Please join us for an evening of networking and panel discussion on “How to Make the FDA Work for You” moderated by Brian Johnson, Co-Founder and Publisher of MassDevice.
This meeting is co-hosted by SEMDA and the Global Center for Medical Innovation, in conjunction with GCMI’s annual open house.
In addition to our very interesting panel topic, we’ll hear about new innovations coming from GCMI and learn about some new capabilities at the Center.
Brian grew up in the medical devices industry — as a child, he and his older brother used the surgical staplers his father sold for U.S. Surgical Corp. as toy guns. One episode involving about $10,000 worth of surgical staples earned him an early lesson about medical technology and its impact on people’s lives.
While pursuing his master’s degree in business and economics journalism from Boston University, Brian covered the 2004 Democratic National Convention in Boston for The Associated Press. He worked as a reporter for The Eagle-Tribune, covering business and economics , local government and crime in the Merrimack Valley.
Brian conceived the idea for MassDevice.com in 2007 and launched the publication in March 2009 with Brad Perriello. As publisher, he has spearheaded the growth of the publication from 0 to 75,000 readers each month and led the company to profitability in 2011, just two years after launch.
Joel began his career in equities analysis and currency trading. While focusing on research and analysis of medical technology companies, he developed an exceptional ability and passion to uncover operational and strategic inconsistencies. He had a deep desire to roll up his sleeves and work with companies to fix these issues to improve a company’s bottom line.
His professional stints range from legal firms to investment advisory companies. Joel was driven to start Blue Pearl Consulting based on his ability to become a trusted advisor to business owners and to help them solve problems. Blue Pearl is built upon his passion for delivering robust, effective, and executable solutions.
In his spare time outside of Blue Pearl (which doesn’t exist), you can find him with his lovely wife and beautiful daughter at toddler gym classes. Through numerous tumbles, rolls, and dismounts, he has found that with intention and practice, you do eventually land on your feet.
Kyle Rose is the President of Rook Quality Systems based in Atlanta, GA. Mr. Rose has vast experience in the medical device field specializing in quality management and manufacturing. Rook Quality Systems provides quality, strategic, and regulatory consulting services to multiple companies around the Southeast. As part of his ongoing consulting relationships Mr. Rose works as Quality Manager for several small and startup medical device companies including Orion Vision, Sensiotec, Cerentex Engineering, and Motus Nova. His mission while working with each company is to improve quality compliance through efficient quality system design.
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 of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management.
Jon started his career in the medical device industry over 17 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.
Julio has thirty seven years of experience. Twenty nine of these years have been in the pharmaceutical, medical devices and pharmaceutical primary container design and manufacturing sectors. This experience has included:
-Manufacturing and distribution of terminally sterilized and sterile filled parenteral products, both small volume and large volume parenterals.
-Support of manufacturing operations in Europe, Latin America and the Far East.
-Certification of facilities to ISO standards in anticipation of the CE mark approach.
-Design and manufacturing of Class I, II and III medical devices.
-Regulatory submissions for Class I, II and III medical devices in the US, CE mark of Class 1, IIa, IIb and III in Europe and registrations in Asia and Latin America
Most recently Julio had the opportunity to lead the establishment of an organization, quality system and infrastructure needed for the manufacturing of a novel primary package container for pharmaceuticals and biotech products. This experience afforded him the opportunity to:
-Work with the design, fabrication, qualification and validation of a 160,000 sq. ft. manufacturing facility that included three 13,000 sq. ft. Class 7 clean rooms.
-Develop and Implement inspection systems to assess the quality of nano scale coating systems.
-Develop a new approach to Container Closure Integrity testing of glass coated containers.
Currently residing in Auburn, Alabama.