FDA and Intellectual Property Strategies for Medical Device Technologies

1. Front Matter

   Pages i-xxiv

   PDF

2. Introduction

   • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

   Pages 1-3

3. FDA Strategies for Medical Device Technology

   1. Front Matter

      Pages 5-5

      PDF

   2. General Overview of Development Process

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 7-26

   3. FDA Meetings and Device Testing

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 27-59

   4. Compiling and Submitting Your Device Application

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 61-87

   5. During and After Review

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 89-117

4. Overview of Intellectual Property Rights for Medical Device Technology

   1. Front Matter

      Pages 119-119

      PDF

   2. Patents

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 121-157

   3. Trademarks

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 159-177

   4. Trade Secrets

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 179-188

   5. Copyrights in Medical Device Technology

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 189-199

   6. Design Protection for Medical Devices

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 201-214

   7. Intellectual Property Issues in Medical Device Labeling and Marketing

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 215-221

   8. Enforcement, Infringement and Monetization of Intellectual Property Rights

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 223-242

5. Implementation Strategies for Medical Device Innovators

   1. Front Matter

      Pages 243-243

      PDF

   2. Successful Implementation of a Medical Device Company’s IP Strategy

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 245-266

   3. Tips for Avoiding and Preventing Intellectual Property Problems

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 267-272

   4. Successful Implementation of a Medical Device Company’s Regulatory Strategy

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 273-289

   5. Tips for Avoiding and Preventing Regulatory Problems

      • Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue

      Pages 291-299

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.

 

This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

• FDA Regulatory Requirements For Medical Devices
• Design Protection For Medical Devices
• Copyrights In Medical Device Technology
• protecting intellectual property
• monetizing intellectual property
• Engineering Economics

“It is a well-written integrated patent and FDA strategy guide that addresses challenges unique to medical devices and ensures success in this fast-changing market. The authors are to be praised for writing a practical and useful guide for readers seeking a quick, deep dive into this challenging area that intersects engineering, science, law and regulation.” (John A. Tessensohn, European Intellectual Property Review, Vol. 41 (12), 2019)

• United Plaza, Volpe and Koenig, P.C. United Plaza, Philadelphia, USA

  Gerald B. Halt

• Volpe and Koenig, P.C., Philadelphia, USA

  John C. Donch

• Miramar Beach, USA

  Amber R. Stiles

• Facet Life Sciences, Inc., Wayne, USA

  Lisa Jenkins VanLuvanee, Dana L. Blue

• Volpe and Koenig, PC, Philadelphia, USA

  Brandon R. Theiss

Gerald B. Halt, Jr. is a Patent Attorney, shareholder and President at Volpe & Koenig, P.C.  Jay focuses his practice on securing, licensing and enforcing the value of intellectual property rights. His practice includes litigation, inter partes matters, administrative proceedings, licensing of trademarks and technology, validity opinions and due diligence reviews. Jay also serves as President of the firm. While his experience with technology is varied, Jay’s particular area of focus is on electrical, electronic and computer software technologies, including optical and wireless communication systems, computers, communication system protocols, microwave systems and components, optical barcode scanners, fiber optic systems and semiconductor devices.  

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