Episode Details

Live Event: Critical Thinking on Clinical Trial Success

Ep. 43

You’ve got a great idea for a medical device!  Now what?

Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success.   With the explosion of Medtech opportunities for startups, what are the current best standards for ensuring the success of your design and clinical trials?

Join us for this Live-Recorded Podcast Event "Proving Your Device Works in The Real World" as we discuss...

- Consideration for the problem you are trying to solve
- Big Questions to answer for Clinical Literature, IP Landscape, Stakeholder and Value Proposition, What is relevant today
- Pre-clinical / Clinical Testing Feasibility
- Planning the Clinical Trial Design – Tactical and Strategic Considerations 
- Regulatory Pathway & Business Strategy
- Design Approach and policy level considerations
- The External Environment  (Legislative, Healthcare Economics, Orange County Talent, Reimbursment and Market Adoption

Expert Panelists Include:

Dr.  Michael Drues - President of Vascular Sciences & FDA Consultant

Jeremy Koehler - Director Of Engineering at NXT Biomedical

Vinny Podichetty - VP Clinical & Medical Affairs at JenaValve Technology, Inc.

Anand S. Patel, MD - Chief of Interventional Radiology at Providence Little Company of Mary, Torrance 

Free Opinion Disclaimer

The views and opinions expressed at this event are those of the panelists and do not necessarily reflect the official policy or position of their respective organizations. Any content provided by our panelists are of their opinion and are not intended to malign any organization, company, individual or any entity.

Ep.43

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Live DA Event: Critical Thinking on Clinical Trial Success | Ep.43

You’ve got a great idea for a medical device!  Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success.   With the explosion of Medtech opportunities for startups, what are the current