Methods Assessment/ Reimbursement for Medical Devices
The requirements for the conformity assessment of medical devices have significantly increased with the Medical Device Regulation (MDR) and the current MEDDEV guidelines. For manufacturers, this means greater effort, more complex processes, and higher regulatory hurdles. But even after achieving CE marking, one crucial question remains:
How do you successfully bring your product to market?
The reimbursement of medical devices by statutory health insurances (GKV) is often the key to market success – and we are your reliable partner on this path. With our comprehensive expertise and a holistic approach to method assessment, we support you throughout the entire process – from the initial methodological evaluation and statistical analyses to the successful reimbursement of your medical device.
Let’s bring your medical device to success together. Turn market challenges into opportunities.
Dr. Stefanie Wüstner
Head of Business and Scientific Innovation
Stefanie is an HTA expert specializing in systematic literature reviews, comparative evidence generation, and strategic consulting at the intersection of clinical research, evidence synthesis, and regulatory requirements.
With an academic background in biosciences and public health and nearly ten years of experience in Health Technology Assessment (HTA), she supports pharmaceutical companies in the successful market positioning of their products - both within the German AMNOG framework and the European EU HTA process.
As Head of Business and Scientific Innovation, she is responsible for the professional advancement of interdisciplinary teams and drives practical, forward-thinking solutions - from automating complex processes and applying novel methodologies to integrating new technologies into everyday work.
She has extensive experience in the planning and execution of HTA dossiers, including the design of accompanying data collection strategies and the integration of real-world evidence (RWE) into assessment processes. Her ability to combine scientific depth with clear communication is reflected in numerous publications and international conference contributions.
Your service expert
Dr. Stefanie Wüstner
Head of Business and Scientific Innovation
Our services include
Strategic consulting on Medical Device reimbursement in Germany
Obtaining GKV reimbursement for medical devices in Germany is a complex process influenced by regulatory requirements. Our strategic consulting helps you take the right steps to secure reimbursement for your products. This includes identifying relevant reimbursement pathways, preparing applications, and communicating with the relevant institutions. We support you in achieving optimal market positioning and long-term reimbursement success.
Feasibility analyses for Method Assessments under §§ 135, 137c, 137e, 137h SGB V
Do you want to integrate your medical device into regular GKV reimbursement?
We work with you to determine the best approach. Whether in outpatient or inpatient care, our feasibility analyses explore the possibilities within your existing clinical evidence to navigate the method assessment process. We identify opportunities, challenges, and risks, while also advising on generating further suitable evidence for method evaluation.
Preparation of required documents for Method Assessment under §§ 135, 137c, 137h SGB V – Strategically, statistically and scientifically sound
We develop and compile all necessary documents for the submission to the Federal Joint Committee (G-BA) as part of the method assessment process.
Statistical consulting on study design, planning, and quality assessment
The planning and execution of clinical studies require solid statistical expertise to generate valid and meaningful results for method assessment. Our statistical consulting services covers designing optimal study frameworks, selecting appropriate patient-relevant endpoints and statistical methods and calculating necessary sample sizes.
Conducting statistical analyses
We provide comprehensive guidance on the statistical requirements for method assessments ‑ from systematic searches for relevant studies and endpoint selection to surrogate validation, subgroup or sensitivity analyses, network meta-analyses, and indirect comparisons. Together, we develop a customized data strategy aligned with your scientific, regulatory, and economic goals. Our experienced HTA statistics team develops HTA-compliant analysis plans, and supports you with complementary analyses based on primary data from your original studies, along with all relevant statistical evaluations.
Support throughout the EU HTA Process: Joint Scientific Consultation (JSC) & Joint Clinical Assessment (JCA) submission file
Starting in 2026, the EU HTA regulation will also apply to selected medical devices. A compelling EU HTA dossier is crucial for success in the Joint Clinical Assessment, providing the best possible foundation for national pricing strategies. In close collaboration with you, we develop a scientifically sound, strategically refined dossier that effectively presents your evidence and meets EU HTA regulatory requirements.
Information retrieval through systematic literature reviews and study registry searches
Using systematic literature reviews (SLR) and study registry searches, we investigate the evidence landscape and identify relevant studies for method assessments.
Preparation of consultation requests at national (G-BA) and european (EU) levels
Effective early communication with HTA authorities is essential for a successful method assessment process. We support you in the pragmatic, goal-oriented preparation of briefing documents to ensure your key messages are communicated clearly and convincingly.
Rely on our expertise to make your consultation meetings focused, efficient, and successful.
Clinical study planning & execution for Medical Devices (pre- and post-CE certification)
We also support you in the planning and implementation of clinical studies for medical devices, both before and after CE certification.
Statistical consulting on study design, planning, and quality assessment
The planning and execution of clinical studies require solid statistical expertise to generate valid and meaningful results for method assessment. Our statistical consulting services covers designing optimal study frameworks, selecting appropriate patient-relevant endpoints and statistical methods and calculating necessary sample sizes.
We also focus on the assessment of methodological quality, including reviewing study data, identifying potential biases, and evaluating statistical robustness. This ensures that study results meet the highest scientific standards and are suitable for reimbursement-related assessments.
Preparation of required documents for Method Assessment under §§ 135, 137c, 137h SGB V – Strategically, statistically and scientifically sound
We develop and compile all necessary documents for the submission to the Federal Joint Committee (G-BA) as part of the method assessment process. This includes:
- G-BA consultations request forms
- Testing trial applications under § 137e SGB V
- Forms for the evaluation of new diagnostic and treatment methods (§ 137h SGB V)
- Corresponding NUB (New Examination and Treatment Methods) requests from clinics
Additionally, we assist in drafting written statements for method assessments under §§ 135, 137c, 137e and 137h SGB V. With a well-structured argumentation strategy and data-driven approach, we ensure your submission is both scientifically robust and strategically aligned.
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