I have worked in medical technology since 1998 – initially in senior roles with responsibility for development, manufacturing and business development, and for more than 16 years also as a consultant to medical technology companies.
My approach today integrates technology, regulatory affairs and business strategy, considering medical devices across the entire development and implementation context.
My degree in aerospace engineering and doctorate in numerical fluid mechanics provide the scientific and engineering foundation for my work.
For many years, however, my professional focus has been medical technology. Key technology areas include aerosol and inhalation technology, biomaterials, catheters and drug-delivery systems.
In senior management roles, I have been responsible for development, manufacturing and business development. This provides a perspective on medical device development that extends beyond technology to manufacturability, organization and commercial implementation.
This experience continues to shape my work at the interfaces between product development, Regulatory Affairs and business strategy.
As an inventor and co-inventor of numerous patents, combined with many years of responsibility for patent-related activities, I have extensive experience with patent analysis, Freedom-to-Operate questions, invention disclosures and building strategic patent portfolios.
The focus is on technical and strategic assessment of innovation and close collaboration with patent attorneys.
For more than 16 years, I have advised medical technology companies on technical, regulatory, organizational and strategic issues.
As a mentor and advisor to start-ups, I also work on strategic direction, quality management and business planning.
I am particularly interested in challenges where technical, regulatory and strategic questions overlap. The objective is to identify these interdependencies early and develop solutions that are technically sound, compliant with regulatory requirements and commercially viable.