In the rapidly evolving field of digital therapeutics, Amara Therapeutics stands out as a trendsetter. Led by CEO – Brendan Staunton, the company is on a mission to develop innovative treatments delivered directly to patients’ smartphones. One of their primary focuses is creating a digital therapeutic for overactive bladder, a debilitating condition affecting approximately 100 million women worldwide.
To bring this groundbreaking product to market, Amara Therapeutics partnered with TEKenable, a company known for its expertise in healthcare software development.
The decision to collaborate with TEKenable was influenced by their impressive track record and their ISO 13485 certification, the gold standard in healthcare software development. This certification was crucial for Amara Therapeutics. They aim to secure FDA and CE approval for their product in Europe and the US.
The collaboration with TEKenable has been a rewarding experience for Amara Therapeutics. Staunton praises the TEKenable team for their top-class talent and dedication. The primary goal of the project was to develop a robust software platform tailored to the unique demands of healthcare. This involved creating a sophisticated functional document that served as the blueprint for the entire development plan. From the outset, cybersecurity, information security, and data management were integral components of the project, areas where TEKenable’s expertise proved invaluable.
Throughout the development phases, the project faced various challenges.
However, these obstacles only highlighted the exceptional quality of the TEKenable team. Their ability to tackle problems and devise innovative solutions enhanced the final product. The result was an ISO 13485-compliant software as a digital medical device standard treatment platform, comprising iOS and Android apps, as well as a clinician portal backend. Additionally, a series of treatment algorithms were developed to integrate the user interface with the backend.
The complexity of the project was immense, requiring the integration of multiple factors such as cybersecurity, information security, and data protection from the beginning. Despite these challenges, the final product exceeded expectations. Staunton expresses immense satisfaction with the outcome, noting that the robust platform is well-prepared to meet regulatory approval standards in both the US and EU.
Communication and collaboration were key to the project’s success. Staunton emphasises the importance of effective communication when developing software externally. The close working relationship between Amara Therapeutics and TEKenable was instrumental in navigating the project’s numerous decisions and challenges. TEKenable’s responsiveness and proactive approach ensured that the project progressed smoothly, even when faced with unexpected hurdles.
Looking ahead
Amara Therapeutics is preparing to initiate a large randomised control trial involving 10 hospitals in the US. This clinical study will be one of the largest ever conducted in the field of overactive bladder and the largest using a digital treatment approach. Following the trial, the company plans to apply for regulatory approval in both the US and Europe, paving the way for commercialisation.
The ultimate goal is to make this innovative product available to patients worldwide. Helping as many people as possible benefit from the hard work and dedication of both Amara Therapeutics and TEKenable.











