Innovation and Safety: The Unique Challenges of Complex Safety-Critical Medical Device

December 7, 2023
2:00 PM – 3:00 PM

Register now

Join Sunrise Labs and AdvaMed for this insightful webinar on medical product development best practices.

Innovation and Safety: The Unique Challenges of Complex Safety-Critical Medical Device

December 7, 2023
2:00 PM – 3:00 PM

Register now

  1. Overview
  2. Speakers

Innovation and Safety: The Unique Challenges of Complex Safety-Critical Medical Device

December 7, 2023
2:00 PM – 3:00 PM

Register now

Hear from Eric Soederberg, CEO of Sunrise Labs, Steve Gemmel, Engineering & Operations Leader – Medical Device Commercialization, and Tracey Wielinski, President & CEO of Qualtra Consulting on best practices for a smooth trajectory for product development through commercialization.

Topics Include:

  • The Market Need
  • The Regulatory Strategy
  • User-Centered Design
  • Technology Readiness
  • Hazards Analysis
  • Requirements
  • Systems Architecture

Meet the Speakers

Headshot of Eric Soederberg

Eric Soederberg, President & CEO, Sunrise Labs

Eric Soederberg considers himself an engineer from birth and is passionate about solving difficult engineering problems. His career spans over 25 years in product development leadership at Draper Labs, Motorola, DEKA.  At DEKA, Eric led and brought to market the world’s first iBOT mobility system: a class III medical device and close cousin to Segway.

In 2008, Eric started transforming Sunrise Labs into a world-class product development services company. With a keen focus on exceeding client expectations, Eric invested in engineering excellence and built a high-integrity, high-respect culture that has proven to be a strong foundation for growth.  

Eric is an active thought leader within the engineering, Medtech, and MIT communities through his involvement as a speaker, moderator, and mentor. Accolades include; 2019 “Entrepreneur of the Year” by NH Tech Alliance, the 2017 “Leader in MedTech for Product Development” award by Medical Design & Outsourcing, and the ‘Top Innovator Award’ by the NH Union Leader in 2017. Under Eric’s leadership, Sunrise placed first in Business NH Magazines’ “2021 Best Company to Work for in NH” competition, and received the 2017 “Business Excellence Award” in Technology by NH Business Review.

Eric earned an MSEE and an MBA from MIT and a BSEE at Worcester Polytechnic Institute, and holds multiple patents in medical device technologies. He loves to ski and hike NH’s White Mountains with his family.

Headshot of Steve Gemmel

Steve Gemmel, Principal, Medical Device Development & Technology | Engineering & Operations, Dyme Medical

Steve Gemmell has over 20 years of experience in Medical Device productdevelopment and commercialization, including R&D and Operations roles at Insulet Corporation, Onduo, Cytrellis Biosystems, Haemonetics, and multiple startups.

Steve started his career as a software systems engineer developing blood processing equipment and infusion pumps. He and his teams have designed & launched several very successful products in diabetes, drug delivery, and surgical markets.

Steve earned an MS in Computer Science and Biomedical Engineering from Worcester Polytechnic Institute and a BSME from Tufts University.

Headshot of Tracey Wielinkski

Tracey Wielinski, President & CEO, Qualtra Consulting, Inc

Qualtra provides Clinical, Regulatory, and Quality System services to the medical device industry. Tracey has almost 30 years of expertise and experience successfully implementing and maintaining Quality and Regulatory Systems in a diverse range of environments, from start-up enterprises to Fortune 500 companies.  Her areas of expertise include Domestic and International Regulatory Submissions, Global Clinical Trial Management, and Development and Auditing of Quality Management Systems.  Tracey has a proven ability to build and manage compliant systems including, but not limited to, product development, design control, and business compliance programs.

Prior to launching Qualtra in 2008, Tracey held several executive management positions with Abbott Laboratories, STERIS, Insulet Corporation, DarioHealth/LabStyle Innovations, Oscient Pharmaceuticals, and Omni LifeScience/Corin Group.  Most recently Tracey was the Chief Regulatory Officer at Eitan Medical.  

Tracey holds an M.S. in Health Product Regulation (2007) and a B.A. in Interdisciplinary Studies from the University of Toledo (1992) and obtained her Regulatory Affairs Certification (1999).

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