Extensive experience with medical devices from technical concept through to industrial implementation. My approach combines in-depth product understanding, manufacturability, standards compliance and regulatory requirements.
My primary technology focus is on aerosol and inhalation technologies, complemented by experience in biomaterials, catheters and drug-delivery systems.
Extensive development and innovation experience in technologies for the delivery of pharmaceutical products by aerosol.
Extensive experience in the development and evaluation of aerosol and inhalation systems, with particular expertise in vibrating membrane nebulizers. My experience covers aerosol generation and drug delivery as well as the interaction between drug formulation, nebulizer, application and the overall delivery system.
Combining a pharmaceutical product with its delivery device creates specific challenges for both product development and regulatory approval. Experience with drug-device combination products and collaboration with pharmaceutical and biotechnology companies provides a strong basis for bringing together the requirements of the drug and the delivery device at an early stage.
Extensive experience in the measurement and characterization of aerosols as well as in the experimental investigation and technical evaluation of inhalation devices. The focus is on technical interpretation: system performance, parameters governing aerosol delivery, optimization potential and sound comparison of technical approaches.
Experience in integrating nebulizer technologies into ventilation and respiratory gas systems, including the specific requirements associated with aerosol delivery to mechanically ventilated patients. The inhalation device is considered as part of an integrated system comprising aerosol generation, respiratory gas flow, ventilation system and clinical application.
Experience with bone cements and bone substitute materials, with particular emphasis on project management, development documentation and regulatory approval.
Additional experience includes the measurement and characterization of biomaterials as well as manufacturing processes and industrial production. The focus is on managing the interfaces between product requirements, manufacturing, verification, development documentation and regulatory approval.
Experience with drainage catheters and catheter-based systems for local drug delivery, particularly with regard to regulatory approval, standards compliance and technical product requirements.
My innovation experience in this field includes a substantial contribution to the development of a technical solution for a drug-delivery catheter system that can be adapted in the operating room to patient-specific requirements. A patent application has been filed for this solution.
Successful medical device development requires more than a technically convincing solution. Standards, risk management, usability, manufacturability and regulatory requirements all influence key development decisions. My experience in product development, project management and regulatory approval enables me to bring these requirements together at an early stage and to assess technical solutions not only on their technical merits, but also with regard to practical implementation and regulatory viability.
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