podcast_matthew romey

In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with bringing many medical device projects to market over the years. He was also a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M.

Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups.

During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for.

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"Design controls are yes, required by law, but they also represent good business practices." - Matt Romey

Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.”

"The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer

One of the most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant.

Today’s highlights include:

  • Matt explains how good quality design control is just part of good business practices.

  • You will hear why the classic “waterfall diagram” may not be the best guideline for a project.

  • Why when you find design inputs, they need to be testable.

"Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey


Transcription:

Narrator:

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:

Hey, this is Jon Speer, Founder and VP of Quality and Regulatory at Greenlight.guru. Yeah, that's right, we've got another awesome podcast. This time we had Matt Romey. Matt is with Azzur Consulting, and he's a 20+ year veteran of the med device industry. Matt's been a part of a lot of start ups and he's worked for a lot of big companies, so there's a lot of things that he's seen throughout that 20+ year career. He's been very focused on design controls, he's had some experiences that frankly, if you're a start-up, you're going to want to talk to a guy like Matt.

 

 

Matt and I, in this podcast, we spend some time about design controls but we focus on the number one tip for capturing your design controls, and it has to do with the design inputs, so listen to this episode of the Global Medical Device Podcast and learn how important those design inputs are to the success or the failure of your project.

 

 

Hello, this is Jon Speer, the Founder and VP of Quality and Regulatory at Greenlight.guru, and welcome to this exciting episode of the Global Medical Device Podcast. Today I have another exciting guest. Yes, that's right, Greenlight.guru, we find the best in the world who are dealing with medical device issues and opportunities to help bring new, exciting products and technologies to patients all around the world. Today, I've got Matt Romey. Matt is a project manager at Azzur Consulting, focusing on providing quality, and engineering services to the medical device industry. Matt has over 20 years of hands-on experience in every stage of medical device product development, from technology research to development manufacturing, clinical trials, and product launch.

 

 

Matt is able to leverage his experience to guide his clients through the product development cycle. He is a strong proponent of design controls, having seen first hand how the degree to which companies are diligent in implementing design control methods can make or break a project. Before Azzur, Matt was the founding employee and member of the leadership team at GluMetrics, a start up company dedicated to the development and manufacture of a continuous glucose monitor intended for use in the ICU.

 

 

Before GluMetrics, Matt working in R&D in Terumo at 3M, developing and bringing to market monitoring devices intended for use during cardiovascular surgery. Azzur Consulting and Azzur Group Company is a GXP compliant and consulting organization dedicated to helping life science and medical device companies succeed. Their experienced staff specializes in manufacturing systems and equipment design, installations start-up, commissioning and verification qualification, computerized systems validation, and process validation. Azzur Consulting also offers GXP compliance and audit services related to regulatory inspection prep, and inspectional finding remediation, as well as general project management support.

 

 

Matt, after reading that, going through your background and Azzur Consulting, I'm thrilled to have you as a guest today, welcome to the Global Medical Device Podcast.

 

Matt Romey:

Thank you Jon, and thanks for having me.

 

Jon Speer:

Oh yeah, absolutely. The thrill is all mine. You and I have known each other, I don't remember when we first met, but I know we've talked quite a bit and collaborated on a few things here and there and I know there's one thing for sure, and that one thing that you and I share is a passion for design controls, and a passion for bringing new technologies to market.

 

Matt Romey:

Yeah, I agree. We have talked before about this extensively over the phone and I think we have similar philosophies. My adage has always been that design controls are yes, a regulatory requirement by law, but they also represent good business by implementing the best engineering practices.

 

Jon Speer:

Right, right. Going through your overview, the thing that stuck out to me going through that, is the degree in which companies are diligent in implementing design control methods can make or break a project.

 

Matt Romey:

Yes. At one company I had taped to my wall, a big blow-up of a line from the FDA guidance document for design controls. It went like this, it says, "It is a well established fact that the cost to correct design errors is lower when errors are detected early in the design and development process."

 

Jon Speer:

Yeah.

 

Matt Romey:

To me that really sums up why it's good business practice to implement design controls appropriately, because as we all know, time is money and the mistakes you make now can take lots of money to fix later. So it's better to find them early.

 

Jon Speer:

Yeah, I'm reminded of a rule. I don't know if this is exactly what the rule's called but in my head I always refer to it as the "One, ten, one hundred rule." That's where, if you fix something early in the design process it may cost you a dollar to fix, and then a little bit later in the process will be $10 to fix, and once you get into production, $100. I realize one, ten, one hundred probably isn't the right scale for a med device, but basically the adage or the rule is, as you get later and later in the process, the cost to address something goes up exponentially.

 

Matt Romey:

That's absolutely correct. A lot of times that is a result of having gone so far down the development process, that to change even one thing has ripple effects through every part of the project and the product. Finding things early can really help compartmentalize the remediations you have to do to get back on track.

 

Jon Speer:

I'm sure we all have war stories. When you've been doing this for as long as you, or as long as I have been doing a medical device product development, and sometimes we like to remember the successes, but sometimes the things that stick out the most to us are some of the times it didn't go so well. I'm sure you have a list of those, right Matt?

 

Matt Romey:

Yeah, I do. I could generalize, just let me do that.

 

Jon Speer:

Yeah, I'm not asking you to throw anybody under the bus by any stretch of the imagination. But yeah, a generalization. Keep in mind, our audience, they're hungry for tidbits and tips and pointers, and anything that they can do now that's going to make their life a little bit easier. I think when we talk about things like design control, it's really easy to think, "Oh, I'll get to that stuff later. I'm going to build a prototype now. Prototypes are fun, they're sexy, they're exciting. Creating documents for user needs and design input, that's boring. Why do I need to mess with that?" Right?

 

Matt Romey:

Exactly, and I know that there are a lot of engineers think it's just a bunch of paperwork, but I always think, if you get on a plane to fly somewhere, would you want to know that the engineer that designed that plane said, "This is just a bunch of paperwork." All the documentation you need to do to design the plane. No, what I want him to say is that they designed it correctly from the very beginning.

 

 

Going the way you said earlier, I think I want to touch on one aspect of, kind of a classic start-up company problem is, when do you start really implementing the design controls? 'Cause as we know, if you have an idea and you're really bootstrapping, of course you're going to end up in your garage or however it may be, inside a lab somewhere, creating a crude prototype before you start doing lots of design control activities.

 

 

It's to at least get some data to get money from your friends or family or wherever you can get it. So the question is, when do you start? And to what level? And when do you start ramping that up? It's a difficult question to answer. Do you have experience with that?

 

Jon Speer:

Yeah, I do, and I've got the experience from both the big company and the small company. I would say, regardless of size of company, there's this, I think it's a bit of a misnomer, but there's this conventional wisdom that seems to prevail. The conventional wisdom that I've observed is there's fear about creating design control documentation too early because it may become cumbersome, and I may need to change it, and I may need to update it, and so on. My reaction to that is, "Exactly" Exactly. That's the whole idea. The documentation, things you write down, are intended to be a way to communicate to your team what's happening and what you're doing.

 

Matt Romey:

Yeah. I agree. Another kind of problem that tends to happen is that you sometimes tend to move from, when you're in a start up mode, move from one investment milestone to the next.

 

Jon Speer:

Yes.

 

Matt Romey:

A lot of times the project plan and schedule are set according to the investment schedule, instead of the product development schedule. Right?

 

Jon Speer:

Yeah. Like, "Get your 5-10K now, and then worry about the design later." Right?

 

Matt Romey:

Yeah. Right. So, show me data. Well then you have now poor review of design inputs, you sometimes jump straight to quote unquote, validation, with a prototype device, which for some things are not possible. [inaudible 00:09:40] that's not really ... Doesn't happen very often, but with things that are less complicated, you can go into the field with something that's not 100%. Those kinds of pressures can create shortcuts in the design control process, especially when you're in a start up mode, that's when money really is critical, that's when time really costs money. That's what you [inaudible 00:10:08] not afford to lose, is two or three months to redesign some aspect of the product because you didn't think of some design inputs, or you didn't do the risk analysis correctly and you overlooked something.

 

Jon Speer:

Yeah, the "But Matt, I want to get to analyst study. I want to get to my first [inaudible 00:10:28]" I can hear the objections right away. I'm sure that you've heard those same objections right?

 

Matt Romey:

Right. Exactly, 'cause they're not going to give you money until they see some confidence. I understand the push and pull. I really do. There's both the two sides to the story, but as engineers and managers for these product development projects, it's up to us to reflect a culture and make sure that it is communicated that this is the correct way to do it. This will save us money in the end. We are on track 'cause here's our project plan.

 

Jon Speer:

Yeah. Let's talk about a little bit, 'cause the one image that's out there and often shared when we talk about things like product development process or design control, is that classic waterfall diagram that you can find in the FDA design control guidance document. Yeah, it shows the nice, linear progression from user needs, to design input, to design output, and then design verification, prove your output can meet your input, then design validation, prove your product meets your user needs, and then there are design reviews sprinkled in there. That's kind of the classic image, anybody that's been through medical device product development at least a time or two, probably has that drilled in or burned into their brain, that they instantly can see that image that I just described.

 

 

So let's talk a little bit about that, and the way a lot of product development processes are always described are very linear, and you and I are talking about the importance of laying that foundation, capturing your user needs and your design inputs early in the project, coinciding with your prototyping and proof of concept work, but laying that foundation before you get too far down the path. So if it's laid out linearly, and all these processes and in that waterfall diagram, that doesn't seem to be how product development really works. It doesn't seem to be really how design control works. So do you have some experience in how to try to keep that managed in a way that's flexible that allows some things to progress faster than others in a project?

 

Matt Romey:

Yeah. I, for one, have always found that waterfall diagram a little confusing. To me it doesn't totally describe, in my mind, the process. It does in a way but it just, to me, it's much more ... What's the word? It's not quite as linear as that. What it kind of doesn't describe is that yes, you have user needs. You get those from your customer and you need to identify those, and you need to source them and make sure that they're justified. The design inputs, I think, are the thing that people really get confused about. Design inputs and design outputs and verification, because design inputs really should be a translation of your user needs to some sort of engineering specification that can be measurable.

 

 

The verification ends up being, "Okay, now I can go and measure to that and say yes or no [inaudible 00:13:48]" So, when you talk about things aren't necessarily linear, what it means is that when you create that design specification or design input, you have to look forward or ahead to design verification, for instance. Will I pass? Do I have a test method that can test this?

 

Jon Speer:

No, totally.

 

Matt Romey:

I might want to create it this way, but if I can't test it, I'll fail design verification. Another example is, you could have too many user needs, 'cause user needs, when you go to validation, for validation you go back to the user. Well if you have 100 user needs, are you really going to go and validate with the users, all 100 of those, with a questionnaire or whatever?

 

 

So think carefully about how you craft those, the user need and the design inputs, making sure that you're going to pass design verification and design validation.

 

 

Also, especially with design inputs, a lot of times there's testing involved, I know that I saw a blog post where you said where it's not always about testing, and that's true, but a lot of times it is.

 

Jon Speer:

Yeah, yeah, yeah.

 

Matt Romey:

And you need to make sure you can test it, and you need to make sure that your test can be validated, 'cause you're supposed to validate that test before you do design verification. Those are the things you need to think about as you're crafting those inputs. That's where it becomes nonlinear, it's like you have to look ahead all the time.

 

Jon Speer:

Yeah. You just painted a very good picture, and from your description, I think we could come up with a few key tips, that anybody that's gone through this product development process for a med device, whether the first time, or the thousandth time, I think you and I can provide a few key tips here today to be able to ... Kind of the take home message.

 

 

The first tip that I have, and you said it very, very well. Those design inputs for your product, my opinion, it's the most important thing that you do during the entire development process. You said it very well and here's why, because how well I do define those design inputs, will determine how easy, difficult, or possible even it is to verify that my outputs meet my inputs. Like you said, testing is a big part of verification, not the only option, but most things you can only run some sort of test to be able to prove that your product meets those design inputs. So design inputs are the most important, that's one thing that always sticks out to me. And it's worse, I read something once, where it should take 30% of your overall project timeline to actually define good design inputs.

 

Matt Romey:

Yeah, I believe that's from the FDA guidance document. I was going to say the same.

 

Jon Speer:

Yeah, you're right. Yeah, yeah yeah. So I think that's a key tip is, focus on those design inputs. I like where you're going with that, you've got to think nonlinear, you've got to think almost three, four steps ahead at times, and then you gotta be able to see into the future, and then bring that future back to present day and figure out, "Okay, well how am I going to prove this?" And I think that's a key aspect of a design input.

 

 

I remember one of the first projects that I had, I didn't fully grasp what we're talking about today. I wrote really, what I thought, were really good design inputs. Well they were really good at the design input stage of a project. They sucked when we got to design verification. When I started going through how I'm going to prove them like, "I don't know how to prove this. It's possible but I'm going to have to build three million units and run a statistical variation and a design of experiment ..." All those sorts of complicated processes, and I realized very quickly after a project or so, the value of understanding that verification piece when I'm designing those design inputs.

 

Matt Romey:

Yeah. I also think that this really highlights where management can come in, because as you know, a lot of times engineers and marketing people don't get along so well, at least that's kind of the stereotype. I think it's up to management to make sure that that relationship is a positive one, because what you don't want to happen is to have marketing come and say, "We need this," and the engineer crafts [inaudible 00:18:18] input for it, but it's never going to pass the design verification. Well they need to push back and say, "Well you needed to rethink that. Or if you really need it, we need to change the design so that we will pass." It needs to be a positive communication between the marketing group, which is usually what represents what the customer wants, and the engineers who say, "Look, this is possible and this is not."

 

Jon Speer:

Right. Yeah, to say somebody's got to play that role of translator too, and that's where you're saying that the executive management, or project manager, or somebody has to serve as, "Here's what marketing's asking for" and be able to translate that into engineering, then take what engineering is saying and put it in the terms of marketing.

 

Matt Romey:

Right. Yeah, and going back to your other tip from before, I think making sure you translate your design inputs correctly and don't overstep and don't over bounds. I think it's really important that people understand what the process really is. I'm really surprised sometimes when I go out in the field and how many engineers don't really totally understand the whole process.

 

Jon Speer:

Yeah.

 

Matt Romey:

And if they don't understand it then they're going to have problems when they go to verification and validation.

 

Jon Speer:

Yeah.

 

Matt Romey:

That's why it really helps to have tools like Greenlight Guru and also having people come in who have done this before to help guide you along and make sure that you don't make those mistakes, and you can craft your inputs correctly. That's another tip that I would give.

 

Jon Speer:

Yeah. So Matt, we've covered quite a bit of ground today. The key tip I think that we both centered our focus around today is how important those design inputs are. I want you tell me a little bit about how you get engaged with companies and what your target customer or med device company looks like and how they work with you as you're consulting. Can you share a little bit of words about that?

 

Matt Romey:

Sure. Azzur consulting, as you heard in the beginning, we have over 200 engineers across the country and we specialize in lots of areas, life sciences, a lot of pharmaceutical, medical devices. I kind of represent medical devices, especially out here on the West coast. My expertise is mostly in the design side, but we also have engineers who can help with manufacturing and process development. [inaudible 00:21:05] facility qualifications, everything. But when I interact with clients on design control issues, it really depends on the size of the company. Large companies usually have methods in place and a lot of times they have quality engineers who are compliant with that, but they still need help especially when it comes to test method development, and test method validation, and sometimes it's just about bodies. They don't have enough ... There's usually crunch times that happen. When you go to do your design verification, it's like, "Alright, we've got 20 test methods we need to validate." 'Cause they're all new, this is a new product, and who's going to do it? Well, that's something Azzur can do. We can come in on a project basis.

 

Jon Speer:

I was going to say, you're probably super busy this time of year. I know it's December and some people start thinking about shutting down and Christmas break, and all that sort of thing. My kids have already reminded me how many days it is until Christmas, and how many days they have left in school this year, and all that sort of thing. But I can imagine a company like yours is very, very busy because a lot of companies have their year end objectives to get their 510(k) into the FDA before 12/31/2015. I was there a couple years ago, I had to get a 510(k) delivered to the FDA, so I can imagine you're pretty busy this time of year.

 

Matt Romey:

Yeah, we can be very busy this time of year. It's also sometimes a time when they shut to do re qualifications, so a lot of times their engineers work through holidays, when everybody else is on vacation.

 

Jon Speer:

Yeah, so Matt, I appreciate you taking the time to be our guest on the Global Medical Device Podcast today, for people that are interested in learning more about how you can help them with their design control, especially in the areas of test method and test method validation, what's the best way to get ahold of you?

 

Matt Romey:

Well you can visit our website, Azzur.com.

 

Jon Speer:

And that's A-Z-Z-U-R, by the way.

 

Matt Romey:

A-Z-Z-U-R, with no E at the end. You can reach out to Jon to get my email [inaudible 00:23:21]

 

Jon Speer:

And Matt, they could probably find you on LinkedIn, Matt Romey, R-O-M-E-Y, look him up. He's a good-looking dude who's got lot's of experience and he's been through med device start ups, some that have gone better than others, so I'm sure if you want to find out some of the mistakes that he's been a part of, and the prior lives and some of the management errors that teams he works with, and the mistakes that he saw coming years, or at least months, maybe not years, but long before they happened, he can certainly be a great person for you to talk to because he can help you see that now, because he's been there. He's done that. He's one of those kind of guys. So Matt Romey, Azzur Consulting.

 

 

Hey, this is Jon Speer, again this is Founder and VP of Quality and Regulatory of Greenlight.guru and you should check us out. Go to greenlight.guru. Yes, that is our domain name, no .com, .guru. G-U-R-U. You can download all kinds of podcasts on design controls and risk management. You can also check out our blog, we have some wonderful content pieces, things like The Ultimate Guide to Design Controls, The Definitive Guide to ISO14971 Risk Management. Be sure to send me a note and let me know one of the topics you'd like to hear about. Again, this has been Jon Speer, and this has been the Global Medical Device Podcast.

 


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