The Fast Track to Commercial Success in the Medical Device Market: How to Navigate IP and FDA Roadblocks

During this seminar Intellectual Property Partner Andrew E. Rawlins, chair of the firm’s Medical Device Team and of the Mechanical & Electromechanical Technologies Practice; Foley Government & Public Affairs Partner David L. Rosen, chair of the firm’s FDA Practice; and Foley Intellectual Property Senior Counsel David J. Rikkers discussed practical strategies for navigating IP and U.S. Food and Drug Administration (FDA) roadblocks that can prevent innovations from becoming thriving in-market products.

The IP Perspective
As intellectual capital — particularly patentable inventions — plays an increasing role in driving business value (intangible assets now constitute 85 percent of a typical company’s market capitalization), medical device companies and investors must be aware of seemingly simple yet too-common missteps that can hinder the effective IP management. Consistently and diligently taking basic steps to secure and protect your IP will make a significant impact in increasing the value of your enterprise. Through real-life examples, this portion of the program addressed:

• Understanding the principles of IP law as they relate to medical devices
  
• Ensuring IP strategy is consistent with business goals
  
• Verifying proper ownership of assets
  
• Securing freedom to operate opinions
  
• Optimizing territorial or geographical coverage
  
• Implementing preventive measures to avoid costly litigation

The FDA Perspective
Changes in FDA leadership and the legislature have prompted many medical device companies to re-evaluate their strategies for product development in an effort to improve the chances of an expeditious device clearance and approval process. Understanding the implications of potential shifts in or amendments to laws and regulations can help you avoid mistakes that can undermine successful commercialization of your innovations as well as protect your investments. During this portion of the program, a veteran FDA/regulatory practitioner shared practical tips for avoiding common pitfalls during each of the following phases of product development:

• Strategic business planning
  
• Product testing and clinical research
  
• Application submission and negotiation
  
• Marketing FDA-approved products
  
• Managing regulatory compliance and enforcement matters

“The Fast Track to Commercial Success in the Medical Device Market: How to Navigate IP and FDA Roadblocks” is part of the Foley Executive Briefing Series.