From Pharmaceutical to Digital Health: A Strategic Leap Through SaMD Development

Company Name

Dr. Pfleger

Location

Germany

Industry

Healthcare Software Development

Services

Data and Analytics

Client

Dr. Pfleger Arzneimittel GmbH is a mid-sized, foundation-owned pharmaceutical company based in Germany. Founded over 70 years ago, the company demonstrates a strong commitment to patient well-being and its specialization in urology. Historically focused on prescription and over-the-counter medications, Dr. Pfleger has recently expanded into digital therapeutics as part of its long-term innovation strategy.

Overview

As a midsize pharmaceutical company with no prior experience in digital health, Dr. Pfleger faced the challenge of building a Software as a Medical Device (SaMD) from the ground up. SaMD development encompassed regulated product development, digital therapeutics design, and full compliance with European medical device and data protection standards.

Based on their experience in urology, the company began developing INKA, a DiGA (Digitale Gesundheitsanwendung) mobile application to support elderly patients with symptoms of an overactive bladder. The INKA application was designed and certified as a Software as a Medical Device (SaMD), and built in full compliance with MDR, GDPR, and ISO 13485 requirements, ensuring patient safety and the secure handling of sensitive health data.

Following successful DiGA approval, INKA is officially listed for prescription and reimbursed through Germany’s public health insurance system, enabling Dr. Pfleger to bring the solution to market and deliver broad, scalable patient access across Germany.

Solution

DataArt supported Dr. Pfleger with end-to-end digital therapeutics development, covering regulated product design, SaMD engineering, and compliance execution:

Built and designed a user-friendly mobile application for elderly users
Ensured compliance with MDR, GDPR, ISO 13485, and DiGA compliance as part of a certified SaMD development process
Developed a backend module for data collection and analysis, supporting:
- Monitor Clinical Study
- Post-market surveillance
- Improve patient adherence

Key Advantages & Outcomes:

Launched a digital health product in line with the company's therapeutic focus
First app of its kind to meet the needs of elderly patients living with urinary incontinence and integrate patient profile with Germany's national electronic patient record system (EPA 3.0)
Expansion into other European countries that also want to launch the “app on prescription.”
Data Analytics component helps Dr. Pfleger generate real-world insights for future innovations

This project highlights DataArt's ability to deliver DiGA-compliant, SaMD-certified solutions that meet strict regulatory requirements, an approach adaptable to other global markets beyond the EU.

Working with DataArt has enabled us to move confidently into the digital therapeutics space. Their team understood our vision and helped translate it into a patient-friendly application that meets the highest compliance standards.

Patrick Sindt

Head of Digital Health at Dr. Pfleger

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