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2016 Annual Symposium
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FMMC Symposium Delivers Again on Quality, Substance

The 10th annual Florida Medical Device Symposium was held May 9-11, 2016, in St. Petersburg and, once again, this yearly FMMC gathering delivered a serious and relevant agenda of industry topics and speakers, coupled with quality networking activities and exhibiting companies. The FMMC would like to thank all of our sponsors, speakers, exhibitors and attendees -- without whom this important Florida medtech industry event would not be possible.

Leading off the symposium, we were treated to a valuable panel session on the new ISO 13485 Revisions (2016): What's Really Changed and What's Important to Know? Our expert panelists -- led by Tamas Borsai (TUV SUD), Mick Howk (SGS), and Jan Flegeau (Oscor) -- provided a thorough and practical review of the significant ISO 13485 changes and key implementation insights and timelines. The first day also welcomed Mark Leahey, President & CEO of the Medical Device Manufacturers Association (MDMA), for his comprehensive update on Congressional and agency action impacting the medical device industry. The big (good) news this year was the recent two-year suspension of the Medical Device Excise Tax and the gameplan going forward to achieve full repeal. Our keynote speaker -- Kim Cobb, IBM Watson IoT Global Executive -- capped off day one with a fascinating talk on how the internet of things (IoT) and cognitive computing are revolutionizing the medtech industry, and the design and deployment of medical devices. The opening night reception and Exhibit Hall grand opening was another big hit this year, as attendees networked with colleagues and vendors; and the evening culminated with live music, cocktails and chamber-of-commerce Florida weather.

Paul Brooks, Senior Vice President Healthcare Solutions with BSI, led off the symposium's second day with a critical Update on European Medical Device Regulation (MDR). The proposal to replace the European medical device directives for CE Marking is in its final stages of adoption, and this session provided timely advice on how to start preparing for and implementing the new requirements. Next, the symposium welcomed an insightful and unique session on the The Evolving Landscape of Medtech Outsourcing. Ben Dunn (Managing Director, Covington Associates), Reid Haney (Hill Ward Henderson), and Tom Black (B. Braun Medical) conducted a lively dialogue on how the growth in the use of outsourced service providers is changing the way OEMs are running their businesses and managing their relationships with contract manufacturers.

This year, the FMMC was also pleased to welcome Susan Turcovski, Florida District Director for the U.S. Food and Drug Administration (FDA), as a featured symposium speaker. Director Turcovski shared helpful information and insights on compliance and enforcement trends facing the Florida District. Director Turcovski is relatively new to Florida, having served as Director Investigations Branch in the Dallas District until August 2014. Her openness and engagement with industry was very much appreciated and the FMMC looks forward to continuing our positive relationship with the Florida District. Jeff Shapiro, with Hyman, Phelps & McNamara, helped moderate the Q&A session with Director Turcovski and also gave an excellent presentation on the the FDA's prohibition on off-label promotion of medical devices, and the current state of play of this issue in light of recent court cases.

John Babitt, EY's MedTech Leader for the Americas, was this year's keynote luncheon speaker. His illuminating presentation, Adapt or Fail: Changing Business Models in Global Medtech, explored the significant challenges medtech companies face (limited R&D productivity, pricing pressures, consolidation of payors and providers, value-based reimbursements, etc), and how these realities demand the adoption of new business models in order to survive and succeed. The afternoon concluded with an important session on lessons in lean manufacturing and continuous improvement led by Honeywell's Bill Thomas and Carl Whitley, R&D Machine & Engineering.

The FMMC continued its tradition of "Day 3" workshops with a full-day session on Key Aspects of Radiation Sterilization for Medical Device, Pharmaceutical, and Biotech Products, presented by Sterigenics. This special session covered key topics such as Laboratory Testing that Supports Sterilization; Introduction to Gamma Irradiation; Emerging Areas of Radiation Sterilization; and Introduction to Dosimetry, among other areas.

We hope to see you next year at the 11th annual Florida Medical Device Symposium, May 8-9, 2017 at the Hilton Carillon Park in St. Petersburg, Florida.






















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