Jon Speer: Founder of Greenlight Guru --- Episode 36
In this episode, Jon and I discuss Greenlight Guru, how he founded the company, thinking about quality early, advice for start-up companies, and why he loves the medical device industry. Jon Speer Bio: Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.
The best design methods for successful development? [Jon Speer]
Medical Device made Easy Podcast
Subscribe I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him. We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in. We discussed particularly the famous FDA waterfall diagram and the Agile methodology. So if you are a company developing Medical Devices, this is an episode that you should not miss. Who is Jon Speer? Jon Speer is the founder of Greenlight Guru, a medical device quality management software solution. Jon is a medical device guru with over 22 years of industry experience who knows the best medical device companies in the world use quality as an accelerator. That’s why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses… Lately, Monir created the Easy Medical Expert platform where you can submit some missions, and experts in the Medical Device field will be able to answer and help you. Links Jon Speer LinkedIn profile: https://www.linkedin.com/in/jondspeer/ Greenlight Guru: https://www.greenlight.guru FDA Guidance – Design control: https://www.fda.gov/media/116573/download Jon speer email: firstname.lastname@example.org Easy Medical Expert: http://easymedicalexpert.com The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast.
How Jon Speer Met His Most Frequent Guest: Mike Drues
Global Medical Device Podcast powered by Greenlight Guru
Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences.Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.
Early in his career Jon was spending too much time updating the team’s Excel spreadsheet which they used to track quality and regulatory-related progress during device development phases. One day he thought to himself “there has to be a better way”, and thus Greenlight Guru was born which simplifies the quality management process for medical device manufacturers. Hear about Jon’s journey from chemical engineer to honorary mechanical engineer to founder of Greenlight Guru. Also check out Greenlight Guru’s The Global Medical Device Podcast. Pipeline Design & Engineering partners with medical device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, or automation equipment but don’t have the bandwidth or resources internally to develop that equipment. You can find us on the web at www.testfixturedesign.com and www.designtheproduct.com
Jon Speer: Bringing Safe Products to Market Fast | Ep.12
DeviceAlliance: MedTech Radio
How does one take a medical device idea on a napkin to a 510k approval to market release as efficiently as possible? How does one manage risk to drive the safety and quality of products and processes, while striving to be first in a innovative market? How does one change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator? How does one understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers? In this episode of DeviceAlliance’s Medtech Radio, we speak with Founder of Greenlight Guru, Jon Speer. Join us as he shares his deep insights in the differences that help medical devices get to market faster with less risk. Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more.
021: Jon Speer | How to Change the Medical Device Industry
The Life Science Effect
WARNING! Focusing on compliance is not the answer. It is the problem. That is the message that Greenlight Guru is preaching these days. And it's why Jon Speer started the company in the first place. After years of making a huge difference with major companies by managing medical device development projects, Jon decided it was time to encode his expertise into a system. A system that would embed quality into the process of designing, developing, and manufacturing medical devices. If you don't know Jon, it's time you got to know him. In one of our best episodes yet, Jon shares why he started Greenlight Guru (you may be surprised how personal this was for him). Jon goes on to share why data and true electronic quality systems are critical today. Jon is on a mission to improve healthcare and the safety of medical devices in this world. Check out this important episode. To connect with Jon and Greenlight Guru, go to greenlight.guru