May 6, 2025
158 | From Protocol to Practice: An Interview with Liana Mari-Gordon
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In this episode, Liz Cumby is joined by Liana Mari-Gordon, an expert in mechanical engineering and surgical training, to discuss best practices throughout the clinical trial phase of medical devices. Liana shares her experiences of learning how what "looks good on paper" may need to be updated when the device is in the hands of a physician. They delve into the importance of standardizing training, capturing and sharing field data, and maintaining honest conversations about challenges and successes. The episode also highlights methods to implement continuous improvements and ensure best practices are disseminated across users.
April 15, 2025
157 | Learning Lessons Along the FDA Approval Pathway
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This week, Rachel and Liz discuss Liz's conversation with Nada Hanafi on the FDA approval pathway and how training can be used to mitigate risk. They share what they learned from Nada about the process and their insights for developing curriculum that has high standards to ensure patient safety.
March 18, 2025
155 | Create the Assessments Before the Curriculum
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Liz and Rachel dive into Liz's interview this week as they discuss competency exams for clinical support reps. As they do so, they share their insights into how creating assessments first can drive curriculum development and contribute toward a successful trial.
February 19, 2025
153 | Learn Today, Improve for the Future
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This week, Rachel and Liz discuss their key thoughts and learnings from Liz's interview with Shienal Patel. They dive into how learning about the procedure in the clinical trial phase can impact the trial itself and the product for years to come. They also discuss the need for a strong clinical trial training strategy, especially as the FDA is requiring different investigators for different phases of the trial, and turn their conversation toward the use of video recordings in clinical trials and the many ways your training strategy can incorporate them.
February 10, 2025
152 | Clinical Trials Are the Time to Train with Shienal Patel
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Shienal Patel joins Liz in this episode to discuss how having strong investigator and clinical rep training strategies can impact the success of your product in the trial and into commercialization.
In their discussion they explore why it's important to invest in training during the clinical trial, considerations for the level of training that needs to be offered, and the possible consequences for not providing great training. Shienal shares her own experiences and the key learnings she has had over her career.
February 7, 2025
151 | The IFU: The Foundation of the MedTech Training Journey
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In this episode, Liz and Rachel discuss Liz's conversation with Kelly Carty about developing procedural consistency during the clinical trials. They'll share the best practices they've learned for training with the Instructions for Use (IFU) and procedure guide and share their own opinions about FDA-mandated training.
Tune in and learn why this procedural consistency is the base of the mountain and an important stop on the journey.
January 16, 2025
150 | A Strong Regulatory Strategy with Kelly Carty
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Liz kicks off this year's Medical Device Training Journey by interviewing Kelly Carty, who advises medical device companies on regulatory strategy throughout the product lifecycle.
During their conversation, they dive deep into the clinical trials process, from how to develop the IFU to implementing best practices into a procedure, and how mandatory training can be a mitigation measure in the risk management process. Join Kelly and Liz as they discuss how a strong regulatary strategy can ensure companies have the best data, documents, and procedural steps to support their products.
In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.
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