STUDENT DESIGN SYMPOSIUM
SPONSORS
MethodSense is an RTP-based Regulatory Affairs and Quality Assurance consultancy and the developers of LuminLogic software. MethodSense is focused on the medical device and combination product industries. MethodSense has earned an international reputation for successfully addressing challenging projects and fast becoming a premier company for developing a professional career in life science consulting.
Rita King, CEO and Senior Regulatory Consultant, and Russ King, President, have appreciated and benefited from the breadth of skills that BME graduates bring to the workplace. Serving as a mentor to students over the years and being a guest lecturer to design classes on multiple occasions, this year, Mr. King has broadened the relationship with the BME department by sponsoring the MethodSense Design Competition. The competition is designed to encourage students to think beyond their innovation product to consider the path to market, including regulatory concerns, reimbursement, capital needs and more. Student design teams will have the opportunity to compete for recognition and a cash award of $10,000 to further support their innovation. Thank you, Russ and Rita King, and MethodSense for your generous support of students and for encouraging the spirit of innovation and entrepreneurship in BME!
The North Carolina Biotechnology Center is a private, nonprofit corporation that transforms North Carolina’s life sciences opportunities into economic prosperity through innovation, commercialization, education and business growth. It’s headquartered in the Research Triangle Park, with regional offices in Asheville, Charlotte, Greenville, Wilmington, and Winston-Salem. More at ncbiotech.org.
Spectrum’s history spans over 60 years of applications expertise in precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, and complex assembly of catheters and other devices. Today, Spectrum is a full-service vertically integrated partner for the development and manufacturing of polymer-based components and finished devices for medical and other demanding applications. With 20 locations and over one million square feet of manufacturing space in six countries worldwide, we have the resources to serve the world’s leading and emerging companies in medical device, life science, aerospace, defense, and critical industrial applications.
Schedule
3:00 PM
3:30 PM
4:30 PM
5:20 PM
6:20 PM
6:50 PM
7:30 PM
Welcome & Introduction
Poster Session 1
Poster Session 2
i4 Public Pitches
Reception
Keynote Speaker
i4 Awards and Closing
KEYNOTE SPEAKER
Craig Nichols
Craig has nearly 10 years of experience in the medical device industry, and currently serves as the Director of Technical Operations for SonoVascular, Inc . Prior to this role, he served as a manager and director with InnAVasc Medical, Inc., which was recently acquired by W.L. Gore & Associates.
Leading up to his time at InnAVasc and SonoVascular, Craig spent 5 years at the FDA as a lead reviewer in the Division of Cardiovascular Devices, leading diverse teams of experts and reviewing over 150 FDA submissions. Throughout his time at the FDA, he developed expertise in reviewing technical engineering documentation, quality system design and management, pre-clinical and clinical testing design for product development, GLP regulations, and medical device manufacturing. Following his time at FDA, Craig was a Fellow in Stanford’s Biodesign Innovation Program, where he learned a proven, repeatable process to identify important healthcare needs, invent novel health technologies to address them, and prepare to implement those products into patient care through start-up, corporate channels, or other channels. Craig and his team evaluated a number of unmet needs during the Biodesign program, including one need that led to the founding of Emme, for which Craig provided initial regulatory strategy. He holds a B.S. in Applied Science/Biomedical Engineering from the University of North Carolina at Chapel Hill.
Directions
McKimmon Conference & Training Center
1101 Gorman Street
Raleigh, NC 27606
From I-40 traveling east from Chapel Hill:
Take Gorman Street Exit #295.
Turn left onto Gorman Street.
Go approximately 1 mile.
McKimmon Center is on the right past Avent Ferry Road, before Western Boulevard.
From I-40 traveling west:
Take Gorman Street Exit #295.
Turn right onto Gorman Street.
Go approximately 1 mile.
McKimmon Center is on the right past Avent Ferry Road, before Western Boulevard.
Parking:
The center has ample free event parking located directly in front of the center.
recognitions
Special thanks to:
Our instructors, Devin Hubbard, Kenneth Donnelly, Bruce Wiggin and Ross Petrella.
Caitlyn Collier and Shawn Gomez for their support in organizing the i4 competition and symposium.