Medical Device IP Consulting

Case study

Objectively Assessing an In Vitro Diagnostic Startup

Electrical Engineering and Computer Science

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. Exponent 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.

Worker scans images and videos on computer screens. Exponent engineers provide support for computer control systems.

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.