Kevin Nalepka

How do our competencies align with your specific needs? MC2 MedTech Commercial Consulting leverages 50+ years of experience from small growth VC backed early stage companies to very large Cap MedTech companies, to provide planning, strategy, structure, deliverables, and oversight through all stages from product inception to final commercialization. MC2 is your full service partner bringing new products to the North American market, expanding your geographic footprint globally, or validating existing strategy. MC2 will leverage proven process methodologies in collaborating with your team to develop comprehensive and integrated solutions, de-risking your Product Realization challenges in an efficient and cost-effective manner. Our team can validate your current strategies, structures, and execution effectiveness to provide independent guidance to your leadership team, board of directors, and investors. MC2 also collaborates with university-based innovation engines on product realization to help monetize those early stage technologies and create a return on investment. Our Services Include: Opportunity and Market Assessment (TAM, SAM, SOM) Regulatory Strategy Claim/Indication Definition/Validation IP Risk Mitigation (Freedom to Operate) Go-To-Market Strategy/Playbook P&L Planning Market Access, Pricing & Reimbursement Marketing and Brand Development Sales Structure & Management increase their revenue. Our Approach MC2 will leverage proven process methodologies in collaborating with your team to develop comprehensive and integrated solutions, de-risking your Product Realization challenges in an efficient and cost-effective manner. Our 3-phase proven Product Realization Process includes: 1) Engagement & Discovery 2) Collaboration & comprehensive solution development 3) Execution & implementation Our work is based on real-life experience with exceptional results over time and diverse business environments (start-up to large cap) and indications.