Question 1

What reimbursement pathways exist in Germany for medical software?

Accepted Answer

Several reimbursement pathways are available in Germany for medical software. These include hospital reimbursement via DRG, supplementary payment or NUB structures, listing in the medical aids directory, selective contracts with health insurers, listing as a Digital Health Application (DiGA) or Digital Care Application (DiPA), and individual care or licence models with healthcare providers. The most suitable pathway depends on the medical purpose, target group, care context, evidence base and regulatory classification of the product.

Question 2

How can AI be integrated into medical software and what needs to be considered?

Accepted Answer

AI can be integrated into medical software for decision support, risk analysis, image or data analysis, personalisation or process automation. Key considerations include medical purpose, regulatory classification, clinical validation, risk management, data protection, IT security, data quality, bias control, traceability, human oversight and change management. In addition to MDR, GDPR and relevant standards, AI systems must also comply with the EU AI Act, particularly if classified as high-risk AI.

Question 3

How long does it take to develop and launch a Class I medical app?

Accepted Answer

Developing and launching a Class I medical app can take more than a year, especially when product strategy, quality management, technical documentation, data protection, information security and market access all need to be built from scratch. With a clearly defined scope, a sound regulatory strategy, efficient project management and existing QMS structures, a launch in around three months is realistic. The prerequisite is that the app is genuinely classifiable as Class I and no Notified Body procedure is required.

Question 4

What is the value of interim leadership at Life Sciences Consulting?

Accepted Answer

Interim leadership provides operational management precisely where critical decisions need to be made and implemented. The value lies above all in risk reduction, clear financial predictability, binding launch timelines, rapid prioritisation, better management of external service providers and a clean integration of product development, regulatory affairs, QMS, data protection, information security and commercial strategy.

Question 5

What is the best advice if I want to sell medical software for the first time?

Accepted Answer

The most important advice is to plan market entry not just as a product launch, but as a regulated business model. This includes a complete product and reimbursement strategy, solid resource planning, a suitable quality management system, early data protection and information security concepts, an evidence and data strategy, and clear processes for sales, support, vigilance, post-market surveillance and product changes. Addressing these topics early saves time, reduces costs and preserves regulatory options.

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Interim Leadership

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