FDA MedTech Regulatory Forum Speakers

BioOhio is proud to present an amazing line up of speakers, moderators, and panelists for FDA MedTech Regulatory Forum. Below you will find brief biographies and links to their respective organizations.

9:00 – Introduction & Opening Remarks

John F. Lewis, Jr., President & CEO, BioOhio

John F. Lewis, Jr., is a 4th generation Ohioan, his family tracing Ohio roots to the mid 1800s. He is a licensed attorney with experience in international business, venture capital investments and economic development. John is an outspoken advocate for industry led, market facing academic/industry collaborations. During the last 16+ years with BioOhio, John has helped raise nearly $1 billion for Ohio bioscience entities. He was a founding partner of the First Fifty Fund and Ohio TechAngel Fund both based in Columbus. John has more than 18 years international experience, lived in Jamaica, Korea and China, the latter two with Perkin Elmer, while traveling to more than 42 others. John is a graduate of Miami (Ohio) University and Capital University Law School.

9:10 – Remediation and Compliance Strategies – A Case Study

Stephen Roy, Vice President, Quality and Regulatory Affairs, North America, Invacare

Stephen Roy currently overseas Design Quality Assurance, Pre and Post Market Risk, Complaint Handling, Regulatory Affairs, Supplier Quality and all North American Manufacturing sites for Invacare. Since joining Invacare in 2016 he implemented Design Assurance and Quality Engineering functions that worked hand-in-hand with Design Engineering to remediate Design History and Risk Management Files. He directly worked with our third-party expert to facilitate the successful audit of current design procedures, remediate design history and risk management files and actions to address 2015 FDA Cert 2 483 observation. All of which led to the issuance of an updated report to Cert 2 and reinstatement of Cert 2 by FDA. Prior to that he worked at Philips Healthcare in Highland Heights as the Director of New Product Introduction for CT and Nuclear Medicine business units and managed Manufacturing and Test Engineering groups. He also, led remediation work streams teams to turn around a voluntary shutdown and optimized/automated processes within Operations. Prior to Philips, Stephen worked in various positions in Engineering and Quality for GE Healthcare (MRI division) and NCR Corporation managing multiple business units. Stephen holds a Master of Applied Science in Management Science and a Bachelor of Science Degree in Electrical Engineering.

10:00 – Current FDA Inspection Issues: FDA Panel Discussion & Q&A

Moderated by Laura Green, President, Green & Associates

Laura Green is the owner of Green & Associates, a boutique Regulatory & Quality Consulting firm specializing in global compliance for the medical products industry.  She and her team have demonstrated success in creating global regulatory strategies and resolving complex regulatory and quality compliance issues.  Laura is an accomplished Regulatory/Quality leader with over 20 years in the medical products industry that includes medical device development & regulatory submission/approvals, quality system implementation, management and remediation.  As a consultant for 10 years, Laura has been advising clients on regulatory strategy, quality compliance and providing oversight and training to assure that “compliance is an outcome of good business.”

Ben Dastoli, Investigator, FDA

Ben has been with the FDA since 2000 conducting both domestic and foreign inspections of medical device manufacturers. Ben has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office and DOJ. Prior to joining FDA, he held positions of certified Senior Clinical Research Coordinator, CCRC, at Case Western Reserve University/ University Hospitals, Andrologist / Embryologist at Mt. Sinai Hospital and has conducted NIH sponsored research at the Cleveland Clinic Foundation. Ben is a graduate of Miami University, Oxford, OH.

Laureen Geniusz, Investigator, Cincinnati District, FDA

Laureen has been with the FDA since 1990. Laureen has extensive experience conducting medical device inspection for both domestic and international firms. Laureen is also a medical device performance auditor for FDA investigators, as well as assisting the accreditation of third party persons from Industry. Laureen has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office, CDC and DOJ. She is a graduate from Bowling Green State University.

11:30 – European Medical Device Regulations (EU MDR/IVDR)

Sarah Stec, RAC., Senior Counsel, Medical Device Regulatory Law, Johnson and Johnson

Sarah H. Stec is a Senior Counsel, Medical Device Regulatory Law at Johnson and Johnson. She has experience in assisting life sciences companies understand new and evolving regulatory duties, including how those international regulations can work together as well as providing guidance on international corporate and regulatory issues. Her experience gives her a unique view on the legal and regulatory requirements for medical device manufacturers. Sarah previously worked with Squire Patton Boggs (US) LLP and LNE/G-MED North America, Inc.

Florianne Torset-Bonfillou, Director of Regulatory Affairs and Education – Lead Auditor, LNE/G-MED North America

Florianne Torset-Bonfillou is the Director of Regulatory, Education and Quality at G-MED North America, Inc. Florianne is a Senior Design Dossier Reviewer and Lead Auditor for the Medical Device European Regulation and QMS. She is also a qualified trainer on the European Regulation, Quality Management, Risk Management, and other Quality and Regulatory topics. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. Florianne has over 14 years of experience in the Medical Device Industry from both the Industry and the Notified Body sides.

Afternoon Program Emcee

Eduard Toerek, President, QUARA Innovations

QUARA Founder and President Eduard Toerek is an acknowledged executive leader with extensive global experience in regulatory compliance, quality systems, total quality management, and industry and government relations. Toerek’s expertise is in providing trusted counsel and advice to innovators in the medical device and life science industries, informed by years of experience with global regulators. Toerek is a member of the American Society for Quality and Regulatory Affairs Professional Society, and he speaks fluent German. His active leadership roles in professional industry groups and government relations include NEMA/MITA, COCIR and the United States Access Board. He has held global leadership responsibilities for sites and employees across multiple regions, including Europe, the Middle East and Asia.

1:15 – Practical Thoughts about Implementing New EU MDR Post Market Surveillance (PMS) Requirements

Laura Green, Consultant, Laura Green & Associates, LLC

Laura Green is the owner of Laura Green, LLC, a boutique Regulatory & Quality Consulting firm specializing in global compliance for the medical products industry. She and her team have demonstrated success in creating global regulatory strategies and resolving complex regulatory and quality compliance issues. Laura is an accomplished Regulatory/Quality leader with over 20 years in the medical products industry that includes medical device development & regulatory submission / approvals, quality system implementation & management. As a consultant for 10 years, Laura has been advising clients on regulatory strategy, quality compliance and providing oversight and training to assure that “compliance is an outcome of good business.”

Swasita Saigal, MBA, CQA, Director of Regulatory Affairs and Corporate Compliance, Exsurco Medical

Swasita Saigal brings 8 years of Medical Device experience, primarily in Complaint Handling and Corrections and Removals. She also has former experience in MDR, Complaint and CAPA remediation projects and third-party audits. She joined Exsurco in 2015. Swasita has been instrumental in building the Quality Management System for Exsurco Medical, Inc. as they became a Medical Device Manufacturer and registered and listed with the FDA in 2017, as well as recently achieving ISO13485:2016 certification. Swasita holds a B.A. from John Carroll University, an MBA from the University of Phoenix and is a CQA, also active member of ASQ and RAPS.

2:00 – Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

Don Pohl, Principal Product Development Strategist, NAMSA

Don R. Pohl joined NAMSA in 1993. He holds a BS in biology from The Ohio State University. He has over 20 years of experience in the medical device industry, having worked in various roles all involving the non-clinical/pre-clinical evaluation of medical devices. During his career, he has held a variety of positions ranging from laboratory supervision / management, GLP Study Director, Technical Specialist covering in vitro/in vivo evaluation of medical devices, Manager of NAMSA Biological Safety and Validation Services, and his current role of Principal Product Development Strategist. His expertise is in the areas of sample preparation per ISO 10993-12 and the design of pre-clinical, in vitro/in vivo evaluations based on ISO-10993-1, FDA Guidance, and other relevant regional and international standards.

2:45 – FDA Regulatory Pre-Market Approval Strategies – Case Studies

Steve Cornelius, CEO, Biolectrics

Biolectrics LLC is a medical product developer combining medical, biological, and electrical research to create pioneering new technologies designed to treat severe gum disease, known as periodontal disease, with a family of oral care devices called OraFlow™. Biolectrics’ first generation product, the OraFlow Pro™, is a dental device similar in form to a mouth guard attached to an electronic controller. It is being designed to aide dentists in the treatment of periodontal disease by providing a take-home oral care device which complements existing dental procedures. The OraFlow Pro™ is intended to be sold through dental offices as a take-home treatment for periodontal disease, as prescribed by a dentist.

Bill Leimkuehler, COO, Biolectrics

Biolectrics LLC is a medical product developer combining medical, biological, and electrical research to create pioneering new technologies designed to treat severe gum disease, known as periodontal disease, with a family of oral care devices called OraFlow™. Biolectrics’ first generation product, the OraFlow Pro™, is a dental device similar in form to a mouth guard attached to an electronic controller. It is being designed to aide dentists in the treatment of periodontal disease by providing a take-home oral care device which complements existing dental procedures. The OraFlow Pro™ is intended to be sold through dental offices as a take-home treatment for periodontal disease, as prescribed by a dentist.

3:30 – Going Global – Regulatory and Business Considerations

James Russell, Director of International Projects / Regulatory Affairs Consultant, RJR Consulting

James (Jim) joined RJR Consulting in 2010 as the Director of Business Development and currently serves as a Consultant and liaison between clients and international affiliate partners to help companies successfully bring their products to other global markets. In addition to providing clients with global regulatory and business intelligence regarding product classification, registration procedures and market strategy, Jim has helped clients obtain medical device marketing approval in a number of different global markets. Prior to RJR, Jim spent ten years in the pharmaceutical and medical device industries with roles and responsibilities including clinical product data quality, business analysis, medical business/IT strategy and pharmaceutical warehouse operations. Jim has his Bachelors degree in Business Administration from Ohio University and regularly provides webinars/seminars on a variety of topics.