Product Manager - Implantable Systems
Responsibilities included: Investigating and developing marketing requirements for novel medical devices; directing market analysis of indications for implantable products; evaluating marketed and novel medical devices for alignment with the Bioness product portfolio, coordinating collaborative efforts from the interdepartmental implantable team (R&D, Regulatory, Clinical, Manufacturing, etc.) to project timelines, reach specific deadlines and reduce the number and impact of items on the critical path; piloting all branding and collateral for clinical study recruitment, labeling and future product launch; developing successful relationships with key opinion leaders and strategic customer groups including Surgeons who pioneered the field of Neuro-modulation; identified and managed Associates, Consultants, and Interns including other Biomedical Engineers.Accomplishments include: Developed the Implantable Systems team, ground up, from conception of medical device requirements and specifications to FDA and IRB submissions to clinical trials and development of branding strategy. Submitted 5 invention disclosures for device improvements resulting in provisional patent applications. Originated and directed the company’s first and subsequent Implantable Systems technical training programs and materials including cadaver labs for clinicians involved in investigational studies. Directed strategy for discovery of potential prior art infringements, technical and inventive mitigation. Reduced timelines to first implant to exceed critical deadlines while increasing the safety and quality of implantation, the device, and usability.
