Based in Minnesota, Elucent Medical is a medical device developer focused on creating precise, wireless surgical navigation tools for tumor identification and excision. Founded in 2014, Elucent is helmed by three veterans of venture-backed biotech companies, CEO Laura King, CTO Dan van der Weide, and Dr. Fred Lee; as well as Dr. Lee Gravatt Wilke, Director of the University of Wisconsin Health Breast Center and chair of the research committee of the American Society of Breast Surgeons.
The team at Elucent has been using Jama Connect™ for about a year to manage requirements, tests, and reviews throughout the product development cycle.
Jason Hiltner, Elucent’s VP of Research and Development, had worked with requirements management solutions like CaliberRM before, and he had seen other product teams depend on IBM Rational DOORS and Microsoft Word and Excel. With those experiences in mind, he knew he needed a more intuitive, centralized platform to support innovation at Elucent.
Jama Connect makes Elucent’s product development process more efficient and more collaborative, while facilitating traceability from requirements through testing in compliance with FDA regulations.
And Elucent is creating some amazing things with the help of Jama Connect. Since it’s difficult to locate precise spots in the body, especially in soft tissue, Elucent has developed the SmartClip™ — a tiny implantable product that marks the location of cancerous tissue so surgeons can identify and excise the cancerous tissue more easily. Patients don’t have to endure repeated excisions because surgeons haven’t located or removed all of the cancerous tissue, and the SmartClip™ eliminates the need for painful and costly radiology localization.
The EnVisio™ Navigation System, which is designed to enable real-time 360° navigation in the surgical sightline and provides distance, depth and direction to the SmartClip(s): guiding a surgeon’s tools to make tissue excision and removal even more exact. The team’s hard work was rewarded when the EnVisio™ Navigation System was granted FDA clearance in 2019.
Elucent’s first market will be surgical excision in breast-conserving surgery, and their technology has wide applicability for localization of cancerous lesions throughout the body. Hiltner says the initial response to the clinical product has been “phenomenal for sure.”
Learn how to move beyond the frustrations of document-based requirement systems, streamline your development and set yourself apart from the competition by watching our webinar, “Balancing Compliance & Innovation in the Medical Device Industry.”
We asked Hiltner and Judson Guericke, Senior Director of Quality at Elucent, to tell us more about how they’re leveraging Jama.
Jama Software: What corporate or industry challenge led to your decision to seek out a solution and ultimately purchase Jama Connect? Was there one particular problem that became a huge pain point?
Jason Hiltner: Obviously, in our industry, we have to have well-documented requirements that start with the customer requirements, go to the product requirements, link to the design descriptions and the software requirements, and lead to verification. If you’re going to do that, you need to start with something that allows you to have traceability. We also needed something with a central database, so we weren’t managing a bunch of different revisions of documents and emailing documents again. The big thing I wanted was a platform I could very easily maintain and not have questions about: I would know where things were and be able to easily do reviews. I also knew we needed something stable, robust and cloud-accessible.
How long have you been using Jama Connect, and what was the adoption process like?
Hiltner: We’ve been using Jama Connect for about a year. We’re a startup, so I talked over the idea [of a requirements management solution] with a small group of people. We’re a very lean and focused organization; we’re at only 11 people. We compared a couple of tools and got recommendations from people who had done a more exhaustive search. We went with Jama Connect in spite of the fact that it was more costly than some other tools. The deployment and implementation process was as smooth as I could have hoped for. We had a bunch of sessions with Zeb Geary, a Jama Professional Services consultant, and we were up and running, creating requirements in less than a week. It’s as flexible as I hoped it would be.
“We were up and running, creating requirements in less than a week.” – Jason Hiltner, VP of Research and Development at Elucent Medical
What was the feature/capability/business aspect of Jama Software that won you over?
Guericke: The collaboration and customer support for implementation. The biggest benefit for us is the efficiency in completing and gaining agreement on requirements and testing procedures.
Hiltner: We wanted something that would be very usable, something that would be maintained and around for a while. Our product has customer requirements that flow down to product requirements, which flow down to software requirements and design descriptions. We also maintain our verification suite within Jama.
Guericke: We needed a solution that would facilitate traceability from requirements through testing to comply with FDA expectations for design control. Jama Connect provided a traceability functionality that worked well for our needs. In addition, the collaboration capability of Jama aided us greatly in the definition of our requirements.
How do you measure success for this project? How are you using Jama Software to get there?
Hiltner: Now that we have that [FDA] clearance on the EnVisio Navigation System, success will mean surgeons utilizing our product to improve patient care.
Guericke: Confidence in assuring complete coverage from customer requirements to product requirements to software requirements to verification and validation. I really like how intuitive Jama Connect is. It was very easy for me to figure out how to navigate and use. There was some learning curve on the system configuration, but the support provided by the Jama Software team made that much easier.
Interested in learning more about using Jama Connect to build medical devices? Download our brochure, “Jama Software for Medical Device Development.”