Hauv -Kev tsom xam qhov tob ntawm Txoj Cai Kev Lag Luam Ib puag ncig, Kev hloov pauv thev naus laus zis thiab kev cia siab rau yav tom ntej ntawm Echo Needle Sector

Txoj kev loj hlob ntawm kev lag luam echo koob tsis yog tsuas yog ua raws li kev xav tau ntawm kev kho mob thiab kev tsim kho thev naus laus zis, tab sis kuj tseem cuam tshuam los ntawm kev tswj hwm thoob ntiaj teb, kev hloov kho kev them nyiaj, thiab kev sib koom ua ke thev naus laus zis. Sawv ntawm qhov tam sim no juncture thiab saib mus rau yav tom ntej, kev lag luam tab tom ua qhov kev hloov pauv ntawm "txhim kho duab" mus rau "kev paub ntse".
I. Ntiaj teb no Regulatory Framework thiab Market Access Barriers
Raws li hom III cov cuab yeej kho mob, kev tshaj tawm cov koob ncha yuav tsum dhau los ntawm kev tswj hwm nruj heev, uas ua rau muaj kev cuam tshuam tseem ceeb rau kev lag luam.
Qhov cuam tshuam loj heev ntawm EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR): EU MDR, uas tau tshaj tawm xyoo 2017, hloov MDD cov lus qhia thawj zaug thiab tau tsim cov kev cai nruj dua. Rau cov tuam ntxhab ntawm cov koob ncha, cov kev cov nyom feem ntau nyob hauv:
* Ib qho tseem ceeb ntawm cov ntaub ntawv pov thawj kho mob: Nws yog ib qho tsim nyog los muab cov ntaub ntawv soj ntsuam nruj dua thiab kev tshawb fawb los ua pov thawj kev nyab xeeb thiab kev ua tau zoo ntawm cov khoom, tshwj xeeb tshaj yog nws cov txiaj ntsig sib piv ntawm cov khoom uas twb muaj lawm. Qhov no ua rau muaj txiaj ntsig zoo rau cov nqi tshuaj ntsuam xyuas thiab lub sijhawm-rau-kev ua lag luam rau cov lag luam.
* Nce kev tshaj tawm- kev saib xyuas kev lag luam (PMS) lub luag haujlwm: Nws yuav tsum tsim kom muaj kev tshaj tawm thiab ua haujlwm zoo dua - kev saib xyuas kev lag luam kom tsis tu ncua sau thiab txheeb xyuas cov ntaub ntawv ua haujlwm thiab kev nyab xeeb ntawm cov khoom hauv ntiaj teb tiag.
* Txhim kho cov saw hlau traceability: Ib qho khoom siv tshwj xeeb (UDI) yuav tsum tau tsim kom ua tiav tag nrho - chain traceability los ntawm raw cov ntaub ntawv mus rau tus neeg mob siv. MDR tau ua qhov kev tshuaj xyuas los ntawm lub cev ceeb toom kom ceev faj, thiab ntau lub tuam txhab me thiab nruab nrab - cov tuam txhab loj tau thim tawm ntawm European lag luam vim lawv tsis muaj peev xwm ua tau raws li cov cai tshiab, ua kom muaj kev lag luam nrawm dua.
2. Txoj kev 510(k) thiab De Novo ntawm US FDA:
* 510(k): Feem ntau cov echo koob tau txais kev tso cai ua lag luam los ntawm kev ua pov thawj qhov sib npaug ntawm cov khoom lag luam raug cai "predicate" (cov cuab yeej sib piv). Qhov tseem ceeb nyob rau hauv kev ua kom pom qhov sib npaug ntawm cov khoom siv, tsim qauv, kev siv, thiab kev ua haujlwm.
* De Novo: Rau cov koob ncha tshiab uas tsis muaj qhov ua tau zoo tab sis yog nyob rau nruab nrab lossis qis - pawg pheej hmoo (xws li cov kev sib koom ua ke tshiab), qhov kev faib tawm De Novo tuaj yeem siv tau. Txawm hais tias nws yooj yim dua li PMA, nws tseem yuav tsum tau muab cov kev ntsuas kev ua tau zoo thiab tej zaum txwv cov ntaub ntawv kho mob. FDA txoj kev tswj hwm txoj hauv kev rau "software as a medical device (SaMD)" kuj qhia tau hais tias yav tom ntej kev txawj ntse algorithm -raws li puncture navigation systems yuav ntsib ntau txoj kev pom zoo.
3. Kev tso npe thiab kev sib tw hauv nruab nrab ntawm Tuam Tshoj NMPA:
* Kev ua kom zoo ntawm kev tshuaj xyuas kev sau npe: National Medical Products Administration (NMPA) ntawm Tuam Tshoj tau txuas ntxiv txhim kho kev hloov kho ntawm kev tshuaj xyuas thiab kev pom zoo, qhib "ntsuab raws" rau cov cuab yeej kho mob tshiab kom nrawm cov txheej txheem kev pom zoo. Qhov no txhawb kom cov tuam txhab lag luam hauv tsev ua tiav cov thev naus laus zis tiag tiag.
* Kev cuam tshuam ntawm qhov ntim hauv nruab nrab-raws li kev yuav khoom (kev sib sau ua ke): Lub ntim nruab nrab-raws li kev yuav khoom ntawm cov khoom siv kho mob tau dhau los ua tus qauv. Txawm hais tias tam sim no nws yog lub hom phiaj tseem ceeb ntawm siab - cov khoom siv muaj txiaj ntsig xws li cov hlab plawv thiab cov khoom orthopedic, cov peev txheej yuav nthuav dav yav tom ntej. Lub "ntim-rau- nqi" txheej txheem ntawm kev sib sau ua ke ua rau muaj txiaj ntsig zoo rau cov khoom lag luam, yuam cov tuam txhab los tswj cov nqi mus rau qhov kawg kom yeej qhov kev sib tw lossis nrhiav kev zam los ntawm cov thev naus laus zis tshiab uas tsis raug rau kev sib koom ua ke. Qhov no tau hloov pauv qhov kev sib tw logic ntawm kev ua lag luam thiab R & D cov tswv yim ntawm kev lag luam.
II. Evolution ntawm Frontier Technologies thiab Cov Khoom Siv Yav Tom Ntej
Lub neej yav tom ntej ntawm koob ncha yuav dhau mus dhau qhov ua haujlwm ntawm "tsim duab", thiab yuav txhim kho mus rau kev coj ua ntawm ntau yam -functionality, txawj ntse thiab kev koom ua ke.
1. Cov koob ntse los ntawm "passive imaging" mus rau "active sensing":
* Lub cev impedance/spectral sensing: Integrate micro-sensors ntawm rab koob los ntsuas qhov hluav taws xob impedance los yog kev cuam tshuam spectral yam ntxwv ntawm cov ntaub so ntswg sib txawv, tiag -lub sij hawm sib txawv ntawm cov rog, nqaij, cov hlab ntsha, paj hlwb los yog qog nqaij hlav, thiab muab "cov ntaub so ntswg hom" ceeb toom thaum lub sij hawm cov hlab ntsha nkag mus rau hauv cov hlab ntsha.
* Kev ntsuas siab / lub zog ntawm lub zog: tiag tiag- lub sijhawm saib xyuas qhov hloov pauv hloov thaum lub sijhawm ua haujlwm. Thaum lub koob taub hau mus txog tawv fascia, cov hlab ntsha phab ntsa lossis cov pob txha, muab cov lus pom zoo los pab kws kho mob txiav txim qhov tob thiab txheej txheej.
* Micro-ultrasonic transducer kev koom ua ke: Tso lub micro-ultrasonic sojntsuam ntawm lub koob taub kom ua tiav qhov tseeb- lub sijhawm ntsuas nyob rau hauv pem hauv ntej ntawm rab koob, paub tiag tiag "lub ntsej muag tsis pom kev", thiab siv los coj cov koob taub kom meej txog qhov sib sib zog nqus ntawm lub hom phiaj los ntawm kev hla cov teeb meem.
2. Kev sib sib zog nqus nrog kev phais neeg hlau thiab kev txawj ntse:
* Neeg hlau- cov koob siv tau: Cov koob tsim tshwj xeeb tshaj plaws nrog cov cuab yeej cuab tam ntawm ib qho ultrasound- coj puncture neeg hlau, nrog cov qauv kev sib txuas sib txuas thiab cov khoom siv tshuab, ua kom tsis siv neeg lossis ib nrab - tsis siv neeg puncture. Qhov no yuav tsum tau standardization ntawm koob specifications, rigidity thiab interface qhov siab.
* AI- pab kev taw qhia thiab kev txiav txim siab- ua: AI algorithms tuaj yeem npaj txoj hauv kev zoo tshaj plaws raws li cov duab ua ntej CT/MRI. Thaum lub sijhawm ua haujlwm, AI tshuaj xyuas cov duab ultrasound hauv lub sijhawm tiag tiag-, cia li txheeb xyuas thiab taug qab cov koob, txawm tias kwv yees txoj haujlwm ntawm rab koob, muab kev taw qhia pom thiab kev tiv thaiv kev sib tsoo rau cov kws kho mob. Cov koob ncha yuav dhau los ua qhov tseem ceeb "cov ntaub ntawv khaws cia" hauv AI navigation system.
3. Tom ntej no - tiam hloov pauv hauv cov ntaub ntawv thiab txheej txheej:
* Ntev- ntev/ntev imaging coatings: Tsim ntau hnav- tiv taus thiab los tiv thaiv- cov ntaub ntawv txheej txheej los xyuas kom meej tias qhov kev ua tau zoo ntawm cov koob tsis poob qis tom qab siv dua lossis los ntawm cov ntaub so ntswg tawv. Txawm tshawb nrhiav kev hloov kho cov hlau nws tus kheej los ntawm qhov chaw micro-nano cov qauv (xws li laser etching cov qauv tshwj xeeb) kom ua tiav cov duab mus tas li yam tsis tas yuav muaj txheej txheej.
* Cov txheej txheem bioactive / teb: thauj cov tshuaj tua kab mob (xws li nyiaj ions, tshuaj tua kab mob) ntawm cov txheej txheem, maj mam tso tawm thaum lub sij hawm puncture, tiv thaiv kab mob kis kab mob; los yog thauj cov ntaub ntawv hemostatic los txhawb txoj kev kaw, txo qhov kev pheej hmoo los ntshav.
III. Kev txiav txim siab zoo rau kev txhim kho yav tom ntej ntawm kev lag luam
Tau ntsib kev koom ua ke thev naus laus zis, kev tswj hwm nruj dua thiab kev them nyiaj siab, cov tuam txhab tsim khoom yuav tsum ua cov tswv yim npaj rau qib siab:
1. Tsim kom muaj "cov ntaub ntawv-tsav" kev kuaj xyuas tus nqi pov thawj: Kev sib tw yav tom ntej tsis yog hais txog kev sib tw ntawm cov khoom, tab sis kuj hais txog kev sib tw hauv cov pov thawj kho mob. Cov tuam txhab lag luam yuav tsum tau sau cov ntaub ntawv tiag tiag - ntiaj teb (RWD) thiab, los ntawm kev tshawb fawb rov qab los yog yav tom ntej, ntsuas tus nqi tshwj xeeb ntawm lawv cov khoom hauv kev txhim kho kev phais kev ua tiav, txo lub sij hawm ua haujlwm, txo qis tus nqi, thiab txo tag nrho cov nqi kho mob. Cov ntaub ntawv no yog cov riam phom muaj zog tshaj plaws los daws cov kev sib tham txog kev noj qab haus huv, tiv thaiv kev kub ntxhov ntawm kev yuav khoom hauv nruab nrab, thiab ua kom muaj kev lag luam siab tshaj - kawg.
2. Embrace "platformization" thiab "ecological" txoj kev loj hlob: tus nqi qab nthab ntawm ib rab koob khoom yog txwv. Cov tuam txhab ua lag luam yuav tsum siv zog los tsim lossis koom ua ke "cov khoom siv duab + cov software ntse + cov khoom siv tshwj xeeb + kev pabcuam kev cob qhia" kev sib koom ua ke. Piv txwv li, koom tes sib koom tes nrog cov tuam txhab khoom siv ultrasound los tsim kev sib koom ua kom zoo ntawm cov koob thiab cov khoom siv duab ua algorithms; los yog tsim kev ywj pheej puncture navigation software systems thiab ntim lawv nrog lawv tus kheej koob.
3. Diversified lub tswv yim rau kev hloov pauv kev them nyiaj:
* High-kev ua lag luam kawg: tsom rau tus nqi-raws li kev kho mob, ua pov thawj tias cov txiaj ntsig kho mob coj los ntawm lawv cov khoom muaj ntau dua li cov nqi, yog li zam kev ua tsov rog.
* Nruab nrab-kev ua lag luam: Txhim kho cov khoom tsim kom zoo, xyuas kom muaj kev ua tau zoo ntawm cov tub ntxhais kawm (cov duab pom tseeb, kev sib tsoo), thiab txo cov nqi los ntawm kev tsim kho kom zoo thiab tsim cov txheej txheem kev tsim kho tshiab los tiv thaiv kev ua haujlwm hauv nruab nrab thiab DRG kev them nyiaj siab.
* Cov kev lag luam tseem ceeb thiab cov kev lag luam tawm tshiab: Muab cov khoom lag luam zoo, txhim khu kev qha, thiab ruaj khov, thiab ntes cov lag luam los ntawm cov khoom siv hluav taws xob loj thiab cov teeb meem loj.
4. Ua kom muaj kev sib koom tes tshawb fawb thiab cov peev txheej tshwj xeeb: Kev txhim kho ntawm - tiam tom ntej echo koob yuav tsum muaj kev koom tes sib sib zog nqus ntawm cov kws tshawb fawb cov ntaub ntawv, hluav taws xob engineers, software algorithm kws txawj, thiab cov kws kho mob. Cov tuam txhab lag luam yuav tsum tsim kom muaj kev sib koom tes R&D pab pawg lossis tsim kev sib koom tes nrog cov tsev kawm ntawv qib siab, cov chaw tshawb fawb los ntawm kev lag luam-University- kev koom tes tshawb fawb.
Kev lag luam echo koob yog tam sim no nyob rau ntawm qhov zoo siab hloov pauv. Nws tsis yog ib qho kev pab cuam rau kev kuaj ultrasound xwb, tab sis xav tias yuav dhau los ua lub davhlau ya nyob twg txawj ntse uas sib koom ua ke kev xav, navigation, thiab txawm tias kev kho mob. Rau cov neeg koom nrog kev lag luam, tsuas yog los ntawm kev coj mus rau pem hauv ntej - saib qhov kev xav thiab sib koom ua ke nrog kev xav tau kev kho mob, kev tsim kho tshiab, thiab cov tswv yim lag luam tuaj yeem taug kev yav tom ntej coj los ntawm "cov koob ntse ntse" no hauv nthwv dej ntawm cov tshuaj precision.