The Medical Device Launch Playbook: Patents, FDA, Reimbursement and Strategic Timing

Bringing a medical device to market requires companies to navigate patent protection, FDA requirements, reimbursement, quality systems and commercialization planning, often at the same time. The central challenge is ensuring that these strategies remain aligned as the product evolves, so that the device a company ultimately brings to market is supported by the appropriate regulatory pathway, reimbursement strategy and intellectual property protection.

In this playbook, Polsinelli attorneys examine 16 key considerations for medical device companies, from early ownership and patent strategy through FDA engagement, reimbursement planning, commercialization and post-launch lifecycle management. The report also includes a strategic timeline highlighting important milestones throughout the development and launch process.