About the series

Through the Thought Leaders Series ZeroTo510 brings industry leaders and experts together to talk about hot topics in healthcare. Set in an interactive forum, these discussions are designed to give the audience a chance to learn from and interact with panelists and speakers so they can derive maximum value from the experience.

Join us for one of our upcoming sessions soon!

June 25th: Avoiding FDA disasters - What Startups need to know about quality management

On June 25th we partner up with the guys at Greenlight.guru to host a talk on quality systems and how to avoid potential disaster with the FDA. We’ll kick the night off with a panel of medical device entrepreneurs and quality & regulatory experts who will take a deep dive into what startups need to know about the importance of a good quality and regulatory strategy in medical device product development.

After the panel, stick around for some BBQ, cocktails, and plenty of good people & conversation. Come out, bring a guest, and enjoy the evening.

Panelists include:

Lilli

Lilli Zakarija

Co-Founder EdgeOne Medical

Lilli Zakarija has over 20 years of experience in the medical device industry, and is Co-Founder and President of EdgeOne Medical Inc, a consultancy and testing firm offering cross-functional integrated services supporting the full medical device life cycle. Her expertise includes development and global launch of various single-use, disposable medical devices and combination products, and strategic/technical development of device platforms. Throughout her career she has held leadership roles in engineering and project management.

Lilli has a Bachelors of Science in Biomedical Engineering and a Masters in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the Board of Directors for Women in Bio – Chicago Chapter, Board of Advisors for Biomedical Engineering Dept at Northwestern University, is a Chicago Innovation Mentor (CIM), and is a speaker on device development and combination products.

Shawn Flynn

Co-Founder, SVP Customer Operations, Restore Medical

Shawn Flynn serves as SVP of Customer Operations for Restore Medical Solutions. Prior to Restore®, Mr. Flynn was Manager of the Sterile Processing Department (SPD) at one of the largest Level-1 Trauma Centers in the southeast. In this position, he used his twenty three years of healthcare/surgical experience to focus on optimizing all areas within the department in order to meet future demands and to distinguish the SPD as a model for other hospitals to emulate. Some of his improvements included restructuring the distribution/sterile storage department for a more efficient workflow, replacing antiquated equipment to meet current standards/demand, implementing a career ladder with a focus on retention/recruitment, consolidating High Level Disinfectant (HLD) within SPD and thereby minimizing patient/compliance risk to the hospital, and updating all policy and procedures to meet current AAMI, AORN, and CDC standards.

Prior to this, Shawn had a lengthy career in Tissue Recovery and Tissue Banking, assisting individuals in need of tissue transplant surgeries.  His experience included preparing the operating room, performing the surgical procurement of human tissue, and training staff on recovery techniques in accordance with FDA, OSHA, and AATB standards.

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Ronny Bracken

Principal, Paladin Biomedical Consultants

Ronald Bracken is the Principal at Paladin Biomedical Consultants, LLC, as well as the, chief operating officer for a tissue engineering start-up and an antimicrobial medical device start-up. He is a former V.P. of R&D for C.R. Bard with 26 years of R&D experience. He spent 18 years with Bard where he oversaw the R&D function for the largest division for approximately 6 years. He has experience in all aspects of global product development and commercialization including quality, regulatory and clinical trials with a successful track record for launching numerous new technology platforms throughout his career. He has

been involved with a broad array of medical products including: infection control, combination products, urology, implants, peripheral vascular, airway management, bowel management, brachytherapy, wound care, wound drainage, feeding, electromechanical devices and biopsy. Ronald currently sits on the Board of Directors for a urological catheter start-up and he is a Trustee for the Georgia Tech Research Coproration Board.

Ronald holds a Bachelor of Science in Polymer Science from the University of Southern Mississippi.

Christine Scifert

Managing Partner, Memphis Regulatory Consulting

Christine has been a Managing Partner at Memphis Regulatory Consulting, LLC for 4 years providing services in regulatory, quality and clinical for medical device companies. Prior to consulting, Christine spent 9 years at Medtronic Spinal and Biologics directing the regulatory department of 22 people. As Senior Director of the group, she set regulatory strategy, oversaw global submissions, developed a design control process, interfaced with FDA and notified bodies, oversaw modification and implementation of procedures to maintain regulatory compliance and performed due diligence activities for potential acquisitions. Prior to Medtronic, she performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents.

Christine received a Bachelor of Science in Physics from Hamline University and a Masters of Science in Biomedical Engineering from University of Iowa. She also completed a Masters in Engineering Management from Christian Brothers University.

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Jon Speer

Co-Founder, VP of QA/RA, Greenlight.guru

Jon is the Co-founder & VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality management software exclusively for medical device companies. He is also the Founder & President of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management. Over his career, Jon has played a part in helping over 40 medical device projects get to market.

Jon started in the medical device industry over 16 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.