004 – Get and stay on the FDA’s good side with Jon Speer

In this episode I sit down with Jon Speer from greenlight.guru and we dive deep into some of the big issues plaguing the medical device industry and why his company makes HELPING others their top priority.


  • Jon’s accidental entry into the medical device industry.
  • How Jon developed an interest in systems and process.
  • How greenlight.guru helps companies develop and efficient approach to design control.
  • The 2 part approach required for your validation to be valid.
  • Opportunities to learn more about the ever changing regulations.
  • Why greenlight.guru’s company culture is so important.

Take Action:
Email Jon Speer to claim your free whiteboard sessions | jon.speer@greenlight.guru

Links to Things Mentioned in This Episode:
Cook Medical
The complete guide to FDA design control webinar
Global Medical Device Podcast
Global Medical Device Podcast on iTunes

Jon Speer (@creoquality) is the founder of greenlight.guru and has spent the last 16 years helping companies bring innovative medical device products to market in order to improve the lives of a larger audience.

Greenlight.guru (@greenlightguru) is a new, innovative eQMS software solution built exclusively for innovative medical device companies to help them bring safer devices to market, faster.

“Good design control is good business sense.” – Jon Speer

Social Connecting:

Guest: Jon Speer
Email: jon.speer@greenlight.guru

Guest Company: greenlight.guru

Host: Meghan Alonso
Email: malonso@imua-services.com

Host Company: Imua Services

All Podcasts:
iTunes: bitly.com/InspiredbyIMUA  

Podcast Transcription:


Megan: Aloha. Welcome to Inspiredbyimua.com. Please welcome today’s guest. He knows his way around regularity and quality and has developed an efficient collaborative cloud based software system called Greenlight.guru. That helps you keep all your documents in one place, all neat and tidy for the FDA. Drum roll, we’ve Jon Speer. Aloha Jon. How are you doing?


Jon: All good. I was waiting for the drums but all is good. I heard them in my head.


Megan: Yes. You’ve got to use your imagination here.


Tell us a little bit about your background. How did you end up in this crazy world of medical devices?


Jon: People ask me that sometimes and I try to have an interesting story. My degree is chemical engineering, which chemical engineers don’t usually get into the med device space. I guess it was somewhat accidental entry into the market. I was in college. There were some friends of mine who were taking biomedical engineering courses. I needed an engineering elective. I took the biomedical engineering. It was really interesting to me. I had some friends that out of school or as they were approaching graduation who got jobs with medical device companies. The chemical engineering job market was terrible. I interviewed with a medical device company and 18 years later, here I am.


Megan: Which company was that?


Jon: I started my career with a company called Cook Medical. They are a private medical device company with headquarters based in Bloomington, Indiana.


Megan: Okay. After that I know you did consulting. Tell me about that journey and how it led you to start Greenlight.


Jon: The Greenlight idea actually started when I was at the Cook organization. I was there for about 7 years and the latter part of my time I got more involved from a systems from a product development standpoint. Trying to insure that our processes were as efficient as they could be while, of course, meeting the FDA expectations from a design control perspective.


Fast forward a few years later I got involved working with a lot of start-ups and started my own consulting practice and trying to help these start-ups and small med device companies bring products to market, deal with quality systems and regulatory matters. One of the things that kept coming up over and over again was this pain around design control and the pain around risk management. I felt the pain a lot because I was the guy that was tasked to do that. That is one of the things that I’m like, there’s got to be a better way. That is really how the origins of Greenlight started.


Megan: Good, so you had that idea to launch it. When did you guys start?


Jon: I should have prepared and actually done my own research. Officially, Greenlight has been a business for a little over 3 years. I’d have to go back to the official filing. It has been a crazy journey ever since. We’ve had actually our product has been in commercial use for a good 2 years, 2.5 years actually. That has been a pretty exciting journey as well.


Megan: You got a lot of momentum?


Jon: We did, yeah.


Megan: That’s good. Give us more of an overview of what goes on in there.


Jon: The challenge is this, companies struggle all day every day with their design controls. How to do it, when to do it, how to coordinate and link, and insure everything is tied together. Design controls are basically objective evidence that one captures and documents and manages and maintains to prove that the device is safe, effective, and meets the intended use. It is certainly something that is expected behavior from a regulatory point of view, but it is just good business sense actually as well.


Companies struggle with capturing and managing that information. That really was our first entry into the market so to speak was the focus on developing a streamline efficient approach that can save a project team hundreds and hundreds of hours during a calendar year in efficiency and hours gained through our platform. From there we just continue to add additional features and modules on to the product.


We’ve got a document management module that allows you to store, manage, and maintain all of your documents and records, quality system procedures, and forms and templates. Do so on a save controlled environment allows you to track revision history, allows you to do electronic signatures. All aligning with the part 11 criteria that is defined by the FDA.


We also have rolled out some pretty exciting features a few months back around risk management. Specifically product risk management that actually aligns and comply with ISO 14971, which is the industries risk management standard. That all integrates with design controls, so all of that all ties together. That is where we are today.


Megan: Your system isn’t necessarily replacing anyone’s job, you’re just making it a lot more fluid and just easier to keep track of everything right?


Jon: Yeah. It is very surprising, and when I learned this my eyes were like giant and my jaw dropped. Did you know that over half of the medical device industry is still using paper based systems to manage their design controls, their risk, and their procedures and documents and records? They are using paper. It is 2016 and there is a lot of reasons why people are still using paper. The perception is paper is less expensive, and paper is easier, and paper is simpler and all those sorts of things. The reality is, paper represents a significant risk to companies. Most companies these days are not co-located. They got people all over the globe, all over the place. To have a centralized repository that is paper based is just not going to cut it from a documentation standpoint.


To move toward electronic document management is really a necessary thing for companies to consider. The other problem with paper is all the time you’re missing signatures, or things get misplaced or gone or get thrown away accidentally. It is just crazy what can happen in a paper world. When you work with a system like what we’ve designed with Greenlight.guru, it is impossible for a document, for example, to get published unless it has everybody’s electronic signature. It just can’t happen. There are just some things that just make life a lot easier. Keep you audit ready. Make sure everything is available in a single source a single location, and again streamline the process to save lots of time for engineers. That is the real advantage.


Megan: With Greenlight.guru do you have that software or the cloud based system validated? Your users don’t have control over your system. What features have you built in for that so it is FDA compliant?


Jon: Software validation, especially when it comes to quality systems and computer systems, it is a bit of … People know that they need to do it, but they don’t always know what that means. I think there is a lot of misconceptions about validation. Often times you’ll hear somebody say well it’s part 11 compliant so therefore I’m good to go.


For validation to be actually valid it is a 2 part approach. At Greenlight.guru we’re doing a significant part of that and we’re doing all of the IQ and OQ activities that would be necessary. But you as a user of the software, you have to do some things too from a validation standpoint. Some of the things that we provide our customers are protocols, and test methods, and test cases and test environments, and we guide them through that process. That is one of the big advantages that we can provide is basically guide our customers through what they need to do to validate and prove that Greenlight.guru is going to meet their particular needs and satisfying the needs of FDA.


There is a lot of things that we’ve implemented as features just core functionality within Greenlight.guru that just doesn’t exist in a lot of other packages. I mean, it helps that Greenlight.guru is designed only for the medical device industry, so we’re only focused on FDA’s 820 quality system regulations and FDA’s part 11 requirements and ISO 13485 and ISO 14971. We only focus on medical device.


Megan: That is really powerful because you write a lot of project management software systems and document control systems claim to do a portion of what Greenlight.guru does, but it is not streamlined towards that.


What about if someone is working on an international level? That’s got to be pretty time intensive to build out a system that not only keeps up to date with what the FDA is doing, but the CE marking process or the Chinese FDA.


Jon: There is a lot of efforts underway. Fortunately, I think from a regulatory perspective to try and achieve some alignment with all these different regulatory bodies, the ISO 13485 the roll out that tap and a couple of months ago the 2016 version is certainly evidence of that. How all these regulatory bodies are starting to try to work together and align with one another. But it is still a challenge because each and every market something changes. Trying to stay ahead of the curve and understand what the requirements are in one market versus the next and how to build, and can you build, one system to address all those particular markets is definitely a challenge that global companies are going to be faced with for sure.


Megan: You guys have a lot of education for your customers. Webinars. Ebooks. Tell us about some upcoming webinars or just opportunities that people can learn more about these ever changing regulations.


Jon: Absolutely. What we found is it is important to try to provide that guidance and direction. We’ve published things like “The Ultimate Guide to Design Controls” and “The Definitive Guide to ISO 14971 Risk Management” and “Guide to Regulatory Product Classification” because it’s confusing. I do this all day every day, this is my profession and even though this is what I do all day every day, sometimes people ask me a question and I’m like, that’s a good question. I can only imagine if you weren’t a regulatory expect and you didn’t eat, breath, and sleep quality systems and design controls that that might be confusing. We focus a great deal of efforts on those guides that I mentioned.


Megan, actually you caught me right in the middle, we’ve been working with David Amor. David is with Medgineering and Medgineering and Greenlight.guru we actually are in the middle of a 2 part series on the complete guide to FDA design controls. We had our first session back on April 12th and our next session is April 26, so there is still time for your listeners to sign up for the 2nd part of the 2 part series. IT is very easy to do. Just go to Greenlight.guru and you’ll see all of the information about signing up for that.


I’ll tell you what, Megan, for your listeners all they have to do is send me a note and I’ll make sure they get the replay of part 1 because it has been recorded and we have that available for download as well.


Megan: Okay. Great. Thank you. Tell me about some of the companies that are currently using Greenlight.guru. What features have they been really happy with? Do you have any success stories to share?


Jon: As you started asking that question I just really started to smile. I feel as though I have the best job in the world because I get to worth with some many different exciting medical device companies that are all trying to change the world for the better. Some of the exciting stories that we have. We’ve got one company before they met us they were struggling with their quality system. They were behind schedule and they were trying to pick up some steam and efficiency and get their quality system back on track, get their design controls were they needed to be because they had some pretty aggressive timelines. Of course, every medical device has aggressive timelines.


They understood what we were doing and they were all in. We’ve been working with them for a year and a half now its just been pretty exciting. They’re kind of finishing up the last little bit of a 510K submission. To see one of customers go from a very early concept proof of concept prototype to putting together their entire design control package and capturing all of their quality system, and then submitting a 510K and finishing answering that last question from the FDA and are days and maybe a couple of weeks way from getting clearance. That is really really exiting. That is one story.


We have a few other companies they’ve been able to achieve ISO 13485 certification because of implementing Greenlight.guru. There is a lot of stories like that. Those are just a couple. Just seeing how people understand when you explain design controls and you’re able to show them a visual simple work flow on how to capture, manage, and maintain that. To see the reaction in people that have been doing this for decades, their reaction is amazing. The people who have never done this before their reaction is amazing. I have a good time working with our customers.


Megan: Good. Your company just seems like a really cool company. You have an awesome video on your website of people playing foosball and everybody’s got these sporty Greenlight.guru gear on. Even your mac computers are green. Tell us a little bit about the company culture.


Jon: The culture is important. First of all our vision is quite simple. Our vision is about being the best in the world. The mission is also something that is pretty special around here. We all believe this and our mission is to improve the quality of lives. I think every person on our team they know what means and what they’re doing whether they’re writing code for the software, whether they’re talking to a medical device company on the phone, whether they’re providing training and support to a customer, they understand that their role does improve the quality of lives. Because we’re helping our customers bring their products to market faster.


The products that our customers are developing are life saving, life sustaining, life improving. We have a part in that. We’re helping make that happen. Plus we’re improving the quality of lives of the medical device professional because we’re giving them software solutions that actually make this process so much smoother an easier than the alternative approach.


Megan: Great. Speaking of helping people through the development of their devices, you have a special freebie for our listeners. Tell us more about that.


Jon: I do. That special freebie is this, I’m willing to offer your listens a free whiteboard session. What that entails would be we’ll carve out a 30 minute time period and that 30 minutes is free time. You can ask me anything you want. You can talk to me about your regulatory struggles or get some advice on building your quality system, or how to capture design controls, or risk management and what to do about that. Anything that you wish to discuss from a medical device perspective. I’m giving your listeners 30 minutes of free time.


It’s very simple, Megan. All they have to do is send me an email to ask for that. My email address is jon.speer@Greenlight.guru. I’m sure you’ll have that in the body of the podcast as well.


Megan: All right. Thanks. I will have it in the show notes so people can always reference that. If you email Jon, just say hey I heard you on Inspired by Imua and I want to take you up on this offer.


Speaking of hearing us on a podcast, Jon you have your own podcast. Our listens will probably be interested in that.


Jon: Sure. The guys on our team make fun of me sometimes because I say I have a podcast voice. I’m not sure what that means. We’ll just leave it at that, I’m not going to go any further than that. Yes, Greenlight.guru does have a podcast. I don’t remember what episode we are one, but we’ve been doing that for quite some time. It is known as the Global Medical Device podcast. It is on iTunes. It is on Soundcloud. Again you can also find that at Greenlight.guru website.


Megan: How often do you publish episodes?


Jon: We’re publishing a few episodes per month, give or take. Like you, we’re covering topics that are of interest to people and sometimes get down in the weeds in the trenches on specific topics that are relevant from a regulatory perspective. Again, it is all about the content and trying to help provide guidance and direction and help education people. We will bring in industry experts who are well known in a particular area and just dive in.


Megan: All right. Guys, check that out. It is a great resource for some more education.


Jon, I just wanted to thank you for being here. You’ve brought a lot of great value. Guys, don’t forget. Email its jon.speer@Greenlight.guru. That’s correct right?


Jon: You got it.


Megan: Okay. There is no .com it’s Greenlight.guru which is pretty cool.


Jon: That’s correct.


Megan: Email him get that free 30 minutes whiteboard session. Register for the webinar and also send him a note if you want the earlier webinar and check out his podcast. You have a lot of homework to do right there.


Hey guys. I just wanted to let you know that obviously the waves of medical device development can be pretty rough and we want a family of support to go through those waves with. Well, good thing we’ve got it. We’ve got the Inspired by Imua Facebook group where we can all share in our journey together. Go ahead and type that in the search bar and I’ll see you in there. Check out Inspired by Imua.com and in the meantime, Imua


Speaker 3: Mahalo for joining us. If you’re new to riding the waves of medical device product development or if you’ve been in development for a while already, Inspired by Imua is here to surf with you. Want to be a master of the waves? Text hangten to 44222. We’ll send you the most company wipeouts companies make in product development so you can avoid them and reach master wave status. Again, that’s hangten to 44222. We publish a new episode very Tuesday, so catch us at Inspiredbyimua.com. Imua.




Link to http://imua-services.com/work-with-us/

About the Author

Meghan M. Alonso
Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for equipping medtech & IVD companies with the knowledge, resources, and connections they need to bring innovative products to market. She’s the IVD Product Marketing Manager for NAMSA and founder of Imua Services. She’s a contributing author for best selling book “Put a Shark in Your Tank” with Shark Tank’s Kevin Harrington, and the prestigious “Molecular Profiling – Methods and Protocols”(a must read in molecular diagnostics). Her podcast, MedTech Inspired, in which she interviews the hottest startups, experts, and investors, won iTunes “New and Noteworthy”. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD companies through development and manufacturing. When she isn’t helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable husky Abby, crossfitting, enjoying great restaurants and fine wine with her husband, soaking up the sun the nearest beach, and promoting the adoption of shelter dogs.

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