Services Categories

Part of our role as a medical technology manufacturer is to train healthcare professionals how to use our therapies properly. In many cases, some training is required by regulatory authorities like the U.S. Food and Drug Administration before some devices can be implanted.

The majority of our training is peer-to-peer, because many physicians have told us the best way to learn is from other physicians who are adept in skillfully using the tools we provide. We enlist expert physicians around the world to help us train in many ways, including:

• Hands-on training of Medtronic FDA-approved products and therapies, including but not limited to: on-site trainings, proctorships, preceptorships and other peer-to-peer types of training, and cadaver lab and other training at testing labs/satellite training centers
• Developing and/or reviewing curriculum and educational materials
• Other training and education activities (not included in the clinical consulting category), including Medtronic Technical Forum, education regarding disease states and therapies relevant to MDT products, etc.

Medtronic has put in place policies and procedures designed to ensure physicians are properly engaged and appropriately paid for training activities they conduct on Medtronic’s behalf.

For example, compensation for participating in an educational activity is based on a “fixed fee” that takes into account the fair market value of the physician’s time to prepare, develop, and deliver the educational content – based on the physician’s sub-specialty and qualifications. The total fixed fee for a project is determined prior to the training or education event.

Medical product innovation often starts in the operating room, in a doctor's office, or in a cath lab, where physicians identify limitations of existing technologies. They may come to us with an identified need and ask us to develop a solution, or we may have identified a need on our own.

To address these identified needs, physicians often collaborate with us in the following areas:

• Scientific, medical, and usability (including human factors) activities related to Medtronic products and therapies, including but not limited to:
  • New devices and medical technology: input on new product/therapy concepts, including their features, components, and/or accessories
  • New applications, such as new indications of existing products
  • Improvements, such as input and/or improvement of existing products/therapies, including their features, components, and/or accessories

• Participating in advisory or focus panels regarding product research and development
• Consulting services to develop a protocol or design of non-clinical research.

NOTE: Consultants may participate as investigators in clinical research if they conform to their institution’s ethics policies, including conflict of interest management.

Physicians provide critical expert advice regarding the market potential for new products and technologies; feedback on improving existing products; and general feedback regarding Medtronic’s performance, reputation, and areas for improvement.

Advisory Services may include:

• Medical and/or strategic perspectives on subjects such as market research or development, therapy-focused activities, healthcare policy, business strategy, scientific or medical advisory boards, and commercial advisory panels
• Developing and/or reviewing the content of marketing materials
• Post commercial safety advisory and monitoring boards (not related to any clinical trial)
• Defined services that do not fit within the other three service categories.

When a physician discovers or develops medical innovations, he or she may receive royalty compensation when the idea is used. Royalty compensation can be substantial based on the number of patients who receive a particular device.

It is Medtronic’s practice to not pay royalties to physicians for royalty-earning products they prescribe or products purchased by their institutions.

Additional considerations related to physicians from whom we have licensed intellectual property:

• Royalty-earning consultants may participate as investigators for clinical feasibility or post-market surveillance studies required by regulatory authorities (e.g. U.S. Food and Drug Administration Section 522 post-market surveillance studies) only if they have approval from their institutional ethics committee regarding conflict of interest management.

• Royalty-earning consultants may NOT participate:
  • As investigators in any other Medtronic-sponsored clinical trial activities whether or not the consultant’s invention is involved in the study
  • In any data safety monitoring board or adverse events adjudication committee for products that incorporate their inventive contribution.

• Consultants who serve as authors, editors, or reviewers for peer-reviewed publications must meet industry-accepted standards for authorship, contributorship, and disclosure of conflicts of interest (e.g., ICMJE) and may not be paid for these activities.

• Physician inventors from whom we have licensed intellectual property are permitted by our policy to provide consulting services such as clinical protocol development, training of investigators on implant technique if they possess unique skills, and expertise that will serve to support the safe and effective use of the product of their invention.

• We have refined our standards for royalty-payments to ensure clear documentation of inventive contribution, limited royalty payments earned to the duration of any patent approved, and defined lower payment levels on royalty payments where no patent is ultimately approved.

Any compensation paid for product development consulting services is considered full or partial payment in lieu of or deduction from future royalty payments that may be earned by a royalty-earning physician.