Share to FacebookShare to TwitterShare to LinkedinSurgeons at the Sint-MaartensKliniek medical center in the Netherlands choose a 3D-printed ... [+] patient-specific hip implant from Materialise for a complex replacement case.Materialise Medical

分享给FacebookShare分享给TwitterShare分享给荷兰圣马丁·斯克利尼克医疗中心的LinkedIn外科医生选择3D打印。。。[+]Materialise针对复杂置换病例的患者特定髋关节植入物。实现医疗

Patients who need a new knee, hip, ankle, or jaw might be surprised to learn that these off-the-shelf implants generally come in small, medium, and large. Like T-shirts, small, medium, or large rarely fits anyone perfectly. When it comes to implants, an imprecise fit can lead to poor outcomes and additional surgeries, which is why the demand for – and the market for – patient-specific, custom-3D-printed implants is surging..

需要新膝盖、臀部、脚踝或下巴的患者可能会惊讶地发现，这些现成的植入物通常有小、中、大三种。像T恤一样，小、中、大三种都不适合任何人。当涉及到植入物时，不精确的配合可能会导致不良结果和额外的手术，这就是为什么对患者特定的定制3D打印植入物的需求和市场正在激增。。

“Over the last 24 months, we’ve really seen a big uptick in medical device firms’ demand for patient-specific implants,” says Daniel Crawford the founder of Axial3D, a start-up software company streamlining the process from patient scan data to patient-specific 3D model. “The industry as a whole is growing pretty aggressively when it comes to implants, surgical guides, and other patient-specific devices..

“在过去的24个月里，我们确实看到医疗器械公司对患者专用植入物的需求大幅上升，”Axial3D的创始人丹尼尔·克劳福德（DanielCrawford）说，Axial3D是一家初创软件公司，它简化了从患者扫描数据到患者专用3D模型的流程。“整个行业在植入物、手术指南和其他针对患者的设备方面都在积极发展。。

The University Hospital Southampton used Axial3D software to produce a 3D model to help diagnose a ... [+] pediatric heart condition.Axial3D/University Hospital Southampton

南安普敦大学医院使用Axial3D软件制作了一个3D模型，以帮助诊断。。。[+]小儿心脏病。Axial3D/南安普顿大学医院

Crawford says large medical device companies are eying patient-matched products as the next differentiation point in the competitive orthopedic implant market.

克劳福德说，大型医疗器械公司正在将与患者匹配的产品视为竞争激烈的骨科植入物市场的下一个分化点。

Joint implant makers, such as Stryker

关节植入物制造商，如史崔克

SYK

SYK

, Smith & Nephew, and Zimmer Biomet

，Smith＆Nephew和Zimmer Biomet

ZBH

ZBH公司

, have shifted resources toward developing more patient-specific care lines.

，已将资源转向开发更多针对患者的护理线。

One of the major hurdles, until relatively recently, has been the software side of things, which consists of translating patient data, such as CT scans and MRI imaging, into an accurate 3D model used for patient-specific procedure planning, 3D printing an exact model, or designing an implant to match exactly..

直到最近，主要障碍之一一直是软件方面的东西，包括将患者数据（如CT扫描和MRI成像）转换为用于患者特定程序规划的精确3D模型，3D打印精确模型，或设计精确匹配的植入物。。

MORE FOR YOUCoinbase Revealed To Be Backing BlackRock s 5 Trillion By 2030 Crypto Game Changer After Bitcoin Ethereum And XRP Price PumpA Tiny Drone With A Directional Airburst Warhead Could Mow Down Enemy Infantry In A 60 Degree ArcOver 99 99 Of March Madness Brackets Are Already Busted One Day Into NCAA Tournament.

比特币以太坊（Bitcoin Ethereum）和XRP Price PumpA（XRP Price PumpA）微型无人机（配备定向空中爆炸弹头）可以在60度弧度范围内摧毁敌军步兵，YOUCoinbase透露，到2030年，将支持贝莱德（BlackRock）的5万亿加密游戏改变者。3月99日的疯狂斗拱已经在NCAA锦标赛的一天被摧毁。

Converting data into a digital 3D model once took 10 days to two weeks. But platforms from Axial3D and another market leader, Materialise, can now reduce that time to one day or less. These companies have plans to further streamline the process with AI to make patient-specific options more accessible for more patients..

将数据转换为数字3D模型一度需要10天至两周的时间。但Axial3D和另一个市场领导者Materialise的平台现在可以将时间缩短到一天或更少。这些公司计划通过人工智能进一步简化流程，使更多患者更容易获得针对患者的选择。。

Can AI Create Implants?

人工智能可以创建植入物吗？

Crawford at Axial3D is quick to point out that AI and machine learning are used to assist in creating the 3D model, not relied on without human oversight. “Our AI algorithms are trained on five or six years' worth of ground truth data sets validated by surgeons and radiologists, with the ultimate goal of creating an automated workflow, but with space for a human to be injected into the process, especially for complex cases,” he says..

Axial3D的克劳福德（Crawford）很快指出，人工智能和机器学习被用来帮助创建3D模型，而不需要人工监督。他说：“我们的人工智能算法是在经过外科医生和放射科医生验证的五到六年的地面真实数据集上训练的，最终目标是创建一个自动化的工作流程，但有空间让人进入这个过程，特别是对于复杂的情况。”。。

As with many of AI's behind-the-scenes applications, Axial3D can use it to replace the tedious manual processes that still requires highly trained professionals.

与许多人工智能的幕后应用程序一样，Axial3D可以使用它来取代仍然需要训练有素的专业人员的繁琐手动过程。

“To pull out the regions of interest from a stack of CT images might take an engineer three to four hours, but using machine learning, the algorithms can run in minutes,” says Crawford.Start-up Axial3D is a medical technology company specializing in the use of 3D printing and AI in ... [+] healthcare, particularly in the field of personalized surgical planning.Axial3D.

克劳福德说：“从一堆CT图像中提取感兴趣的区域可能需要工程师三到四个小时，但使用机器学习，算法可以在几分钟内运行。”。Startup Axial3D是一家专业从事3D打印和人工智能应用的医疗技术公司。。。[+]医疗保健，特别是在个性化手术计划领域。轴向3D。

“The two levels in which AI adds value in personalization is in automating the process to remove as many manual steps as possible, and then the second is really to aid in the clinical decision making,” says Sebastian De Boodt, director of medical 3D software at Materialise. While AI and other types of automation are already responsible for much of the personalized applications offered in the market, AI in clinical decision making is far less mature today because it requires a lot of good data on treatments and outcomes, which is still being collected..

Materialise医学3D软件总监塞巴斯蒂安·德布特（SebastianDeBoodt）表示：“人工智能在个性化方面增加价值的两个层面是自动化过程，尽可能多地删除手动步骤，其次是真正帮助临床决策。”。虽然人工智能和其他类型的自动化已经为市场上提供的许多个性化应用负责，但人工智能在临床决策中的成熟程度要低得多，因为它需要大量关于治疗和结果的良好数据，这些数据仍在收集中。。

“Where we see a big added value of AI today, is to free up the time of the experts and the surgeons to actually work with the patient more, and not spend time in front of a screen,” says De Boodt.

德布特说：“我们今天看到人工智能的一个巨大附加值，就是释放专家和外科医生的时间，让他们更多地与患者一起工作，而不是花时间在屏幕前。”。

Faster access to accurate patient-specific digital 3D models enables faster turnaround for 3D printed surgical planning models and for implant designers. It is also igniting new markets peripheral to implants, such as virtual reality surgical software, robotic surgeries, and other mixed-reality applications..

更快地访问准确的患者特定数字3D模型，可以更快地实现3D打印手术计划模型和植入物设计师的周转。它也点燃了植入物周边的新市场，如虚拟现实手术软件、机器人手术和其他混合现实应用。。

Dimension Inx, for example, is a start-up working with medical device companies to 3D print resorbable materials for implants that may, one day, replace titanium.

例如，Dimension Inx是一家与医疗器械公司合作的初创公司，它将3D打印可再吸收的植入物材料，这些植入物有朝一日可能会取代钛。

From 3D Model to Actual ImplantMaterialise 3D prints patient-matched implants, like these hip and shoulder devices available in ... [+] Europe, for better surgical outcomes.Materialise

从3D模型到实际植入物Materialize 3D打印患者匹配的植入物，如这些髋关节和肩部设备可用于。。。[+]欧洲，以获得更好的手术效果。实现

For a patient-specific surgical guide or tool, the time from the digital model to the 3D-printed part can take as little as a few days, which includes printing, testing, certification, and sterilization.

对于特定于患者的手术指南或工具，从数字模型到3D打印部件的时间可能只需要几天，包括打印，测试，认证和灭菌。

For patient-matched metal joints and other metal devices, however, the time is much longer.

然而，对于患者匹配的金属接头和其他金属装置，时间要长得多。

“Right now, the standard time for the major medical device manufacturers to create a patient-specific implant can be somewhere between three months and 18 months, which is a long time for a patient to wait for an implant, especially when there are off-the-shelf options that surgeons can pull from,” says Amy Alexander, head of mechanical development in Mayo Clinic’s Division of Engineering and internal additive manufacturing facility..

梅奥诊所工程与内部增材制造设施部机械开发负责人艾米·亚历山大（AmyAlexander）表示：“目前，主要医疗器械制造商制造患者专用植入物的标准时间可能在3个月至18个月之间，这对患者来说是一段很长的等待时间，尤其是当外科医生可以从现成的选项中获益时。”。。

Reducing the time from model to implant is one of the primary goals of manufacturers in this space.

减少从模型到植入的时间是制造商在这一领域的主要目标之一。

“There are companies that are doing this in a seven-day turnaround, but they're far outside of the norm,” says Alexander.

亚历山大说：“有些公司在七天的周转期内这样做，但它们远远超出了标准。”。

Materialise is one of the companies working at this pace, in part because it controls the entire process from the patient data through to the 3D printing. In 2023, Materialise produced more than 7,000 patient-specific implants and surgical guides in the U.S., and opened a new metal 3D printing facility in Michigan..

Materialise是以这种速度工作的公司之一，部分原因是它控制着从患者数据到3D打印的整个过程。2023年，Materialise在美国生产了7000多种针对患者的植入物和手术指南，并在密歇根州开设了一家新的金属3D打印设施。。

Yet the demand is larger than the current supply of manufacturers, prompting hospitals, including the Mayo Clinic and Walter Reed, to establish their own patient-specific 3D printing labs.

然而，需求大于目前制造商的供应，促使包括梅奥诊所（MayoClinic）和沃尔特·里德（WalterReed）在内的医院建立了自己的针对患者的3D打印实验室。

“One of the driving factors for Mayo Clinic to produce patient-matched implants in-house is to provide a level of speed that is not being met with third-party suppliers,” says Alexander. “We are essentially becoming a small medical device manufacturer and the goal is to be able to fill those gaps where the commercial entities haven’t been able to, yet.”.

Alexander说：“梅奥诊所内部生产与患者匹配的植入物的驱动因素之一是提供第三方供应商无法达到的速度水平。”。“我们基本上正在成为一家小型医疗器械制造商，目标是能够填补商业实体尚未填补的空白。”。

Mayo Clinic began 3D printing about 17 years ago focusing on models for surgical planning and has progressed to the point where it 3D prints its own surgical guides in-house, designs implants for fabrication off-site, and soon, will begin 3D printing titanium implants on large industrial metal 3D printers..

梅奥诊所大约17年前开始3D打印，专注于手术计划的模型，并已发展到在内部3D打印自己的手术指南，设计用于场外制造的植入物，不久将开始在大型工业金属3D打印机上3D打印钛植入物。。

“It makes sense for Mayo Clinic to have its own facility because we are a destination medical center where people come to us on their third or fourth try at getting something right,” notes Alexander. “The whole point of having the manufacturer on site, like we do, is to be able to treat these patients very quickly.”.

亚历山大指出：“梅奥诊所拥有自己的设施是有道理的，因为我们是一个目的地医疗中心，人们在第三次或第四次尝试做正确的事情时会来找我们。”。“像我们一样，让制造商在现场的全部目的是能够非常快速地治疗这些患者。”。

3D Printed Implants In Patients TodayBelgium-based Materialise offers patient-matched implant solutions combining digital planning with ... [+] 3D printed implants and guides primarily in Europe, but expanding to the U.S.Materialise

3D打印植入物在患者中的应用今天，位于比利时的Materialise提供了与患者匹配的植入物解决方案，将数字规划与。。。[+]3D打印植入物和指南主要在欧洲，但扩展到美国

In addition to the thousands of 3D printed hips, knees, and shoulder implant surgeries a year worldwide, one of the fast-growing application of a patient-matched 3D-printed part is jaw and facial bone implants known as cranial maxillofacial (CMF) implants.

除了全世界每年数千次3D打印的臀部，膝盖和肩部植入手术外，与患者匹配的3D打印部件的快速增长应用之一是颌骨和面部骨骼植入物，称为颅颌面（CMF）植入物。

Materialise says it saw significant adoption of its FDA-cleared cranial maxillofacial patient-specific implants in the U.S. in 2023 for cancer and trauma patients.

Materialise表示，2023年，该公司在美国为癌症和创伤患者大量采用了FDA批准的颅颌面部患者专用植入物。

“When it comes to patient-specific implants, the cranial maxillofacial area is really the furthest along,” says De Boodt. “CMF determines how you look as a person, so it has a very strong impact on the patient's life. This is where there’s a very strong and clear value of using a personalized device over something standard.”.

德布特说：“当涉及到患者特定的植入物时，颅颌面区域实际上是最远的。”。“CMF决定了你作为一个人的样子，因此它对患者的生活产生了非常强烈的影响。这就是使用个性化设备而不是标准设备的非常强烈和明确的价值所在。”。

To measure the value, and balance it against the cost, hospitals are starting to explore the total return on investment in personalized devices.

为了衡量价值，并使其与成本相平衡，医院开始探索个性化设备的总投资回报率。

For patients, the benefit of a custom fit is well-documented. As Alexander explains, “With a patient-matched implant, you can ensure that osseointegration happens in a much tighter way and everything is meshing and melding the way that you want it to for that bone to solidify and become one. This increases the operative results, reduces operative time, decreases the number of days in the hospital post-operation, and allows for surgeries to happen faster to keep patients under anesthesia for less time.”.

对于患者来说，定制的好处有据可查。正如Alexander解释的那样，“通过与患者匹配的植入物，你可以确保骨整合以更紧密的方式发生，一切都按照你想要的方式啮合和融合，使骨骼凝固并成为一体。这增加了手术效果，减少了手术时间，减少了手术后住院天数，并允许手术更快地进行，以使患者在麻醉下的时间更短。”。

For hospitals, the extra cost of a patient-matched implant can be recouped in lower peripheral expenses, more patient visits per day, and fewer extra corrective surgeries when implants don’t fit properly. With more education on the topic, hospitals and insurance companies are coming around to the larger, long-term cost savings of patient-specific implants, says Alexander.Mayo Clinic's additive manufacturing facility coordinator, Robbie Highet, cleaning an implant test ...

对于医院来说，与患者匹配的植入物的额外成本可以通过降低外围费用，每天更多的患者就诊以及在植入物不合适时减少额外的矫正手术来弥补。Alexander说，随着对这一主题的更多教育，医院和保险公司正在转向为患者特定植入物节省更大的长期成本。梅奥诊所的增材制造设施协调员罗比·海耶特正在清洗植入物测试。。。

[+] build.Mayo Clinic.

[+]构建。梅奥诊所。

Today, however, in the U.S., the wide range of health insurance and reimbursement levels can make patient-specific implants a less clear option.

然而，今天在美国，广泛的医疗保险和报销水平可能会使患者特定的植入物成为不太明确的选择。

“One thing that I would say to patients is that they need to advocate for themselves,” says Alexander. “Ask, what size implant am I getting, and how are you sure it’s the right size for me?” Often, insurance reimbursement is based on the procedure not the type of implant, yet “patients should always confirm reimbursement options with their care team.”.

亚历山大说：“我要对患者说的一件事是，他们需要为自己辩护。”。“问一下，我得到的是什么尺寸的植入物，你如何确定它适合我？”通常，保险报销是基于手术而不是植入物的类型，但“患者应始终与他们的护理团队确认报销方案。”。

In reality, though, in America, the number of patients that have this option today, is low, says Alexander. “The decision right now to use a patient-matched implant is coming from the surgeon and not necessarily coming from the patient,” she says. This is because patient-specific implants are still the exception to the rule and are used for instances where a standard implant simply wouldn’t work at all, not that it isn’t the best option.

Alexander说，实际上，在美国，今天有这种选择的患者人数很少。她说：“现在使用与患者匹配的植入物的决定来自外科医生，不一定来自患者。”。这是因为特定于患者的植入物仍然是该规则的例外，并且用于标准植入物根本不起作用的情况，并不是说它不是最佳选择。

Mayo Clinic performs a few hundred patient-matched implant surgeries a year..

梅奥诊所每年进行数百例患者匹配的植入手术。。

When Will Custom Be the Norm?

什么时候习惯会成为常态？

“As a market, patient-specific implants are certainly not mainstream yet, but I think it's getting to the point where it will be the standard of care for certain applications,” says Crawford. Axial3D’s on-demand cloud-based platform is used in more than 300 hospitals worldwide generating thousands of 3D models a month..

克劳福德说：“作为一个市场，特定于患者的植入物肯定还不是主流，但我认为它将成为某些应用的标准护理。”。Axial3D的按需云平台在全球300多家医院使用，每月生成数千个3D模型。。

“This technology isn't new,” adds Crawford, “the problem has been a matter of accessibility.” As patient-specific 3D modeling software decreases the time-to-patient and adds more automation, and manufacturing technologies like 3D printing become more accessible and affordable, it becomes much easier to scale up patient-specific devices..

“这项技术并不新鲜，”克劳福德补充道，“问题在于可访问性。”随着特定于患者的3D建模软件减少了患者的时间并增加了更多的自动化程度，以及3D打印等制造技术变得更容易获得和负担得起，扩大特定于患者的设备变得更加容易。。

Europe has more readily accepted patient-matched implants as a new gold standard of care, says Alexander. “We are slightly behind because we don't exactly know how to regulate hospitals that are doing medical manufacturing.” The FDA is expected to issue guidance on 3D printing of implants at the point of care in early 2024..

亚历山大说，欧洲更容易接受与患者匹配的植入物作为新的护理黄金标准。“我们稍微落后了一点，因为我们不知道如何规范从事医疗制造的医院。”FDA预计将于2024年初发布植入物3D打印指南。。

Although it isn’t necessary for every hospital to have its own lab, says Alexander. “What they need is a robust supply chain in order to meet the needs of every patient requiring a patient-matched implant. For this, I think the future is probably colocation because the proximity between the engineers doing the work and the surgeons telling them what to do is an important piece of it.”.

亚历山大说，虽然并非每家医院都有自己的实验室。“他们需要的是一个强大的供应链，以满足每个需要与患者匹配的植入物的患者的需求。为此，我认为未来可能是共同定位，因为从事工作的工程师和告诉他们该做什么的外科医生之间的距离是其中的一个重要部分。”。

One current example of an orthopedics manufacturer setting up shop at a hospital is LimaCorporate, which established its ProMade Point of Care Center for Complex Orthopedic Solutions at New York City's Hospital for Special Surgery in 2019. The partnership’s first implant surgery was in 2022.

利马公司（LimaCorporate）是目前骨科制造商在医院开设店铺的一个例子，该公司于2019年在纽约市特种外科医院建立了ProMade综合骨科解决方案护理中心。该合伙企业的第一次植入手术是在2022年。

As more patients learn about patient-specific implants, there will be more demand for it and more hospitals considering it, experts agree.

专家同意，随着越来越多的患者了解特定于患者的植入物，对它的需求将越来越大，越来越多的医院正在考虑它。

To grow the application of patient-matched implants, Alexander says surgeons need to be educated that that's an option, patients need to be educated, and the medical device companies doing it today need to figure out how to streamline and speed up the delivery.

亚历山大说，为了扩大与患者匹配的植入物的应用，外科医生需要接受教育，这是一种选择，患者需要接受教育，而今天这样做的医疗器械公司需要找出如何简化和加速分娩。

“Where we want to get to as a company is to be at the center of this patient-specific surgical approach, where custom implants are used more often than not for hundreds of thousands or millions of cases a year,” says Crawford. “It's been slowly ramping up that way, but, now I think we're very much at an inflection point in the market in terms of our technology and the way that the market is viewing patients-specific surgery.”.

克劳福德说：“作为一家公司，我们希望成为这种针对患者的手术方法的中心，每年有数十万或数百万例患者经常使用定制植入物。”。“它一直在以这种方式缓慢增长，但现在我认为，就我们的技术和市场看待患者特定手术的方式而言，我们在市场上正处于一个转折点。”。