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How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues: In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within t... by Global Medical Device Podcast powered by Greenlight GuruUNLIMITED
How to Solve the Medtech Value Equation with Quality Data
FromGlobal Medical Device Podcast powered by Greenlight Guru
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How to Solve the Medtech Value Equation with Quality Data
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
33 minutes
Released:
Dec 5, 2019
Format:
Podcast episode
Description
Which medical technology, product, or device are you focused on bringing to market that will positively impact and improve the quality of life? What are the obstacles and challenges you can expect to experience? How will you overcome those?
Today’s guest is Devon Campbell, founder of Prodct, LLC, who joins Jon Speer to discuss the value equation for MedTech companies to elevate and escalate quality and improve value.
Some of the highlights of the show include:
- Data Process: Sooner than later, think through the deployment and infrastructure for a company’s quality management system (QMS) to generate quality data.
- Quality Strategy Mindset: Learn to appreciate, understand, and demonstrate the value and purpose of quality data.
- Due Diligence: Multiple reasons exist for MedTech companies getting their product or process into the hands of users sooner and serve as revenue source.
- Deliver not just data, but extensive confidence in that data and in a way that end users and stakeholders value and trust, as well as reduce risk.
- Quality data is not a one-time occurance. Reproduce and repeat data consistently for process validation and scalability.
- How does QMS strategy inform and offer value? Provides ability to articulate and appreciate quality by knowing where you are and want to be with your company.
- Elements to consider for a value equation include technology, quality infrastructure, go-to-market regulatory strategies, and data integrity.
Today’s guest is Devon Campbell, founder of Prodct, LLC, who joins Jon Speer to discuss the value equation for MedTech companies to elevate and escalate quality and improve value.
Some of the highlights of the show include:
- Data Process: Sooner than later, think through the deployment and infrastructure for a company’s quality management system (QMS) to generate quality data.
- Quality Strategy Mindset: Learn to appreciate, understand, and demonstrate the value and purpose of quality data.
- Due Diligence: Multiple reasons exist for MedTech companies getting their product or process into the hands of users sooner and serve as revenue source.
- Deliver not just data, but extensive confidence in that data and in a way that end users and stakeholders value and trust, as well as reduce risk.
- Quality data is not a one-time occurance. Reproduce and repeat data consistently for process validation and scalability.
- How does QMS strategy inform and offer value? Provides ability to articulate and appreciate quality by knowing where you are and want to be with your company.
- Elements to consider for a value equation include technology, quality infrastructure, go-to-market regulatory strategies, and data integrity.
Released:
Dec 5, 2019
Format:
Podcast episode
Titles in the series (100)
- 31 min listen