Ubushinwa na Amerika Abakora Urutirigongo: Nigute Twasuzuma Uruganda rutera umugongo urenze ikiguzi

Umugabuzi wese wumugongo ahura nikibazo kimwe mugihe runaka: Tugomba guturuka kubashoramari bo muri Amerika cyangwa Abanyaburayi bashinzwe nka Stryker, Synthes, cyangwa Medtronic? Cyangwa twakagombye gutekereza kubakora mubushinwa nkabatanga icyiciro cya kabiri cyangwa abafatanyabikorwa bambere?

Igisubizo gisanzwe kiroroshye: Abakora iburengerazuba = igiciro cyinshi ariko ubuziranenge bwagaragaye. Abashinwa bakora = igiciro gito ariko ingaruka zo kubahiriza.

Igisubizo cyukuri hashize imyaka 10. Ntibikiri ukuri.

Aka gatabo kanyura muburyo bwo gusuzuma mubyukuri uwaguhaye umugongo - yaba ashingiye muri Amerika, Uburayi, cyangwa Ubushinwa - akoresheje urwego rutandukanya ibicuruzwa nukuri.

Igiciro nyacyo cya 'Izina ryikirango ' Kwimura umugongo

Reka duhere kubyo abagabuzi bazi ariko gake tuganira kumugaragaro: abakora inganda nini zo muburengerazuba bishyura premium idafite aho ihuriye nibikorwa byo hejuru.

Iyo uguze sisitemu ya TLIF ya Stryker cyangwa Synthes, uba wishyuye:

• Icyamamare (30-40% by'igiciro cyo kugurisha)
• Ibikorwa remezo byo kwamamaza ku isi (ibindi 15-20%)
• Imbaraga zo kugurisha ninkunga yubuvuzi (10-15%)
• Gukora, ubuziranenge, na R&D (hasigaye 25-35%)

Ibicuruzwa nibikorwa byiza - igice cyingenzi mumutekano wumurwayi - ntabwo gihenze cyane. Mubyukuri, abahinzi benshi b'Abashinwa ubu bashora imari cyane mubikoresho bimwe, sisitemu nziza, hamwe nimpamyabumenyi nkibirango byiburengerazuba.

Abatanga ibicuruzwa bagura umugongo kumasezerano yibitaro bahura nigitutu nyacyo: ibitaro byawe biteze ubuziranenge bwa Stryker cyangwa Synthes kubiciro bigufasha gutsinda amasoko. Ikintu kigomba gutanga.

Igisubizo ntabwo ari ukubangamira ubuziranenge. Nukumva ko ibyemezo byubuziranenge no kubahiriza bidasaba aderesi yuburengerazuba.

Icyahindutse: Abashinwa bakora umugongo Noneho bafite ibyemezo

Imyaka icumi irashize, iyi mpaka ntiyagenze neza kuko yari impamo: inganda nyinshi zAbashinwa zabuze icyemezo cya FDA, ikimenyetso cya CE, cyangwa sisitemu nziza. Wahisemo hagati yo kubahiriza nigiciro.

Uyu munsi, ibintu byahindutse kubatanga isoko nziza mubushinwa.

Abakora uruganda rukomeye rw'umugongo bafite ubu:

• ISO 13485 hamwe na sisitemu yuzuye igenzura
• CE Kumenyekanisha umugongo (EU igenzura inzira)
• FDA 510 (k) Kwemeza ibicuruzwa byihariye byumugongo (kwinjiza isoko muri Amerika)
• Icyemezo cya MDSAP (gikubiyemo FDA, Kanada, Ubuyapani, Burezili)

Ibi ntabwo ari ibyemezo byo kwisiga. Buri kimwe gisaba:

• Sisitemu yubuyobozi bufite ireme igenzurwa buri mwaka ninzego zindi
• Raporo yikizamini cya mashini kuri buri cyiciro cyibyakozwe (imbaraga zingana, umunaniro, biocompatibilité)
• Gukurikirana byuzuye kuva mubikoresho fatizo kugeza nimero yuruhererekane
• Raporo yibikorwa bibi nibikorwa remezo byo kugenzura nyuma yisoko

Iyo uruganda rwabashinwa rufite ISO 13485 + CE + FDA, bayoboye igenzura rimwe nkabanywanyi bose bo muburengerazuba. Itandukaniro nuburyo ibiciro byabo bikomeza kuba munsi ya 30-50% kubera akazi, ibikoresho, hamwe nigiciro cyo hejuru - ntabwo kugabanya ubuziranenge.

Ubu ni bwo buryo bwingenzi abakwirakwiza ubushishozi bakunze kubura: Abashinwa bemewe ntabwo bafata shortcuts kubintu abagenzuzi bagenzura. Bakoresha inyungu zububiko mu bice abagenzuzi batagenzura neza.

Kuki Gutanga Urunigi Ihamye Mubyukuri Birenze Igiciro

Hano niho Ubushinwa na Amerika bigereranya bigenda byerekana abashinwa batanga ibicuruzwa byinshi.

Abakora umugongo wiburengerazuba batezimbere ubunini bunini, buteganijwe. Bakeka ko uziyemeza kugura ibicuruzwa buri gihembwe. Niba ukeneye kongera ubushobozi cyangwa guhindura SKU ivanga vuba, urimo ukora kurwanya injyana yabo yo gukora.

Inganda zAbashinwa, cyane cyane izikorera amasoko mpuzamahanga, zubatswe kugirango zihinduke.

Gereranya nukuri kubikorwa:

Ibikorwa bikora	bisanzwe US ​​/ EU Inganda	Yemerewe Gukora Ubushinwa
Ibarura	60-70% ya catalog mububiko	80-90% ya catalog mububiko
Ububiko-Kuri-Ubwato Bayobora Igihe	Iminsi 7-14 isanzwe	Iminsi 3-5 isanzwe
MOQ Guhinduka	Rigid; ingano y'imanza	Biroroshye; Igice 1 kurubanza
Ikirango cyihariye / Gupakira	Igihe kinini cyo kuyobora, ikiguzi kinini	Yinjijwe mubikorwa bisanzwe
Iteganyagihe	Ntarengwa; akenshi bahanishwa ibihano	Imikorere isanzwe; gucungwa mu mpamvu
Igisubizo kuri Surge Amabwiriza	Ibyumweru byo kwakira	Iminsi yo kwakira (mubushobozi)

Ubu busumbane bukora ntabwo ari impanuka. Abashinwa bakora ibicuruzwa mpuzamahanga bamenye ko igiciro cyonyine kidatsindira amasezerano maremare. Gutanga kwizerwa, uburebure bwimbitse, hamwe no kwitabira gukora.

Ku bagabura ibicuruzwa byumugongo, ibi birakomeye. Iyo umuganga abaga ateganya uburyo bwa TLIF cyangwa PLIF, ibitaro bikenera akazu, sisitemu ya screw, nibikoresho biri mukiganza - ntibishobora gutinda iminsi 10 itegereje gukora. Utanga ibicuruzwa bikomeza kubarura 90% hamwe nubwato muminsi 3 biba bidasimburwa.

Ikibazo cyo kubahiriza: Ese abashinwa batewe n'abashinwa bafite umutekano koko?

Iki nikibazo abagabuzi babaza bonyine ariko ushidikanya kubaza abatanga isoko.

Igisubizo cyinyangamugayo: Biterwa rwose nu ruganda rwabashinwa urimo gusuzuma.

Hariho intera nini cyane hagati:

• Icyiciro cya mbere Abashinwa bakora: ISO 13485 + CE + FDA yemejwe, laboratoire yemewe ya CNAS yemewe, yanditse ibizamini bya mashini kuri buri cyiciro, imyaka 18+ mubikorwa byamagufwa, ikorera ibitaro mpuzamahanga 500+
• Icyiciro cya 2-3 Abashinwa bakora: ISO 13485 bonyine (cyangwa icyemezo giheruka), inyandiko ntoya yerekana, uburambe buke mpuzamahanga

Ikibazo nabagabuzi benshi ntibazi gutandukanya ibyo byiciro.

Dore icyerekana mubyukuri gukura:

• Icyemezo cya MDSAP: Ntabwo ari FDA 510 (k) gusa, ahubwo MDSAP yuzuye (ikubiyemo FDA, Kanada, Ubuyapani, Ositaraliya, Berezile). Ibi bivuze ko batsinze igenzura icyarimwe muburyo bune bwo kugenzura. Abashinwa bake cyane bakora ibi. Niba babikora, ni ikimenyetso gikomeye cyo kubahiriza ubuhanga.
• Laboratoire yo Kwipimisha murugo: Bafite laboratoire yemewe ifite ibikoresho nkimashini zipima umunaniro wa Instron, kugenzura ibipimo bya CMM, no gupima topologiya ya 3D? Aya ni $ 2M + mu ishoramari. Inganda zikora ishoramari kuko ntabwo zujuje gusa kubahiriza - zirahatanira ubuziranenge.
• Raporo Yipimisha Urwego Rurwego: Buri cyiciro cyumusaruro kigomba kuba cyanditseho ibizamini byumunaniro, imbaraga zingana, hamwe no gupima ubukana. Ibi bigomba kubikwa mumyaka 3+. Baza ingero hanyuma ubaze niba ushobora kugenzura iyi nyandiko. Ubushake bwabo bwo kukwereka bwerekana icyizere.
• Ibikorwa Remezo bya Traceability: Bashobora gukurikirana buri kato ka TLIF cyangwa pedicle yagarutse mugice cyacyo kibisi? Buri kintu cyose cyatewe kigomba gushyirwaho lazeri hamwe numero yihariye. Inyandiko zerekana ibicuruzwa zigomba kwerekana igihe zakozwe, umurongo wogukora, umugenzuzi wa QC wasinyiye, nuwoherejwemo. Nuburyo ugaragaza umutekano mubihe byo kwibuka.

Isuzuma ryihariye ryo gusuzuma: Gutera umugongo (TLIF, PLIF, Pedicle Screw Sisitemu)

Iyo usuzumye uruganda rukora umugozi wa TLIF / PLIF hamwe na sisitemu ya pedicle screw, dore urutonde rufatika:

Igipimo cyemeza (Kugenzura: amasaha 48)

• Saba ISO 13485 umugereka. Emeza ko itwikiriye neza uruzitiro rwumugongo hamwe nuduce twa pedicle (ntabwo ari plaque gusa).
• Saba CE dosiye tekinike cyangwa yamenyeshejwe raporo yubugenzuzi bwumubiri. Kwemeza urwego rurimo ibikoresho byo guhuza abantu.
• Saba FDA 510 (k) inzandiko zemewe. Emeza ko bikubiyemo ibicuruzwa byawe byihariye (TLIF, PLIF, intera ya diameter).
• Niba usaba MDSAP: saba ibimenyetso. Ntabwo ari icyemezo rusange kandi ibisabwa bigomba kugenzurwa kubitabo byemewe bya MDSAP.

Ibisobanuro by'ibikoresho (Kugenzura: Gusubiramo inyandiko)

• Icyiciro cya Titanium alloy: Akazu ka PEEK kagomba kwerekana urwego-rwubuvuzi-ibikoresho bya PEEK. Ikarito ya Titanium / screw igomba kwerekana ASTM F136 (Ti-6Al-4V ELI) cyangwa ibisa nayo. Baza: Bakomoka kuri TC20 yo mu rwego rwa TC20 (isuku irenze, isaba uruhushya mubushinwa)? Iki nikimenyetso cyo hejuru.
• Ibyemezo byibikoresho: Ibikoresho bito bigomba kuza hamwe nundi muntu wa gatatu ibyemezo byuruganda byerekana imiti nubukanishi.
• Igeragezwa ryicyiciro: Saba raporo yikizamini cyibikoresho 5 byanyuma. Ibi bigomba kwerekana imbaraga zingana, gutanga imbaraga, kuramba, nubuzima bwumunaniro kurwego rwa ASTM.

Ibarura no gutanga ibyiringiro (Kugenzura: Ikiganiro + Reba)

• Cataloge yibaruramari: Baza ijanisha ryurutonde rwumugongo ubitse muri iki gihe. Igisubizo cyemewe: 80% +. Igisubizo cyiza: 90% +.
• Igihe cyambere cyo kubika ibintu: Nigihe ki gihe cyubwato kububiko bwimigabane na sisitemu ya screw? Biremewe: iminsi 7. Byiza: iminsi 3-5.
• Ubushobozi bwo gukora buri mwaka: Gutera umugongo byumwihariko (ntabwo ari ubushobozi bwamagufwa gusa). Birahagije gukura kwijwi ryanyu mumyaka 2-3?
• Igipimo cyo gutanga ku gihe: Baza ibipimo byabo bya OTD mumezi 12 ashize. Biremewe: 90% +.
• Konti zerekana: Saba 3-4 isanzwe ikwirakwiza, cyane cyane ku isoko rya geografiya. Hamagara ubabaze: 'Mugihe ufite itegeko ryihutirwa, bakira bate? Mugihe kubyara byatinze, bavuganye bate? '

Gukurikirana no kugenzura nyuma yisoko (Kugenzura: Igenzura ryimikorere)

• Sisitemu yimibare ikurikirana: Buri kato ka TLIF, akazu ka PLIF, hamwe na pedicle screw bigomba kugira ibiranga byihariye biranga laser. Bagomba gushobora kukubwira icyiciro cyumusaruro, itariki yumusaruro, hamwe na sterisizione numero yihariye yuruhererekane.
• Inyandiko zerekana ibyangombwa: Inyandiko zerekana umusaruro zigomba kubamo: ibishushanyo mbonera, intambwe zo gukora, kugenzura QC, ibisubizo byubugenzuzi, ibyangombwa byo kuboneza urubyaro, hamwe nuburenganzira bwo gusohora bwa nyuma. Ibi bigomba kubungabungwa ubuzima bwose + imyaka 2.
• Ibikorwa bibi byo gutanga raporo: Niba umuganga abaga avuga ko bitoroshye, ni ubuhe buryo bwo gukora iperereza? Bafite ibyangombwa byo kurega? Bakurikirana imigendekere?
• Ibuka ubushobozi: Bashobora gukurura icyiciro runaka mugihe cyamasaha 48 nibisabwa nababishinzwe?

Guhuza ubuziranenge (Kugenzura: Kugenzura Icyitegererezo)

• Saba ingero: Shaka ibice 2-3 bya kasho ya TLIF hamwe na pedicle screw mubunini bwawe bukoreshwa cyane. Basabe kugenzurwa muburyo bwa gatatu (cyangwa QC yawe). Gereranya nimpapuro zerekana.
• Kwihanganirana kugipimo: Ni ubuhe buryo bwo kwihanganira uburebure bw'akazu, diameter, n'ikibaho? Biremewe: ± 0.1mm. Ibi ntibishobora kuganirwaho kubitera umugongo.
• Kurangiza isura: PEEK yatewe igomba kuba yoroshye nta nenge igaragara. Amashanyarazi ya Titanium agomba kuba afite ubuso buhoraho (grit yaturitse cyangwa isize). Baza ibikoresho byabo byo kugenzura hejuru.

Ibyiza byihishe byabashinwa bemewe bumugongo

Iyo ubonye uruganda rwabashinwa rwujuje ibi byose byavuzwe haruguru, ubona ikintu abakora iburengerazuba baharanira gutanga:

Imitekerereze yubufatanye nyabwo.

Abakora iburengerazuba babona abagabura nkabakiriya batanga ibicuruzwa. Abashoramari b'Abashinwa bagamije amasoko mpuzamahanga babona abayagabana nk'abafatanyabikorwa mu kubaka umugabane ku isoko.

Ibi birerekana muburyo bufatika:

• Ubushake bwo guhindura gahunda yumusaruro kubyo ukeneye ibihe
• Ishoramari mukwiyandikisha kwawe (gutanga dosiye tekinike, amakuru yubuvuzi, gushyigikira ibimenyetso)
• Kuranga ibirango byihariye na Private-label amahitamo nta byibuze bibujijwe
• Ibiciro birebire bihamye kuruta kuzamuka kwumwaka
• Itumanaho-nyaryo kubyerekeye umusaruro, ntabwo buri gihembwe gisubirwamo

Ku bagabuzi bubaka ingamba nyinshi-zitanga isoko, iyi mitekerereze yubufatanye ihinduka inyungu zo guhatanira. Ntabwo ugura ibyashizweho gusa - ugura isoko yizewe yo kwihanganira.

Urugero rufatika: Nigute wagereranya uruganda rukora umugongo nu Bushinwa na Amerika Umutwe-ku-mutwe

Reka tuvuge ko urimo gusuzuma sisitemu ya TLIF yo mukarere gashya:

Ihitamo A: Uruganda rwiburengerazuba (Synthes, Stryker ihwanye)

• Igiciro kuri buri kato: $ 800-1,200 (bitewe nurwego)
• Igihe cyo kuyobora: iminsi 10-14
• MOQ: Ingano yimanza (mubisanzwe ibice 10)
• Ibarura: Gusa ibika 60% ya catalog mububiko; ikiruhuko cyakozwe kuri gahunda
• Kwandika wenyine: Birashoboka ariko bihenze; Iminsi 90 ntarengwa yo kuyobora

Ihitamo B: Abashinwa bemewe (ISO 13485 + CE + FDA + MDSAP)

• Igiciro kuri buri kato: $ 400-600 (ubuziranenge bumwe, ibipimo byemewe)
• Igihe cyo kuyobora: iminsi 3-5 (ububiko) cyangwa iminsi 14-21 (ibisobanuro byihariye)
• MOQ: igice 1 (guhinduka byuzuye)
• Ibarura: Igumana kataloge 90% mububiko
• Ibirango byihariye: Byinjijwe mubikorwa; Iminsi 30 yo kuyobora

Kuzigama 50% biragaragara. Ariko imikorere ihinduka - cyane cyane mumasoko agaragara aho ibyifuzo bitateganijwe - birashobora kuba bifite agaciro kuruta kuzigama wenyine.

Ikintu kimwe gisanzwe: Icyo ugomba gushakisha mugusuzuma kwawe

Inkomoko yo gutera umugongo ntabwo ari uguhitamo Ubushinwa hejuru yuburengerazuba cyangwa ubundi. Nibijyanye no gushakisha uwabikoze - utitaye kumwanya - utanga ihuriro ryimpamyabumenyi yimbitse, itangwa rihamye, nigiciro gihuye nubucuruzi bwawe.

Abacuruzi benshi bavumbuye ko uruganda rwemewe rwabashinwa nkumushinga wibanze cyangwa urwa kabiri rutanga icyifuzo gikenewe: kwihanganira amasoko ahendutse kandi bitubahirijwe.

Inganda zikwiye gusuzumwa nizo zashora mubikorwa remezo byuzuye. Shakisha ibimenyetso: Icyemezo cya MDSAP (cyatoranijwe cyane), laboratoire yo gupimisha munzu ifite urutonde rwibikoresho byatangajwe, ibyiciro byo mu rwego rwa tekinike yo gupima imashini, hamwe n’ibisobanuro byatanzwe n'abacuruzi mpuzamahanga mu karere kanyu. Ibi bimenyetso byerekana uruganda ruhatanira kubahiriza no kwizerwa, ntabwo ari igiciro gusa.

Igitekerezo cya nyuma: Icyemezo cyiza ni isi yose, ntabwo ari geografiya

Inzego zemeza ubugenzuzi ISO 13485, CE kubahiriza, na FDA 510 (k) ntizita aho uruganda ruherereye. Bita niba sisitemu nziza ikora.

Iyo uruganda rwabashinwa rufite ibyemezo bimwe nkumunywanyi wiburengerazuba, batsinze igenzura rimwe, berekana inyandiko imwe, berekana ubushobozi bumwe bwo gukurikirana.

Itandukaniro ryibiciro rituruka ku nyungu zubatswe - umurimo, ibikoresho hejuru, gutanga urwego ruhagaze - ntabwo biva mu guca inguni kubintu abagenzuzi bagenzura.

Kubagabuzi bubaka ingamba zihamye, zihenze-zingirakamaro zo gutanga umugongo, ubu nubushishozi bwingenzi buhindura ibipimo byose.