISO 13485 (si nye dɔwɔƒe ƒe nyonyomedzikpɔkpɔ ƒe dzidzenu), CE MDR (adzɔnuwo ƒe ɖoɖo nu, na Europa ƒe asi), FDA 510(k) ƒe mɔɖeɖe (kpɔɖeŋu ƒe ɖoɖo nu, na United States, si ƒo nu tso adzɔnu tiatia aɖewo ŋu), kple MDSAP (si nye agbalẽdzikpɔkpɔ ƒe ɖoɖo ɖeka si dzi woda asi ɖo le ʋɔnudrɔ̃ƒe atɔ̃ me). Wo dometɔ ɖesiaɖe wɔa sedede ƒe taɖodzinu vovovo, eyata ele be nuƒlelawo naɖo kpe ga si woatsɔ axe fe ɖe woƒe adzɔnuwo kple teƒe tɔxɛ siwo woayi la dzi.
Ðe ɖaseɖigbalẽ ɖeka ku ɖe asi siwo katã wotsɔ ɖoa duta ŋua?
Ao, sedziwɔwɔ ƒe mɔɖeɖewo nyea asitsalawo tɔ eye zi geɖe la, wonyea kpɔɖeŋu tɔxɛwo tɔ. Ðaseɖigbalẽ si le dɔ wɔm le nuto aɖe me meɖea mɔ le eɖokui si be woadzrae le nuto bubu me o. Dɔwɔɖoɖowo abe MDSAP ene ateŋu akpeɖe asi geɖe ƒe mɔnukpɔkpɔ ŋu, gake ele kokoko be nuƒlelawo naɖo kpe asi ɖesiaɖe si woɖo taɖodzinu na dzi le wo ɖokui si.
Aleke nusiwo woakpɔ tso adzɔnuwɔƒe si woɖo anyi gbɔ ɖea afɔku dzi kpɔtɔnae?
Nudzrala si si nyonyome ƒe ɖoɖo siwo ŋu woate ŋu aɖo kpee, asi ƒe ɖaseɖigbalẽ siwo keke ta, kple nuwɔwɔ ƒe ŋutete si nɔa anyi ɖaa le ate ŋu akpe ɖe nuƒlelawo ŋu be woaƒo asa na sedziwɔwɔ gbugbɔgawɔ, nudɔdɔ ƒe megbetsitsi, kple asi me yiyi ƒe mɔxenuwo — si aɖe gazazã kple afɔku siaa dzi akpɔtɔ le ƒomedodo si me wokpɔa nu tsoe me.
