Digital health and medtech software development firm Sequenex announced in late August that it achieved International Organization for Standardization (ISO) 13485:2016 certification.
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. Certified organizations can be involved in one or more stages of the lifecycle, including design and development, production — even technical support.
“Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485,” according to ISO.org.
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).
“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.”
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.
“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.
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.”
Seeing a need
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. “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.”
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.
“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.
Avoid cutting corners in software development for medical devices
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.’”
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.
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. They have Bluetooth issues and regular usability problems.
“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.
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.
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.
“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.
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.
“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.”