Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

October 12, 2017

If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. This episode's guest is Juan Carlos Serna, co-founder of Right Submission. Juan and his team are medical device professionals who spent the late nights writing and formatting 510k submissions just like the rest of us.

The hours lost creating submissions for the FDA inspired Juan Carlos to build a software that makes 510k submissions easier. The product is called Right Submission. Juan Carlos tells me about his “lightbulb moment” and why he believes the 510k process is old fashioned and in need of some upgrading. He also explains what exactly his product can do to make your next 510k submission painless.


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Here are this episode’s highlights:

  • The 3 reasons why 510k submissions are stressful.
  • The old fashion submission process that really hasn’t changed much.
  • The 3 things Juan Carlos believes need to change in the 510k submission process.
  • How Right Submission changes this process for the better.
  • How Right Submission works.



Right Submission LLC


FDA 510(k) Submission Insider Tips, Tricks and Timelines from a Former FDA Reviewer


Episode quotes from Juan Carlos:

"We knew we could improve the way medical device technologies get cleared by creating software to facilitate that."

"If you spend enough nights and weekends at the office doing it [510k submission] the old fashioned way, eventually that light bulb is going to fall on your head."

"You put all these factors into a bucket and you stir it, and you get a lot of noise and uncertainty in the process that is 100% avoidable if we as an industry take the time to really reevaluate the way we work and make some changes."


Announcer: 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.

Jon Speer: Have you ever put together a 510(k) submission? If you have, you know how frustrating and challenging that can be. It's not so much about putting the information into the 510(k), the frustration usually comes in the formatting, and the pagination, and putting the right sections in place, and then making sure you've got your eCopy all figured, out and all those sorts of things that are so important. Did you know that nearly a third of 510(k)s are rejected because of things that are 100% in your control? Crazy, I know. Imagine having a cloud-based software solution to help you not only compile the content of your 510(k) submission, but click a button and it's already formatted, and it's ready to submit. That's crazy, right? Well, it's reality. There's a company that's out there, Right Submission, that has built this product for you. And I get a chance to talk to the founder of that company, Juan Carlos Serna, on this episode of the Global Medical Device Podcast, and we dive into next generation tactics for 510(k) submissions. So enjoy this, and I'm really excited about this and I hope you are too.

Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is your host, the founder and VP of Quality and Regulatory at Greenlight.guru, and welcome to another exciting episode. Today, I'm really excited about this one, folks, because I learned about this company called "Right Submission" recently and it's Right, R-I-G-H-T Submission, and you can go their website, Rightsubmission.com. I learned about them recently and I had a chance to talk to our guest today, and I was like, "Oh my goodness, this is so awesome." And I mean this with all sincerity because it has to do with putting together 510(k)s. Their product is really revolutionary, and Juan Carlos Serna, the founder of Right Submission, is gonna tell us a lot more about their product and 510(k)s and all that here in a moment. But we're gonna dive into this topic, and the topic is "Next Generation Tactics for 510(k) Submissions." So let me do a proper welcome to Juan Carlos Serna from Right Submission. Juan Carlos, welcome.

Juan Carlos Serna: Thank you very much, Jon. Thanks for having me. Your podcasts are a great service to the medical device community and I'm really honored to be here with you today.

Jon Speer: Well, it's my pleasure. And this... I've put together a lot of 510(k)s in my career and I probably did it the terrible way, the old way, so to speak, old generation, OG, whatever. But you've got a product that's pretty revolutionary and I guess it'd probably be a good place to start if you can talk a little bit about why 510(k) submissions have been so challenging for organizations. What is going on here? What is the frustration? What is the challenge for companies?

Juan Carlos Serna: Sure. There's probably at least three reasons we can talk about today. One is 510(k) s are a really high-stakes milestone for companies. For a startup, they've got limited funds, and their valuation and strategic options are absolutely dependent on the submission going well. For larger companies, 510(k) clearances are always critical milestones in their project plans and it gets the C-level attention and scrutiny. The second reason why I think 510(k)s are so challenging is that the average person actually does one to two submissions in their lifetime. That means there isn't a well-defined process or a documented knowledge base to help companies and individuals through the 510(k) submission process. And then, I'd say the third reason is that 510(k)s are getting more and more complex every year. They're starting to look a lot like PMAs in some regards, and it requires a multidisciplinary team to execute. These teams are often not in the same physical location, they're not using the same file-sharing system, and they're often blinded to other sections of the 510(k) submission. So I would kind of peg those three reasons as probably the three biggest reasons, or the challenges.

Jon Speer: Yeah, and it's a really good point. And it's not like the general person isn't... It's not like they're doing a 510(k) submission every day, or even every month, for that matter. These are usually moments in time that you're compiling massive amount of information and trying to get it structured and organized in a certain way. And I know the times that I've done a 510(k), it's not that I have to go back and kinda learn all over again, but I have to go back and, "Wait. What does this section include and how do I need to structure this information?" and "Hey, by chance, did FDA change something about the formatting?" or "What I need to do is put in a 510(k)," and I'm sure that that's something that you've seen as well.

Juan Carlos Serna: It is. Absolutely true. Even for veterans like you and myself, there's a lot of uncertainty when we put together a 510(k).

Jon Speer: Absolutely. And so, I'm guessing that you observed over time some of, we'll call them "the old tactics" since we're gonna talk about next generation tactics, but what are some of the old tactics that you've seen people involved in the 510(k) process using? What are they doing to address these types of problems.

Juan Carlos Serna: Let me tell you a little story. I'm sure you guys do, at Greenlight Guru, we spend a fair amount of time looking at what people are searching for on Google to get some kind of intelligence on what people are up to, and you wouldn't be shocked by how many people are searching things like how to write a 510(k) or 510(k) guidance.

Jon Speer: Oh, yeah. Yeah.

Juan Carlos Serna: And that later search, the 510(k) guidance, if you do that search on FDA's guided website, you're gonna get 187 different guidance documents as of the last time I checked.

Jon Speer: Holy cow.

Juan Carlos Serna: And you know, you nor I nor anybody else listening to this podcast has the time to keep up to date with 187 guidance documents. [laughter]

Jon Speer: No.

Juan Carlos Serna: And then obviously, people use consultants. But it's a challenge to match your particular needs and budget to their expertise and availability. The good consultants are in really high demand, and they might not know exactly your product need. And so, most of the time, companies come to the realization that they could do a lot of... They can and should do a lot of the work themselves, and then have a consultant for some of the key, critical sections. You put all these factors into a bucket and you stir it, and you get a lot of noise and uncertainty. And the process that's 100% avoidable, if we as an industry take the time to really re-evaluate the way we work and make some changes.

Jon Speer: Yeah, it's a really valid point that you share, and I have heard this statistic, and I hope that my memory of the statistic is accurate. But it's something like 69% of 510(k) submissions are rejected at some point in that process, which you know, that's a large, large number whether it's 69% or 72% or whatever the case may be, it's pretty clear today that the quality of 510(k) submissions, seems to be waning a bit, and I'm sure that you're very cognizant of that. I guess, do you have any thoughts or comments on how we, as a med device industry, are doing with respect to the quality of our 510(k) submissions?


Juan Carlos Serna: Yeah, that's a good question, Jon. FDA releases a report every year, and we actually also have some kind of proprietary databases that we've assembled, and the number we have for submissions that are rejected purely on administrative review, this is the RTA refused to accept process of FDA, is 34%, and these are 100% avoidable mistakes. These are things like the pages aren't numbered. We don't have a complete section on sterility, or the indications for use are inconsistent. It doesn't take that many... If you do the math of company delay times burn, it's really easy to get to unicorn-sized numbers of the value that we're throwing out the window because we insist on doing things the old fashioned way.

Jon Speer: Yeah, I wanna kinda dive into that statistic a little bit more. I wanna re-emphasize to folks listening. 100 submissions, 510(k) submissions, Juan Carlos has data that supports 34%. So 34 out of those 100 510(k) submissions are rejected because of things that are 100% in your control as the submitter. That is pretty massive, and more or less, a third of 510(k) submissions are being rejected because of, frankly, human error, or things that we can do something about.

Juan Carlos Serna: Sure, and as you know from all your design history work, human error is avoidable. It's use error, it's process error, more than the individual making a mistake.

Jon Speer: Yeah. And now I'm really starting to understand even more so why I was so excited when I first discovered Right Submission and learned about what you're doing. The data doesn't lie here in this case. There's a huge need for this, but let's talk a little bit about what you see as some of those next-generation tactics. What are some things that you've observed that really needs to be changed?

Juan Carlos Serna: Yeah, so I like to think in a series of threes Jon, as you know. I think there's probably three things that companies, especially in the healthcare industry, need to do to evolve the way they do work. Whether it's with regulatory submissions, 510(k)s, other aspects of a regulated industry, and I would peg them at these three things. We need to adopt to a changing workforce. Highly-experienced individuals and the bright millennials don't wanna be stuck inside a cube, nine to six. And they're willing to work hard, and they want to collaborate with their teams, but they want the flexibility to get that work done on their terms. So just like Greenlight.guru, our software and some other software solutions out there, facilitate work done in an asynchronous fashion across time zones and across countries. Adopting to that workforce need is probably one of the primary things you can do to change the way you work. The second one is visibility and transparency. The reason things like SCRA methodology is so popular these days is 'cause it provides visibility to things that used to be hidden in the back offices of executives.

Juan Carlos Serna: Whether it's your software or our software, or other tools people use, everybody from the CEO to the intern should be able to get an instant status update as to the process, understand the big picture, and if the CEO wants an update, she should be able to log in and get an instant update, regardless of who's working on the project. So, that would be the visibility bucket. And then the third one is automation. Automation, in my opinion, isn't just for Uber and Tesla to figure out, it's for all of us to think, what is it about my job, and my work flow, that I can automate? Because in three to five years, we're all gonna be looking at a very different workflow, regardless of what we do. And thinking of it, embracing automation, and building it into our workflows is gonna be critical to any company.

Jon Speer: Yeah. I like all those points, and I love the point about the visibility element of that, because it's crazy to me. And this is... I don't have the exact percentage, but, it's still an overwhelming percent of the medical device industry is still heavily reliant on a paper-based, and very archaic-based approaches, with document management, and information sharing, and things of that nature. And that's one of the biggest areas from a Greenlight.guru perspective that we've found, is that companies are really... I think time is good. I think companies are finally hungry, or realizing the importance of having data and information readily available wherever they are in the world. And that's where your product, Right Submission is, I'm sure has made a lot of... Opened up a lot of opportunities. And I know that's what Greenlight.guru has opened up a lot of opportunities, as well, because these are actually solutions that have been built and designed specifically for the medical device industry, based on the needs of medical device professionals. And so that's a key thing. Knowledge is power, and one of the key things to have in that knowledge, is having good information. And historically, systems that have been used by medical device companies have not been an enabler. They've actually been a disabler. Yeah, I'm certainly wrapped around that concept very well.

Juan Carlos Serna: I think you're absolutely right.

Jon Speer: Alright. Given all these different next-generation tactics, these three key salient points that you've observed, and that you see as drivers. I guess, talk to me a little bit about what was the trigger? What was the motivation? What led you down that path to say, "Aha, I gotta do something about this?"

Juan Carlos Serna: You know, Jon, if you spend enough nights and weekends at the office doing things the old fashioned way, eventually, that light bulb's gonna fall on your head.

Jon Speer: Yeah. Yeah. And I know, I asked you a question, but let me interject a story on that. And I'm sure you can relate to this. And then I'd love to hear your thoughts about it. But, I was putting together a 510(k) submission for a company a few years back, and it was a start-up company, and I was doing a lot of things for them; quality system, regulatory, and that sort of thing. But, we had a company goal/objective to submit our 510(k) before the end of the year. And literally, I kid you not, on December the 31st, at about 6 PM, I was at the FedEx Kinkos office, there. I think the people were so gracious, they stayed a little bit later than they were scheduled. But I was there making all the copies, and getting all the pagination, and all the sorting, and all that organization squared away, and getting it ready to ship. We met the goal, but after I got it all organized, at the FedEx Kinkos, I had, there were no more drop-offs, or no more pick-ups for shipments that night. I had to drive about 15 miles to a little bit of a mini-hub, so to speak, to get the shipment out before the end of the year. I'm sure you're talking about the light bulb falling on your head. I'm sure you've got stories like that as well.

Juan Carlos Serna: And Jon, and I do. And I think most people who have done more than two 510(k) submissions have stories like that. That span over the last 15-20 years. The fundamental workflow hasn't changed in that amount of time. And that's why we started Right Submission. We knew that we could improve the way medical device technologies get cleared by creating software to facilitate that.

Jon Speer: Yeah. I'm sure... You talk about that light bulb falling on your head, what was the... 'cause I know for me, with Greenlight.guru, when we started that, the idea was, sometimes I don't like to share this with folks, because it's like, "Why didn't I do something about it sooner?" But the idea was stuck in my head for quite some time before we actually turned it into a company, and I suspect you probably have a similar sort of story.

Juan Carlos Serna: Sure, I think every time you work on a 510(k) submission, and you kind of scratch yourself and say, "Oh next time I'm gonna do [chuckle] something to make this faster and better. I'm gonna write a template, I'm gonna write some Macros in Word," whatever it is. And then, truth is, you never get around to doing that 'cause the next submission's right on the heels.

Jon Speer: Yeah.

Juan Carlos Serna: So, it's an accumulation of those pain points. And I think one thing that is worth pointing out is that both of our softwares were conceived and developed by people actually experiencing the pain points, right? I think that differentiates us from some of the other solutions out there that have historically been around, but maybe have not gotten that adoption, because they were developed by software companies trying to fill a need in the medical device industry, whereas our software were developed by medical device individuals using software tools available at the time.

Jon Speer: Yeah, really good point. For medical device professionals developed by medical device professionals, absolutely. Good point.

Juan Carlos Serna: Yeah. And, ultimately, when we can see that our first... We are working to... We are working on other products outside of the 510(k), but when we developed the 510(k) software we had some kind of specific pain points that we wanted to address. We wanted to make sure that people from around the world and different even cultures and languages as their... Even if English wasn't their primary language, could contribute in realtime to writing the submission. So that collaboration aspect of it. We wanted to make sure it was 100% visibility. We think sunshine is more than just a disinfectant. It's an accelerator. And when people know that there's a log of all your activity, you're gonna make sure you prioritize this 510(k) appropriately in your workstream. And the third aspect is we automate a lot of the process. We automate that... Truthfully, none of us like doing. None of us like hyperlinking PDF documents or creating tables of content.

Jon Speer: No.

Juan Carlos Serna: Or making sure that the tables are numbered sequentially and all those mind-numbing tasks are fully automated in our software so that we can spend our time doing the things that we enjoy, which is writing and thinking about the strategy behind the 510(k) Submission.

Jon Speer: Yeah, and I not just enjoy, but actually I always hated as an engineer, I felt like a paper-jockey sometimes. I just gotta... I felt like I had to push the pile paper from one location to the next and sometimes putting together a 510(k) can definitely feel like that. And it's like I'm a smart person, I have a great mind and I'm not using it to any real advantage here. I'm just figuring out how to put page numbers on a document in the right order and I was like "That's crazy!". And I'm guessing you've got... That's sort of what you're talking about here right?

Juan Carlos Serna: That's exactly right. And as... I used to be a consultant before I started Right Submission and, truthfully, I felt guilty about the amount of time and money that clients were paying me to hit "search" and "replace" on 14 different documents, 'cause they changed their mind about something.

Jon Speer: Yeah, so I guess let's get on with this. Tell us all about... I mean, in a few minutes, anyway. And, folks, Juan Carlos is gonna give us a little bit of an overview of what Right Submission is and a little bit of, I guess, a taste as much as you can from an audio presentation, what Right Submission is all about and, certainly, encourage you all to go to Right Submission. Again, that's rightsubmission.com and you can request demos and learn more information from their website as well, but tell us a little bit about what the Right Submission product is.

Juan Carlos Serna: Sure, so our high level or kind of our mission in life is to bring life-changing technologies to the market via smarter and faster regulatory submissions. We looked at the market, we realized that 510(k) submissions are probably the most in need of a software solution, so we started there. And our software solutions, you can look at it on our website, we have some demos available. And you log on, you get a username, you assign a project and you have the list of 20 some odd nodes of different sections that need to be populated. Each section we bring in all the FDA resources that are applicable to that section to you. If there's databases that need to be... That you need to interact with, like the product database or the product codes or the 510(k) predicate, we bring those into the software so you don't have to be distracted or navigate away from them. And we also have a concept of "answer once and only once". So for the most part, for example, your indications for "you" statement. You enter it once and the software automatically pushes it to all the different sections that it's required. That way you're guaranteed to have consistent indications for "you" statement, which is, by the way, the fifth leading reason why that 34% number exists.

Jon Speer: That's crazy to think about, but it's true. The indications for "you"s... Finds its way, I forget the count off the top of my head. You probably know exactly, but it's at least in five different places in a 510(k). And the standard... The old tactic that people are using is you do a copy-paste, but... And sometimes it's kinda, to paint a picture a little bit more about this that, kinda the the old way of doing this is you kinda, sometimes you divide conquer you'll split a 510(k) up, but there is this point where somebody says "You know, we really need to change that indication for "you"s", and it gets changed in one section, but it doesn't always find its way in those other four, five, six places where it's located. What you're saying is within Right Submission product, you enter that data element one time and it puts it everywhere where it needs to.

Juan Carlos Serna: That's exactly right. Another aspect is that it... The end product is a PDF that's ready to go right to FDA. It's named according to the naming convention, it passes FDA electronic submission screening process and you don't have to do... It used to take maybe a week, maybe two weeks where a publishing group, if you had one, if you're lucky to have one or for the DYI couple of nights just sit there and make sure everything was working.

Jon Speer: Yeah. Oh, yeah.

Juan Carlos Serna: That now you hit export and it takes maybe two minutes to compile all the different sections into one PDF that's ready to go.

Jon Speer: That's amazing. And that... That goes back to my December 31st story from a few years back. I was literally there all... The entire day, and that was the last step. It did not count all the time that I spent formatting and getting everything's ready. Prior to that so just... I'm not even talking about the content of a 510(k), there's work that's involved there, but that's where I got to use my brain. I'm talking about just the formatting stuff, that takes so much time. It definitely could take 20, 30, 40 hours, sometimes more, just to get all the formatting right. And so, what I'm hearing you say is Right Submission does that automatically.

Juan Carlos Serna: It sure does. And a tip, a free tip for the listeners, FDA is now unofficially, but practically speaking, not requiring paper submissions of 510(k). You have to wordsmith your cover letter, and if you email me, I'll be happy to provide anyone the language that you should put in your cover letter. But nowadays you can submit your cover letter, your cover sheet, and the CD, and you're done. Kinkos... You only have to go to Kinkos to burn the CD if you don't have a burner.

Jon Speer: And folks, that's a big deal too, because historically putting together a 510(k), you send them the big giant pile of paper in addition to the e-copying. So, knowing that there's a way to eliminate the need for that paper version, that's huge. Not only are you saving time, but, if you care about the environment, you're not printing out all that paper, so that's pretty awesome too. That's cool, very cool.

Juan Carlos Serna: And ultimately, our clients are happy. I think our best example is we did a submission, we alongside with the company in 10 days from start to finish, and went right through the RTA process, no issues, it got cleared in 54 days. And that... It just, would not have been possible without the software.

Jon Speer: Wow! No. No, not at all. And, I had a chance to talk to Juan Carlos, prior to today's conversation. And one of the things that you should know about their approach with Right Submission is they've been I think partners or at least collaborators with FDA specifically on their product and their process. And I don't know if you can speak at all to the reaction from the few folks that you've interacted with from the FDA or not, but if you can share that, that'd be really great to hear too.

Juan Carlos Serna: Sure. Yeah, to be clear, FDA cannot pick winners and losers, but we have interacted with FDA. We showed them an early version of the product to the device division and there was probably about, six or seven people down in... At the FDA office. And they were extremely enthusiastic and encouraging with us. They feel the pain. Imagine if you're a reviewer and you get, 34% of the submissions you get are administratively incomplete, that you can't even start you review. That's extremely frustrating and a loss of good resources. The more consistent and well-written submissions are, the easier it is for them to review and to quickly get to a determination. It obviously doesn't mean they're gonna clear it just 'cause it's formatted correctly, but at least they can give you an answer and feedback that much sooner.

Juan Carlos Serna: They've also, we've also done some work with Mathematic and FDA, where they have shown us their smart review template, which is the software that FDA uses internally, to review the 510(k). So, they have a 510(k) on one screen of the PDF document and then they have their software on the other screen. So we're working through understanding that workflow, to make it even easier, so that our output directly matches their reviewer template.

Jon Speer: Very cool. Well, Juan Carlos, anything else that you think is worth sharing with our audience on next generation tactics before we wrap up today's conversation?

Juan Carlos Serna: I think in closing, I would just encourage the listeners to... It could be daunting, it could be daunting to change the whole culture of your organization, or old habits, but if you just start with a few things at a time, you look back at the end of the year, you're gonna wonder "Jeez, how... Why did we do that, so archaically, for so long?"

Jon Speer: Yeah, that's a... That's such a great point. And Right Submission is here and Greenlight.guru are here for... Well, ultimately we're trying to improve the quality of life. We're trying to help get products to market faster. And the other ways that both Right Submission and Greenlight.guru improves the quality of life is to streamline workflows and improve efficiencies within medical device companies. Let's get you back to using your big old brain to be engineers or regulatory professionals, rather than those paper jockeys that are trying to format and push paper from one location to the next. If you wanna learn more about Right Submission, I encourage you to go to rightsubmission.com. There's some videos there, there's some additional content that you can check out. It's really a great site, and of course there's an opportunity to learn more about how Right Submission can work.

Jon Speer: And if you wanna learn how to improve your design control process and your risk management process and your quality management system, I would also encourage you to go over to www.greenlight.guru and learn more information there. And if you like what you see in either case, there's an opportunity to request a demo, there's an opportunity to request more information and learn more about how both Right Submission and Greenlight.guru are here to help you get your product to the market faster with less risk. So I wanna thank my guest today, Juan Carlos Serna from Right Submission, and this is Jon Speer your host, the founder and VP of Quality and Regulatory at greenlight.guru.


About The Global 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.

Jon Speer is a medical device expert with over 20 years of 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.

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