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June 7, 2018 @ 7:30 am - 4:30 pm
This program features industry experts who will provide a comprehensive introduction to some of the topics encountered during the development of medical products. This presentation is designed for those who are new to medical device engineering or who work within or in conjunction with the development teams and want to learn more about the essential steps within product development. This program will also serve as a refresher course for those who may be working in new areas of responsibility or as a foundation for those working within other disciplines.
Thursday, June 7 — 7:30 am – 4:30 pm
at UEL — 1000 Westgate Drive St Paul 55114
1st Floor Conference Room 1 – South Entrance
Course Fee: $175
EARLY BIRD: $150 (Register by May 29!)
Group discount for (3) or more from the same company. Contact Lynne at LOsterman@uelmn.org for the promo code
Course fee includes course materials, breakfast and lunch.
7:30- 8:00 am Networking and Registration (Breakfast Provided)
8:00-9:00 am Regulations and the Product Development Process – An overview of the responsibilities to FDA, accountability, and how the product development process lines up with regulations.
9:00-10:00 am Usability and Human Factors – Environment, user, design, and validation
10:00-10:30 am Break
10:30-11:30 am Design Inputs – How to identify stakeholder needs and build successful product requirements.
11:30-12:30 pm Risk Management – How do you document the risk profile of your product?
12:30-1:30 pm Networking Lunch
1:30-3 pm Product Design and Development (including software for medical devices) – How products are developed/key needs and processes
3-3:30 pm Cyber Security – Cyber security concerns for medical devices
3:30-4 pm Review of the Day & Q&A Session
4:30-6 pm Networking at Surly Brewing
Dr. John Ballard has more than 12 years’ experience in research and product development experience in the medical device field. He has extensive experience in ultrasound imaging, therapeutic ultrasound, and signal processing algorithm development. John has worked on an array of medical device products including: medical imaging products, surgical devices, cardiac monitoring equipment, and in vitro diagnostic systems. Prior to joining Design Solutions, Dr. Ballard was a Senior Innovation Fellow at the Medical Device Center at the University of Minnesota and co-founder of Andarta Medical, a start-up from research work developed at the Medical Device Center. John has a BSEE degree from Michigan State University, a MSEE degree from the University of Minnesota and a PhD in Electrical Engineering from the University of Minnesota.
Serge Dubeau has more than 20 years of experience leading design and engineering teams in a variety of projects for both Fortune 100 and start up companies, resulting in various design awards and more than a dozen patents. He currently leads the design and human factors engineering teams at Worrell, focusing on user and patient safety. Serge is a member of multiple design and human factors associations (IDSA, AAMI, HFES) and has been a guest speaker at multiple conferences. He holds a degree in Industrial Design from the University of Montreal, has lived and worked in Spain, Canada and the United States.
Greg Schultz has 30 years of product development experience, almost entirely in the medical field. He has extensive experience developing software ranging from real-time embedded systems to Windows-based applications. Greg has experience developing software used in both Class II and Class III medical devices, complying with the IEC 62304 Software Life Cycle Processes standard for both new and legacy devices. Prior to co-founding Design Solutions, Greg held lead software engineering and management positions at Angeion, Medtronic, Beckman Coulter, CNS Inc. and ACIST Medical Systems. Greg has a BSEE degree from the University of North Dakota and an MBA from the University of St. Thomas.