Working in medical technology since 1998 – in senior management roles and for the past 16 years as a consultant to medical technology companies. Extensive experience combines product development, regulatory affairs, intellectual property and business strategy.
Four areas of expertise combine extensive medical technology experience with regulatory insight, innovation expertise and strategic perspective.
Medical devices from technical concept to industrial implementation.
Particular expertise in aerosol and inhalation technologies, biomaterials, and catheter and drug-delivery systems – combined with extensive experience in regulatory requirements and standards compliance.
Learn more →Understanding regulatory requirements and integrating them successfully into product development and regulatory strategy.
Extensive experience with standards compliance, risk management, usability and regulatory documentation, as well as audits, authority requirements and international regulatory processes.
Learn more →Identify, assess and strategically protect technological innovations.
Long-standing experience as an inventor and with strategic patent responsibility in an international company – from invention disclosures and freedom-to-operate analyses to building strategic patent portfolios.
Learn more →Turning technological ideas into viable product and business strategies.
Long-standing experience in strategic business development and as a mentor and advisor to start-ups – from strategic direction and quality management systems to robust business plans.
Learn more →In senior management roles, I have been responsible for the development, manufacturing and business development of medical devices. For more than 16 years, I have also advised medical technology companies on product development, Regulatory Affairs, and organizational and strategic issues.
Whether product development, international regulatory pathways, patent assessment, technical feasibility or strategic development: let’s discuss your challenge.