A digital therapeutics startup with nearly $10 million in Seed funding received an FDA breakthrough device designation for a smartphone-assisted fibromyalgia management program. Fibromyalgia is a condition that causes widespread musculoskeletal pain, as well as fatigue, sleep disorders and mental health issues.
Since it was classified as a condition in 1990, only three drugs have been approved for treatment for fibromyalgia, which has no cure to date. Beyond medication, there is some evidence that an Acceptance and Commitment Therapy Program (ACT Program) can help patients live better with chronic pain.
Which is exactly what this company set out to tackle: They had a goal of adapting the established ACT program so that the protocols would work as an app on a phone.
The overall vision was that the company’s smartphone platform would be prescribed by a doctor and used as a treatment management tool. The patient’s 12-week ACT program would appear as “daily doses” on their phone. Each “daily dose” would be a task associated with a typical ACT Program, such as a mindfulness session or a short writing session prompted by the app.
Before it could go to market however, the startup had to complete and submit a study to the FDA for full approval of its platform. And before that could happen, it needed a software development partner to build the product’s UI & UX. The company was looking for a partner who had a more flexible and modular approach to its app development so that it could scale and add new features in the future.
Going into the project, the digital therapeutics firm had an existing software partner it was not happy with. Nexient was asked to replace the partner but the Nexient team and the outgoing software partner overlapped by about a month.
“The original software partner had lots of stringent processes in how they would operate and they were very inefficient,” said Nexient team leader Anmol Gupta. “They were pushing expensive approaches such as pair programming for everything.”
Because of the overlapping period with the other partner, Nexient was able to identify key pain point areas for the client — areas that they would focus on in order to provide a more flexible, agile, and efficient experience for the client. At the start, the development of the company’s product was getting bogged down in process. The company was not moving as fast as it needed and Nexient’s team offered speed with precision. For example, Nexient would use pair programming only when it was necessary for something complex, but not for routine tasks and they would stick to industry standard tools instead of inflexible proprietary tools.
“It was becoming very difficult for the client to work with its [existing] partner,” said Nexient team co-leader Kent Symanzik. “They had an extreme agile approach with no flexibility while Nexient’s approach is practical agile.”
Nexient was able to use a product mindset to match its skills to the needs of the client.
“When you're at a startup, you're constantly putting out fires. And when somebody is in a fire, screaming for help, you have to run into the building to save them. You can’t wait until after lunch. You just have to get the job done now,” Symanzik said. “Nexient is good at understanding and executing with the startup mindset. It’s why we’re so flexible.”
While the product needed to be built quickly, Nexient was also under pressure to make sure it met stringent FDA standards. The app was considered a treatment, which meant Nexient had to put extra care into its work to ensure consistency - just as you would making prescription medications.
“There were standards we had to follow,” Symanzik said. “There were requirements for signatures and audits that we had to take care of. The right processes had not always been followed, so we had to address that.”
A system that allowed for automation to consistently produce quality software did not previously exist so that is what Nexient focused on first.
In order to create consistent software, the Nexient team put mobile DevOps and automated testing in place. The automated testing allowed Nexient to run through a test suite in one or two hours versus several days of manual regression testing.
“We focused on implementing good practices that could really accelerate the development,” Gupta said. “Our goal was to not let the process get in the way of the product development.”
Using a mobile-first DevOps platform that is cloud-based for the software development was key rather than retrofitting a web-based platform.
“In the cloud, you can stand up everything much faster, rather than trying to do something on prem,” Symanzik said.
The Nexient team brought in open source test automation framework Appium and used the AWS Device Farm to test against a range of browsers and device combinations. They chose to use Google’s mobile and web development platform Firebase as the backend.
Initially, the product was strictly a mobile app. But there was also a need for administration capabilities in a web application, which the Nexient team was able to build quickly using its approach and its industry standard toolsets.
The architecture and the design had to accommodate a daily regimen for fibromyalgia patients. They couldn’t receive all the information at once. It had to be given piecemeal, as a daily dose. This requirement had implications for the architecture of the application.
“Every day, there needs to be new content on the app for the patient to walk through,” Symanzik said. “Our solution was to build an application that can dynamically consume content so that we don't have to update it every time they need to change what the dosing is going to be, or to adjust the pacing of the content. We had to build an architecture that could dynamically ingest and change content.”
Nexient also added features to the web application so content could be easily modified on the backend to tailor the patient’s program.
The Nexient team started on the project in April 2020 with four developers, one quality engineer, and one DevOps specialist. From there, the team varied in size from seven to 10 members at the peak.
By the second week on the job, Nexient started to produce deliverable code based on issues the team had identified — demonstrating a much faster approach than the startup had seen with its previous vendor.
“They saw the momentum shift as our team took control of the project,” Gupta said. “By week four, Nexient had displaced the previous vendor and we started working with the client on a long-term approach on how to build the product.”
The client was also impressed how Nexient’s developers seemed to instinctively know how to produce and deliver items in sync with the design before it was even finished.
“We knew what was coming because we were part of their team in discussing everything,” Symanzik said. “Our developers understood the product, which helped them proactively anticipate what was going to be required. There was a harmony of things coming seamlessly together at the same point in time. This made the client really happy.”
It enhanced the trust factor between Nexient and the startup company. The initial contract started with a three-month project and soon became six months. Then it was extended to one year. Now it is an annual contract reflecting the depth of the partnership.
Nexient helped the company go to market with its product, which is being used in a live setting in the clinical field. Nexient is also helping the company roll out new features as the company seeks FDA approval.
This means the quality assurance and quality engineering led by Nexient is vital.
“You have to have a real interest in the product to be able to go in and see how the patients experience it, to know how and where the product could break,” Symanzik said. “Nexient goes the extra mile and this has helped the client enormously as they seek FDA approval. It’s exciting to go along the journey with them.”