MD&M Florida Seminars Schedule:
|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:
|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:
|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:
March 7, 2013
|Seminar 4 – 10:00-12:00pm|
Implantable Devices: Product Design & Development
10:00am – 11:00am
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:
|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."
|Seminar 6 – 3:00-5:00pm|
|Combination Products: FDA Requirements & Clinical Testing
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.
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.