Customising based on the particular anatomical structure and condition of the patient allows metal 3D printing technology to be rather successful. In the field of orthopaedics, for instance, exactly matched implants can be tailored for individual patients, therefore enhancing the success rate of surgery and the effect of patient rehabilitation. There is nothing like this customising power available from conventional manufacturing techniques.
Medical devices with intricate internal structures and shapes-like implants with porous structures-can be produced by this method. Porous construction can enhance the stability and biocompatibility of implants as well as help bone tissue to grow and merge. At the same time, though, such systems often provide difficulties for performance assessment and product quality control.
Athraíonn tréithe fisiceacha, ceimiceacha agus meicniúla ábhar miotail éagsúla; Dá bhrí sin, is féidir le paraiméadair phróisis priontála 3D-mar luas priontála, tiús ciseal, cumhacht léasair, srl.
For three types of medical devices-including orthopaedic medical implants, which demand rigorous clinical research and approval procedures-the National Medical Products Administration (NMPA) operates a production licence and product registration system in China. The Medical Device CE Certification Regulation MDR 2017/745/EU sets high standards on medical device quality, safety, and efficacy inside the European Union. The FDA Tá rialacha agus treoirlínte cruthaithe aige chun deimhniú feiste leighis a rialú sna Stáit Aontaithe {. Sainmhíníonn na rialacha seo na cúinsí agus na caighdeáin do bhailíochtú cliniciúil .
Clinical validation mostly serves to assess the safety and efficacy of medical equipment in useful application. Clinical trials allow data on the use of products in various patient populations to be gathered to grasp their performance, possible complications, and adverse reactions, therefore guiding product innovation and optimisation. Simultaneously, clinical validation is also a crucial basis for regulatory agencies to license new products; Ní féidir ach le hearraí a rith bailíochtú cliniciúil údarú margaíochta a fháil .
Metal 3D-printed medical devices' complicated architecture and customising features mean that their performance and quality could be somewhat questionable. By means of real-world use, clinical validation can confirm the safety and efficacy of products as well as spot possible hazards and flaws. For instance, certain research has revealed that 3D-printed porous structure implants might have issues including in vivo implant loosening and Comhtháthú cnámh bocht . Is féidir le bailíochtú cliniciúil na fadhbanna seo a fheiceáil ar an bpointe boise agus gníomhartha gaolmhara a chur i bhfeidhm .
Relevant laws state that most metal 3D-printed medical equipment needs clinical validation to get market approval. The design of rules aims to protect patient rights and interests and guarantee that available medical equipment satisfies safety and efficacy criteria. Companies run legal danger and may pay fines if they neglect clinical verification in line with regulations.
Cuir fás aonfhoirmeach an tionscail chun cinn .
Maidir le hearnáil na bhfeistí leighis priontála miotail 3D, is féidir le bailíochtú cliniciúil critéir agus sonraíocht chomhsheasmhach a thairiscint . Cuidíonn bailiú agus anailís le linn na céime fíoraithe le sonraí feidhmíochta agus taithí chliniciúil ar an táirge a thiomsú, ag tairiscint tagartha do dhul chun cinn teicneolaíochta agus caighdeán an tionscail a bhunú . Is féidir le bailíochtú cliniciúil an t -iomaíochas a ardú mar go n -ardóidh an t -iomaíochas agus an t -iomaíocht atá ag an gcomhoibriú agus ag an gcomhoibriú mar gheall ar an gcomhoibriú a bhaineann le huathoibríoch a chur chun cinn mar gheall ar an gcomhoibriú agus an t -iomaíochas a bhaint amach mar atá ag an gcomhoibriú. Forbairt .
Using the 3D printed acetabular cup jointly created by Aikang Medical and Peking University Third Hospital as an example, the product has been thoroughly clinically tested to confirm its safety and efficacy in clinical uses. Compared to conventional acetabular cups, 3D-printed acetabular cups demonstrate improved bone integration effects and reduced loosening rates according to the results of clinical Trialacha . le haghaidh feistí leighis clóite miotail 3D, léiríonn an cás seo go hiomlán an gá le bailíochtú cliniciúil .
Tá ríomh méid an tsampla dúshlánach ós rud é go bhfuil ionchlannán gach othair uathúil mar gheall ar na hairíonna saincheaptha saincheaptha de ghléasanna leighis miotail 3D-chlóite . dá mbeadh méid an tsampla ró-bheag, d'fhéadfadh go mbeadh spleáchas neamhleor ag torthaí an staidéir; Má tá méid an tsampla ró -ard, is féidir costas agus am na staidéar cliniciúil a mhéadú .
Rogha an Ghrúpa Rialaithe: D'fhéadfadh sé go mbeadh dúshlán ag baint le grúpa rialaithe oiriúnach do roinnt feistí leighis clóite 3D nua 3D le haghaidh ionchlannán ortaipéideach clóite 3D nua, mar shampla, b'fhéidir nach mbeadh ionchlannán traidisiúnta meaitseála ann mar rialú, rud a chuirfeadh le dearadh trialach cliniciúil agus le forghníomhú .
Dúshláin leantacha fhadtéarmacha: Iarrann éifeachtúlacht fhadtéarmach trealaimh leighis 3D-clóite 3D ar staidéar leantach fadtéarmach . leantach fadtéarmach, áfach, a chuireann dúshláin ar fáil, lena n-áirítear caillteanas othar do dheacrachtaí leantacha agus do dheacrachtaí bailithe sonraí a fhéadann cur isteach ar fhírinneacht na dtorthaí trialach cliniciúla . {}} {}} {}}
Tar éis teicnící staitistiúla ciallmhara: Maidir le ríomh mhéid an tsampla, is féidir teicnící staitistiúla a chur i bhfeidhm le haghaidh ríomhaireachtaí eolaíochta mar aon le tionchair réamh -mheasta an táirge agus na n -éileamh cliniciúil chun an méid samplach oiriúnach . a fháil amach i gcomhthráth leis an dearadh oiriúnaitheach seo agus teicnící eile a cheadaíonn ceann 1 chun an méid samplach a mhodhnú go tapa ag brath ar na sonraí a fuarthas le linn na cóime turgnamhach}}}}}}} an méid a mhodhnú go tapa ar na sonraí a fuarthas ag na sonraí a fuarthas}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}} le teicnící sainiúla an tsampla ar na sonraí a fuarthas i rith na Sonraí Turgnamhach i rith na Sonraí Turgnamhacha i rith na Sonraí Turgnamhacha.
Cumraíocht an Ghrúpa Rialaithe Bunaidh: I measc na dteicnící tá rialú stairiúil agus féinrialú, ar féidir iad a chur i bhfeidhm i gcásanna nuair is deacair grúpa rialaithe oiriúnach a aithint . is féidir othair a úsáideann ionchlannáin chlóite 3D, mar shampla, a mheaitseáil le hothair roimhe seo ag baint úsáide as gnáth-ionchlannáin nó táscairí an othair féin roimh agus tar éis ionchlannáin {{}}}}}}}}}}}}}}}} {{{{{}}}} ag iarraidh iad a úsáid {} ag iarraidh iad a bheith ag úsáid {{{{{} is féidir le grúpaí ag teicníc a bheith ann gur féidir iad a dhéanamh
Improve patient follow-up and treatment. Create a thorough patient management system, increase patient compliance by means of follow-up and patient communication, and so boost patient compliance. Mobile medical apps and other information technologies help to streamline data-collecting efficiency and quality as well as to enable patient comments.