Belgian contract manufactureramnovis和医疗设备服务提供商BAAT Medicalhave teamed up to offer an innovative and rapid turnaround process for 3D printed medical devices.
Pooling their expertise, the two companies are developing a complete process spanning initial design to manufacturing and validating end-use devices which will enable medical device start-ups and OEMs to benefit from faster time-to-market and deliver improved patient outcomes.
“We are extremely proud to collaborate with BAAT Medical,” said Ruben Wauthle, CEO and Co-founder of Amnovis. “We see great potential in jointly innovating various AM medical device applications.
“我们彼此认识多年，共享相同的创新驱动力，并进行密切的协作，以更好地使设计和开发与材料选择和制造。”
A joint force in medical device 3D printing
Both Amnovis and BAAT Medical boast substantial experience in 3D printing medical devices for a range of certified end-use applications.
amnovishas been deploying additive manufacturing to make high-end medical device products since 2008, and was reportedly among the first to use LPBF for printing titanium medical devices such as orthopedic and spinal implants. Most recently, the company was selected by medical device firmCairnSurgicalto3D print its patient-specific Breast Cancer Locator（BCL），旨在帮助外科医生更精确地定位和去除乳腺肿瘤的定制手术指南。
同时，Baat Medical率先开发了3D印刷的脊柱融合植入物，这些脊柱融合植入物已获得许多CE Marks和USFood and Drug Administration（FDA）批准。在22年的时间里，该公司迄今已生产了50,000多个植入物，并为200家公司完成了300多家项目。
“It is great to intensify our collaboration with the AM innovators of Amnovis, with whom we successfully worked with before,” said Gert Nijenbanning, Managing Director of BAAT Medical. “We believe that efficiency in development and production throughout the whole chain is essential to keep investments in innovations of medical devices feasible, especially for European markets where MDR is a reality.
“Together, we want to build on the complementary expertise of Amnovis and BAAT Medical to collaborate and take 3D printing of medical devices to the next level.”
Innovating medical device manufacturing
amnovisand BAAT Medical are now combining their respective expertise and experience to offer a new and optimized turnaround process for 3D printing medical devices. The firms will work together to tune the design and development of various devices, material selection, and manufacturing of specific 3D printed medical device applications.
这些公司将在联合技术和应用路线图上工作，将积极验证新的3D打印技术，并为特定类型的医疗设备树立新标准。该合作伙伴关系还将看到Amnovis和Baat Medical调查新的3D打印材料和后处理方法，以及探索自动化和验证过程的方法。
“As preferred partners, our joint offering comprises of the complete process for customers and prospects to aim high and move fast, while removing hurdles in medical device development, validation and manufacturing,” said Wauthle. “At Amnovis, we rely on our comprehensive AM workflow and production platform, which is entirely ISO 13485:2016 certified.
“Digital process automation enables us to provide full traceability and repeatability to flexibly scale up manufacturing of standard and patient-specific AM medical devices.”
通过合作伙伴关系，Amnovis和Baat Medical正在寻求提高医疗部门新3D打印技术的业务潜力和市场的潜力和时间。通过为3D打印的医疗设备提供新颖，快速的周转过程，这些公司希望鼓励医疗设备初创企业和OEM之间更具创新性的业务模型，同时也改善了患者的结果。
Nijenbanning说：“作为首选合作伙伴，我们能够涵盖从初始想法到认证产品的完整过程。”“我们合作，最佳地利用当前和将来的AM技术的可能性作为改善患者结果的医疗设备的新业务模型的一部分。
“ Amnovis和Baat Medical一起推动了医疗设备OEM的创新边缘，并在开发，验证和制造阶段移动更快。”
Regulating AM medical devices
Additive manufacturing is increasingly being used for the fabrication of patient-specific medical devices thanks to its customization, speed, and cost benefits. As the technology advances and opens up new applications within this field, the certification of 3D printed devices is becoming ever more important.
去年10月，全球认证公司TÜV SÜDreleased an industry-first 3D printing-specific guide to repeatedlyproducing safety-compliant medical devices. The guide outlines the specific standards that manufacturers need to meet at each stage of the additive manufacturing workflow from qualification through to post-processing.
In December,Health Canada批准了它的第一个Canadian-made 3D printed medical implant, a customizable mandibular plate for use in reconstruction surgery, while the FDA issued a public call for comment on afuture-proof regulatory frameworkit is working on to ensure the quality of 3D printed medical devices.
最近，标准开发人员ASTM Internationalintroduced a新标准，F3456，为医疗设备制造商提供指导，以在PBF 3D打印过程中重复使用粉末。
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Featured image showsthe 3D printing stage of Amnovis and BAAT Medical’s AM medical device workflow for a spinal implant. Photo via Amnovis.
