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I have spent the majority of my 20+ year career as in-house counsel to global healthcare companies, where my participation on cross-functional teams focused on the clinical and commercial success of medical devices, pharmaceuticals, and services. My primary areas of expertise include regulatory (FDA and global counterparts), compliance, and a broad range of commercial/transactional work.
At GE Healthcare, I supported dozens of product teams and provided regular legal counsel on FDA matters, including compliant medical device promotional practices at all stages of product development– from feasibility assessments, through early adopter clinical research, to full commercial launch of multiple Class II and III devices in oncology, cardiology, and neurology.
In addition to 510(k) go-to-market strategies, QSIT/directed audit support, and tradeshow promotional reviews, I was the lead commercial attorney that managed an FDA consent decree negotiation, including writing the provisions that accounted for virtually all of a formerly $500M surgical c-arm business unit’s revenue during an initial global shutdown.
In a $2B global computed tomography unit, I was the lead division counsel that helped manage a major radiation-related legal, regulatory, and public relations matter, including class-action litigation, an FDA audit/hearing, a Congressional hearing, and intense media scrutiny, all while continuing to support existing customers and launch new products. I handled thousands of commercial contract negotiations involving hundreds of millions of dollars for capital equipment and services purchased by hospitals in the US, as well as dozens of complex research and clinical trial agreements for investigational radiology devices evaluated at major academic medical centers in the US, Europe, and Asia. In addition to working with internal teams (e.g., sales & marketing, QA/RA, product development, legal, finance, P&L leadership), I have direct experience with clinical customers, suppliers, regulators, alliance partners, and other stakeholders in major countries around the world.
At Baxter Healthcare, I provided upstream and downstream support to a renal dialysis division, including counsel on global privacy issues associated with the first-in-industry cloud-based data connectivity capability on a medical device that was the biggest product launch in over 20 years in the US and Europe. With respect to reimbursement and market access, I worked closely with internal and external lobbying experts focused on improving CMS renal dialysis-related coverage in ways that would benefit patients, industry, and payors. As part of a coordinated industry effort, I was part of a team that met in person with Congressional representatives to discuss specific issues, such as the medical device tax.
In addition to day-to-day product sale agreements with hospital and mid-sized clinic customers, I negotiated all legal aspects of a multi-billion-dollar supply agreement with the company’s largest customer. I also provided strategic legal guidance with respect to the company’s most profitable dialysis drug in the US that was also subject to the FDA’s REMS (Risk Evaluation and Mitigation Strategy) rules and potentially life-threatening drug/device interactions with the products of seven other companies.
My experience also includes the following: supplier/sourcing/procurement agreements; acquisitions & divestitures, including transition services and due diligence to manage post-closing challenges; new legal entity formation; venture capital funding rounds; compliance-related risk assessment of healthcare investment opportunities, joint venture and alliance agreements; global product distribution agreements; intellectual property protection and negotiation; and direct-to-patient issues (e.g., marketing, data privacy, and therapy support groups).