| Start Date: | 4/15/2016 | Start Time: | 4:00 PM |
| End Date: | 4/15/2016 | End Time: | 5:30 PM |
|
Event Description
BIOMED Seminar
Title:
A Love-Hate Relationship: FDA and Industry – Medical Device Pathway to Commercialization
Speaker:
Sonna Patel-Raman, PhD
President and COO
NuPulse Incorporated
Details:
Many companies face the following two scenarios when they wish to market their device:
1) You have spent the last 3 years developing a new medical device to treat stenotic eustachitis. Your device design is finalized with completed bench testing and animal studies. You were able to leverage existing literature on a similar device, and you believe your device is Class II. What does it take to get clearance from the FDA?
2) You recently finished your first-inhuman study of a Class III, gastroapical shunt closure device. This device requires a large clinical trial to demonstrate safety and effectiveness because of the patient risk and life-sustaining nature of the device. What are the requirements to obtain approval for a Class III medical device?
The FDA and industry organizations have long engaged in a love-hate relationship because both sides believe in their mission: FDA wants to promote and protect the public health, while industry strives to rapidly market a therapy that is safe and effective. FDA’s dual mission of protection and promotion can only be achieved through appropriate regulation of innovation and permission to allow patients access to novel therapies in the United States. To some, this is perceived as a barrier; to others, there is not enough regulation. With a past that is on record for being overly conservative and lengthy, and riddled with inconsistent feedback, many seasoned veterans of device development believe that the FDA is not, and cannot, be forward thinking. Fortunately for industry, that typically conservative paradigm is changing. With extensive internal training and industry education, the benefit to risk paradigm is being more frequently applied to marketing applications with greater focus on benefits instead of risks.
This seminar will discuss FDA market approval/clearance pathways for medical devices and how devices are reviewed for approval and clearance in the United States. In addition, this presentation will highlight some industry secrets for maximizing FDA interactions.
For more info, please visit drexel.edu/biomed.
WATCH WEBCAST
Biosketch:
Dr. Patel-Raman joined NuPulseCV in 2015. She has more than 15 years of device experience in product development and testing, clinical trial design and conduct, and device research and development. Prior to joining NuPulseCV, Dr. Patel-Raman served as a branch chief and senior reviewer for 8 years in the Center for Devices and Radiological Health at the FDA. She worked on a variety of projects related to cardiovascular devices including adult and pediatric blood pumps, transcatheter and surgical heart valves, hemostasis devices, cardiac bypass machines, and occluders. At FDA, Dr. Patel-Raman managed a large staff of reviewers and clinicians and worked in industry in the review and development of regulatory submissions (pre-submissions, PMAs, HDEs, IDEs, 510ks); managed preparation of regulatory issues to FDA’s advisory panels; provided technical leadership and judgment in the evaluation of complex devices for market approval; addressed post-market, trial conduct, and compliance issues; developed, communicated, and implemented high-level strategic plans related to device product areas internally and externally; and implemented the FDA Safety and Innovation Act and Medical Device User Fee Act III (MDUFA III) goals.
Dr. Patel-Raman earned a Doctor of Philosophy and Master of Science in Biomedical Engineering and a Bachelor of Science in Chemical Engineering from the University of Virginia. She has written and presented extensively on ventricular assist devices, reliability, medical device regulation, and clinical trial design. |
|
Location:
Papadakis Integrated Sciences Building (PISB), Room 120, located on the northeast corner of 33rd and Chestnut Streets. |
Audience:
Undergraduate StudentsGraduate StudentsFacultyStaff |
Special Features:
Online Access |
|
