GMDP-header-Jesseca-Lyons

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. 

Listen as Jesseca shares her insights on the importance of design controls and how a deep understanding of the different pieces and parts can lead to improved outcomes for both the device and patients who use it.

 

LISTEN NOW:

Like this episode? Subscribe today on iTunes or Spotify.

 

Some highlights of this episode include:

  • Customer Success Team: Jesseca is passionate about the medical device industry and connecting with customers to make a difference in their lives.  
  • Jesseca’s favorite aspect of being a guru is the opportunity to work on different types of devices and ideas from beginning to end of the development process.
  • Customer Success Stories: Audits can be intimidating, but terrified customers are put at ease due to Jesseca’s extensive preparation tips and best practices. 
  • Opportunities to help medical device companies worldwide improve quality of life is a rewarding experience for patients, providers, engineers, and everyone else.
  • The Greenlight Guru True Quality Virtual Summit and other content/conferences are opportunities to share knowledge and experience that makes an impact.
  • Jesseca is a Type A personality that enjoys being in control and telling people what to do based on the best options available and to get things done. 
  • Design controls are necessary, exist, and may change. Most people either like or dislike design controls, but they have a much greater impact than realized.      
  • Probable or Improbable? Jesseca once hated risk management until figuring out that nobody wants to cause harm. Now, risk management is important and fun.

 

Links:

Jesseca Lyons

Creating a Culture of Quality at Your MedTech Company

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS

ISO 14971:2019 Medical Devices - Application of risk management to medical devices

FDA - Medical Devices

ISO 14971 vs. FMEA

Sharknado Film Series

Medical Device Resources from Greenlight Guru

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from this episode:

“Think about the entire system and all of the different pieces and parts as a whole when going through and thinking about design controls.” Jesseca Lyons

“Bringing a device to market, that’s really hard and challenging because of all of the rules, regulations, documents, complexity behind it.” Jesseca Lyons

“There’s also nothing more guaranteed to end up incorrect than going through and trying to document it all, after the fact.” Jesseca Lyons

“When you’re dealing with risk, consider using ice cream and sharknados as examples to keep it a little more lighthearted.” Jon Speer


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

medical_device_podcast

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.