R.K. Roeder
University of Notre Dame,
United States
Keywords: bioactive composites, medical device
Summary:
The journey of translating new technology from concept to commercialization is an exciting entrepreneurial adventure but fraught with many potential pitfalls, including the so-called “valley of death” between academic research and commercialization. There is no single formula for success but rather lessons learned from experience. Therefore, the objective of this presentation is to describe a 15 year journey to develop and commercialize a porous and bioactive polyetheretherketone (PEEK) interbody spinal fusion cage for improved surgical outcomes. This materials-enabled implant technology is a significant departure from current PEEK implants that do not promote bone ongrowth, but are typically encapsulated with fibrous tissue, and do not have porosity to facilitate bone ingrowth for biological fixation. The presentation will cover both the technological and business development, from the point of view of an inventor, investor and academic entrepreneur, beginning with the original conceptualization and academic research up to the formation of a venture-capital backed startup and FDA 510(k) submission. Key aspects will include intellectual property, networking, team-building, market assessment/readiness, fundraising, de-risking, manufacturing, and the regulatory process.