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Bringing your medical device to market requires a complex interplay of protecting your intellectual property while still complying with Food and Drug Administration regulations. On Thursday, September 27, at 1 pm EDT, you are invited to join FOI Services and Reedfax for a teleconference that will address strategies you should consider in order to fast track your new medical device to commercial success. This ninety-minute session will be presented by Andrew Rawlins and David Rosen of the firm Foley & Lardner and will discuss integrating two perspectives on the premarket process for medical devices:

The Intellectual Property (IP) Perspective - With intellectual capital (especially patentable inventions) increasingly driving business value (intangible assets now constitute 85% of a typical company's market capitalization), medical device companies must be aware of seemingly simple, yet all too common, blunders that can get in the way of effectively managing your IP assets. Consistently and diligently addressing basic steps in securing and protecting your IP for a device destined for market will make a significant impact in increasing the value of your enterprise.

In this section, through real-life examples, you will learn:

• The basics of IP law principles as they relate to medical devices
• To ensure your IP strategy is consistent with business goals
• The importance of verifying proper ownership of assets
• Why you should secure freedom to operate opinions
• How to optimize territorial/geographical coverage
• How to implement preventive measures to avoid costly litigation

The FDA Perspective - Common mistakes can kill your chances of FDA allowing your product onto the market. Changes in FDA leadership and Congress have prompted many medical device companies to re-evaluate their strategy and processes for product development. Understanding the implications of potential directional shift and amendments in the laws and regulations will help you stay clear of mistakes that can undermine successful commercialization of your innovations while protecting the value of your investments.

In this section, a veteran FDA/regulatory practitioner will share practical tips and pitfalls to avoid in the processes of :

• Strategic business planning
• Product testing and clinical research
• Application submissions and negotiation
• Marketing FDA-approved products
• Regulatory compliance and enforcement matters

A wrap-up will address how to reconcile potential conflicts between your IP strategy and FDA submissions and allow time for questions and answers.

Who Should Participate:

Make sure that everyone involved in bringing a device to market understands the importance of coordinating regulatory requirements while still protecting your intellectual property. The speakers recommend this content for the entire premarketing team -- business development and planning, legal, regulatory affairs, research and development, and management.

About Your Presenters:

Andrew E. Rawlins is a partner and the leader of Foley & Lardner's Medical Device IP practice.

Before joining the firm, Mr. Rawlins served as a patent examiner at the United States Patent and Trademark Office. Since joining the firm, Mr. Rawlins has focused on patent litigation, including trials and arguments before various trial courts and the United States Court of Appeals for the Federal Circuit. He also has maintained a practice involving the management of patent portfolios and strategic counseling on patent issues. Mr. Rawlins has particular experience with optical and medical devices and products for certain commercial and institutional markets.

Mr. Rawlins received his engineering degree from The Pennsylvania State University, where his academic credentials permitted his election to Alpha Pi Mu, the national industrial engineering honor society. His Juris Doctor was earned magna cum laude from the Washington College of Law of the American University.

David L. Rosen is a partner and co-chair of Foley & Lardner's Life Sciences Industry Team. He has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting medical devices , prescription and over-the-counter pharmaceuticals, and biologics. Mr. Rosen was formerly employed by the FDA for 14 years. Mr Rosen is a frequent speaker before national and international audiences on issues impacting the review and clearance/approval of medical devices and pharmaceutical products.

Mr. Rosen earned his J.D. at The Catholic University of America, Columbus School of Law (1991). He also holds a Bachelor of Science degree from the University of Connecticut School of Pharmacy (1978).

How it Works:

Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price.  FOI Services will provide a handout of about 50 pages approximately two days before the teleconference.  The materials may be duplicated for anyone attending.

Where:

In your office or conference room.