Access1 Solutions, LLC

Access1 Solutions is a product realization consulting group with our core competency in early-stage innovative spine and orthopedic technologies. We specialize in working directly with physicians and startups to help advance their ideas at any point in the product lifecycle from concept into commercialization and beyond. Our combined experience spans over 45 years of: - Medical device project management (with and without surgeon design teams) - Engineering design and development (primarily class II implants and instrumentation) - Marketing product management (upstream and downstream marketing strategy) - Regulatory Strategy creation and execution (3 successful class II 510(k)s in 2019) - Quality System strategy and implementation - Medical education content creation and execution (development of surgeon and sales training hands on curriculum including cadaveric bioskills training) - Supply chain and commercialization strategies We’ve managed countless medical device projects from idea stage through commercial launch and into post market support. This includes navigating numerous class I and class II devices through the FDA regulatory process. The approved systems included implantable devices and all necessary instrumentation to support implantation including sterile packaged product. Beyond product development, we have a strong understanding of the complex considerations that must be made when building an early stage medical device company as we have held and continue to hold executive leadership roles in small to mid-size innovative medical device companies.