CSI FOCUS INNOVATION
DEVICE DEVELOPMENT WORKSHOP
Wednesday, june 28, 2023
The Innovation Process In A Changing Environment
We invite you to join us for the Device Development Workshop, aimed at the innovators among us: physicians, founders of companies, CEOs and corporations. We will discuss the monumental impact of the fast changing global environment, the new technologies that are required to meet the existing unmet needs, the fast changing regulatory approval map and much more. It is a new world out there that requires new approaches. Do not miss this highly informative workshop!
WHO SHOULD ATTEND?
We will bring together different areas of expertise to discuss device development, innovation and the company side of devices, including inventors, engineers, company leaders, regulators, physicians and venture capitalists. Anyone with an interest in driving new medical devices forward should attend.
CSI INNOVATION AWARD
Get your company onto the CSI stage! Applications for this award are open to start-up companies and should cover the unmet clinical need addressed, the feasibility of your technology, preclinical testing completed or planned, regulatory pathways and commercialization options. Submissions will be reviewed by our panel of discussants, comprised of experienced innovators, investors and physicians.
Award Criteria:
- Clear and large unmet clinical need
- Proposed solution/device/technology
- Existing market/competition/barriers to market entry
- Intellectual property status
- Current and proposed/future funding
- Regulatory pathways
- Milestones
Submission deadline: Monday, May 29th
The winner of the CSI Innovation Award will be announced during the CSI grand opening session on Friday, June 30th.
PRELIMINARY PROGRAM
INVITED FACULTY: Kathleen A. Marshall, Sameer Gafoor, Rafael Beyar, Bassil Akra, Florian Ludwig, Mark Deem, Sujith J. Shetty, James C. Leiter, Richard S. Lilly, Susan Alpert, Sapna Hornyak, Yuval Binur
| State of the Space |
| Introduction to DDW |
| The impact of Covid on financing |
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The MDR: now where are we? |
| Digital vs Mechanical: has the world changed? |
| FDA and FIH: the world has changed! |
| Preclinical: Momentum in the midst of Change |
| Ideation and clinical need: Is it worth it? |
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Design verification and validation: The criticality of context |
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Start-Up Presentation 1 |
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Start-Up Presentation 2 |
| Regulatory: Charting the Course |
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Trial Design: How and when to adapt? |
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FDA: Five Essentials for Start-ups |
| Start-Up Presentation 3 |
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Start-Up Presentation 4 |
| Clinical Survival and Success |
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Successful clinical studies: Top 10 Tips |
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Post-Market Evidence: Why? |
| Start-Up Presentation 5 |
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Start-Up Presentation 6 |
| Final Session |
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CSI MAXIS Innovator Award(s) Presentation |
This session is part of CSI Frankfurt 2023, the leading conference on congenital, structural and valvar heart disease interventions, which will take place June 28 - July 1, 2023 in Frankfurt, Germany. Drop in for the day, or join us for the full 4-day program providing a comprehensive overview of the field presented by experts and key opinion leaders from all over the world.
BROWSE THE FULL CSI 2023 PROGRAM