The Medical Device R&D Handbook

Theodore R. Kucklick has extensive experience in the hands-on design and commercial development of medical devices, including radio frequency ablation devices, microwave catheters for minimally invasive therapy, in-home diagnostics devices, surgical closure devices, battery-powered devices, disposables, and general surgery tools. Ted is currently the cofounder, CEO, and CTO for Cannuflow, Inc., an arthroscopic instrument start-up company, and design director for TRKD Medical Device R&D, a medical device design and development company. Ted is the inventor of more than 40 U.S. and international patents, and he is a member of the IEEE/Engineering in Medicine and Biology Society, the Industrial Designers Society of America, and the Association of Medical Illustrators.

Materials for Medical Device R&D. Introduction to Medical Plastics. Getting Stuck in a Good Way: Basics of Medical Device Adhesives. Introduction to Needles and Cannulae. Assessing Biocompatibility: A Guide for Medical Device Manufacturers. Processes for Medical Device R&D. Catheter-Forming Equipment and Operations. Basics of Catheter Assembly. Rapid Prototyping for Medical Devices. Medical Applications of Rapid Technologies: Technology Update. Reverse Engineering in Medical Device Design. Prototype or Produce? How to Decide. Elements of Injection Molding Style for Medical Device R&D. Methods for Medical Device R&D. Clinical Observation: How To Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory. ABCs of NDAs. Intellectual Property Strategy for Med-Tech Start-Ups. Regulatory Affairs: Medical Devices. 510(k) Reform: The Stakes Are High. Brief Introduction to Preclinical Research. Using Medical Illustration in Medical Device R&D. Case Study: The BACE™ Mitral Regurgitation Treatment, Device: Supplement to Chapter 18, Using Medical Illustration in Medical Device R&D. Interviews and Insights for the R&D Entrepreneur. Interview with Thomas Fogarty, MD. Interview with Paul Yock, MD. Interview with Dane Miller, PhD. Interview with Ingemar Lundquist. Interview with J. Casey McGlynn. Keys to Creating Value for Early Stage Medical Device Companies. Female Leadership in the Medical Device Industry. Medical Device Sales 101. Invention, Innovation, and Creativity: Or How Thomas Edison Never Changed the World by Creating the Light Bulb. How to Fail as an Entrepreneur. Raising Money for Your Medical Device Start-Up. Index.