Steve Herbowy

Background

About Steve Herbowy

My focus is technology development, particularly in compelling early-stage projects in the sustainability and healthcare industries. At Pelvalon, I personally led all aspects of technology development from concept through commercial launch and acquisition.|| Led R&D: Recruited and led effective team of engineers and technicians, conducted upstream customer research, developed strategy and executed plans || Designed and developed the key products from inception, leading hands-on design, prototyping, and testing; and continuing through leadership and guidance as the project advanced || In-depth work on all regulatory and governmental matters, including FDA clearance, and Medicare reimbursement processes. Included strategies, content drafting, and in-person meetings with regulatory bodies and governmental agencies. Resulted in FDA clearance & creation of new device category, and new Medicare reimbursement code & payment || Managed IP portfolio, including claims strategy, drafting, managing external counsel || Recruited and led effective MFG/Ops team, developed manufacturing processes, trained and oversaw techs, hired and managed manufacturing leader || Developed quality system to support early clinical work, hired a quality leader and supported implementation of robust QMS for commercialization || Planned, designed, and executed clinical trials, generating several publications and podium presentations.|| Directly supported sales, including frequent sales calls and deployments, project management, development of Sales Ops tools, and training || Jointly recruited employees and developed teams for Marketing, Quality, and Clinical.|| Multiple rounds of fundraising, due-diligence activities for M&A My specialties are Research & Development, Technology Assessment, Product-Market Fit, Hands-on Engineering, Engineering Leadership, IP Development, Clinical Deployment & Training, Technical Sales Support.