​​📊 Market Analysis & Strategy

Have a digital health idea or prototype, but not market-ready yet?
We:

• Analyse your target market, customers, and competitors

• Assess reimbursement and funding potential

• Develop strategic options to guide your next steps

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🖥 Content Development & UX

With experience across diverse healthcare services and products, we:

• Evaluate your digital care offer

• Adapt it to the German healthcare context

• Map the patient journey to highlight benefits early

• Tailor messaging for key stakeholders

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🏥 Approval as a Medical Device

Recognition as a Class I or IIa CE-marked medical device is the first step to reimbursement under SHI.
Our regulatory medical writing team supports you through:

• Documentation preparation

• Approval applications

• Regulatory compliance at every stage

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📂 BfArM Directory Entry

We guide your DiGA (Digital Health Application) through inclusion in the BfArM Directory, a vital step for SHI reimbursement. Our experience ensures a smooth process from submission to listing.

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📈 Evaluation of Care Relevance

For DiGA reimbursement, proof of positive supply effects is essential.
We help you:

• Design and implement robust evaluations

• Demonstrate medical benefits or structural improvements

• Present evidence in formats accepted by decision-makers

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⚡ Fast-Track Procedure

If approved under the new MDR, your DiGA can enter statutory health insurance via a fast-track procedure — similar to pharmaceuticals, but with lighter evidence requirements.
We provide:

• Pharmaceutical market expertise

• Regulatory navigation

• End-to-end application support

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💶 Price Negotiations & Reimbursement

We support the final steps towards reimbursement by:

• Leading price negotiations with the GKV umbrella association

• Advising during the 12-month self-pricing phase

• Securing a final reimbursement price

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🧠 Our Approach

• Evidence-based & scientific — ensuring objectivity, credibility, and resilience

• Tailored project teams — bringing together diverse expertise at the right time

• Focus on results — for our clients, patients, providers, and health insurers