Impulses on Digital Health 2.0

A single client enquiry can trigger a company formation. The p4mx health GmbH i.G. demonstrates how the journey from business idea through GmbH incorporation to a signed first project takes around 30 days. Online notarisation, clear role division and consistent use of AI tools make this pace possible.

Around 50% of patients with chronic conditions do not take their medication as prescribed. Companion apps address this problem while creating value for patients, payers and pharmaceutical companies.

AI-powered apps for pharma and MedTech no longer require a classic IT project. How internal and external data are connected and what this means for operational processes.

Software can be listed as a medical aid in the GKV medical aids directory. This route is little known among digital health manufacturers, yet it offers direct access to standard care coverage across all statutory health insurers. For eligible products, it is faster than the DiGA pathway and involves less regulatory effort.

Many AI-powered medical devices are automatically classified as high-risk systems under the EU AI Act — adding a second compliance layer alongside the MDR. What matters now is not another silo, but an integrated architecture. We map the legal landscape and show how two regulatory frameworks become one process.

Digital health applications are becoming part of standard care. The Digital Act raises expectations for manufacturers. Demonstrable benefit in everyday care is now the decisive factor.

Successful digital health projects combine product vision, regulatory clarity and operational execution. Life Sciences Consulting supports companies as a specialised partner from analysis through to go-live. This article shows what such a collaboration looks like in practice.

Foreign MedTech and SaMD manufacturers rarely fail in Germany due to lack of market potential but rather at MDR compliance and the complex GKV reimbursement system. Those who consider both from the outset significantly improve their chances.

Some clients want change – but not instruction. The key lies not in better recommendations but in the right question at the right moment. Making the client the co-author of their own solution overcomes resistance without breaking it.

What investors should examine regarding reimbursement, evidence and operating model. Due diligence in digital health is a specialist discipline – those who rely solely on classic M&A instruments systematically overlook the risks that determine success or failure in this sector.

Only 55% of projects meet their original goals (PMI 2024). The most common reason: a lack of synchronisation in the final phase. Four structural safety mechanisms, early stakeholder communication and a consistent post-go-live retrospective determine whether a deadline holds – or not.

Why digital health projects fail – and how to prevent it. The most common cause is not a technical but an organisational problem: missing or inadequate project management. Four levers determine whether a project succeeds.

Transformation phases, market entry, scaling or the sudden departure of a key person: there are situations where a company needs capable leadership quickly. Interim leadership offers more than a bridging solution. In the right hands, it becomes a strategic lever that not only stabilises companies but deliberately moves them forward.

The German DiGA market offers enormous opportunities in a complex regulatory environment. The BfArM review process, the high requirements for clinical evidence, the reimbursement pathways via statutory and private health insurance: those who do not understand these mechanisms lose valuable time and resources. Particularly for providers from inside and outside Europe, there are invisible hurdles that make a well-founded market entry strategy indispensable.

A future-proof digital health company is defined not primarily by an isolated application, but by a highly integrated business ecosystem. This ecosystem maps the entire value chain – from initial patient acquisition through clinical documentation to automated billing. The isolated development of a patient app without embedding in a scalable backend inevitably leads to structural growth barriers in the current market environment.