podcast_allison komiyama

Do you work with regulatory consultants to implement a quality system or 510(k), or perform other tasks? Are you asking your consultants the right questions?

On today’s episode, Jon Speer talks to Allison Komiyama of AcKnowledge Regulatory Strategies about tips, pointers, and key questions to consider before hiring consultants to help you with quality and regulatory work.

Many companies ask the wrong questions. Allison offers them the right questions to ask multiple consultants to find the best fit.

 

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SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:

● Example of what not to ask: Have you done a submission for this exact type of device? Instead, ask: How many submissions have you worked on recently?

● Ask questions about familiarity and price - pay more to get the job done correctly and through FDA faster.

● You need to like the person you’re dealing with; be comfortable with your consultant because they will be your coach and extension of your team.

● Collaborate with other consultants to fill knowledge gap, don’t view them necessarily as competition.

● Familiarity with current FDA and other regulatory best practices and expectations tends to be more important than being familiar with a specific type of device.

● Avoid consulting experiences gone bad. Lots of experience does not equal the right type of experience you need for your product. Review their references.

● For quality systems, don’t focus on how much it costs. Instead, does the consultant build a sustainable system that scales, grows, and meets needs?

● A quality system and design controls do not need to be painful; should be designed to avoid gaps and prevent mistakes.

 

LINKS:

Acknowledge Regulatory Strategies

Medical Devices - FDA

FDA Device Advice

PMA Approvals

Greenlight Guru

 

QUOTES:

“While the 510(k) process has been around for a long time, the regulations change weekly sometimes.”

“Of course you want to pay more, if you know the job is going to get done correctly and get through FDA faster.”

“Being comfortable with your consultant - you have to like the person you’re dealing with.”


Transcription:

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: How many of you are working with quality and regulatory consultants? Are you asking your consultants the right questions before you hire them to do work for you, whether that be implement a quality system or put together a 510(k)? Well, you're gonna hear from a couple of pros, myself included, on this episode of the Global Medical Device Podcast, where I talk to Allison Komiyama. Allison's with AcKnowledge Regulatory Strategies. She's been doing this a long time as well and does a lot of consulting. She and I talk a little bit about some of the tips and pointers and key questions that you should consider before hiring consultants to help you with quality and regulatory work.

Jon Speer: Hello, and welcome to the Global Medical Device Podcast. Last time I got to talk with our guest today we had a great time. I'm just gonna confess, every time I talk with Allison Komiyama from Acknowledge Regulatory Strategies, that she and I just... We find ourselves laughing. And folks, I guess that's good, because you get a quality person and a regulatory person who are having a good time with what we're doing. And Allison, welcome to the Global Medical Device Podcast.

Allison Komiyama: Thanks, Jon. Thanks for having me back.

Jon Speer: Well, you threw out this idea recently and I think it's a good one. What questions should I, as a medical device company, be asking when I'm looking for a consultant? And it's really insightful and I think it's important too, because there's a lot of important aspects to that. I know you have some initial ideas about what you had in mind when you threw that idea out. So, what are you thinking about this?

Allison Komiyama: Sure, and I guess it was... The past two weeks, I've had many calls. I think everyone's all of a sudden coming to... I don't know. Was there a big milestone that people hit in funding, fundraising that just happened? 'Cause I feel like all of a sudden people are looking for regulatory consulting. [chuckle]

Jon Speer: Yeah.

Allison Komiyama: And that's what brought that topic to the forefront of my mind. I just feel like I deal with a lot of small start-ups and a lot of medical device companies that are shopping around for regulatory consultants. I'd love to hear your opinion too about the quality side of things, because I sometimes feel like they're asking the wrong questions. And so, part of my job in that half an hour to an hour free conversation, consulting hour that I give, is just to talk about, "Hey, don't just stop here. I'd love for you to use me as your regulatory person, but I encourage you to go out and talk to two, three, four more people."

Jon Speer: Right.

Allison Komiyama: "Get their opinion on your device. I might not be the right fit, and ask the right questions." And so I try and supply them with some questions that they can take and use for other consultants and figure out, where is the right consultant for me?

Jon Speer: Yeah. You said sometimes you get asked questions and you're like, "Dude, you're not even asking the right question." So does something jump to the top of your mind as an example of a question that may not be the right question?

Allison Komiyama: Especially for FDA regulatory submissions, I think one of the questions I get is, that I just don't think is really the right one to ask or start with is, Have you done a submission for this exact type of device? Because I do think, some companies will find our consulting company going through the FDA database and finding, looking at the predicates, looking at their competitors and saying, "Oh, hey, Allison, or somebody over at Acknowledge Regulatory Strategies did a 510(k) for this, our predicate. So let's call her up."

Allison Komiyama: And well, that's a great idea. It's like, okay, yeah. Clearly, we have familiarity in that product device type. The issue with that is, that's not always the right fit, still. I think the question to ask is, "How many submissions have you worked on recently?" Because I do think the regulations change. While the 510(k) process has been around for a long time, the regulations change weekly sometimes, right? FDA keeps... Evolving, right?

Jon Speer: Their interpretation like sort of the... Yeah, right, right.

Allison Komiyama: Exactly. One time I even gave a small company that called us up, I said, "Hey, I don't think I'm actually the right fit for you. Here are three other consultants just based on the type of device you have that I think would be a better fit, because I know they do a lot of submissions that might include the type of testing that you're looking at doing." So I think asking, How familiar are you with the type of submission that we're going to need? Of course, price isn't important, but I don't think that should be the only thing. Of course, you wanna pay more if you know that the job's gonna get done correctly and get through FDA faster, right?

Jon Speer: Yeah.

Allison Komiyama: Just understanding the comfort that your consultant has with those types of submissions. I think with that said, I think also just being comfortable with your consultant. You know, you have to like the person you're dealing with. [chuckle]

Jon Speer: Oh, for sure.

Allison Komiyama: I sometimes feel like companies will come to me and say, "Hey, we had a consultant and they fought us, they pushed us and had us do these things that we didn't really feel comfortable doing and now we've gotten this horrible NSE letter from FDA. Can you help us? We think part of the issue might have been the consultant." And so, I always question what went down, what happened, but at the same time, you have to feel, have a good rapport with your consultants and know that they're gonna be a good liaison for you with the agency, and also that they're just gonna be a coach for you, as well.

Jon Speer: No, those are really good points. Folks, when you bring a consultant on board, the consultant should... You should view them as an extension of your team. At least in my experience, I consulted for 10 years before starting Greenlight, and I never liked the word consultant personally, because I think it has a lot of negative connotations, has a lot of baggage. The classic view of a consultant is somebody who's gonna come into your business, and they're gonna try to stay as long as they can, and you're gonna be a source of revenue or income for them for as long as possible. And if your consultant isn't adding value to the thing that you're doing, then it's probably not a real good fit. They're part of your team and they need to feel like part of your team, they shouldn't feel like an expense that you have to incur because you've signed a long-term contract with them.

Allison Komiyama: That's very well said, yeah. You wanna have them feel like they're part of your team, they care about your device, they care about what you're trying to do, and the goals of your company and your mission statements. So, I'm always curious to find out like, "Okay, what are you trying to do? What's your long goals for this company, for this device?" I also like to always understand the back story of the device. Oftentimes, for a lot of these companies that have a... You know, they might be a small start-up, or that have one product that they are... It's a team of three or four people. This is sometimes their PhD project, right? This is sometimes their baby, that they're trying to get to FDA. If I'm gonna hold your baby, I'm gonna take care of it, I'm not gonna... [chuckle] I don't want someone who'll be throwing the kid around.

Allison Komiyama: And I think consultants, especially in the regulatory field, I don't know, I think it's such a cool space to be in because I find consultants are very collaborative. I've worked with other regulatory consultants. Sometimes there will be two or three of us on a file and we all have very different personalities. But the collaboration between the regulatory consultants has been, I don't know, it's unparalleled. I just feel like there's not so much competition in this field. Maybe it's because there's a lot of demand for consultants. You don't wanna hire someone for $175,000 a year to be your regulatory person if you know maybe all you have to do is get this through FDA and then your regulatory person might not be 24/7, like we are sometimes.

Jon Speer: Right.

Allison Komiyama: So, I think making sure that your regulatory consultant plays well with everyone at your company, but also plays well with your other consultants. I work with you guys, I work with some of the quality consultants that you guys work with, and I find that if there's a collaborative energy between all of us, it really helps the device get to market faster.

Jon Speer: I totally agree. And I like what you said about the company that you consult with, understanding what the big picture is, what it is that they're actually trying to do. And if the company says, "Well, we're trying to get a 510(k) cleared." Okay, that's a tactic that they're trying to do, that's a specific set of activities, but there's gotta be a bigger picture beyond just getting 510(k) clearance. Hopefully. I know this sounds silly to say, but hopefully what they're trying to do is improve quality of life in some way, shape, or form since they are designing and developing and eventually planning to manufacture and sell the medical device.

Allison Komiyama: Exactly.

Jon Speer: Yeah. But you said another key thing; the collaboration. Like I said, the consultant that you bring on your team, they are a team member. Sometimes they're a player coach so to speak, sometimes you bring in expertise to fill a gap in knowledge that maybe you and the other people at your company don't have. And I think there are some important things that you as a medical device company hiring a consultant should be doing to properly vet that. And you've hinted at a few of them. Familiarity with the device phase from a regulatory perspective is pretty important, but maybe more important, and correct me if I'm wrong, is familiarity with current FDA and other regulatory body best practices and expectations. That's probably more important than being familiar with a specific type of device or technology. Can you talk a little bit about that?

Allison Komiyama: Yeah, absolutely. I think if you looked at the guidance documents that have been recently coming out from FDA, they've had a big push in the past four or five years, and I think this has a lot to do with the user fee or the MDUFA goals that they're pushing forward with is. They really are trying to make sure that FDA guidance is getting to industry and also to FDA reviewers and to the medical device manufacturers themselves faster, so we all can be on the same page and understand what the expectations are for these files or for specific devices. They do have device-specific guidance. And I think with that understanding what's changing, and really we get in our inboxes everyday, their new guidance documents.

Allison Komiyama: Actually, we've instituted a journal club and it speaks to my days in graduate school where we sit around and we talk about an interesting journal article that comes out. We do guidance journal club and so every guidance that comes out, we sit around, everyone reads it beforehand, we come with questions and we talk about the guidance documents, because I feel like that helps internally at the company here, we understand how that's going to impact our clients. So understanding not only what's changing with the regulations, because those take a little longer to actually change, but to understand the guidance and how FDA is interpreting the regulations is critical to understand, to really give that consulting or that knowledge to our clients.

Jon Speer: I knew that you liked to have a good time, but I had no idea that you sat around and read the guidance documents for fun.

Jon Speer: But it's a really good point, folks, because I'm subscribed to all the email updates from FDA and I know Allison is too. Every time there's a new guidance document, and in the past couple weeks there have been a ton.

Allison Komiyama: A ton, yeah.

Jon Speer: A ton. And so, that's my job, that's Allison's job to be up to speed with state of the art and current thinking. I know some of you out there are thinking, "Yeah, but it's a guidance document. It's not regulation." Okay, let me paint a picture for you. Yeah, theoretically, you are correct. The regulation is the "law" but the guidance, some people are like, "Oh, it's optional." Okay, it represents the current interpretation of the law from the agency. So, it's not really optional, just keep that in mind. It is an accepted best practice that folks of the FDA and oftentimes folks in the industry have collaborated on to define these guidances, these best practices, these expected behaviors, so they're not really optional.

Allison Komiyama: Yeah. And I would even say the draft guidances, sometimes they... We'll find a draft guidance from 2010. [laughter] It's like, "Hey, like why is this still on draft format?"

Jon Speer: Yeah.

Allison Komiyama: But FDA reviewers will still use it, which is great for us. I feel like even if there's draft, if there's something out there that we can understand better how the agency is thinking about things, it really can benefit our process. So, yeah, I think staying up to date with those and understanding how FDA is interpreting the regulations is very valuable.

Jon Speer: Yeah. In my world, I sometimes hear stories. Sometimes I am the recipient of the story, about... And you've had it as well, you mentioned a couple even today, but the consulting experience gone bad. Folks, I assure you, there are people out here in the quality and regulatory space, they provide fantastic consulting services, that our interest is to help you learn what you need to learn, to help ensure that your company has the necessary processes and procedures and documentation placed, and ultimately, to help you get your product to market and ideally make sure that that product is as safe and effective as it can possibly be.

Jon Speer: But I hear stories about, "Oh, I worked with this guy or this girl, and I originally hired that person because they said they have 29 years of experience." And I'm like, "Well, what else did you ask?" They're like, "Well, they've been doing it for 29 years." I mean, like, "Okay, you gotta dig below the surface. You can't just stop there, you have to understand... " Alright, number one, were any of those 29 years of experience, did they pertain anything that you need them to do? Just because they've been in the industry and they've been around for a while doesn't automatically make them a good candidate.

Allison Komiyama: No, absolutely. I think even when you're looking at contract manufacturers, it's important to know, are they comfortable with medical devices? [chuckle] There are a lot of contract manufacturers that are breaking into this space, which is fabulous. I think it's been good to have the breaths of different types of manufacturers out there because, again, you wanna shop around and find the right one for you. But just because you have a ton of experience or many many years of experience, make sure it's the right type of experience for your company.

Jon Speer: Yeah. And check references.

Allison Komiyama: Yeah.

Jon Speer: Every consultant, every contract manufacturer. Do your homework. There are review sites that are out there, that you can find... For some of the larger firms and larger organizations, but even with that, every consultant should have a body of knowledge, a list of customers that they're willing to provide to you upon request as a reference. And make sure that when you get that reference that you wanna... You're trying to compare the customer reference. Ideally, you want them to be as close to apples and apples, as what you're wanting from this particular consulting resource.

Jon Speer: And if not, try to find another customer reference that can match similar circumstances that you're in. But really get your finger on the pulse, really try to understand who this person is, because you're gonna spend a decent amount of money with them, they're going to be doing things for your business that are gonna be put in front of FDA and the worst possible outcome, specifically for things like submissions is, is you get that NSE letter and you gotta start all the way over, that's no fun. I know you're gonna help this company out that got the NSE letter, but oh my goodness, consultants don't like to do that. Whenever I get called to pick up a flaming dog turd from something else that went bad, it's not fun.

Allison Komiyama: Yeah. Absolutely.

Jon Speer: Alright. So I've hit you with a couple of things. What questions do you have for me from more of the quality side of things?

Allison Komiyama: I'm very honest when people come to me and say, "Well, can you also do our quality system for us?" That was a service that we used to provide, and honestly, we just weren't doing enough of them. We weren't implementing enough quality systems that I didn't feel comfortable saying, "Alright, yeah, sure, we can do that for you." [chuckle] Because I think their needs are better met by someone who does quality systems day in and day out. One of the things that I do recommend is that they talk to, again, multiple consultants. Try and find the right fit. But I'm curious for you, Jon, what did you find for the quality system side, I know there's different questions that should be asked. What are the questions that medical device manufacturers should be asking either to the quality consultant or also quality software, 'cause I know that there are programs that people can choose from?

Jon Speer: Sure.

Allison Komiyama: What should they be asking just to get the right answers?

Jon Speer: Yeah, I love the question. I think a lot of times people, similar to you, I think they're asking the wrong question. The question that I seem to get asked the most is, "How much does it cost?" when they're looking at, for example, evaluating Greenlight. 'Cause sometimes, Greenlight Guru EQMS software and the support services that we provide is being compared side by side with a consultant. And oftentimes, the dollar amount difference between the two is not dramatically different, they're same order of magnitude a lot of times. And so my recommendation to companies that are evaluating on a consultant to help build and establish a quality management system versus hiring Greenlight Guru and implementing the EQMS platform that we've built, at the end of the day, when the consultant has finished implementing the quality system, the procedures, forms, templates and that sort of thing, what format is it in? And did they build a system to check a box? Or did they build a system that could be sustainable and that can grow with you as a business?

Jon Speer: It's a little bit tough, and this might be a somewhat controversial response, but if you're working with a consultant that is only interested in getting a paycheck, that's only interested in checking the box, that's only interested in helping you get ISO certification and not interested in helping teach you what you need to know for your quality system to be managed and maintained by you and your executive team, they're doing you a disservice. Yes, they may accomplish that initial objective to get that certification or get through this audit or inspection or whatever the case may be, but quality is something that the top management and every medical device company needs to embrace, they need to be knowledgeable and have a working competency when it comes to quality management systems. Because not just procedures, it really should be a way of life within a company.

Jon Speer: And to your point earlier as well, at Greenlight, we have a whole host of partners that we work with. Some of the companies we work with, they're just looking for a solution, they've got the in-house expertise. Other times, they want, excuse the expression, a little bit more hand-holding through the process. And sometimes the Greenlight Guru team can help do some of that hand-holding, sometimes they need a lot more hand-holding than we're equipped for internally, so we'll partner with a quality system consultant, there are plenty of people in that regard. I think it's really about making sure that the source or the solution that you choose is gonna be there for you and grow with you as a company, not just check a box. That's really the first thing that I think is really important.

Allison Komiyama: Yeah, that's very interesting, 'cause I've done some quality audits of companies and what I found, one of the hardest things for small medical device manufacturers, in particular, is that they would end up with this quality system that was massive, and it was like, "Who did you use?" It was like this one size fits all quality system, but it was built for a company that had 500 products, but they only had one thing, it was like, "Oh, my gosh. The amount of burden that that consultant has put on your company." And it's hard to back out of that, right?

Jon Speer: Yeah.

Allison Komiyama: At least, that's my understanding, I was like, "Oh, my gosh, to try and get rid of some of this burden is way more... It's gonna take you a lot more time than you had expected." And that's been hard for me looking at, "Here are the documents I need, but it takes five change orders, and an act of God for something to come through and be updated in the quality system."

Jon Speer: Yeah. And that kinda reminds me of another common thing that I've come across throughout my career, and I'm not saying these are... These are good people, don't mishear me, but sometimes when I hear a start-up, they're like, "Oh, I heard this consultant that's gonna help build my quality system. And the person worked for Medtronic or J&J or Boston Scientific, they've worked for them for 29 years." I keep going back to 29. I don't know what the number 29 means, but...

Allison Komiyama: Well, those are all great companies, right? It's like, "Yeah, that's great, but... " [laughter]

Jon Speer: Yeah, I mean probably knows their stuff, probably knows the regulations inside and out. However, have any of those people ever built a quality management system for a three-person start-up?

Allison Komiyama: Yeah.

Jon Speer: Because there's a difference. And to your point, if they bring the Medtronic way of doing things to your three-person start-up, every document that you implement is gonna require five different change orders or this burden that really is not gonna fit your business. It's gonna cripple your business, it's going to stifle certainly productivity, it's gonna create a lot of red tape, a lot of bureaucracy. And I think that sometimes this is what people don't like quality systems, this is why they don't like regulations, not because of regulations are bad, but because their particular experience with respect to how it was implemented within their company wasn't right-sized for that company.

Allison Komiyama: Yeah, perfectly said. I agree.

Jon Speer: I was gonna say the other part that you asked me on. Sometimes Greenlight is compared against other software tools that are out there, and I guess just buyer beware, that a lot of the options that are in front of you, I mean, you can go the low-cost, low barrier to entry price point. There's certainly some options there that are available. You can also spend a little bit more, but the key thing that you'll need to factor in is; how much time are you going to have to spend customizing and configuring that software tool to meet your needs? If you're willing to spend the six, nine, sometimes 12 months to customize and configure that software to meet your needs, do you have the expertise that you need to do it? If you have that expertise, if you're spending that much time, effort and energy, customizing and configuring a software tool, what is not getting done? Is your product submission gonna be delayed?

Jon Speer: So those are three questions that I think are really important for people to get a firm understanding of that, and that's one of the things that I do think makes us different at Greenlight is, we're ready out-of-the-box, there's no customization, no configuration required. We have different packages available where we can augment your in-house knowledge on quality. If you need something more than we're providing, again, we're working with different partners. If you need regulatory resources we're gonna give Allison and AcKnowledge Regulatory Strategies a ring and get you in touch with her and her team as well. So it's really trying to build a system that's right-sized but can scale and grow.

Allison Komiyama: Yeah. And I think you guys provide... What I love is the wealth of information that you guys have for free on your website. I check in just to see what new blogs that you've put up and they've been very valuable for my customers as well, which is awesome.

Jon Speer: Oh, that's good to hear. Good to hear.

Allison Komiyama: Yeah. I think you brought up a funny point, something that made me think of a funny story about... Their first question is often like, "How much is this gonna cost me?" And that's a fair question, right? Like everyone wants to know, how long is this gonna take and how much is it gonna cost me? And I remember a potential client that came and said, "Hey, listen, I found a consultant that can do it for a third of what you're saying you can do it for." And I said, "Oh, my gosh, go with them. If you really feel like they can do the job and you really like that consultant, choose them, sign that consulting agreement." Because I can't, I can't work for that price, but I hope it's the right fit for you. I wasn't being rude at all. I was just thinking, "That's really great and let me know if you need help, but otherwise go for it."

Jon Speer: Yeah.

Allison Komiyama: I just wonder, for some of the work you gotta make sure that you're getting the quality work that you deserve for your product, right? It's like, again, if this is your baby, make sure that you're vetting multiple consultants and figuring out who's the right fit for me. They might not be necessarily the cheapest. They might be the $900 an hour consultant, but if you feel comfortable with them, then spend the money to get the work done right and right the first time.

Jon Speer: Yeah. I think that's important. Sometimes the cheapest solution seems attractive. But again, buyer beware a little bit, because the low cost option isn't always the best option, because what's hidden in, sometimes not always, but oftentimes, what's hidden in that low cost option is, it may take that person a tour or that choice that you make, it may take you three or four times longer with that option. And so pretty soon, even though it seemed like it was gonna be less expensive in the beginning, it becomes the most expensive choice that you could have made, rather than going with... Value is the toughest thing to measure. In my world and Allison's world, demonstrating that value, demonstrating that return on investment is a tricky thing. We all say, "We're gonna help you get your product to market faster." But how are you ever gonna measure that, you know?

Allison Komiyama: Yeah.

Jon Speer: 'Cause we're dealing with uncertainties like FDA sometimes.

Allison Komiyama: Yeah.

Jon Speer: But it really comes down to, you just gotta do your homework.

Allison Komiyama: Yeah. Another question for you, 'cause I get this a lot when I ask a company, "Hey, how's your quality system?" "Have you been working on your design controls?" And they say, "Oh, yeah, we have everything in Excel, and we're just gonna do that forever."

Jon Speer: Oh, my gosh.

Allison Komiyama: How do you respond to that when a potential customer says that to you?

Jon Speer: Well, I lived that dream for... Gosh, probably 15 years of my career before starting Greenlight, where... I go back to the story. I was like 20, I think I was 23, first job out of school, product development engineer, and I was working on some sort of central venous catheter device. And I was project manager, and it was the first project as project manager that was under my watch, that was gonna be submitted as a 510(k). This is back in the late '90s, so I've dated myself a little bit, but we didn't... Traceability matrix wasn't a... That wasn't, it was very uncommon, let's just say. It wasn't an expected best practice then. We've had file cabinets with drawers and binders. Yeah, we typed Word documents and Excel documents and things like that, but everything found its way into a paper format and into a binder. And I just had this feeling or this idea, it was my first 510(k), I wanted to make sure everything was good. And so, I thought I invented a traceability matrix. [chuckle] And so I lined up my user needs and inputs and outputs, all my design controls, to make sure everything was... There were no gaps basically. And this was a week before the 510(k) submission, so pretty late in the process. We were putting together all the different sections of the 510(k), and I had discovered a huge gap, and you'll appreciate this from your background.

Jon Speer: We had forgotten, or rather I had forgotten to do a particular biocompatibility test, I think it was sensitization or something like that, I don't remember the exact test but it was missing. And dollars for doughnuts, that was gonna be expected from FDA. You don't submit a 510(k) for a central venous catheter and have missing biocompatibility evidence. So I had to go tell my boss that I had forgotten it, and that it was gonna be an eight-week test and it was gonna cost like $15,000 and here we were a week away. So not the kind of news that you wanna deliver at any age, especially on your first project that's gonna be submitted as a 510(k). But teams try to manage this on Excel and it's unwieldy, it really is. If you've ever done it in Excel before, you do it because you have to, not because you like to. You do it because you're trying to make sure you don't have stories like what I just shared where there's a gap.

Jon Speer: And I've talked to so many project managers over the past 20 years. They're spending 10, 15 hours a week on a per project basis keeping this Excel traceability matrix up to date with the current state of things, 'cause things are very dynamic, especially when you're iterating and prototyping and doing bench testing, that sorts of thing. Keeping your Excel's spreadsheet up to date with all those permeations, it's a nightmare. Engineers and project managers, like I said, they've accept it as the pain that comes with the job. But it doesn't have to be painful.

Allison Komiyama: It doesn't have to be painful. I think that should be you guys' new tagline.

Jon Speer: For that exact scenario, that's what motivated me to start Greenlight.

Allison Komiyama: Yes, but what happened? Did you get fired? What was it? No.

Jon Speer: No, I didn't get fired. I interrupted my boss at lunch, he was reading a book. I don't know if it was a warm piece but it was a thick book. He slammed it shut. I'm joking a little bit. A book is a thing that has pages so I know that maybe... I don't think my kids know what a book is these days, even their coursework is on a computer. But anyway, he slammed the book shut, it was loud, and I swear, he reached his arm back, like he was getting ready to throw it at me, now he did not throw it at me, but he was pretty pissed. Let's just say I didn't make that mistake ever again. I went into Excel hell on every project thereafter and made sure that I didn't forget anything. But again, the amount of time that I was spending updating Excel spreadsheets all time like, "Wait a minute, I'm a smart person, I have an engineering degree for God's sake. Why am I spending all this time just updating Excel? I got a big brain that I'm capable of doing so much more than just updating spreadsheets." That's what motivated me to start Greenlight, and that's the first product that we rolled out five years ago was about addressing design controls in a much more simple manner that didn't require updating Excel.

Allison Komiyama: That's cool. This is your origin story. I did not know that.

Jon Speer: Yeah, a little bit of the origin story, yeah.

Allison Komiyama: Were you 29? Just kidding. That seems to be the magic number.

Jon Speer: No, I wasn't 29, but there must have been something important that happened at 29. So what about you? You get to deal with probably not so much Excel, but I imagine you get to deal with a whole variety of things. What are some of the best practices that you would advise people as they're working with a regulatory consultant to put together pre-subs and 510(k) s of that nature? Any hot tips that you can share with the audience?

Allison Komiyama: A lot of the documentation we use is straight from their quality system. For the device description or for the substantial equivalence chart, a lot of the documentation that they've already put together with, who are the competitors, what are the user needs. Some of those things are very valuable when we go to put together a pre-submission or your 510(k) or your PMA, so it's having that information and working with your consultant to get the information that they're asking for. It makes our jobs a lot easier when you have some clean documentation on your side. [chuckle]

Jon Speer: For sure, for sure. And folks, I think one of the things I just heard Allison say, correct me if I'm wrong, but she's working from documents that are in your quality system, so that implies that you have one. [chuckle] And this is something that it kinda irks me if I'm being honest, I'll talk to a company and they're like, "Well, what you have at Greenlight is cool, and yeah, I get the design control work flow that you have, and risk and all that sort of thing. But we haven't really started formally documenting that yet. We're keeping some good lab notebooks, and the next milestone that we're focused on is our 510(k) submission, and we'll get to the design history file on the design controls after we do our 510(k)." And it just drives me crazy, so I don't know if that drives you crazy or not, but it really does irk me, so do you have any thoughts about that?

Allison Komiyama: Yeah, no, there are a number of companies that are like, "510(k)'s our first milestone, and then we're gonna put our design controls and our design history file together." And it's like, "Oh, okay, that's terrifying." I don't wanna say there's nothing wrong with it, I think the FDA's not gonna come knocking on your door until you've registered and listed your device, and that comes after you have a device that's cleared or granted, if you have a De Novo or approved, if you have a PMA, but at the same time... Or actually, take that back. PMA, they are gonna come inspect you before you get approval. But to have a working quality system, or even just the start of one that you've started to put together at least, at least with your design controls, can really help you once you get that clearance to go market the next day. You could really turn things around and have everything ready to go, and I think you do yourself a disservice by not even thinking about your quality system before your FDA submission time.

Jon Speer: Yeah. And I think the part that irks me about it is, I've seen it too many times, and hear me out, I've made plenty of money fixing problems of companies that didn't do it, because a lot of times when the company says, "Oh, we'll get to the design controls and we'll update this and we'll do that after we do our submission," sometimes they don't do it, and they just let it go 'cause they move on to the next project or the next hot thing that's on their plate. The best time to document all of your design control activities is while they're happening, not after the fact. That's the whole premise behind design controls is to be iterative with you, to be a tool for you to collaborate with your product development project team.

Jon Speer: Like I said, I've been called in many times over the years, company had an FDA inspection, and if you get a 510(k) device that is your first device, eventually you will have an inspection. You may not believe me, you may not believe Allison, but it will happen. And if it's your first product, of course on that inspection they are going to evaluate your quality management system. You don't have to believe me, you can wait and see, but they are also gonna look at your design history file. And if you don't have one, that's gonna be a significant red flag, most definitely a 483, could even escalate above and beyond that. And like I said, I've been called many times from companies in that situation, and they need to remediate and retrospectively document design control activities, and that's not fun. It's not a fun activity as a consultant, and as a company I hope that you don't put yourself in that position.

Allison Komiyama: Yeah. I don't know about you, but my memory, I take notes for any phone call because I sometimes can't remember some of the stuff that I talked on the phone about yesterday. Tomorrow, I might not remember this call, sorry Jon.

Jon Speer: I know. That's okay, we'll record it and it will be available for you to listen to anytime you want.

Allison Komiyama: Remind myself. That's the crazy thing is trying to retrospectively put together a design history file, like, "Oh, when was that conversation that we talked about that design or that user need, and then we... Oh, when was that?" It's like, "Oh, my gosh, I'm not gonna remember any of that stuff." You know what I'm saying?

Jon Speer: There's one of the design control clauses, design and development planning, how in the world can you plan something after it's already happened? I guess, your planning should be very good at that point, but anyway, any other thoughts that you wanna share about questions or things that people should consider before they bring on a consultant?

Allison Komiyama: I think as long as the consultant is comfortable with how you wanna do things. I know there are a lot of consultants that say, "Hey, listen, all we expect from you is you give us everything and we're gonna do your file for you. And there's gonna be minimal interaction with us." And I think for a lot of the small start-up companies I work with, I encourage them to be very involved with their file. I say, "We're happy to do the heavy lifting. If you want us to do the whole file, we'll do it for you." But I love it when people want to be involved in the process, because it actually gives them more insight into what FDA is caring about, why should they be involved in their quality system? Because it is going to help them understand what's important.

Allison Komiyama: So I think having a company involved with either, if they wanna be involved in the writing process, to have them do a lot of the editing and to review the file as we go along, I find that to be very rewarding for a lot of the companies. Again, some companies are like, "We don't wanna even touch it, please just do it for us, submit it, and let us know how it goes." [chuckle] "Let us know of FDA's questions and we'll get you the documents you need." But for a lot of companies, and I find it happening more and more is, again, this is their baby, they wanna work together on getting it into college. [laughter]

Jon Speer: Well, I think it's a good tip whether it's a regulatory submission or a quality system or design controls and design history file or risk management. You as a medical device company, it is in your best interest to be an active participant in that. Because like I said, you will be... And not that I should... I'm not trying to strike fear in your minds here, but do realize that you will have audits and inspections by suppliers, by customers, by regulatory agencies. And there's a good chance that Allison nor I will be there when that happens. So if you're relying on us to contain and retain that knowledge and we're not there when those types of events happen, it's gonna raise a lot of those red flags during those audit situation. So do yourself a favor and be an active participant.

Jon Speer: Well, Allison, like I said, I can't wait to do this again, and I don't know what we're gonna talk about, but I'm sure we'll have a good time. I wanna thank Allison Komiyama. Allison is with AcKnowledge Regulatory Strategies. You can learn more about her in her consulting practice on the beautiful Internet, acknowledge-rs.com. Allison, thank you so much.

Allison Komiyama: Jon, thank you.


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