Understanding the Value of a Medical Device Guru

Global Medical Device Podcast powered by Greenlight Guru

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