1. Sponsor perspective of clinical research with clinical accounts
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2. Clinical Trial Principles
Committed to evidenced based medicine.
Dedicated to scientific integrity and ethical principles in the design, conduct and reporting of human subjects research. The well-being of the patient is paramount.
Support transparency for clinical trials, which promotes continued public trust and safety.
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3. Clinical Trials Will Be Conducted:
To provide relevant data pertaining to product safety, efficacy, cost-effectiveness and appropriate use.
Without bias and with scientific rigor to ensure statistically meaningful and defensible results.
In compliance with all governing laws and regulations, and with adequate oversight to ensure valid outcomes and appropriate documentation.
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4. Individuals involved in designing, conducting or presenting data from clinical trials will:
Receive fair and equitable compensation, taking into account all circumstances surrounding a particular trial, general market rates, and market compensation paid by other parties or institutions.
Not be compensated with Sponsor stock or stock options.
Comply with the Sponsor Business Conduct Policy on consulting, research and advisory arrangements that establish work product and compensation rates.
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5. Sponsor Team In-House Study Team and Management
Field Customer Specialists
Field Clinical Engineers
Evaluation of sites for future clinical trials
Data collection at implant and follow-up of clinical trial patients
Technical consultant for IDE device questions
Clinical study liaison between center and Medtronic clinical teams
Resource to center and physicians for information on research, Sponsor contacts, etc.
Field Monitors
Field Scientists
Field Sales Team
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6. Conducting Clinical Research
Field Clinical Organization | Medtronic Confidential

7. Types of Studies Pre-market studies Post-market studies
Investigator-initiated External Research Program (ERP)
Sponsor scientist/feasibility studies
Other, smaller studies such as proof-of-concept studies
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8. Pre-market Studies Purpose Gather evidence to:
– Support FDA approval to market a device.
– Determine the safety and efficacy of a medical device.
– Determine economic value or other benefit, or to gain reimbursement approval.
– Create a compelling, evidence-based rationale to show clinical benefits.
Requirements
Studies must meet robust criteria set by FDA, other governing bodies.
Strict study protocols and investigator requirements.
Typically requires significant institutional research infrastructure.
May have longer enrollment and follow-up times.
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9. Post-market Studies Purpose Gather clinical evidence to:
– Discover more about an approved product’s patient outcomes, effectiveness, use in clinical settings or economic outcomes.
– Improve current generation product use, expand the patient population, or determine next generation features/benefits.
– Meet condition of FDA approval (in certain cases).
Requirements
Less stringent study protocols and investigator requirements than pre- market due to demonstrated safety and efficacy during FDA approval.
Institutional IRB approval.
Number of patients and scope determined by clinical evidence goals.
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10. Investigator-Initiated External Research Program (ERP)
Purpose
Build scientific relationships with customers to discover and disseminate knowledge.
Innovate by pursuing novel clinical evidence that supports sponsor strategy/areas of interest.
Generate protected intellectual property for areas of commercial interest.
Educate and inform customers on emerging clinical evidence in support of Medtronic products and features.
Requirements
Study proposal is submitted by physician for sponsor review.
Study is evaluated based on scientific merit and alignment with Medtronic business strategy/areas of interest.
Study must be “novel” in nature, and generally subject to commercial intellectual property protection (e.g., not published or redundant with current studies).
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11. sponsor Scientist/Feasibility Studies
Purpose
Evaluate early concepts for evidence of efficacy.
Determine the initial safety profile and the magnitude of treatment response.
Establish expected performance for larger-scale trial objectives.
Gather data to educate and inform customers on emerging clinical evidence in support of Medtronic products and features.
Further general scientific knowledge regarding a therapy, disease state or system.
Requirements
Studies must meet robust criteria set by Sponsor.
Some studies also require approval by the FDA or other governing body.
Strict study protocols and investigator requirements apply. Unique knowledge or experience requirements often limit number and types of investigators.
Many studies are limited to a small number of subjects and centers due to potential risk and lack of well-established benefit.
Results are not intended to serve as pivotal data for market approval.
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12. Research Process / Site Selection
Evaluation
Nomination
Confirmation
Activation
Enrollment
Monitoring
Study Closure
File Archives
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13. Evaluation
A center is evaluated for a study based on a number of factors:
Center’s capability and bandwidth
Physician’s areas of interest
Center’s performance on past studies
Applicable equipment (e.g. echo, BNP)
Targeted patient population and volume
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14. Nomination Identify centers that best fulfill study goals
Clinical staff meet to develop final prioritized list of candidates.
Clinical centers are selected.
The following criteria are part of the evaluation:
Center resources
# coordinators, implant volume, interest, etc
Device study experience
Fast activation
Appropriate patient population
Performance on past pre/post-market studies
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15. Confirmation
Should a site be selected for invitation into the study, the sponsor will then approach the PI and staff for consideration.
Confidentiality agreements are signed at this time (if needed)
The study requirements for the center are checked against the resources available.
If the PI or the clinical representative feels that the study is not a good fit for the center at that time, it would be best to attempt to find another area of interest that would be a better fit in the future.
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16. Activation Negotiate and finalize contract/budget.
Secure IRB and any other required institutional approvals.
Site personnel and Sponsor field personnel are to be trained.
Site personnel should also complete ICH/GCP training during this time. (if needed)
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17. Enrollment Recruit potential patients.
Enroll appropriate patient candidates.
Collect data and follow study protocols.
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18. Monitoring
Study monitors help verify source documentation and ensure traceability of data for the study.
First monitoring visit usually scheduled within 3 months of first patient enrollment.
Monitoring occurs at least annually, depending on trial parameters.
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19. Study Closure
At the end of a study, patients are contacted regarding study exit.
Study Exit patient visits may need to be scheduled.
Study monitors will visit to ensure all data has been collected and documentation completed.
The center will be notified of the closure of the study.
Final report will be sent to the center.
Clinical study data will need to be archived
Duration of data archive is determined by FDA guidelines, federal and state laws.
Minimum duration is at least two years.
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20. Attributes of a High-Performing Clinical Trial Center
Investigator engagement, interest and leadership to drive study process.
Concurrent IRB and contract processes.
Rapid IRB approval and documentation turnaround times
Consistent enrollment rates above the minimum requested for the study.
Well-defined methods of screening patients and/or referring patients into the study.
Strong collaborations with referring physicians and nurses.
Ability of research coordinator to schedule patients and to group study patient follow-ups.
High levels of compliance (patients being seen within the study-mandated follow-up windows).
Minimal protocol deviations.
Minimal data queries and clarifications needed.
Ease of communications.
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21. Attributes of a high-performing clinical trial center
Dedicated research coordinator
Organized & efficient
Good patient consenting skills
Thorough screening process
Time
Good communication with sponsor and investigator
Compliance
Follow GCP
Adhere to protocol
Adhere to IRB regulations
Subject follow up completed fully and in window
Submit data and address queries in a timely manner
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22. Sponsor goals for clinical research
Gain clinical knowledge
Are we on the right path?
Evidence for market approval
What do we need to provide to support a PMA?
Evidence for post approval
Satisfy post-market requirements for approval
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23. Avoid this….. STOP RELEASE OF NEW PRODUCT SHUT DOWN MANUFACTURING
CRIMINAL CHARGES
WILL DO WHAT IS IN THE BEST INTEREST OF THE PUBLIC
WILL NOT BE LIFTED UNTIL FDA DEEMS ACTIONS ARE SUFFICIENT (CAPA)
SPONSORS CAN SUPPORT EFFORTS
FCO | Confidential, for Internal Use Only

24. THANK YOU
Field Clinical Organization | Medtronic Confidential