Trends in FDA Approvals 

This session will inform you about what changes you can expect to encounter when seeking device approvals, including those in the digital health space.

Medical device software has evolved significantly since the original regulations and guidance documents of the 1990’s that primarily anticipated embedded software. The FDA has been hard at work identifying and classifying the expanding universe of device and digital health software that falls under their regulatory responsibility. An understanding of the new terminology (SiMD, SaMD, MDDS, etc.) used by the FDA will aid compliance with regulatory quality system and submission requirements. This talk helps you understand where your software fits in, what your regulatory responsibilities are for the software, and if they have changed.

When Innovation Outpaces Regulation: Updates on the latest FDA guidance on emerging technologies and its impact on products liability exposure

Colleen Hill and Sean Burke from Duane Morris will provide an update on the latest developments from the FDA as it relates to emerging technologies and innovation. As the FDA tries to keep up with fast paced innovation, suppliers, manufacturers and end users are left trying to employ best practices to comply with the newest guidance.

Commercialization of New Medical Devices

George Strom, Director of Intertek’s Connected World business, hosts a panel of medical and regulatory experts from Intertek to discuss the ever-changing requirements when launching new medical devices to market. These include topics such as safety, EMC, performance testing, cybersecurity and more covering both traditional med devices and new/emerging technologies.

Eric Bannon
Vice President of Regulatory and Clinical Affairs
AlvaMed

Eric has led clinical trials on three continents and implemented successful regulatory strategies for multiple product areas, including Endoscopy, Orthopedics, Gastroenterology, and Metabolic Diseases. Eric’s regulatory successes include dozens of 510(k) submissions, CE mark approvals, Investigational Device Exemptions, De Novos and Pre-Submissions. He has built clinical operations teams to support the execution of large pre- and post-market clinical trials and has supervised complex trial record keeping and reporting for clients.

Bob Barrett
Vice President Systems Engineering and Quality
Full Spectrum

Bob is an experienced engineering leader and team builder with a focus on results. With technical strengths gained from more than 30 years in medical device systems engineering, systems and software validation, safety risk analysis, quality management and project management. Bob spent 15 years Baxter’s drug delivery division, where he led the systems engineering group. Bob has the role of player coach at Full Spectrum, leading the Systems Engineering Team, while providing his deep insights directly to our clients. Bob is a strong believer in cadence driven project management techniques. His ability to be hands-on or lead cross-functional teams accelerates our client’s medical development programs from concept to market release.

Matt Eisendrath
President and Chief Commercial Officer
Full Spectrum

Matt is an innovative leader within the Life Sciences and Medical Device industry, joining Full Spectrum after leading Medical Device and Life Sciences in the Americas for Capgemini. A proven strategic thinker and leader with over 20 years in the healthcare industry, Matt has experience leading and growing businesses and divisions that maintain high and differentiated value in the market. An entrepreneur at heart, Matt understands the interplay and impact of technology, industry challenges/opportunities, and regulatory evolution and has worked throughout the industry forging the creative teaming relationships required to develop market changing products.

Kevin Go, MBA, RAC, CQA
Senior Principal, Regulatory and Quality Practice 
RQM+

Kevin Go is Senior Principal of Regulatory and Quality Practice at RQM+ and helps clients navigate U.S. and EU regulations. Before RQM+, he worked at the FDA for more than 5 ½ years, serving as a Lead Reviewer in the Division of Orthopedic Devices, where he reviewed numerous pre- and post-market submissions. Additionally, Kevin served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses.

Alexia Haralambous
Manager, Regulatory Affairs
Stryker

Alexia Haralambous is a Manager of Regulatory Affairs at Stryker and has nearly 10 years of experience in medical device regulatory affairs. Prior to Stryker, she spent 3.5 years at the FDA as a Lead Reviewer of spinal devices in CDRH’s Office of Device Evaluation in the Division of Orthopedic Devices (now OHT-6). She joined the Regulatory Affairs team at Stryker’s Spine division in 2017. In her current role at Stryker, she oversees regulatory strategies and submissions for new product development within the spinal implants and enabling technologies portfolios, and is responsible for regulatory support of global compliance initiatives and marketing efforts. She obtained both her BS and MS degrees in Biomedical Engineering from Johns Hopkins University and has also earned her US RAC.

Michael Owens
Senior Regulatory Affairs Manager
NuVasive

Michael Owens has over 15 years of experience in medical device regulatory affairs.  He started his career at FDA within CDRH’s Office of Device Evaluation (ODE) where he worked in the Division of Orthopedic Devices (recently rebranded to Office of Health Technologies Six or OHT6 within the Office of Product Evaluation and Quality (OPEQ)).  He held positions as a Lead Reviewer, Team Leader, and Assistant Director within the Division of Joint Arthroplasty Devices.  After over 14 years at the FDA, Michael took a position as a Senior Regulatory Affairs Manager at NuVasive where he now oversees a large portfolio of comprehensive spinal implants and instruments.  He is responsible for developing and implementing regulatory strategies, overseeing all aspects of regulatory submission development, and interfacing with health authorities.  Michael earned his bachelor’s degree from the University of Florida in Mechanical Engineering and his master’s degree in Biomedical Engineering from the University of Tennessee. He has also earned the Regulatory Affairs Certification (RAC (US)).

Julie Perkins
Senior Director, Regulatory Affairs
Insulet

Julie Perkins is Sr. Director of Regulatory Affairs at Insulet Corporation, responsible for North America and Europe medical device compliance and marketing authorizations.  Julie has over 15 years of medical device experience providing regulatory strategy for innovative devices globally.  Prior to Insulet, she was responsible for regulatory affairs at DEKA Research and Development and at Agamatrix, Inc., where she also supported clinical studies and post-market surveillance.

Amra Racic

Senior Director, Government Strategy

Veeva MedTech

As Senior Director of Government Affairs at Veeva MedTech, Amra is responsible for understanding the challenges and opportunities of medtech companies as well as representing the company in major industry associations to help foster industry progression.  She has more than 23 years of experience in the Healthcare Industry, most of which were in large Medical Device companies in a variety of regulatory roles. Most recently, Amra led Regulatory Intelligence activities for Abbott’s Medical Device Division where her team was responsible for receiving, analyzing, and interpreting regulations that had the potential of impacting Abbott or wider industry. Prior to Abbott, Amra held leadership roles across regulatory, clinical, and quality at Bayer and Medtronic.  She has also represented the medical device industry in various association working groups include Advamed, RAPS, WHO, IMDRF, and the FDA. 

David Vogel
Internal Regulatory and Quality Advisor
Full Spectrum

David Vogel was the founder and president of Intertech Engineering Associates, Inc. from 1982 to the 2020 merger with Full Spectrum. Intertech had served the medical device industry by providing medical device development and validation engineering services for a large variety of device manufacturers. During that tenure, he participated in hundreds of medical device projects for clients. David was also an active participant with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard. He worked with other joint AAMI/FDA workgroups to develop Technical Information Reports (TIR32:2004) for Medical Device Software Risk Management, and TIR36:2007 on the Validation of Software for Regulated Processes. As the author of Medical Device Software: Verification, Validation, and Compliance (2010, Artech Publishing), and as an AAMI instructor, Dave created and taught an AAMI workshop based on his textbook for nearly 10 years. David received a bachelor’s degree in electrical engineering and computer science from Massachusetts Institute of Technology, and from the University of Michigan he earned a master’s degree in bioengineering, a master’s degree in electrical and computer engineering, and a doctorate in bioengineering. Dave has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan, and was named as one of MD&DI Magazine’s “100 Notable People in the Medical Device Industry”.