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Combination Product Expert Carolyn Dorgan Joins Suttons Creek As Principal Systems Engineer, Regulatory Affairs
Carolyn Dorgan is bringing her 10+ years of experience in the Medical Device and Combination Product industries, including 6 years leading the FDA’s Infusion Devices team, to Suttons Creek.
Known in the international regulatory community from her active speaking engagement schedule, Carolyn has literally “set the standard” by participating in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. Her knowledge of international Combination Product standards and, more critically, their interpretation and application to various drug delivery devices will play a crucial role in SCI’s regulatory services team, led by Rob Schulz, VP of Regulatory Affairs & Technical Consulting.
“Carolyn is well known for her active engagement with both medical device and pharmaceutical companies during her tenure at the FDA and was in the regulatory approval of products for which there are no established performance or regulatory standards – such as pediatric medical devices, novel on body drug delivery systems, and rare disease combination products,” says Schulz. “We are excited to have her on board to forge new pathways to success for our clients’ innovative and groundbreaking projects.”
Carolyn has a B.S. in Biomedical Engineering from the University of Minnesota and M.S. in Technology Commercialization from the University of Texas. These academic diplomas, in conjunction with her multi-disciplinary career experience in engineering, software, cybersecurity, human factors, and business will make Carolyn a critical contributor on many Suttons Creek client projects to come.
Steve Badelt, PhD – Steve is a seasoned expert with over 20 years of experience in combination products, engineering management, systems engineering, and business development. He founded consulting firm Suttons Creek, Inc. in 2012, which has served as the device team for pharma on over 50 combination product programs. Steve values helping others learn and grow, and when he is not consulting on behalf of Suttons Creek, he is advising startups, sitting on industry boards, speaking nationally on combination product and connectivity issues and serving as a Graduate Professor at Loyola Marymount University. LinkedIn: Steven Badelt, PhD