Twelve Saul Ewing attorneys contribute to book covering the A To Z’s of medical device product development and marketing
Medical device and other health product manufacturers operate in one of the most heavily regulated industries in the U.S. economy.
Now in its 3rd edition, this book provides a comprehensive, detailed roadmap for companies looking to bring a new device to market. A dozen Saul Ewing attorneys, representing multiple legal disciplines, share practical and strategic lessons to help the companies advance their medical device ideas to marketed products.
From protecting one’s intellectual property to establishing a business and shepherding a device through the design, development and approval process, this book will guide medical device entrepreneurs and manufacturers through the myriad stages and regulatory hoops one must go through on the path toward creating and marketing a medical device. Some of these stages include: protecting intellectual property; establishing your business (strategy, employee policies, best practices); developing your medical device (FDA regulatory schemes, premarket approval, clinical trials, Good Manufacturing and Good Laboratory Practice, and product liability); payment and coding; legal issues (compliance, postmarket, HIPAA); and postmarketing events.
This is the 3rd edition to which Saul Ewing attorneys have contributed. The 1st edition was released in 2001, followed by a 2nd edition in 2006.
To learn more about the book and to purchase it, please click here.