Medical device commercialization requires its own playbook. Your regulatory pathway, 510(k), PMA, de novo, CE marking, shapes your commercial timeline and what you can say. Your buyers are surgeons, hospital administrators, procurement committees, and IDN executives, each with different motivations and different language. Your distribution model may involve GPOs, specialized distributors, or direct hospital relationships. The agencies that serve pharma don't understand device commercialization. The agencies that do devices often default to clinical evidence communication at the expense of market positioning and demand generation. HTG brings both, and we know what you can and can't claim at each stage of the regulatory process.