Guide Outlines Key Steps for Bringing Medical Devices to Market
A new playbook from Polsinelli examines 16 considerations for medical device companies as they move from development to launch. It covers patent ownership, FDA engagement, reimbursement planning, quality systems, commercialization, and post-launch lifecycle management. The report also provides a strategic timeline of milestones for the process.
Polsinelli attorneys Steve Stranne, Jacek M. Wnuk, and Claire Davies authored the playbook, published Oct. 8, 2026. It identifies 16 issues medical device firms should weigh as they move from development toward launch, including who owns patents, FDA interaction, reimbursement preparation, quality controls, market entry, and lifecycle management after launch.
The report also offers a milestone-based timeline for the development and launch journey. Its broader point is that regulatory, reimbursement, and intellectual property choices need to stay coordinated as a device changes, so the final product fits the right pathway and protections.
This guidance could help startups and small medical device developers avoid costly missteps, potentially speeding patient access to new technologies. Investors, clinicians, and patients may benefit if clearer planning reduces delays or failed launches. Law firms and consultants may see demand for similar strategic advice. However, the playbook's impact depends on how companies apply it; it may not resolve broader cost, coverage, or access questions.