Building a medical device means clearing two bars at once: protect the invention before someone copies it, and satisfy the FDA before you can sell it. We work with device companies, from first-prototype startups to established manufacturers, on the patents, regulatory submissions, and liability questions that decide whether your technology reaches patients and stays on the market.
Patents For Device Innovation
Device patents have to cover hardware, software, and method-of-use, often all in the same product. Our attorneys came out of engineering, so we draft claims that hold up to how the device actually works and how a competitor would design around it. We build utility and design portfolios, run freedom-to-operate analyses before you commit to a design, manage filings abroad, and litigate when a competitor crosses your claims.
FDA Regulatory Pathway
Picking the wrong regulatory route can cost you a year or more, so we help you choose it deliberately. We advise on whether your device fits a 510(k), De Novo, or PMA pathway, prepare and shepherd those submissions, paper your clinical trial and site agreements, and keep you aligned with post-market surveillance and reporting duties. We also map out approvals when you plan to sell outside the United States.
Product Liability And Risk
A cleared device still carries liability exposure once it is in clinical use. We help you build that risk in from the start, through labeling and instructions for use, supplier and quality agreements, and clear allocation of responsibility with manufacturers and distributors. If an adverse event or recall hits, we coordinate your reporting obligations, insurance response, and defense so a single incident does not become a market-wide problem.