An FDA-compliant COPD web application in just 9 months
Improving the quality of life through innovative therapies is the goal of an internationally active, family-run pharmaceutical company. From research and development to production and marketing, dedicated teams around the world are working to drive innovation and actively shape the future of healthcare. A particular focus is on respiratory research. This highly specialized expertise has enabled the company to develop groundbreaking therapeutic solutions for respiratory diseases such as chronic obstructive pulmonary disease (COPD).
Digital product to support COPD therapy
In addition to a physical form of therapy, a digital product was developed to supplement the treatment of COPD patients. For the US market, the pharmaceutical company was looking for a solution that could be used both on mobile devices and in the browser on a PC.
Fast project start with a proven partner
The project team quickly found a suitable partner for the development: “We already knew BAYOOMED from a previous joint project and therefore knew that they were the right partner for the implementation of the new product,” recalls the Pharma Solution Lead.
Requirements for the new web application
The new web application should optimally accompany users on their way to a healthier lifestyle with a digital behavior change intervention (DBCI) approach. On the one hand, the application should motivate better medication adherence through a diary function. On the other hand, methods for self-regulation should be taught – for example through (breathing) techniques that COPD sufferers can use to improve their respiratory flow.
Technology selection and project start
Once all the requirements had been defined, the project could officially begin. However, suitable technologies had to be selected before the actual software development could begin. “It was particularly important for us to rely on modern technologies and a model-based approach,” explains the Pharma Solution Lead.
Microservices, standards and data security
The aim was to develop a microservice architecture. Based on this, the BAYOOMED team selected suitable tools, frameworks and the system architecture. “We also asked the BAYOOMED team to draw on existing standards during development,” adds the Pharma Solution Lead. To ensure the secure exchange of medical data, the application was developed in accordance with the FHIR standard.
First successes after less than a year
Development began, and after less than a year, the first successes could already be recorded. Together, the pharmaceutical company and BAYOOMED reached the first major milestone: Feature Complete – after the implementation of over 600 individual pages.
Just three months later, development was completed and the product was launched on the US market. The special feature: although the application was deliberately not registered as a medical device, the development was still carried out according to medical standards – based on BAYOOMED’s ISO 13485-certified quality management system and in compliance with all FDA regulations.
Project manager Kersten Klein from BAYOOMED recalls: “There was a lot of content and UI designs to implement – over 600 screens in total.” To meet this challenge, the team developed its own technical solution for generative page creation, with which content could be produced and maintained efficiently.
Even after the go-live, BAYOOMED remained a reliable partner: they took over the hosting and operation of the software, provided 2nd and 3rd level support and took care of regular function and security updates.
“From the initial idea to archiving the recorded data, we were able to experience the entire product life cycle in fast motion. It was an exciting and enriching experience for us. And that’s why we look forward to continuing to work with the team.”
Kersten Klein, Project Manager at BAYOOMED
A limited test – and yet a success
The application was planned from the outset as a commercial pilot with a limited duration. During the test phase in the USA, it was used by COPD patients who had been selected by doctors. At the end of the test phase, the pharmaceutical company decided to discontinue the project – not out of dissatisfaction with the product or the collaboration, but for strategic reasons.
Despite the discontinuation, the project remains a positive example of successful collaboration between technology and pharma. “We really value the development team because we meet as equals and drive projects forward together,” emphasizes the Solution Lead.