Corporate Compliance at Axis Spine Technologies (AST)
Below we provide a high level overview of Axis Spine Technologies’ (AST’s) Corporate Compliance Program — including its policies, procedures and contact information for the Chief Compliance Officer.
As part of its normal business operations, AST is committed to ensuring corporate compliance with all applicable laws, rules and regulations. We strive to promote the core values of integrity and professionalism in our interactions with customers, patients, and colleagues. We demonstrate our commitment to good corporate citizenship by following compliance industry best practices.
AST’s Compliance Committee
Axis Spine’s Compliance Committee is comprised of team members from cross-functional departments responsible for reviewing, approving, and monitoring activities to ensure consistent and compliant business practices. The Committee is dedicated to ensuring and promoting ethical business conduct and to meeting the requirements of ever-changing laws, rules, and regulations that govern our business activities.
AST and Health Care Professionals
AST routinely retains and works with Health Care Professionals (HCPs) as consultants. As part of its commitment to compliant business practices, the Axis Spine Technologies Compliance Committee reviews and approves such relationships and activities to ensure that they support bona fide business needs and are consistent with all applicable AST policies and procedures.
Health Care Professionals (HCPs) refers to individuals who are (1) involved in providing health care services and/ or items to patients and (2) in a position to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe AST products. The term “Health Care Professional” is to be interpreted broadly and includes both persons providing services (such as physicians, physician assistants, nurses, operating room staff, et al) and persons who do not provide services directly (such as hospital administrative or office staff), but who may be involved in the decision to purchase, lease, or recommend AST products. Health Care Professionals also includes purchasing agents, contract administrators or managers, physician practice managers and management within group purchasing organizations.
Ethics and Compliance in the Medical Device Industry
For medical technology companies, including AST, interacting with Healthcare Professionals (HCPs) is a key component of day-to-day activities. HCPs are an integral part of the R&D process and a source of innovation, clinical expertise and creativity during the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical devices throughout the United States and beyond. Companies are also required to provide HCPs with appropriate instruction, education, training, service and technical support to ensure delivery of modern, safe and effective medical technology and care to patients. The medical technology industry is represented by MedTech, Advanced Medical Technology Association (AdvaMed), and Medical Device Manufacturers Association (MDMA), and is committed to ensuring that its collaboration with HCPs adheres to the highest ethical and professional standards as reflected in the guidelines published by these Industry Associations.
Axis Spine Technologies’ relationships with Consultants, including surgeons and other Healthcare Professionals (HCPs), are governed by and follow the MedTech Code of Ethics: Guidelines on the Interaction with Healthcare Professionals, Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code) and the MDMA.
Reporting Compliance Concerns
If you have compliance related questions or concerns or believe a violation of applicable law, regulation and/or policy may have occurred, please contact AST’s Chief Compliance Officer:
Colleen Nelson, M.A., J.D.
Chief Compliance Officer
Phone: +1 425-614-6196
cnelson@axisspinetech.com
As an alternative, questions, concerns and reports of violations or suspected violations can also be made electronically via email at compliance@axisspinetech.com
Last updated August 2024
