MD&M Florida | Expo & Conference: March 6-7, 2013 | Orlando Convention Center | Orlando, FL

MD&M Florida Seminars Schedule:

March 6, 2013


Seminar 1 – 10:00-12:00pm
FDA & 510(k) Update     
  

This seminar, led by industry experts on FDA regulatory affairs, will walk you through the latest changes to the 510(k) program, including the new Quick Review program and tactics around establishing “substantial equivalence.” The session includes an interactive case study on successful 510(k) submission strategies. Key concepts that will be covered in this seminar include:

  • What’s new in Draft Guidance and what to do with Draft Guidance recommendations
  • Recent FDA case studies on how to establish “substantial equivalence” in submissions
  • Best Practices on successful 510(k) submission strategies

Co-Presenters: 

  • Christine Park, President, Quality Architech
  • Marc Sanchez, FDA Regulation Attorney



Seminar 2 – 12:45-2.45pm
Market Clearance for Medical Devices

This seminar will take you through the key final stages in product development. Learn how to successfully get your devices cleared for market, overcoming FDA regulatory hurdles and learning from many experiences. Fast-track your products to market! Key concepts to be covered include:

  • FDA regulatory updates affecting approvals for new medical devices into the marketplace
  • Recent FDA case studies on approvals for medical devices utilizing new technologies and processes
  • Lessons learned from 2012: common reasons why approvals are delayed
  • How to fast track products while remaining compliant with FDA procedures
  • How to develop a marketing strategy
  • How and when to apply the strategy to the product life cycle

Co-Presenters:

  • Charlotte Christou, President, Christou Strategic Consulting
  • Stephane Grobon, Vice President, Product Development, Andrew Technologies LLC



Seminar 3 – 3:00-5:00pm
New Materials: Selection & Qualification  

Learn how to develop a risk-based approach to materials selection and understand the role of material biocompatibility, especially for implantable medical devices. The seminar also addresses challenges with miniaturization and uncovers innovations in micro-machining and micro-molding. Key concepts to be covered include:

  • Developing a risk management strategy for materials selection in the design and development of medical devices
  • The role of material biocompatibility in material selection
  • Handling challenges with miniaturization
  • Innovations in micro-machining and micro-molding

Co-Presenters:

  • Mel Schwartz, Consultant and author of Innovations in Materials Manufacturing, Fabrication, and Environmental Safety and the soon to be published Materials and Processes for Medical Devices
  • Kristen Roenigk, Manager, Medical Devices, Granta Design

 

March 7, 2013


Seminar 4 – 10:00-12:00pm

Implantable Devices: Product Design & Development

10:00am – 11:00am
Implantable product development and design: How to navigate the FDA regulatory landscape through each phase This seminar introduces the topic of lean design, a systematic process for developing new products that employs methods of continuous quality improvement to ensure that product development projects are completed on schedule, within budget, and with acceptable quality. It will also review practical examples of minimum essential design, the practice of creating product designs that satisfy all customer needs for performance and safety with the minimum necessary set of engineering controls. While the material draws from experience in the medical device industry, and relates these design practices to the requirements of the FDA Quality System Regulation, these methods are universally applicable for cost-effective design of high reliability electromechanical systems. This seminar will address the following key themes:

  • Overview of implantable medical device requirements and design
  • Lean design of implantable medical devices: Relating engineering controls to the failure mechanisms they are intended to mitigate risk
  • Incorporating FDA feedback into the development process

Presenters:

  • Daniel J. Cooke, Manager, Defibrillation Leads Development, Boston Scientific Corporation

Innovative Wireless Implantable Medical Devices.

11:00am – 12:00pm
Dr. Richard Gitlin of the University of South Florida and Innovatia Medical Systems and Dr. Gabriel Arrobo of the University of South Florida will present trends in the technology and networked architecture for implantable devices, such as sensors and actuators. This presentation will also describe innovative wireless technologies that have the potential to change the future of implantable devices and systems, and thus move procedures, such as Minimally Invasive Surgery, to the next paradigm by enabling safer, faster, and less-invasive surgery on par with open-cavity surgery without the negative aspects. Dr. Gitlin will address the following key themes:
  • Overview of today's wireless devices.
  • The IEEE Wireless Body Area Network Standard (802.15.6)
  • Networked wireless implantable medical devices.


Co-Presenters:

  • Dr. Richard Gitlin, Distinguished Professor, University of South Florida and CTO, Innovatia Medical Systems.
  • Gabriel Arrobo, Post-Doctoral Scholar, University of South Florida



Seminar 5 – 12:45-2.45pm
Power Consumption in Wireless Medical Device Systems            
       

This seminar will feature the Senior Director of Patient Management Systems (R&D) at Sorin Group. The seminar’s objectives are to help device manufacturers understand the challenges and opportunities in the design of today's biomedical systems which "have become a fusion of a variety of technologies: sensors, processors, software, user interfaces, and communications technology, with many influences becoming apparent from the consumer product space." Masoud informs on some of the challenges designers face, "As these devices become smaller and more power efficient, the pressure to add functionality, whether measured by capability or capacity, continues to grow as does the need to monitor or treat chronic conditions on a more continuous basis."

Presenter:

  • Javaid Masoud, Senior Director, Patient Management Systems, SORIN GROUP



Seminar 6 – 3:00-5:00pm
Combination Products: FDA Requirements & Clinical Testing                                      

3:00 -3:40pm
From the FDA Office of Combination Products: Understanding the FDA position and meeting new requirements
The OCP Director and Associate Director will present the latest requirements for the design and development of combination products, how to work across CDRH, CDER and CBER, as well as how to determine the Primary Mode of Action (PMOA) for your combination product projects. You will learn about the FDA position on cGMP as it relates to combination products and how the agency makes risk-based decisions.                                    

Presenters:

  • Dr. Thinh X.Nguyen, Director, Office of Combination Products FDA
  • John B. Weiner, OCP Associated Director for Policy, Office of Combination Products FDA
3:40pm-4:20pm
U.S. patent law changes and the impact on medical device combination products
The U.S. change to first-inventor-to-file patent law system, under the America Invents Act, affects all inventors and innovative entities, especially medical device designers and manufacturers. As the patent process is typically initiated long before the FDA approval process, to ensure commercial success, getting a patent application filed properly is vital to even allow a new medical device project to continue. The patent process is complicated even further by the complex elements of medical device combination products as they involve multiple components that may require different patent pathways. This presentation will provide you with an overview of the new patent law system and how to ensure your combination products will achieve patent success.

  • Clark Wilson, Partner, Gardner Groff Greenwald & Villanueva

4:20pm-5:00pm
An overview of pre-clinical testing for combination products
This presentation will give you an overview of key requirements to comply with pre-clinical testing requirements for combination products, assessing the product biocompatibility, material characterization and understanding different clinical aspects related to combination products.
  • Don Palme, Ph.D, Senior Principal Scientist, NAMSA

 

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