Jeff Zigler Email & Phone Number

Austin, Texas Area

Austin, Tx

Austin, Texas Area

As Senior Manager, I provide support to all divisions in developing economic value propositions for the company's products. In this role, I directly assist and enable marketing and sales efforts. I help strategize SJM's future economic messaging and marketing initiatives to support current and future products and solutions.I develop economic models demonstrating the impact of SJM's solutions – to effect this, I often advise statisticians on parameters for analyses, and work with clinician experts. I have contributed to original, peer-reviewed health economic outcomes research in the areas of cardiac implantable electronic devices and interventional cardiology procedures.I devise and implement US hospital risk-based agreements for SJM's cardiovascular procedures, based on quality metrics and patient-level adverse events. This requires establishing key contract terms, conditions and risk assessment with Legal, Compliance Finance and Sales Operations assets.A large part of my role has been educating and training the US field sales force (1,500+) on core reimbursement and health economic principles, and models demonstrating meaningful improvement in patient outcomes / economic cost avoidance opportunities via SJM technology solutions and services.Notably, I conceived the idea for SJM's current healthcare economics iPad app tool, used by 350+ users/month to demonstrate economic modeling and other solutions. To keep the tool current, I oversee software developers, create core content, manage authentication / certification / training processes, and advise on analytics to support customer engagement.As a subject matter expert within SJM, I also support sales leadership directly by meeting with decision makers within GPOs, hospital executives and purchasing officers, physician groups as well as health systems.I currently supervise operation of telephone hotlines providing recommendations on SJM's procedural coding, and Patient Therapy Access to SJM technologies.

As Director, my duties involved significant business development and company value messaging on our services, which included health economic and reimbursement support, both post-commercialization as well as during clinical study.I provided counsel on the development and management of IDE clinical study design considerations which contemplate clinical safety and efficacy, as well as economic value drivers, key to comparative effectiveness research currently required in today's environment.I also facilitated and managed client companies' reimbursement programs, policies and procedures which allowed for third party payments from government and commercial carriers.My experience with post-approval product commercialization support for new or established medical technologies included payor and patient advocacy; physician society consensus-building; core scientific literature review, meta-analysis and issue brief synthesis; as well as hospital value analyses and presentations made before assembled committees.

As Reimbursement Manager, I was responsible for the development, implementation, and oversight of the client IDE clinical trials' reimbursement policies and procedures, contract development and negotiations, and repayment administration in compliance with FDA and OIG guidelines. This included AdvaMed Code of Ethics, Medicare Secondary Payor Rule, Stark self-referral laws, and as well as the anti-kickback statute.

After graduating law school, I joined the firm as an Associate and began developing core competencies including FDA/CMS regulatory authority and behavior; as well as mechanisms for FDA clearance or approval of medical technologies, and government payors' coverage of them.

As a Regulatory Associate, I consulted with small, mid-size, and multinational medical technology corporations on FDA submissions and regulatory pathways. I reviewed, drafted, and file various internal FDA applications and forms, including international and domestic establishment registrations and device listings, traditional and special 510(k)’s, and sponsors’ IDE and pre-IDE presentations. Worked directly with the firm's Vice President of Regulatory Affairs, previously Orthopedic Branch Chief at FDA.

Worked during attending law school full-time at a growing startup Continuing Legal Education company, providing online streaming videos and downloads to meet customers' needs and ease of use. Developed new business, cultivated current customer base to grow company's "Firm CLE" and "Unlimited CLE" service lines. Presented unique CLE workshops on health law-related topics. Worked directly with CEO of company.

Juris Doctor, Law

Activities and Societies: Charles W. Froessel Intramural Moot Court Competition

J.D., Food And Drug Law (Visiting)

Bachelor Of Science, Corporate Communication