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Research Proposal Contacts and Guidelines

Research Proposal Contacts and Guidelines

The Medtronic External Research Program (ERP) reviews investigator initiated human clinical research proposals that seek support from Medtronic.

Overview

Medtronic's Neuromodulation External Research Program (ERP) reviews investigator-initiated human clinical research proposals that seek support from the Medtronic Neuromodulation (Neuro) Business Unit. Investigators from the United States and all geographies except Western Europe and Canada must use this process.

Definition of Investigator-initiated Studies

Unlike Medtronic-sponsored studies, investigator-initiated studies are completely managed by a sponsor-investigator. This sponsor-investigator independently performs all the necessary work: creating the concept and design, developing protocol, following necessary regulatory and legal requirements, collecting data, conducting the statistical analysis, and publishing the study.

Investigators who plan to conduct an investigational device exemption (IDE) or investigational new drug (IND) study must submit the FDA application and conduct the study per the Code of Federal Regulations 812 or 312, respectively.

Medtronic is not responsible for writing, submitting, or conducting the study.

Sponsor-investigators are required to follow their local regulatory requirements for investigational studies.


Types of Support Offered

  • Letter of Interest: A letter from Medtronic that is requested by an Investigator stating Medtronic’s research area or areas of interest. Letters of Interest are non-binding and do not state the intent to support research.
  • Letter of Support: A letter from Medtronic that is requested by an Investigator who is seeking research support from a governmental (e.g., NIH) or other (e.g. medical foundation) agency. A Letter of Support states that Medtronic supports the study idea or has technology that is compatible with the proposed study. As with proposals requesting funding and/or product donations, Letters of Support must be reviewed through the Neuromodulation Clinical Research Board process.
  • Right-of-reference (ROR): A letter from Medtronic, submitted by a sponsor-investigator with an IDE or IND application, that allows the FDA to reference proprietary information on file with FDA. Medtronic will not disclose proprietary information, such as manufacturing details, and device verification/validation testing, directly to an sponsor-investigator.
  • Devices: Medtronic devices and/or equipment.
  • Funding: Monetary support for study conduct.
Submission Requirements for Investigator
Type of Requests for Support Completed Online Form Study Protocol CV Informed Consent IP Checklist* Budget
Funding ($) with or without products X X X X X X
Products only X X X X X X**
ROR only X X X X    
Letter of Support X X X X    
Letter of Interest only (no products, no funding) X X X      

  *Part of submission form
**Product type, model number, number of products requested
   


Investigator-initiated Research

The following conditions must be met in order to conduct an investigator-initiated study supported by Medtronic:

  • Letter of Interest
    • Review and approval by the Neuromodulation Clinical Research Board
  • ROR, Devices and/or Funding
    • Review and approval by the Neuromodulation Clinical Research Board
    • Executed Investigator Agreeement
    • Appropriate regulatory authority approval(s) (i.e. IRB/EC, FDA, etc.). Medtronic will request copies of approval letters.

Beginning August 1, 2013, Medtronic is required by the Sunshine Act to track all payments and Transfers of Value (including medical devices or supplies to be used for research purposes) it provides to U.S. physicians and teaching hospitals. Medtronic is required to report this data to the government in March of 2014 and every year thereafter. The government will make the data available in a public searchable database.

Medtronic’s reporting of clinical and research transactions will include data on the institution or entity that was paid for the work, the Principal Investigator or primary individual overseeing the conduct of the research on behalf of an institution or entity, and the study name associated with the payment. For more information visit the Centers for Medicare and Medicaid Services Open Payments Website.

Investigator and Sponsor Responsibilities

The investigator of an investigator-initiated trial assumes the roles and responsibilities of the study sponsor, including from a regulatory perspective. As the study sponsor, the investigator has ownership of the study protocol and controls the data generated during the study.

Furthermore, the investigator is also responsible for securing all appropriate regulatory approvals as well as conducting the study and assuring the validity of the study data. The chart below highlights examples of some potential differences between an industry sponsored and an investigator-initiated and sponsored study.

  INDUSTRY SPONSORED INVESTIGATOR-INITIATED/SPONSORED
PROTOCOL OWNERSHIP The company owns the protocol and invites investigators to participate The investigator owns the protocol and can submit to multiple funding sources for support
DATA The company controls data with subject consent; the investigator typically has access to their data only The investigator controls data with subject consent and gives company rights to use the data
MONITORING The company may monitor the data to ensure validity The investigator is responsible for study conduct and data validity
INTELLECTUAL PROPERTY The company has rights to all intellectual property developed from the study data The company may define the scope of intellectual property, which may vary by study protocol
DELIVERABLES Usually dictated by the company The investigator and company determine
PUBLICATION The company and steering committee determine authorship The investigator determines authorship

Areas of Interest

The following are current research areas of interest, by therapy.

Deep Brain StimulationDeep Brain Stimulation

Medtronic has interest in the following research areas:

  • Target refinement, programming optimization, and mechanism of action of DBS for movement disorders, epilepsy, and neuropsychiatric disorders
  • Objective symptom quantification methods for assessment of individual patient profiles and treatment outcomes
  • Electrophysiologic (e.g., LFP) and other biomarkers for movement and other neurological disorders treated with DBS
  • Investigation of novel programming approaches (e.g., interleaving, cycling) in various DBS indications
  • Cost-effectiveness of DBS therapies
  • Outcome assessments of DBS for essential tremor

Percutaneous Tibial NeuromodulationPercutaneous Tibial Neuromodulation

Medtronic has interest in the following research areas:

  • The effects of tibial neuromodulation programming parameters (acute and chronic measures of physiology and efficacy)
  • Comparative methods / techniques for selecting patients for treatments of OAB.
  • Physiological and biological predictors of therapy success
  • Short and long term safety, efficacy and patient satisfaction of tibial neuromodulation.

Sacral NeuromodulationSacral Neuromodulation

Medtronic is interested in the following research areas:

  • The effects of sacral neuromodulation programming parameters (acute and chronic measures of physiology and efficacy)
  • Comparative methods / techniques for selecting patients for treatments of OAB, urinary retention, or fecal incontinence
  • Physiological and biological predictors of therapy success
  • Short and long term safety, efficacy and patient satisfaction of sacral neuromodulation.

Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS)Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS)

Medtronic has interest in the following research areas:

  • Best practices for use of AdaptiveStim capabilities
  • Novel uses of AdaptiveStim feature for SCS or PNS
  • Use of AdaptiveStim Diary/sensing tools for motivating patients
  • Functional outcome assessment of SCS therapy; use of external sensors and objective monitoring
  • Sensing physiological signals and relationship to chronic pain, SCS, and programming
  • Investigation of frequency (rates) on SCS or PNS therapy outcomes
  • Investigation of new stimulation paradigms for SCS or PNS
  • Early intervention for SCS
  • Quantifiable patient stratification methods for improving patient selection (especially FBSS)
  • EMR algorithm to improve patient selection for SCS or PNS
  • Economic and administrative factors
  • Factors affecting trial to implant
  • The role of specific goal setting in patient outcomes and satisfaction
  • Assessing the impact of post-implant follow-up on outcomes

Targeted Drug Delivery (TDD) for Chronic Pain or Severe SpasticityTargeted Drug Delivery (TDD) for Chronic Pain or Severe Spasticity

Medtronic has interest in the following research areas:

  • Patient Segmentation/Stratification
    • Differences in patient response to therapy (responder vs. non-responder/magnitude of response)
    • Drug dynamics
  • Catheter Tip Location
    • Anterior or posterior
    • Cephalad or caudal depending on patient need
  • Infusion Flow Rates
    • Bolus dosing regimens
    • Drug concentration relationships
  • Cyproheptadine use in acute baclofen withdrawal
  • Biomarkers

Guidelines

All research proposals are reviewed to ensure they:

  • Have a scientifically valid study design
  • Are aligned with business strategy and priorities
  • Provide incremental value to current body of knowledge
  • Are ethically appropriate
  • Are conducted by experienced and qualified investigators
  • Adhere to Medtronic's Business Conduct Standards and applicable local, state, and federal laws and guidelines
  • Result in a publication or meets generally accepted publication criteria

Submission Process

Register or login to your account on grantproposal.com.

Medtronic will acknowledge receipt of your proposal and communicate support decisions.

If you have questions about submitting a research proposal, please contact us by e-mail. Please include the following information in your e-mail: your name, address (including city, state and country), e-mail, phone number, and your question.

United States