Principal Consultant
CurrentIndependent consultant focused on providing planning and implementation support to help companies with development and commercialization of their medical device and combination products.Most recent project experiences have been focused on the development and commercialization of combination drug-device delivery systems. Activities performed include:• Development oversight for new combination drug-device products including establishing design controls and coordinating development activities between alliance partners, contract manufacturer, and technical service providers.• Performing audits to assess compliance to device design controls and regulatory requirements with follow up support that included generating documentation to address compliance gaps. • Acting as systems integrator for coordinating design requirements and verification between alliance partners and contract manufactures to ensure technical issues were identified and appropriately addressed.• Planning and management of manufacturing transfer and scale up for commercial combination drug-device product from device developer to contract manufacturing partner.• Human Factors planning, assessment and documentation oversight for ensuring safe and usable medical device design.
