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Episode 208  |  32:02 min

Understanding the Value of a Medical Device Guru

Episode 208  |  32:02 min  |  05.26.2021

Understanding the Value of a Medical Device Guru

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This is a podcast episode titled, Understanding the Value of a Medical Device Guru. The summary for this episode is: <p><span style="color: rgb(0, 0, 0); background-color: transparent;">Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.</span></li><li><span style="background-color: transparent;">Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a product or pass an audit. Gurus want their customers to succeed the first time.</span></li><li><span style="background-color: transparent;">Do you want to be a medical device guru at Greenlight Guru? You are encouraged to be curious, inquisitive, and willing to learn and help because you are exposed to different medical device companies and technologies.</span></li><li><span style="background-color: transparent;">The process of setting up a medical device quality system, getting your product to market is much more overwhelming than it actually is. First, focus on design controls and risk management. You can add more later.</span></li><li><span style="background-color: transparent;">Build as You Go: Use phased approach to implement a QMS to make paperwork less of a burden and less tedious to add value and improve business efficiencies.</span></li><li><span style="background-color: transparent;">Market Research: You need to know your industry and understand your users and their needs. Talk to as many people as possible - clinicians, patients, etc.</span></li></ul><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable quotes by Tom Rish:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“We found early that our customers are coming to us with a lot of different questions.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”</em></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.greenlight.guru/blog/author/tom-rish" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Tom Rish</a></p><p><a href="https://www.fda.gov/medical-devices" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Medical Devices</a></p><p><a href="https://www.fda.gov/industry/fda-basics-industry/guidances" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Guidance Documents</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">510(k) Submission Process</a></p><p><a href="https://www.greenlight.guru/blog/fda-inspections-and-iso-audits-what-is-the-difference" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA Inspections and ISO Audits: What is the difference?</a></p><p><a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Software as a Medical Device (SaMD)</a></p><p><a href="https://eumdr.com/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">European Union Medical Device Regulation (EU MDR)</a></p><p><a href="https://www.bsigroup.com/en-US/medical-devices/Our-services/IVDR-Revision/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">In Vitro Diagnostics Regulation (IVDR)</a></p><p><a href="https://www.greenlight.guru/blog/nih-radx-initiative-lessons-learned" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH</a><span style="background-color: transparent; color: rgb(0, 0, 0);">&nbsp;</span></p><p><a href="https://www.greenlight.guru/blog/regulatory-tips-pointers-from-a-former-fda-reviewer" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewer</a></p><p><a href="https://www.greenlight.guru/blog/meet-tom-rish" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global&nbsp; Medical Device Podcast, Episode 158: Meet a Guru - Tom Rish</a></p><p><a href="https://www.greenlight.guru/blog/meet-guru-jesseca-lyons" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 155: Meet a Guru - Jesseca Lyons</a></p><p><a href="https://www.greenlight.guru/blog/meet-guru-taylor-brown" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 153: Meet a Guru - Taylor Brown</a></p><p><a href="https://www.greenlight.guru/blog/meet-wade-schroeder" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 160: Meet a Guru - Wade Schroeder</a></p><p><a href="https://www.greenlight.guru/blog/meet-sara-adams" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 188: Meet a Guru - Sara Adams</a></p><p><a href="https://www.greenlight.guru/blog/meet-laura-court" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 206: Meet a Guru - Laura Court</a></p><p><a href="https://www.greenlight.guru/blog/meet-etienne-nichols" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Global Medical Device Podcast, Episode 207: Meet a Guru - Etienne Nichols</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru</a></p>

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.

Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.

Some highlights of this episode include:

  • Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.
  • Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a product or pass an audit. Gurus want their customers to succeed the first time.
  • Do you want to be a medical device guru at Greenlight Guru? You are encouraged to be curious, inquisitive, and willing to learn and help because you are exposed to different medical device companies and technologies.
  • The process of setting up a medical device quality system, getting your product to market is much more overwhelming than it actually is. First, focus on design controls and risk management. You can add more later.
  • Build as You Go: Use phased approach to implement a QMS to make paperwork less of a burden and less tedious to add value and improve business efficiencies.
  • Market Research: You need to know your industry and understand your users and their needs. Talk to as many people as possible - clinicians, patients, etc.

Memorable quotes by Tom Rish:

“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”

“We found early that our customers are coming to us with a lot of different questions.”

“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”

“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”

Links:

Tom Rish

FDA - Medical Devices

FDA - Guidance Documents

510(k) Submission Process

FDA Inspections and ISO Audits: What is the difference?

Software as a Medical Device (SaMD)

European Union Medical Device Regulation (EU MDR)

In Vitro Diagnostics Regulation (IVDR)

Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH 

Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewer

Global  Medical Device Podcast, Episode 158: Meet a Guru - Tom Rish

Global Medical Device Podcast, Episode 155: Meet a Guru - Jesseca Lyons

Global Medical Device Podcast, Episode 153: Meet a Guru - Taylor Brown

Global Medical Device Podcast, Episode 160: Meet a Guru - Wade Schroeder

Global Medical Device Podcast, Episode 188: Meet a Guru - Sara Adams

Global Medical Device Podcast, Episode 206: Meet a Guru - Laura Court

Global Medical Device Podcast, Episode 207: Meet a Guru - Etienne Nichols

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

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Examining the HHS Proposal for Premarket Notification Exemptions

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Building your Brand as a Medical Device Professional

Meet a Guru: Etienne Nichols

Meet a Guru: Laura Court