MedTech Compliance Bootcamp

Michelle D. Axelrod is the Managing Principal of Porzio, Bromberg & Newman’s New England office. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional
content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

Alfred R. Brunetti is a seasoned counselor who guides clients through the increasingly complex matrix of data privacy and security laws, regulations and guidance impacting business across all industries. Fred combines his in-depth knowledge of existing and emerging privacy laws and best practices with his extensive nationwide litigation and compliance experience to regularly advise clients, both large and small, on all manner of data privacy issues relating to the collection, processing and management of personal information throughout its life cycle.

He leads the firm’s Data Privacy Practice Group and is certified by the International Association of Privacy Professionals (IAPP) as both a Certified Information Privacy Professional in the laws of the United States (CIPP/US), a designation evidencing information privacy expertise with advanced concentration in domestic private sector laws, and a Certified Information Privacy Manager (CIPM), a designation evidencing expertise in the creation and management of a comprehensive privacy program.

Fred began his legal career as a law clerk for the Hon. Elaine L. Davis, P.J. Crim., in Hudson County, NJ, and then as an assistant prosecutor in the Union County Prosecutor’s Office in Elizabeth, NJ. He is a graduate of Seton Hall University and Seton Hall University School of Law, where he was an award-winning member of the Interscholastic Moot Court Board.

Pat Fogarty is the Deputy General Counsel & Senior VP of Legal at the Advanced Medical Technology Association® (AdvaMed®). AdvaMed® advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives. In addition to providing in-house legal counsel to the organization, Pat leads AdvaMed®’s litigation reform legal policy work and related stakeholder outreach, which are emerging priorities for medtech innovators and patients who rely on FDA’s safety determinations. He also manages the association’s amicus curiae program, including filing multiple briefs on a myriad of issues in U.S. federal and state courts. Pat holds a B.A. from Virginia Tech and a J.D. from the Syracuse University College of Law. He is admitted to the District of Columbia Bar.

Masha Goodman-Khan is the Senior Director & U.S. Compliance Officer at Zealand Pharma. With more than a decade of experience in the biotech and medical device industry, she brings deep expertise in compliance strategy, legal operations, and cross-functional leadership. Masha holds a B.S. in Biological Sciences from Georgia State University and a Master of Science in Jurisprudence from Seton Hall University School of Law, with dual concentrations in Pharmaceutical & Medical Device Law & Compliance and Hospital & Health Law, as well as a Healthcare Compliance Certificate.

Her professional journey includes leadership roles at Vericel, Ironwood Pharmaceuticals, Abiomed, and Sunovion, where she helped shape compliance frameworks and strengthen organizational integrity. Recognized in Seton Hall Law’s Alumni Spotlight, Masha emphasizes the importance of mentorship, networking, and continuous learning. She remains committed to advancing ethical practices and supporting organizational growth across the life sciences sector.

Ms. Nassar manages AdvaMed®’s ethics and compliance policy working groups on the AdvaMed® Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed®’s global legal policy working groups, which seek to establish common global standards for anti­ corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance. Prior to AdvaMed®, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice, managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years with the Hollingsworth law firm managing life sciences products liability litigation.

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

Dan Spicehandler is currently the vice president for Compliance Commercial Divisions at Stryker, a leading international medical device and technology company. He is responsible for leading a team of compliance officers who support the commercial divisions at Stryker through a proactive, principles and risk-based program.

His career has involved multiple operational and leadership positions across the medtech, biotech, and pharmaceutical industries. Prior to Stryker, he served as the U.S. compliance officer for Sanofi Pasteur; led the monitoring, auditing, policy, and risk team at Novo Nordisk Inc.; and served as the director of compliance for Meda Pharmaceuticals (acquired by Mylan). His career has involved both compliance and legal positions, and he has also served as in-house counsel at both Novo Nordisk and Meda. Dan’s experience at both large multinational organizations under monitorships for Corporate Integrity Agreements and REMS programs and smaller U.S.-based companies have helped him to understand the importance of developing compliance programs designed to fit the needs of the business and adapt to the changing expectations of regulators.

Prior experience also includes work as a consultant in developing compliance programs with Polaris Management Partners (now IQVIA) and as a lawyer with the firm of Reed Smith LLP. He is a graduate of Fordham University School of Law, where he serves as an alumnus on its Advisory Board for Compliance Programs, and Union College in Schenectady, New York.

Kathryn Stager brings nearly 20 years of experience in the medical device industry and presently leads SPR’s Regulatory Affairs, Quality Assurance, and Compliance functions.  With a passion to always put the best interests of patients first, Kathryn has established the company’s Compliance Program and ISO 13485-certified Quality Management System.  Kathryn has obtained numerous regulatory approvals for SPR’s clinical studies and products, and holds a US Regulatory Affairs Certification.  Prior to joining SPR, Kathryn worked at NDI Medical, supporting clinical studies and regulatory approvals for a neurostimulation technology designed to treat multiple urological indications that was ultimately acquired by Medtronic.  Kathryn holds a master’s degree in bioengineering from the University of Pittsburgh and a bachelor’s degree in physics from Miami University (OH).