Munich, London, New York, Dubai – February 10, 2026 – DataArt, a global software engineering firm that delivers breakthrough data, analytics, and AI platforms, has partnered with Dr. Pfleger Arzneimittel GmbH, a privately owned German pharmaceutical company, to develop INKA, a DiGA (Digital Health Application) designed to support elderly patients with urinary incontinence. The collaboration marks Dr. Pfleger's first venture into the digital therapeutics space and reflects a growing trend in the pharmaceutical industry to create value beyond traditional medication.
Patrick Sindt, Head of Digital Health at Dr Pfleger said:
"With DiGA, we want to consolidate our strong position in urology and see great opportunities for the future in the digital expansion of our portfolio. We were only able to overcome the many hurdles on the way to official approval thanks to the excellent partnership-based cooperation with our central service providers."
From Pharma to Digital Health
As a midsize pharmaceutical company with a strong track record in, Dr. Pfleger saw an opportunity to expand its impact through digital health despite having no prior experience in the field. The result is INKA, a user-centric DiGA application which is the first of its kind built to meet the needs of elderly patients living with urinary incontinence.
Developed in full compliance with Germany's strict regulatory framework, the INKA DiGA solution adheres to comprehensive standards, including:
- Medical Device Regulation (MDR) and ISO 13485 compliance as Software as Medical Device (SaMD)
- GDPR and BSI (German Federal Office for Information Security) security and data protection standards
- BFARM (Federal Institute for Drugs and Medical Devices) guidance for digital therapeutics · DiGA certification criteria — Germany's framework for digital health apps that can be prescribed by physicians and reimbursed by public health insurance
DataArt provided end-to-end support throughout the project lifecycle, including design, development, regulatory compliance engineering, and data analytics platform integration for this SaMD solution. The collaboration underscores DataArt's ability to deliver compliant SaMD solutions that meet strict regulatory requirements — an approach adaptable to global markets beyond the EU.
Ivan Pantykin, Head of HCLS DACH, said:
"It's great to see a company like Dr. Pfleger take such a bold step into digital health. They brought the medical expertise; we helped bring it to life in a compliant DiGA format that's secure, regulatory-aligned, and truly focused on patients. We're proud to be part of this journey and to help turn their vision into something that can really make a difference in people's lives."
Data Analytics and Real-World Evidence
The DiGA solution includes a robust backend module for secure data collection and analysis, allowing Dr. Pfleger to:
- Monitor clinical study process
- Conduct post-market surveillance
- Improve long-term patient adherence
These capabilities provide valuable insights into patient behavior, clinical outcomes, and product performance, laying the groundwork for future innovation.
