The 100th Episode: A Few of My Favorite Moments

April 25, 2019

Jon_solo podcast

Drumroll, please. It’s time to celebrate the 100th episode of the Global Medical Device Podcast!

Jon Speer, 2-series podcast host, VP of QA/RA and founder of Greenlight Guru, reflects on some of his favorite moments and highlights through the years.

“I’m a product development nerd. I’m a design control nerd. I geek out when I get to talk to some folks.”




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Some highlights of this episode include:

  • Human Factors: Mary Beth Privitera and Bryant Foster
  • Design Controls and Product Development: David Amor, Mike Fisher, and Scott Phillips
  • Regulatory Testing and Safety: Leo Eisner
  • Regulatory Affairs and Strategies: Allison Komiyama
  • FDA Case for Quality Pilot Program: George Zack
  • Device Marketing Authorization and Facility Registration: Jim Gianoutsos
  • Preparing Biomedical Engineers Entering Workforce: Andrew DiMeo
  • Most Popular and Frequent Guest: Mike Drues of Vascular Sciences



Episode 93: Design Validation vs. Human Factors Validation with Mary Beth Privitera

Episode 55: An Overview of What Medical Device Developers Need to Know About Human Factors with Bryant Foster

Episode 11: Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Episode 47: How Process Excellence Leads to Product Excellence with Mike Fisher

Episode 92: Medical Device Product Development Value Proposition with Scott Phillips

Episode 13: Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Episode 32: Tips for Success When It Comes to IEC 60601 with Leo Eisner

Episode 78: Regulatory Tips & Observations from a Former FDA Reviewer with Allison Komiyama

Episode 89: Aligning True Quality and Compliance with MDDAP with George Zack

Episode 83: Streamlining The Device Marketing Authorization Process with Jim Gianoutsos

Episode 61: Helping Prepare Biomedical Engineers Entering the Workforce with Andrew DiMeo

Mike Drues of Vascular Sciences

MedTech True Quality Stories Podcast

Greenlight Guru


Memorable quotes by jon speer:

“David Amor offers a real fresh perspective, a real progressive perspective on best practices and ways to structure and organize your product development process.”

“Leo Eisner’s the 60601 guy. He knows that standard inside and out. He’s always involved with the latest, greatest revisions and updates to that standard.”

“Allison Komiyama really is truly one of my favorite medical device people in the world...trying to lead the charge; get regulatory professionals together talking about best practices.”

“When I was talking with Andrew might hear my emotional reaction, but it was sincere. I really do love giving back to this community, to this industry.”


John Speer: Welcome to the Global Medical Device Podcast 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.

John Speer: Oh my goodness, can you believe it? That's right, we have been doing the Global Medical Device Podcast now for quite a few years, and this is a special episode because this marks episode number 100, that's right, a round of applause. In all seriousness folks, this is one of the best things that I get to do as part of my job, it makes the ride so much more enjoyable. And it's not gonna be a super long or informative podcast today, but I do wanna hit on... Or touch on a few of the highlights that some of my favorite moments if you will, from the Global Medical Device Podcast. Let me remind you a few that were really exciting for me and some of the folks that I've gotten to talk to. So you get to talk to some human factors experts, Bitman. There are no better resources out there on the topic of human factors than Mary Beth Privitera. Mary Beth is principal human factors expert with HS Design. She knows her stuff, she's written books about it, I always enjoy talking to her. But not to be outdone, I wanna remind you all of Bryant Foster and the design... Sorry, VP of Research and Design at Research Collective also very pragmatic, very helpful advice and tips when it comes to human factors.

John Speer: I'm gonna share all of these episodes that I'm talking to you about today. I'm gonna share links to all of those in this, the copy that accompanies this particular episode but human factors, big topic these days, you all know this. Research Collective, HS Design, two fantastic firms to consider working with your human factors challenges.

John Speer: I'm a product development nerd, I'm a design control nerd, and I geek out when I get to talk to some folks or when I've had a chance to talk to some folks on the topic of design controls and product development, and we've had some really, really good guests on that topic as well. My good buddy, David Amore, David is doing some fantastic things now with therapeutics but prior to that he did a lot of consulting, he's an expert with design controls and product development. I've had the real opportunity to share the stage with him a few times, we've done some webinars together on design controls. He understands the difference between research and development. We dove into that on an episode a while back, really fantastic dude. If you get a chance to me him, just a real fresh perspective, real progressive perspective on best practices and ways to structure and organize your product development process, David Amore.

John Speer: Another gentleman that I always enjoy talking to and he is the Director of Product Development at GCMI down in Atlanta. This guy, Mike Fisher, he's been at big companies, he's worked for smaller companies, but he just... He talks about product excellence a lot if you have a chance to talk to him and understanding how important the process is to leading you towards that product excellence. So again, another really fresh perspective on medical device product development.

John Speer: One other guy when I'm talking about product development that I've been admiring for quite some time is Scott Philips. Scott is the CEO of StarFish Medical. And the firm StarFish Medical, they've been doing this, I think for over 20 years now but really fantastic work that they're doing and they've been really leading the charge with medical device product development for quite some time, so check out the work that they're doing. And again, I'll share that episode where Scott and I talked about value proposition from a product development standpoint. A few other folks that are also worth mentioning that are top of the field that are frankly, they're assets that you should know about. First guy I want to mention to you on this space, this is kinda getting into regulatory and product testing and safety, a guy named Leo Eisner. Leo is Principal Consultant of Eisner Safety Consultants. The reason I bring him to your attention, we've done some podcasts, we've done some webinars with Leo. He is the 60601 guy, he knows that standard inside and out, he's always involved with the latest greatest revisions and updates to that standard. But if you're dealing with electro-mechanical device and you need to deal with electrical safety, there's none other that knows his stuff when it comes to IEC 60601 other than Leo Eisner. So be sure to check him out.

John Speer: One of my favorite people to talk to in the world, man, I just laugh every time she and I chat and smiling from ear to ear, even thinking about it right now but, Allison Komiyama, she is Principal Consultant with AcKnowledge Regulatory Strategies. And she used to be with the FDA and she was on the review side from FDA, so she's kind of been on the inside. Now she's working with companies of all shapes and sizes with really progressive regulatory strategy. I know she's starting a new event in her world, Regulatory Affairs, a group she's got an event coming up later this year in 2019. So you're gonna wanna check out what AcKnowledge Regulatory Strategies is doing. They're trying to lead the charge, get regulatory professionals together talking about best practices. So Allison Komiyama, she really is truly one of my favorite medical device people in the world. I love the work that they're doing.

John Speer: A couple other folks that I wanna mention and I'm gonna share all of these podcasts for you, these are all things hopefully, you've already listened to them, if not, go take a listen, be sure that you're going back in time and listening to some of these episodes, some really good stuff. As I reflected back on doing this for over 100 episodes now it's... We've had a chance to cover a lot of ground, a lot of topics. But you might remember back in 2018, I got involved at Greenlight and helping promote the FDA Case for Quality initiative. And I was at an event on the case for quality and there was a gentleman speaking about giving an update on the pilot and this guy, his name's George Zack. George is with Two Harbors Consulting and during this presentation he was talking about the medical device discovery appraisal program and the work that he and CMMI Institute have been doing as part of the pilot program and I asked the question, and it was interesting because George had a... His body language shifted, he reacted in some way, and I didn't pick it up until later that the reason his body language shifted is he recognized my voice from the Global Medical Device Podcast, so we had a good laugh about that.

John Speer: But George has been a guy I've talked with quite a few times and we're doing some work with and just really trying to promote best practices, especially around quality systems and business systems within a company. So expect to hear more here soon from George Zack and Two Harbors Consulting and case for quality. Couple other folks while I'm at it. A guy that I met quite a few years ago and at the time he was venturing into the consulting world and the medical device industry, and this has... He had an idea and he knew that obviously we had an idea, or I had an idea once upon a time at Greenlight Guru that we turned into a software platform and he shared some of his idea and I shared some of the stories that we went through, some of the challenges, some of the things that we learned the hard way. And that's one thing. And then he put his head down and he has done the same thing. So, James Gianoutsos, Jim is founder and president of Rimsys Regulatory Management Software. So they have built a fantastic platform to really help with regulatory product registration and a whole lot more. But Jim, we did a recent episode with him where we talked about streamlining the regulatory authorization process and it's just a really fresh look at things as well, so a good one to listen to.

John Speer: I think of all the episodes that I've done, the one where I get the most emotional, the most choked up in a good way, was when I was talking with Andrew DiMeo. At the time, Andrew was a Biomedical Engineering professor at UNC in North Carolina State, little known fact University of North Carolina and NC State they have a joint Biomedical Engineering program. But anyway, at the time Andrew was a professor of BME there and we had been working together. Greenlight had been working with UNC, NC State and some of the things that they're doing to try to teach design controls and risk and other quality system best practices in the classroom for undergrads. And he shared a moment where Greenlight is really making a difference in helping to inform and educate students on how to be medical device professionals. So when you listen to that you might hear my emotional reaction, but it was sincere. I really do love giving back to this community, to this industry, like I said, this Global Medical Device Podcast is one of the best things that I get to do.

John Speer: And of course I would be remiss if I didn't mention maybe one of the more popular guests that we've had on the Global Medical Device Podcast, and that would be Mike Drues President of Vascular Sciences. I tell you man, he is, when it comes to progressive, creative, innovative, regulatory approaches and strategies this guy is on his game. So we've had a lot of chats over the years we've gotten to know each other pretty well. We love talking about regulatory and from time to time quality, but you're gonna wanna give his episodes a listen too. While I've got your attention, for a few moments. I think one of the coolest things that we've gotten to do, and this is more recent, is we've really launched another brand when it comes to podcasts. We recently launched the MedTech True Quality Stories. And as we've rolled this out and I've have had chances to talk to a couple of CEOs and med device professionals who are really in the trenches.

John Speer: The stories that I get to hear from these folks, some of the challenges they've had to overcome, some of the dreams that they've had for their products and the way that they have just been driven companies and driven individuals and driven leaders to get their product to the market. It's just, I love living vicariously through these stories, but just really fantastic. So you're definitely gonna wanna go check out the new podcast from Greenlight Guru, MedTech True Quality Stories. So anyway, like I said, short and sweet today I wanted to share some of my favorite moments, some my favorite episodes on the Global Medical Device Podcast. Here soon I'll be sharing I'm sure, with you some of my favorite moments from MedTech True Quality Stories, and as always, I'm honored to be your host and the founder and VP of Quality and Regulatory at Greenlight Guru, John Speer.



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.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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