Medical Device Submissions Workshops

Jhumur Banik, Policy Analyst, Biomedical Engineer at FDA

Jhumur Banik, MS, PMP is a Policy Analyst with the PMA, HDE, Q-Submission and Device Tracking Lifecyle (PHQ) Team in the Division of Submission Support (DRP1), Office of Regulatory Programs (ORP) in FDA/CDRH. She is involved in policy development and providing her regulatory and technical expertise on PMAs, PMA GMP, and Q-submissions for internal and external stakeholders among various other duties. Previously, she was a Lead Reviewer/Biomedical Engineer with Office of Health Technology 2 where she conducted numerous lead and consulting reviews while also contributing to the standards and guidance development efforts in the cardiovascular devices space. Before joining FDA, she worked in Regulatory Affairs for medical device manufacturers. She received her BS and MS degrees in Biomedical Engineering from Rensselaer Polytechnic Institute (RPI) in NY.  

Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific

Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation.  Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions.  

Jennifer has nearly 30 years’ Regulatory experience.  She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device.  She also works with integration projects, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program.    

Jennifer has supported global strategies for some of Boston Scientific’s mechanical circulatory support devices, transcatheter aortic valves, left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons/guidewires, and vascular surgery grafts/fabrics.  Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics). 

Raffy Brown, Director, Regulatory Affairs – Medical Devices, Dexcom

Raffy Brown is a director of regulatory affairs at Dexcom, Inc. with over 25 years of experience in the pharmaceutical and medical device industries. Her areas of expertise include global medical device and combination product regulations related to vascular therapies and diabetes management. She has a master’s degree in chemistry from the University of Kansas.

Amrin Chowdhury, MS, Health Scientist , FDA 

Amrin Chowdhury is a Health Scientist for the Division of Clinical Policy and Quality and within the Office of Clinical Evidence and Analysis (OCEA) at the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). She joined the FDA in 2022 serving as a Policy Analyst within OCEA. Prior to joining the FDA, Amrin served as a Project Manager at the Foundation of the National Institutes of Health (FNIH). She was part of a team overseeing a major non-small cell lung cancer (NSCLC) umbrella clinical trial, Lung-MAP.  

Amrin received her MS in Health Science from George Washington University. 

Kristin Duggan, Partner, Global Regulatory, Hogan Lovells  

With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For over 20 years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products. 

Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years – including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels – Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date. 

Kristin also assists companies with compliance challenges, including 483 and Warning Letter responses, adverse events reporting, recalls, Department of Justice (DOJ) investigations, and product liability litigation, as well as with due diligence for investments and acquisitions. 

Kristin’s practice covers products in many therapeutic areas, including software products, cardiovascular products, orthopedic and gynecologic implants, plastic and reconstructive surgery devices, radiology devices, gastroenterology devices, wound care products, dental implants, endoscopes and minimally-invasive surgical solutions, and in vitro diagnostics. 

Kristin previously served as Vice President for Strategic Consulting at a Washington, D.C.-based scientific consulting firm. Throughout her career, she has published and presented on various FDA regulatory issues. She is also an adjunct professor teaching an experiential seminar on FDA Regulation of Medical Products (Medical Devices, Drugs, and Biologics), which is part of the Executive Master of Science in Health Systems Administration (EMHSA) program at Georgetown University’s School of Nursing and Health Studies. 

Jacob Dyer, Senior Regulatory Officer, FDA 

LCDR Jake Dyer is a Senior Regulatory Officer in the Regulatory Inspections and Audits Team at CDRH’s Office of Regulatory Programs. He is currently serving as a Program Analyst and Assessor for the Medical Device Single Audit Program (MDSAP) where he leads efforts associated with MDSAP development and implementation with other regulatory authorities and industry.  Jake began his career with the FDA over 8 years ago as an FDA Medical Device Investigator and is a licensed Professional Engineer, Lean Design for Six Sigma Black Belt, Certified Project Management Professional (PMP), Certified Quality Auditor, and a level 2 certified FDA medical device investigator. LCDR Dyer earned his degree in Mechanical Engineering from the University of Rochester and Master of Science Degree from Eastern University. 

Melissa Hall, Founder and Principal Consultant , Statera Regulatory Consulting LLC. 

Melissa is a seasoned medical device regulatory expert with over 10 years experience at the FDA. She has held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. Her review expertise ranges across all premarket submission types, with a specific focus in the orthopedic device space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes, and as a policy analyst, she served as a regulatory expert addressing complex regulatory issues and ensuring laws, regulations, and guidances were applied consistently across the center. Now serving as a consultant, she continues her dedication to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategy that best aligns with their business goals. 

Quynh Hoang, Consultant, FDA and Life Sciences, King & Spalding

Quynh Hoang is a senior regulatory consultant in the FDA and Life Sciences practice of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process for medical devices and combination products with a device constituent part (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as, in the FDA’s postmarket process for adverse signals.   

Sally Maher, Regulatory Consultant, Sally Maher

Sally Maher is the founder of the consulting group S Maher Consulting, a premier medical device consulting organization. Ms. Maher served on the Board of Directors for ACell Inc. Previously she served as the interim Chief Operating Officer for ACell Inc. Before that she was Vice President of Regulatory and Clinical Affairs at Edwards Lifesciences, Critical Care. She has more than 30 years of medical device and combination product experience in regulatory, clinical, reimbursement, healthcare compliance, and product development. 

Prior to joining Edwards, Ms. Maher held various Senior Vice President roles at Smith & Nephew’s Advanced Surgical Products Division including: Regulatory and Clinical Affairs, Reimbursement and Healthcare Economics, Healthcare Compliance, Research and Development, and New Business Development. Prior to Smith & Nephew, Ms. Maher worked in regulatory, quality, and clinical roles for various organizations including Johnson & Johnson, Pfizer, and the US Food and Drug Administration. She received a bachelor’s degree from Ohio Wesleyan University, and a law degree from the University of Baltimore. 

Monica Montanez, MS, RAC, CQA, Principle Strategy Consultant – Regulatory

Monica Montanez has over 25 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals.  

Monica began her medical device career with Millar Instruments and then with Cyberonics (now Liva Nova), CONMED, Generic Medical Devices, Inc, Cochlear and before joining Medtronic in 2010. With NAMSA, Monica then moved into consultancy where the focus of her work has always been working with manufacturers with complex submissions for novel devices. She is the in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica also holds a Master’s of Science in Regulatory Science from the School of Pharmacy University of Southern California.  

Jessica Ringel, Partner, FDA and Life Sciences, King & Spalding

Jessica Ringel advises medical device and other life sciences manufacturers and distributors on matters spanning the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.  She further assists life sciences firms with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program.    

Jessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.  She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance. 

Ken Skodacek, Center for Devices and Radiological Health, Deputy Ombudsman, FDA

Ken Skodacek has been working with medical devices for over 30 years and serves as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH).  In this role, Ken provides a confidential, independent, and impartial resource that informally investigates complaints and resolves disputes.  He typically prevents and resolves misunderstandings through candid conversations and facilitated meetings with external stakeholders and FDA staff. The CDRH Ombudsman Program also ensures fair and efficient processing of appeals of CDRH decisions. Outside of his responsibilities at FDA, he has served as the Co-Chair of the American Bar Association’s Ombuds Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association. 

He previously served in the Center’s Clinical Trials Program, where he led the development and implementation of policies and programs intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process.  He represented the CDRH Innovation Team as a founding member of the Center’s Payor Communications Task Force, which provides opportunities to improve patient access to innovative medical devices important to public health by engaging manufacturers, payors, and healthcare technology assessment organizations.  He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement. 

Prior to joining FDA/CDRH in 2008, he worked for ~20 years in the medical device industry, serving in engineering and leadership roles with a focus on managing teams that served as the clinical and technical interface between the company and healthcare providers.  He has extensive experience designing and testing devices, conducting animal studies, conducting IDE and international clinical trials, preparing regulatory submissions, negotiating with FDA, and launching products for marketing and sales in U.S. and international markets. 

Anne Talley, Chemical Engineer, FDA

Anne Talley is a Chemical Engineer in the Division of Clinical Policy and Quality within the Office of Clinical Evidence and Analysis (OCEA) in the Center for Devices and Radiological Health (CDRH) at FDA. Anne has over 7 years of experience at FDA, both as a Lead Reviewer/Team Lead in the Office of Orthopedic Devices (OHT6) and within OCEA.