Digital health and medtech software development firm Sequenex announced in late August that it achieved International Organization for Standardization (ISO) 13485:2016 certification.

数字健康和medtech软件开发公司Sequenex于8月下旬宣布实现国际标准化组织（ISO）13485:2016认证。

Geneva, Switzerland-based ISO is an independent, non-governmental organization representing 169 national standards bodies, including the American National Standards Institute. ISO 13485:2016 focuses on requirements for a quality management system (QMS), with an organization having to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

瑞士日内瓦的ISO是一个独立的非政府组织，代表169个国家标准机构，包括美国国家标准协会。ISO 13485:2016侧重于质量管理体系（QMS）的要求，组织必须证明其能够提供始终如一地满足客户和适用法规要求的医疗设备和相关服务。

Certified organizations can be involved in one or more stages of the lifecycle, including design and development, production — even technical support..

认证组织可以参与生命周期的一个或多个阶段，包括设计和开发，生产-甚至技术支持。。

“Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485,” according to ISO.org.

根据ISO.org，“医疗器械行业的安全和质量是不可协商的，这就是我们开发ISO 13485的原因”。

In the case of Sequenex, a company that specializes in the diabetes space, the ISO certification demonstrates that its QMS meets all applicable quality requirements and employs robust practices for the design and development of Software as a Medical Device (SaMD).

对于专门从事糖尿病领域的公司Sequenex而言，ISO认证证明其质量管理体系符合所有适用的质量要求，并采用强有力的实践来设计和开发作为医疗器械（SaMD）的软件。

“Most companies getting this certification are… doing it for their own purposes for developing their own medical devices,” said John Krlin, Sequenex chief technology officer and cofounder. “In our case, we’re the services provider, so we bring the software, and we bring the expertise in how to build software for a medical device.”.

Sequenex首席技术官兼联合创始人John Krlin说：“大多数获得此认证的公司都是为了自己开发自己的医疗设备而进行的。”。“在我们的案例中，我们是服务提供商，因此我们带来了软件，并带来了如何为医疗设备构建软件的专业知识。”。

Krlin described San Diego-based Sequenex as providing software development for third-party companies — mostly device manufacturers — many of which are startups that don’t have a lot of software expertise.

Krlin将基于圣地亚哥的Sequenex描述为第三方公司（主要是设备制造商）提供软件开发，其中许多是没有很多软件专业知识的初创公司。

“It could really go both ways — either startups that don’t have a lot of software expertise… or a large company that has that but needs help getting a certain project done,” he said.

他说：“它可能真的有两种方式-要么是没有很多软件专业知识的初创公司……要么是一家拥有这方面但需要帮助完成某个项目的大型公司。”。

The ISO certification was a Sequenex milestone, given that the company has not yet celebrated its fourth year in business. “It’s a bit of a vetting for us,” he said. “When we say we’re certified it carries a lot of weight.”

鉴于该公司尚未在业务中庆祝其第四年，ISO认证是Sequenex的里程碑。他说：“这对我们来说有点审查。”。“当我们说我们获得认证时，它的重量很大。”

Seeing a need

看到一个需要

Sequenex’s founders learned about the need for a niche company that could provide compliant, reliable medical device software while working at diabetes device manufacturer Dexcom, where Krlin said the regulatory burden was high. “A lot of the software engineers didn’t like it, and it made the software development kind of painful to an extent,” Krlin said.

Sequenex的创始人了解到需要一家利基公司，该公司可以在糖尿病设备制造商Dexcom工作时提供合规，可靠的医疗设备软件，其中Krlin表示监管负担很重。Krlin说：“很多软件工程师都不喜欢它，这使得软件开发在一定程度上变得痛苦。”。

“When we set out to start [Sequenex], we were looking for a way to make the process easier and less burdensome while being able to achieve the same high standards.”.

“当我们开始[Sequenex]时，我们正在寻找一种方法，使过程更轻松，负担更轻，同时能够实现相同的高标准。”。

ISO certification gives companies some leeway in how they develop processes, but companies that seek certification have to have procedures that document their processes, and those processes have to achieve certain standards, according to Krlin.

根据Krlin的说法，ISO认证为公司提供了一些开发流程的余地，但寻求认证的公司必须有记录其流程的程序，并且这些流程必须达到某些标准。

“With that experience from Dexcom, we came up with processes that were streamlined for the software space as opposed to the hardware space,” he said.

他说：“根据Dexcom的经验，我们提出了针对软件空间而不是硬件空间进行简化的流程。”。

Avoid cutting corners in software development for medical devices

避免在医疗器械软件开发中切入角

Diabetes and other medical device startups often focus on hardware and not necessarily software. Company CEOs and CTOs know they need software and often think it’s easy and should be inexpensive to develop, Krlin said, continuing, “It’s their mindset. ‘[We] can just hire some software engineers, and they’ll get this thing done in no time.’”.

糖尿病和其他医疗器械初创公司通常专注于硬件而不一定是软件。Krlin表示，公司首席执行官和首席技术官知道他们需要软件，并且经常认为它很容易并且开发成本低廉，“这是他们的心态。”[我们]可以聘请一些软件工程师，他们将得到这件事在任何时候完成。“。

The reality is that medical grade software has to pass a certain quality standard. “[Bad software] could potentially kill people, so bugs are not something you can afford,” he said.

现实情况是，医疗级软件必须通过一定的质量标准。他说：“[坏软件]可能会杀死人们，所以虫子不是你能负担得起的东西。”。

One example of what bad quality software can do throughout the medical device manufacturing process is: when a device is going into a clinical study to start collecting data, and the company or clinic that’s doing the study is having difficulties with the software. It’s not working reliably. They have connectively issues.

在整个医疗器械制造过程中，劣质软件可以做什么的一个例子是：当设备进入临床研究开始收集数据时，正在进行研究的公司或诊所在软件方面存在困难。它不可靠。他们有连接的问题。

They have Bluetooth issues and regular usability problems..

他们有蓝牙问题和常规可用性问题。。

“Even from a data collection aspect, the people building the software just don’t understand the setting for how the software is intended to be used. They make poor choices in how it’s designed. And it becomes a nightmare for the company,” Krlin said.

“即使从数据收集方面来看，构建软件的人员也不了解软件的使用设置，他们在设计方式上做出了糟糕的选择，对公司来说成为噩梦，”克林说。

Quality software might cost more but can help to avoid those challenges, as well as add new capabilities. The Sequenex QMS, for example, has built in continuous delivery, which means after writing the software and finishing a feature, one can release that software with a push of a button, according to Krlin..

优质软件可能会花费更多，但可以帮助避免这些挑战，并增加新功能。例如，Sequenex QMS内置了连续交付，这意味着在编写软件并完成功能后，可以按下按钮发布该软件。。

This kind of capability used to be considered an impossibility with medical software because documentation including a risk assessment would need to be written before the release could be executed. The Sequenex process has all that built in at development time.

这种能力过去被认为是医疗软件不可能实现的，因为包括风险评估在内的文档需要在发布之前写入才能执行。Sequenex流程具有开发时内置的所有功能。

“If you’re not a class 3 device — let’s say you’re a class 1 or class 2, when the feature is done, you can release the software without having to do any additional work. I haven’t heard of anyone else doing that,” he said.

“如果你不是3级设备-假设你是1级或2级，当功能完成时，你可以发布软件而无需做任何额外的工作。我还没有听说过任何其他人这样做，”他说。

Krlin said Sequenex is looking to expand its market outside diabetes because there isn’t a big difference between delivering quality software for a diabetes company and software for a general connected medical device. This is as the outsourcing of its software and other subsets of the company enables a better focus on the core business, which is becoming more of a trend in the industry, he said. .

Krlin表示，Sequenex正在寻求扩大糖尿病以外的市场，因为为糖尿病公司提供高质量的软件和为通用连接医疗设备提供软件之间没有很大差异。他说，这是因为其软件和公司其他子集的外包能够更好地关注核心业务，这正成为该行业的一种趋势。 .

“There is not an easy process to do that,” Krlin said. “You have to find a partner that can alleviate your anxiety as far as the quality aspect. A lot of companies don’t want to give up control because they don’t really have trust in other partners. It’s a slow trend, but even large companies… are looking to outsource.”.

Krlin说：“这样做并不容易。“你必须找到一个可以减轻你焦虑的合作伙伴，就质量而言，很多公司不想放弃控制，因为他们真的不信任其他合作伙伴，这是一个缓慢的趋势，但甚至是大公司……正在寻求外包“。