Ethical Collaboration with Experts

KEY POINTS

• Medtronic’s collaboration with external experts is a critical part of the invention, ongoing study, safe use, availability, and monitoring of medical devices.  We are proud of our work with physicians and other external experts, and we have policies that require our interactions with them are principled and appropriate. 
• The cooperative relationship between manufacturers and physicians is particularly important for medical devices (such as pacemakers, intravascular devices, or insulin pumps), because such devices often include complicated technologies and may require training and practice before they can be used safely on patients.  Given the pace of technological advancement, collaboration is essential to help physicians and patients understand new treatment options in a rapidly changing technological landscape.
• In accordance with our Global Business Conduct Standards, Medtronic fairly compensates experts for their time and expenses, not to endorse or promote Medtronic’s products.

Overview

1. The Importance of Collaboration with External Experts
   
   

   Collaboration between innovators and external experts (such as surgeons, physicians, and researchers who identify unmet needs) has long served as a foundation for the development of medical breakthroughs, including, for example, penicillin, the Polio vaccine, CAT scans, laser eye surgery, cholesterol-lowering statins, and vaccines for chickenpox and hepatitis.  This collaboration is critical to the invention, ongoing study, safe use and monitoring of medical devices.  Indeed, Medtronic’s first revolutionary product—a wearable, battery-powered cardiac pacemaker developed in the 1950s—was the result of close collaboration between Medtronic co-founder Earl Bakken and a pioneering heart surgeon at the University of Minnesota Medical School.

   Medtronic works closely with outside experts to discover new technologies, evaluate our products, monitor their safety, and improve their performance.  This is done in various ways, including through sponsored research, advisory committees, consulting relationships, and other interactions.  We are proud of our work with physicians and other external experts and we have policies that require our interactions with them are principled and appropriate.

2. Collaboration with External Experts on Medical Device Training
   
   

   Medtronic relies on external experts to help educate their colleagues on the safe and effective use of, and indications for, our devices and therapies and where they fit in the continuum of care.  The cooperative relationship between manufacturers and physicians is particularly important in the medical device industry.  Medical devices (such as pacemakers, intravascular devices, or insulin pumps) often include complicated technologies and may require training and practice before they can be used safely on patients.  These, and other devices utilize rapidly evolving technologies.  Healthcare providers who intend to use these devices must fully understand how they work, how they should be used, and how their use should be tailored to the needs of individual patients.  Experienced physicians and other healthcare professionals who may treat patients who could benefit from new technologies often are best equipped to educate their colleagues on these topics, as they can share methods and techniques to help obtain the best possible outcomes for patients.

3. Transparent, Fair-Market Value Payment to External Experts, with No Inducement
   
   

   Medtronic supports research and education, to help make accurate information about our products available to healthcare providers and patients, so that they can make informed, independent treatment decisions.  In accordance with our Global Business Conduct Standards,¹ Medtronic compensates experts for their time and expenses, not to endorse or promote Medtronic’s products.

   Medtronic relies upon external market data and applies well established methodologies to set fair market value (FMV) rates to determine the hourly or daily payment rate for physician collaboration, which may vary based on geography, specialty and level of experience.  We compensate outside experts because we are asking them to take time away from their work, patients, and families to help improve our products and therapies.

   Medtronic’s standard consulting agreements make clear that, no physician is ever expected or required to purchase or recommend Medtronic products in exchange for a consulting payment.  The “fair market value; no inducement” clause of the standard consultant contract states:  “The parties agree that the payments hereunder: (a) are consistent with the fair market value of the Services and (b) have not been determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties.  Nothing contained in this Agreement shall be construed in any manner as an obligation or inducement for Consultant to purchase, order, prescribe, or recommend any Medtronic products or any products of any Affiliate.”

   We understand the importance of public trust in how we collaborate with outside physicians, and we are committed to transparency in order to increase patient confidence. To further these principles, we initiated our own voluntary disclosure of payments to U.S. physicians on our website going back to 2010, years in advance of the U.S. Physician Payments Sunshine Act requirements for the CMS Open Payments Database in 2014. And since the Sunshine Act became effective, we have also devoted ourselves to ensuring that we have robust systems to track and report physician payment data as needed.

See also:

• Responsible Promotion and Compliance