Episode 151 | Nikki Batista, Vice President at MCRA and Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Regulatory | Project Medtech

This podcast episode explores the importance of strategic regulatory planning for startups in the medical device industry. It emphasizes the need to consider the end goal and indication for use in regulatory planning and highlights the significance of placing regulatory milestones throughout the product development lifecycle. The episode also discusses the implications of FDA clearance, the challenges of commercialization, the importance of a global regulatory strategy, and the role of the FDA in ensuring product safety. It emphasizes the need to engage with the FDA early in the product development process, collaborate with regulatory consultants, and build a strong team for startup success.

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Episode 151 | Nikki Batista, Vice President at MCRA and Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Regulatory

Project Medtech

Setting Up Your Medtech Company: Regulatory Considerations for Success and Acquisition

The Significance of Regulatory Planning in Achieving Startup Success

Leveraging Regulatory Milestones for Early Success in Medical Device Development

Considerations for Regulatory Strategy and FDA Clearance

Factors to Consider When Expanding Globally and Achieving FDA Clearance

The Importance of Regulatory Strategy and Consideration of Additional Effort

The Challenges of the FDA and Effective Communication for Review Process

The Role of FDA in Regulating Medical Practice and Innovation

The Importance of Pre-Submission Meetings with the FDA

Tips for Discussing Your Product with the FDA

The FDA Pre-Submission Process and the Use of 513G

Understanding Classification and Regulatory Assessment for Medical Devices

Understanding Combination Products and the Regulatory Process

Strategies and Resources for Understanding Regulatory Aspects in Early Stage Companies

The Importance of Regulatory Strategy for Early Stage Companies

Importance of Professional Opinion and Building a Strong Team for Startup Success

Episode 151 | Nikki Batista, Vice President at MCRA and Devon Campbell, Founder and Managing Director at Prodct | Setting Up Your Company to be Investable, Acquirable, and Successful: Regulatory

Project Medtech

00:00Setting Up Your Medtech Company: Regulatory Considerations for Success and Acquisition

Setting Up Your Medtech Company: Regulatory Considerations for Success and Acquisition

06:22The Significance of Regulatory Planning in Achieving Startup Success

The Significance of Regulatory Planning in Achieving Startup Success

11:54Leveraging Regulatory Milestones for Early Success in Medical Device Development

Leveraging Regulatory Milestones for Early Success in Medical Device Development

16:13Considerations for Regulatory Strategy and FDA Clearance

Considerations for Regulatory Strategy and FDA Clearance

20:32Factors to Consider When Expanding Globally and Achieving FDA Clearance

Factors to Consider When Expanding Globally and Achieving FDA Clearance

22:59The Importance of Regulatory Strategy and Consideration of Additional Effort

The Importance of Regulatory Strategy and Consideration of Additional Effort

28:04The Challenges of the FDA and Effective Communication for Review Process

The Challenges of the FDA and Effective Communication for Review Process

32:04The Role of FDA in Regulating Medical Practice and Innovation

The Role of FDA in Regulating Medical Practice and Innovation

36:40The Importance of Pre-Submission Meetings with the FDA

The Importance of Pre-Submission Meetings with the FDA

40:02Tips for Discussing Your Product with the FDA

Tips for Discussing Your Product with the FDA

43:10The FDA Pre-Submission Process and the Use of 513G

The FDA Pre-Submission Process and the Use of 513G

46:24Understanding Classification and Regulatory Assessment for Medical Devices

Understanding Classification and Regulatory Assessment for Medical Devices

48:46Understanding Combination Products and the Regulatory Process

Understanding Combination Products and the Regulatory Process

51:41Strategies and Resources for Understanding Regulatory Aspects in Early Stage Companies

Strategies and Resources for Understanding Regulatory Aspects in Early Stage Companies

54:14The Importance of Regulatory Strategy for Early Stage Companies

The Importance of Regulatory Strategy for Early Stage Companies

57:30Importance of Professional Opinion and Building a Strong Team for Startup Success

Importance of Professional Opinion and Building a Strong Team for Startup Success