Medical technology and medical device manufacturers
Medical devices are of central and continuously growing significance in healthcare. The medical technology sector is highly innovative and constitutes an important economic factor. Approval, market entry and financing of medical devices are highly regulated—similar to drugs. Strong international competition and increasing complexity of statutory requirements present major challenges to the producers.
Our clients
- Large industrial medical technology companies
- Smaller and medium-sized medical technology providers
- Industry and trade associations at national and international levels
Our services
- Product development and market entry
- Market analysis and assessment of inpatient and ambulatory sector potentials
- Consulting services for market entry and establishing sales structures
- Portrayal of individual product reimbursement pathways
- Assistance with review processes conducted by the Federal Joint Committee (G-BA)/Institute for Quality and Efficiency in Healthcare (IQWiG), as well as consulting services for new examination and treatment methods (NUB) over the entire course of development, from R&D to market entry
- Training for market-access and reimbursement
- Clinical research
- Developing study designs
- Organizing and conducting trials (implemented by our partners CSG Clinische Studien Gesellschaft mbH)
- Preparing and evaluating trial data
- Post-market surveillance
- Applied and observational studies (implemented by our partner CSG Clinische Studien Gesellschaft mbH)
- Registries
- Health economic evaluations and studies
- Efficiency evaluations for new products
- Piggyback studies
- Description and evaluation of the benefits of medical devices
- Systematic literature reviews, meta-analysis
- Health technology assessments (HTAs)
- Dossiers (e.g. core value dossiers)
- Publications
- Presentations
- Scientific publications
- Specialist articles
