Collaboration between doctors and the medical device industry must be based on solid, ethical principles to avoid the potential for conflicts of interest. These conflicts, both real and perceived, can affect patient and stakeholder confidence in clinicians, products, companies – and the entire medical device industry.

Medtronic has been an industry leader in enhancing confidence in physician collaborations and protecting patient’s interests. In 2010, we reviewed and strengthened all internal policies and procedures around compensation and collaboration with U.S. physicians to meet our goal:

To sustain and enhance medical innovation through principled collaboration

Through this effort, we developed guiding principles and standards to preserve physician collaboration for the benefit of patients, while minimizing actual or perceived conflicts of interest.

Guiding principles

  • Preserve the integrity of physician-patient relationships
  • Remain transparent about compensation and policies

Standards

At Medtronic, we take our ethical responsibilities seriously. We developed guiding principles for our physician collaborations to ensure that treatment decisions are driven by patient needs and physician expertise.

Medtronic adopted a company-wide process to plan for health care provider (HCP) and health care organization (HCO) consulting service agreements. This process includes enhanced documentation and analysis regarding the business need for services and the selection of a particular HCP/HCO to perform those needed services.

The needs assessment process seeks to ensure that collaboration with HCPs/HCOs is based on legitimate business need, is limited in scope, and payment is based on principles of fair market value compensation.

The needs assessment process examines key aspects of each HCP/HCO engagement, including:

  • The services we need from HCPs/HCOs and the reasons they cannot be performed without the involvement of HCPs/HCOs
  • The bona fide need for the service
  • The necessary HCP/HCO qualifications for the services we seek

The level of management review and executive oversight of requests for services correlates with the anticipated scope and level of services being requested.

Medtronic will continue to use our documented fair market value methodology to compensate U.S. physicians. Our methodology is based on data compiled by three national health care provider compensation surveys and applies a tiering approach based on physician experience and other objective factors. It includes:

  • A higher level of review for larger payments
  • A fixed-fee compensation model for training and education activities
  • Restrictions on royalty earners and their participation in clinical research

Medtronic reports transfers of value to CMS, as required by the Sunshine Act.

Although not required, we also voluntarily publish an annual list of charitable donations to U.S. customers and organizations in support of independent medical conferences, charitable events and research and public education programs.

We constantly monitor and evaluate additional activities to ensure our collaboration with physicians is based on the most appropriate principles and guidelines. We conduct regular holistic reviews of each physician relationship, including annual reviews of projects and agreements.

Medtronic engages interested stakeholders in dialogues on best practices and critical issues in physician-industry collaboration. We have actively engaged with AdvaMed and with the Healthcare Leadership Council and its affiliated National Dialogue for Healthcare Innovation to advance understanding and best practices around innovation and patient care issues.