How do we help clients approach medical device IP issues with understanding and confidence?
Medical device ideation and manufacturing is a rapidly evolving and continually expanding landscape. It has become increasingly important for innovators, attorneys, and other key stakeholders to understand emerging medical technology (medtech) to ensure intellectual property confidence. Ä¢¹½tv is an industry leader in intellectual property consulting for medical device innovation, manufacturing, and distribution.
Our multidisciplinary teams are recognized for their contributions to regulatory standard-setting and monitoring in the technological intellectual property space and are recognized leaders in medical innovation and intellectual property rights.
Our medical device IP consulting covers a wide scope of work.
IP Consulting Experience
Infringement
Validity
Claim interpretation
Prior art
Trade dress
Trade secrets
Due diligence
Valuation
services
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Identifying technology and business development opportunities in healthcare
• Supporting design and manufacturing planning and development activities
• Providing guidance on regulatory and compliance standards
• Assisting with trademarks and copywriting
• Assessing and advising on medtech safety guidelines
• Advising on packaging and design, including warning labels and advisory language
• Conducting battery testing and surrogate research of wearable devices
• Identifying the opportunities to develop IP in the medtech industry
• Examining energy and power management for medical devices
• Evaluating requirements and constraints originating from patients, physicians, and regulatory agencies
• Providing medical device regulatory support
• Advising FDA on infection rates and infection prevention in medical device product designs
• Helping medical device manufacturers, attorneys, and others navigate complex FDA and EU CE marking regulations
• Providing technical support for premarket strategy, testing, and submissions
• Conducting risk and hazard analysis and failure investigation
• Consulting on corrective and preventive action and recall activities
• Responding to FDA and notified body inspection and warning letter response and litigation
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Experts
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Corporate Vice President, Practice/Office Director and Principal
Senior Managing Scientist
Insights
