In this digital era, people are constantly connected through phones, computers and other devices. Continued technological advances are changing the way we operate, including how patients interact with healthcare professionals. As digital health technology continues to advance the healthcare ecosystem, many companies are seeking to develop software that can directly improve patient outcomes via a new class of products called software as a medical device (SaMD).
An SaMD is software intended to be used for medical purposes, but function without being part of a hardware medical device. With the help of ZSers like Caronne Colepalmer-Hayes, we are proud to announce the launch of the ZS SaMD Factory, an affiliate of ZS.
The SaMD Factory—which consists of a cross-functional team of experts on regulatory, quality and compliance (RQC), project and product management, operations and technology—will advise our clients on the many complexities of SaMD strategies and help them execute on the design, build, validation and deployment of clinical-grade digital solutions.
And it’s because of dedicated and talented ZSers like Caronne that these new SaMD products will be at the forefront of healthcare innovations.
Where passion changes lives
As a program manager based in Boston, Caronne has been instrumental in the launch of the ZS SaMD Factory. She joined ZS with the acquisition of Medullan, a digital health technology company.
“I made the switch to healthcare because I wanted to make a tangible difference in the way people live their lives,” she says. “Working at ZS allows me to create impact, grow and work with some exceptional people every single day. I build products that help people heal themselves or at least live a better quality of life with their chronic disease.”
This motivation impassioned Caronne and her team as they built a quality management system (QMS), a repository of processes, tools and policy documents necessary for designing, building and continuously improving a regulated product. The team used that QMS to help develop Covision, an app that allowed patients to track their COVID-19 symptoms and get notified when they should see a doctor or call emergency services.
“Going to a doctor is expensive, both for the patient and the hospital,” Caronne explains. “So we wanted to create a way to track a user’s symptoms while they are at home, to prevent the user from coming back to the hospital unnecessarily.”
Next, Caronne led her team at ZS through a noncommercial release of Covision, organizing patients who had been diagnosed with COVID-19 to test the app. With ZS as the contract manufacturer, this was the best way to obtain user engagement. The goal for Caronne and her team was to see how they could make product improvements, certify their post-market surveillance processes and document how we addressed user questions, feedback and complaints, as an FDA- and ISO-compliant device. The post-market surveillance process will be used to support clients in monitoring their devices once they are launched for sale into the market.
“The product, Covision, led to us to obtain an ISO 13485 certification and build out our QMS and capabilities. That was the big win,” Caronne says with pride. “Now we have the foundations to build similar monitoring products for future clients, build other algorithm-based SaMDs or even provide post-market surveillance support. Because of our ISO certification, we are able to launch the ZS SaMD Factory and contract manufacturing capabilities.”
Today, Caronne is helping clients build new products through the ZS SaMD Factory.
“These products address a wide variety of patient needs, like medication adherence, cognitive behavioral therapy, clinical decision support, symptom monitoring and tracking,” Caronne says. “For example, an SaMD can help support people in taking their medication when and how they're supposed to. This can have a huge impact on their life. I’m proud to be working on something this important.”
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