Guidelines and submission process

External Research Program

Types of studies supported

The Medtronic External Research Program supports unique, independent research studies of scientific merit and strategic fit involving Medtronic products and therapies. These studies are intended to add to the base of scientific knowledge expanding the practice of evidence-based medicine.

Studies that may be supported include:

  • Studies consistent with business strategy and applicable legal, regulatory, and internal policy requirements.
  • Studies may be clinical (prospective or retrospective) or non-clinical (benchtop, algorithm, cadaver, or animal studies).
  • Well-designed studies having an appropriate statistical plan, reasonable sample size, and follow-up timelines.
  • Studies having budgets that are of fair market value.
  • Medtronic may consider multicenter research studies if there is a need and proper research support is in place. For multicenter ERP studies, the sponsor is responsible for the overall conduct, coordination and compliance with regulations, laws, and guidelines at all study sites. Medtronic will only contract with the sponsor, and it is the responsibility of the sponsor to contract with the additional center(s).

Types of support which may be requested

Support requested for investigator-sponsored research via the External Research Program may include the following:

  • Funding

If requesting funding support for all or part of the study costs, an itemized budget must be submitted via the ERP application system, and reflective of reasonable study-related costs in alignment with fair market value. Your budget will be compared with other ERP studies (also referred to as investigator-sponsored research), Medtronic-sponsored research studies, CMS, or other resources to determine its equivalence with fair market value.

For more information on budget content, please see the Budget template (.xlsx) and/or FAQ page.

  • Provision of products (including loan of equipment).
  • In some cases, data and/or limited technical support may also be provided.

Please note: No support will be provided until an executed agreement is in place.

Submission process

The Medtronic External Research Program (ERP) application system is used to manage your research proposal through the entire process from submission to completion. As the Sponsor-Investigator of the study, you are responsible for all aspects of your study including the conduct of the research and reaching all legal and regulatory requirements.

1

Register for an ERP account

Register for a user ID and password for access to our online application system and select “New Application.”

If you already have a User Account, simply log in and select “New Application."

2

(Optional)
Submit a Concept

While a Concept submission is not required, it is highly encouraged and allows for Medtronic’s assessment of study interest/feasibility prior to the Sponsor-Investigator investing substantial time into a study protocol.

 

Information requested as part of a Concept includes general Contact information, a brief summary of your Study Proposal and anticipated support to be requested from Medtronic.

If your Concept is approved, you will be asked to submit a full application (see Step 3).

*Please note that the final support decision is made on the Full submission and not the Concept submission alone.

3

Submit a Full Submission

Information requested as part of a Full Submission includes:

  • Contact information.
  • Details about the proposed study.
  • Detailed request for support.
  • Information about your research experience and available resources.


As well as attachment of a version-controlled study protocol, a detailed budget (if funding is requested) and Principal Investigator CV.

To assist, the following templates are available:

4

Board review

Once submitted, your application will be assessed by the appropriate internal, cross functional ERP review board at the next available review meeting.

This cross functional board carefully assesses the details of your application including scientific soundness, safety, technical feasibility, budget alignment with Fair Market Value (FMV), and strategic fit.

5

Contracting

If the full submission is approved by the ERP Review Board, a research agreement will be drafted and negotiated with your institution.

Support will be contingent upon full execution of a research agreement between your institution and Medtronic.

Contact information

For any questions regarding the External Research Program (ERP), please contact us.