及时生产更多的呼吸机帮助新冠肺炎患者已经够难了。那么制造这种先进设备所需的临床测试呢?生产病人使用这种设备所用的病床呢?是不是难上加难?
以上是萦绕在约翰•卡尔森脑海中的问题,他是美国强生公司前高管,目前担任跨国公司伟创力医疗制造主管。作为众多医疗器械公司(和其他行业)的签约制造商,伟创力在全球22个地区生产呼吸机等抢手的医疗设备,在美国和墨西哥也设有几处工厂。
目前,伟创力正在牵手其他“非传统”公司(比如汽车制造商),助力它们实现生产线转型,以满足医疗器械制造业的严格监管要求。“他们甚至对这个行业的基本规章制度一无所知,”卡尔森指出。“但他们的供应网跟我们的不一样,有利于他们充分利用各种人才的不同能力。现在,我们的合作宗旨就是尽量拯救生命,尽可能地把生产出来的产品送往需要的地方。”
卡尔森在接受《财富》的采访过程中,阐述了各个公司争分夺秒解决全球呼吸机短缺问题时所面临的其他挑战。以下为整理后的精简版对话内容:
《财富》:在呼吸机制造的供应链中,你认为存在哪些特定的限制条件?
卡尔森:任何医疗器械内部的零件,都是由大量现成的通用组件和少量特别定制元件组成的。这些定制元件,我们需要花很多时间来确保得到供应。就呼吸机而言,通常需要的是与泵系统相关的组件,而阀门就是[供应链]的瓶颈所在。
还有什么因素阻碍了制造商,使其无法及时生产医疗设备来满足美国的需求?
产品的最终测试通常要求使用特定的设备。能够大规模地迅速完成测试也是一个方面的限制。对于像呼吸机这样的设备来说,你需要人工肺进行测试,以确保呼吸机有适当的流速与合适的压力控制。这些测试设备非常精密。要想很快开始复制这些设备,需要保证的,不仅是获得零件,还有合理组装这些零件并[确保]它们按照设计的功能运行。
呼吸机和N95口罩短缺已经引起了大量关注。你认为还有哪类医疗设备是特别需要的?
氧气浓缩机或[基本的]便携式制氧系统,这些设备可供肺免疫功能受损的病人使用。在医院里,有些基础设施是整合到医院内部的。例如,医院墙壁上有负压吸引系统,还有供氧和静脉注射系统。但现在,他们尝试把病人安排在酒店客房和宿舍房间等医院之外的任何地方,而这些基础设施都不可能在这类房间中找到。因此,我们认为,基本设施以及像病床这样简单的东西,需求量会越来越大。
伟创力的医疗器械制造工厂遍及世界,而本次疫情大流行也波及了全球,这对公司运营和员工带来了怎样的影响?
我们员工在进入工厂前会测体温排查。我们给他们发放口罩,定期检查身体,也制定了制度和流程,要求员工之间保持适当的距离。2月份的时候,我们从中国工厂的制造环境中学到了很多。所有这些都发生在春节期间,那时很多员工都在[春运途中],不久他们都被隔离在中国的某些地区,不能返回工厂。但最近几周中国开始复工,员工也回来了,目前我们位于中国的所有工厂基本上都回到了满负荷生产状态。
据估计,美国新冠肺炎住院患者的呼吸机短缺率达20%。你们公司与合作伙伴能及时增大产量吗?
[停顿思考了很长一段时间] 我不知道该如何回答这个问题。像这样的项目,无论哪个公司来做,通常都需要12到24个月的时间;而那些以前花费数月来完成的工作,我们已经缩减到数日和数周完成了。我们将竭尽全力,希望能对拯救很多人的生命起到重要的作用。我实在是不知道该怎么量化速度是否足够快。实际上,永远都跟不上趟,因为如果今天有人没产品可用的话,我们就不够快。(财富中文网)
译者:夏晴
及时生产更多的呼吸机帮助新冠肺炎患者已经够难了。那么制造这种先进设备所需的临床测试呢?生产病人使用这种设备所用的病床呢?是不是难上加难?
以上是萦绕在约翰•卡尔森脑海中的问题,他是美国强生公司前高管,目前担任跨国公司伟创力医疗制造主管。作为众多医疗器械公司(和其他行业)的签约制造商,伟创力在全球22个地区生产呼吸机等抢手的医疗设备,在美国和墨西哥也设有几处工厂。
目前,伟创力正在牵手其他“非传统”公司(比如汽车制造商),助力它们实现生产线转型,以满足医疗器械制造业的严格监管要求。“他们甚至对这个行业的基本规章制度一无所知,”卡尔森指出。“但他们的供应网跟我们的不一样,有利于他们充分利用各种人才的不同能力。现在,我们的合作宗旨就是尽量拯救生命,尽可能地把生产出来的产品送往需要的地方。”
卡尔森在接受《财富》的采访过程中,阐述了各个公司争分夺秒解决全球呼吸机短缺问题时所面临的其他挑战。以下为整理后的精简版对话内容:
《财富》:在呼吸机制造的供应链中,你认为存在哪些特定的限制条件?
卡尔森:任何医疗器械内部的零件,都是由大量现成的通用组件和少量特别定制元件组成的。这些定制元件,我们需要花很多时间来确保得到供应。就呼吸机而言,通常需要的是与泵系统相关的组件,而阀门就是[供应链]的瓶颈所在。
还有什么因素阻碍了制造商,使其无法及时生产医疗设备来满足美国的需求?
产品的最终测试通常要求使用特定的设备。能够大规模地迅速完成测试也是一个方面的限制。对于像呼吸机这样的设备来说,你需要人工肺进行测试,以确保呼吸机有适当的流速与合适的压力控制。这些测试设备非常精密。要想很快开始复制这些设备,需要保证的,不仅是获得零件,还有合理组装这些零件并[确保]它们按照设计的功能运行。
呼吸机和N95口罩短缺已经引起了大量关注。你认为还有哪类医疗设备是特别需要的?
氧气浓缩机或[基本的]便携式制氧系统,这些设备可供肺免疫功能受损的病人使用。在医院里,有些基础设施是整合到医院内部的。例如,医院墙壁上有负压吸引系统,还有供氧和静脉注射系统。但现在,他们尝试把病人安排在酒店客房和宿舍房间等医院之外的任何地方,而这些基础设施都不可能在这类房间中找到。因此,我们认为,基本设施以及像病床这样简单的东西,需求量会越来越大。
伟创力的医疗器械制造工厂遍及世界,而本次疫情大流行也波及了全球,这对公司运营和员工带来了怎样的影响?
我们员工在进入工厂前会测体温排查。我们给他们发放口罩,定期检查身体,也制定了制度和流程,要求员工之间保持适当的距离。2月份的时候,我们从中国工厂的制造环境中学到了很多。所有这些都发生在春节期间,那时很多员工都在[春运途中],不久他们都被隔离在中国的某些地区,不能返回工厂。但最近几周中国开始复工,员工也回来了,目前我们位于中国的所有工厂基本上都回到了满负荷生产状态。
据估计,美国新冠肺炎住院患者的呼吸机短缺率达20%。你们公司与合作伙伴能及时增大产量吗?
[停顿思考了很长一段时间] 我不知道该如何回答这个问题。像这样的项目,无论哪个公司来做,通常都需要12到24个月的时间;而那些以前花费数月来完成的工作,我们已经缩减到数日和数周完成了。我们将竭尽全力,希望能对拯救很多人的生命起到重要的作用。我实在是不知道该怎么量化速度是否足够快。实际上,永远都跟不上趟,因为如果今天有人没产品可用的话,我们就不够快。(财富中文网)
译者:夏晴
Making more ventilators in time to help coronavirus victims is hard enough. But what about manufacturing the sophisticated equipment needed to clinically test them? Or hospital beds for the patients using them?
Those are the sorts of questions occupying John Carlson, a former Johnson & Johnson executive who now oversees medical manufacturing for multinational Flex. As a contract manufacturer for medical-device companies (among other industries), Flex makes ventilators and other in-demand health care equipment at 22 locations globally, including several in the U.S. and Mexico.
Now it’s also working with some unspecified “nontraditional” companies (think automakers), to help them switch over their production lines to the highly regulated world of medical-device manufacturing. “They don’t even know what the basic rules and regulations are to do this,” Carlson says. “But they have a different set of supply networks than we do, so they can tap into different people with different capabilities. There’s a collaborative spirit right now that’s really about saving lives and getting product out there.”
In the following edited and condensed conversation with Fortune, Carlson explains some of the other challenges for companies racing to fix the global ventilator shortage.
Fortune: Where are you seeing specific constraints in the supply chain for making ventilators?
Carlson: Inside any medical device, you’ll have a bunch of common components that you could buy off the shelf, and then a few very custom components that we’ll spend a lot of time making sure we have a supply of. For ventilators, it’s typically components relating to the pump system and the valve where you’ll find the [supply-chain] bottleneck.
What else is holding back manufacturers from producing medical equipment in time to meet U.S. demand?
The final testing of the products usually requires very specific equipment. Being able to rapidly scale that test is another area that can be a constraint. For something like a ventilator, you’ll have an artificial-type lung that the device has to be tested against, to make sure that it has the right flow rate, the right pressure control. Those pieces of the test equipment can be pretty elaborate. Duplicating them is something that we jump on very quickly to make sure that not only can we get the parts, but can we assemble them and [make sure] they perform as they’re intended.
Shortages of ventilators and N95 masks have gotten a lot of attention. What other kinds of medical devices are you seeing particular need for?
Oxygen concentrators, or a [basic] portable system to generate oxygen for patients with compromised lung function. When you’re in a hospital there’s a bunch of infrastructure built into it: You’ve got vacuum systems in the wall. You’ve got oxygen. You’ve got IV systems. But now they’re trying to put patients into hotel rooms and dorm rooms and any place you can to keep them out of the hospital—and none of that infrastructure exists in a hotel room. So some of those basic supplies, as well as simple things like hospital beds, are products where we’re seeing an increase in demand.
Flex manufactures medical devices around the world, but this pandemic has had equally global reach. How have your operations—and your employees—been affected?
We screen their temperatures before they come into the plant. We issued them masks. We check on them regularly. We’re putting in systems and processes to allow them to maintain appropriate distances. We learned a lot with our manufacturing environment in China in February. All this started over the Chinese New Year, where many of our employees [were traveling], and then they were locked down and prevented from coming back. But over the last several weeks, we’ve been able to bring it back, and we’re back to basically full production across all of our China facilities.
The U.S. has less than 20% of the ventilators it might need for hospitalized coronavirus patients, according to some estimates. Can you and your partners ramp up in time?
[Long pause] I don’t know how to answer that. Typically a program like this would take anywhere from 12 to 24 months, and in what used to be months we’re now getting done in days and weeks. We will do enough that it can have a significant impact on the lives of many people. I just don’t know how to quantify if it’s fast enough. It’ll never be fast enough—because if there’s someone today who doesn’t have a product, then we’re not fast enough.