FDA MedTech Regulatory Forum Speakers

BioOhio is proud to present an amazing line up of speakers for the 2019 FDA MedTech Regulatory Forum. Below you will find brief biographies and links to their respective organizations.

Speakers (in order of appearance)

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

John F. Lewis, Jr., 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 is a graduate of Miami (Ohio) University and Capital University Law School.

Laura Green, President, Green & Associates

Laura Green is the owner of Green & Associates, 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.”

Allyson Capadona, QMS Consultant, Green & Associates

Allyson Capadona is a QMS Consultant at Green & Associates. Prior to Green & Associates, Allyson has held positions at Invacare, STERIS, Philips Healthcare, and GE Healthcare. Allyson received her BS in Mechanical Engineering from University of Toledo.

Jina Tweed, Vice President, Quality Assurance, PartsSource

Jina Tweed is the Vice President of Quality Assurance at PartsSource. Over 17 years of quality experience coupled with expertise in process improvement, supplier quality, test automation, and six sigma master black belt certification. Jina is a self starter, a change agent with a quality mind set focused on the customer, with an impressive track record that demonstrates her understanding of quality.

Holly Lee, Senior Manager, Post-Market Surveillance, Philips

Holly Lee is the Senior Manager, Post-Market Surveillance at Philips. Holly has been with Philips for over 10 years.

Ben Dastoli, FDA Investigator, Cincinnati District

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, FDA Investigator, Cincinnati District

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.

Anthony M. Piotrkowski, RAC, CQA, Director, Regulatory Affairs, STERIS

Tony is Director of Regulatory Affairs at STERIS Corporation in Mentor where his team is responsible for ensuring compliance with design controls throughout the product lifecycle. Tony is also involved in standards development both domestically: through AAMI where he chairs sterilization standards Working Group 4 and serves on various Sterilization and Quality Systems standards Working Groups including Risk Management for Medical Devices; and internationally where he serves on several ISO Working Groups. Tony is also an ASQ CQA, holds a US RAC and has taught the RAC preparation course for RAPs.

Afif Ghannoum, CEO, BIOHM Health

Afif is the CEO of BIOHM Health, a microbiome company. He’s a named inventor on multiple patents, and he’s licensed a technology to one of the largest pharmaceutical companies in the world, that’s now a product sold in over 100,000 stores in the US and Canada. He’s also raised almost $11 million in venture funding.

Andrea Martter MPH, RAC, Senior Regulatory Affairs Specialist, GOJO Industries

Andrea Martter has been with GOJO since 2004. She graduated from Kent State University with a Master’s Degree in Public Health.

Nancy Morrison, Executive Director of Regulatory & Quality Consulting Services, R&Q

Nancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.

Dan Banick, Chief Information Security Officer, Warwick, Inc

Dan Banick is Chief Information Security Officer at Warwick Communications where he is responsible for internal IT risk strategy and leads the organizations information security services practice. Joining the organization in early 2019, Dan has become an advocate for the design and adoption of risk-based security programs tailored specifically for Warwick customers. Dan studied Bio-Medical Engineering at Case Western Reserve University in Cleveland, Ohio, and attended the School of Chemistry, Physics, and Environmental Science at the University of Sussex in Brighton, England. 

Melissa Masters, President, CMD MedTech

Melissa Masters is a medical device development expert and has more than 18 years of experience in product development as a project manager, systems engineer and design engineer, serving as the project manager and lead systems engineer on medical device development and sustaining engineering programs. Capabilities include leading a large multi-disciplinary team, leading risk assessments, creation of design inputs, design, specification creation, design verification, task management and conducting clinical trials involving human subjects.

Kevin Tambascio, Manager, CyberSecurity Medical Devices, Cleveland Clinic Foundation

Kevin Tambascio leads Cleveland Clinic’s efforts to put patients first by managing cybersecurity risks in devices employed in all Cleveland Clinic heath care delivery facilities. Previous to joining Cleveland Clinic, Kevin had eight years of experience in key cybersecurity roles at Rockwell Automation, an industrial controls systems vendor, and Keyfactor, a Public Key Infrastructure (PKI) firm. He earned a bachelor of science degree in computer engineering from Case Western Reserve University in 2000.

Carla Wiese, Senior Product Development Strategist/Regulatory Consultant , NAMSA

Prior to working at NAMSA, Carla was at the FDA serving as a lead reviewer and engineering consultant in the Division of Cardiovascular Devices for three and a half years and the program lead for the Early Feasibility Studies program for the last year and a half. Carla also worked as a research and development engineer in industry for over a decade in both a large company and a startup.

Walter Kawula, Partner, Hahn Loeser

Walter Kawula is a Partner at Hahn Loeser Parks, LLP. Walter graduated with a degree in Electrical Engineering from the University of Illinois. Early in his career he designed communications equipment at Rockwell International. After experiencing the process of patenting one of his designs, he decided to pursue a career in patent law. Walter now practices law in the intellectual property and data security / data privacy fields with respect to numerous communications technologies.

Sagar Patel, Lead Medical Security Engineer, Medical Devices and Health Analytics, Battelle

Sagar Patel is committed to mitigating cybersecurity risks in medical devices. He is the CyberSecurity lead for Battelle’s DeviceSecure® Services, helping medical device manufacturers identify and resolve potential cyber security threats at all stages of product development. In addition to working with device manufacturers, Sagar is also responsible for developing new testing tool-sets, conducting research into novel penetration testing techniques, and collaborating with software engineering teams for security aspects of internal product development. Sagar holds a Bachelor’s degree and a Master’s degree in Electrical & Computer Engineering