What does true quality mean? How does it relate to compliance?

Today’s guest on The Global Medical Device Podcast is George Zack of Two Harbors Consulting. 

George shares his thoughts on these two tough questions and describes his involvement with the FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP).

 

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Some of the highlights of the show include:

  • MDIC oversees programs developed to assess organizations’ beyond compliance of regulations to produce quality products.
  • Capability Maturity Model Integrated (CMMI): Third-party appraisal is performed against participating manufacturing organization to provide feedback.
  • Besides getting the appraisal and feedback, participating facilities are eligible for some regulatory modifications and benefits.
  • Compliance vs. Quality: Devices need to not only be compliant, but safe, effective, and readily available.
  • There are similarities and differences between practices, assessments, appraisals, and audits. Don’t prepare or study; be open and transparent.
  • Understand how the business operates to see the big picture. Practice areas include product integration, configuration management, and incident resolution.
  • FDA’s Medical Device Single Audit Program (MDSAP) can involve more money, time, and people. MDDAP strives to be non-interruptive, streamlined, and faster.

 

Links:

Two Harbors Consulting

CMMI Institute - Medical Device Discovery Appraisal Program (MDDAP)

FDA Case for Quality Program

FDA Case for Quality: 2018 Comprehensive Review

Medical Device Innovation Consortium (MDIC)

MDIC Annual Public Forums

MDICx Webinar Series Part 1

MDICx Webinar Series Part 2

MDICx Webinar Series Part 3

MDICx Webinar Series Part 4

Dr. Jeff Shuren

Medical Device Single Audit Program (MDSAP)

Premarket Notification 510(k)

Greenlight Guru

 

Quotes:

The facilities that participate are also eligible for some regulatory modifications. - George Zack 

We’re not just looking for devices that are compliant. We are looking for ones that are going to be safe and effective. Are they also readily available? - George Zack

With this appraisal program...engineers are more likely to bring these changes to the surface. To enable changes is to enable opportunities for improvement. Jon Speer


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: What does true quality mean? How does this relate to compliance? These are really tough questions to answer sometimes, if you think about it, and probably no secret to any of you listening that I'm a huge fan of the program from FDA CDRH Case for Quality, and I'm really thrilled to have my guest on this episode of The Global Medical Device Podcast George Zack. George is with Two Harbors Consulting and a big part of the Medical Device Discovery Appraisal Program being conducted by the CMMI Institute, on behalf of Case for Quality. So be sure to take a listen to this episode of The Global Medical Device Podcast.

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, Jon Speer. And really excited for this episode of The Global Medical Device Podcast. A few weeks ago I had a chance to meet George Zack. George is with Two Harbors Consulting. And I'm real excited because of a lot of the things that George is involved with, and really this whole Case for Quality initiative, and we'll dive into that a little bit here in a moment. But George, welcome to The Global Medical Device Podcast.

George Zack: Hey good morning Jon, really happy to be here. I've enjoyed the podcast for quite some time. I think I shared with you that I listen to it quite often, and when you spoke up at that meeting that you came out to, I didn't recognize your face, but as soon as I heard your voice, since you've been plugged in my ears many times, I was really pleased to meet you and happy to be here this morning.

Jon Speer: Yeah folks, when I was at this event. It was an MDIC Case for Quality event recently, and I asked a question, and I thought it was a pretty good question, and then George had a... His body language shifted, and I'm like, "Alright, maybe that wasn't such a good question." And then I learned after the session, and I had the chance to talk with George [chuckle] one on one, that he recognized my voice, that was the reaction, but it threw me off a little bit. But George, I know you've been very involved in the Case for Quality initiative, but before we dive too deep in those topics, tell us a little bit about your background and a little bit about Two Harbors.

George Zack: Sure. I'm a consultant. I'm part of a small consulting firm that's, as you said, called, Two Harbors Consulting, and our job is we help organizations and businesses achieve better performance and quality outcomes. The team that I work with, we came out of the healthcare space a few years ago. We've actually engaged with firms in all sorts of markets, in healthcare, medical devices, software, public school systems, defense systems, essentially what we're doing is we're leveraging a variety of tools and standards and frameworks and regulations to help those organizations so that they can... Say they're a software organization and they want to become Agile, we will help them with their Agile journey. If they're a device company and they wanna be more compliant to the QSR, we can help them with that. And our view is, if they happen to be a software company that's making medical devices or a SAM D, we can help them do both. One of the frameworks that we use, that I think you and I will be talking about at some point today, is the capability maturity model or the CMMI. And that's one that we leverage within this program that we'll be talking about today. So yeah, essentially, small consulting firm that helps companies be better. I know that sounds just a quick phrase there, but that's our objective. We've got a lot of success with it, and we've only been around three years, but we've had a lot of success with it, in a variety of markets including medical device space.

Jon Speer: Yeah, and obviously, I connected with you because of your efforts with the CMMI Institute and the appraisal model that the Medical Device Discovery Appraisal Program. And I guess, if you can maybe share a little bit about how the MDDAP, and that one just doesn't roll off the tongue yet, I'll confess, but how [chuckle] that appraisal program fits into the overall FDA Case for Quality initiative, and maybe talk a little bit about that, because for me, it was a little confusing to try to connect the dots. But I know you've been doing this for a bit and it might help and enlighten and share how all this fits together.

George Zack: Yeah, so I'll try to cover it here but I'd also give a little bit of credit to, where credit's due. Over the holidays Jon, you wrote a really good, and published a really good white paper on the Greenlight site, on the overall effort related to Case for Quality, and well how this program, or what I call MDDAP, there's a variety of names for it, which is its own conversation unto itself. But that Medical Device Discovery Appraisal Program, how that is a part of it. So, I'd certainly point people to that and they can get into a lot of the details. And you did a great job connecting the dots there.

Jon Speer: Oh, thank you.

George Zack: But, in short, this appraisal program is a part of that Case for Quality. The Case for Quality has roots that tie back several years where CDRH's, Dr. Jeffrey Sherrin noted astutely that they were compliant and having quality issues, or they were not compliant and still producing a quality product. And so, he recognized that compliance was simply not enough. It wasn't to say it wasn't necessary, but it was not enough, and leveraging a public-private partnership, the Medical Device Innovation Consortium, MDIC, they started to explore several programs in ways that they could assess organizations beyond just compliance to the regulation. They saw, "Great, you know what, we're seeing that we have CAPA, as an example, as our number one cited, 43 finding year after year after year. Well, is there a different way we should be looking at organizations?" And so, that has spawned a variety of efforts that MBAC oversees as a part of the Case for Quality. MBAC being a place where industry and the agency can connect together and work on these problems. From one of those efforts was learning how a maturity model would provide insight to the capabilities of an organization to produce quality products. So above and beyond just compliance, were there specific practices or typical practices that organizations demonstrated that would help them achieve higher quality outcomes in the products and the services that they produced.

George Zack: There was, a few years ago, there were several maturity models reviewed. And the capability maturity model integrated with CMMI, which had been known for two decades, mostly in defense space, but it's applicable to a variety of markets. It was chosen as the model for the pilot that was running 2018. So with that, a third-party appraisal is performed against a participating medical device manufacturing organization that results in feedback to that organization as to how they're performing against the practice areas that are in scope for this particular program, gives them feedback as to areas in which they can improve, and where they're demonstrating strong capabilities. These are organizations that have already demonstrated a strong history of compliance. So the facility itself is something that's already undergone its establishment registration. They haven't had any official action indicated over the last handful of years.

George Zack: By way of participating in this, in addition to getting that appraisal performed and feedback, the facilities that participate are also eligible for some regulatory modifications, which include that they don't undergo the routine inspection, they have streamlined submissions for the review of changed notices and cite changed submissions. We're also working through some other potential benefits between what industry wants and what the agency is able to provide. So, in 2018, we had 18 organizations enroll that represented 36 facilities undergoing an appraisal, and we had a lot of positive feedback and a lot of success. I think that's in a nutshell, we can break down into the different parts that you think that you're most interested in, Jon.

Jon Speer: Yeah, so I made a couple of notes here. We'll dive into a few of those here in a moment, but I wanna revisit the comment that, I don't know if it's famous yet, but Dr. Sherrin has come out and made the statement that compliance is not enough. I think I've even heard at one point in time, either Dr. Sherrin or somebody from CDRH has made the statement that they hope to purge the term compliance from their lexicon within the [chuckle] next few years. And I get the idea, the notion behind that, but let's talk a little bit more about the compliance versus quality, and I guess specifically and without giving away any proprietary information, what has your experience been? You said that for a company to be involved in case for quality and a part of the appraisal program, that they have to basically have a clean bill of health, so to speak, when it comes to compliance, but what anecdotes or information can you share about the difference between being compliance-minded and quality-minded?

George Zack: Yeah, I'm gonna give a non-medical device example, because it seems to get people of our age, Jon, to understand it very quickly. Before you hit record, we were talking about the holiday break and I mentioned that I have two teenage children. And a couple of years ago, I went through that wonderful experience of bringing my children to get their driver's licenses. And that's the coming of age onto itself for both them, but I felt much more me. And I really recognized that ticket of the day my son got his driver's license that he was a compliant driver, he had demonstrated by going and getting his driver's licence. And holding his hands on the wheel at 10 two, and even doing that thing where you reach up and you touch the rear view mirror, so that the person who's proctoring the driver's test is like, "Oh yeah, they're looking at their mirror." He was a compliant driver. Now, was he a quality driver? Certainly not.

George Zack: And I think he thought he was a quality driver, but it's gonna take time and experience for him to get to that. He's better now, thankfully. And I think, similarly, it's very easy for organizations... You're right, it was Dr. Sherrin who made that statement about the compliance being dropped from the lexicon in the device field. We don't necessarily think of, when we get on an airplane of just being in compliance, we're also looking for a quality experience as a part of our flight. And the same thing in the device space, I think that we're not just looking for devices that are compliant, but we're gonna, as consumers of those devices or having family members that are consumers of those devices, we're looking for ones that are going to be safe and effective, but I know those are the terms that are thrown out the most often, but are they also readily available? Is that value stringed through that particular business bring those devices to market in a fashion where they're accessible to me? And so one of the things that we're doing in the appraisal is across the practice areas we're looking more of holistically than just at compliance, we're not just saying, "Hey, drum out your DHF, so that we can look at how you've tied your input to your outputs and design controls, but we're also looking at how the organization has estimated and planned that work and how they're responding to incidents. So it's...

George Zack: In many areas, it's probably... And looking at the appraisal there's probably many things that you'd look at and say, "Oh yeah, when I look at that practice area within CMMI. That sounds a lot like 820.whatever, but there's other things that are broader than that, and in addition to it, just being compliant we're also, working with the organizations to identify areas in which they can really improve so that they can better those quality outcomes. So I'm not sure I directly answered your question there...

Jon Speer: No.

George Zack: Maybe with the driving example... Maybe not necessarily it... Driving example from...

Jon Speer: No. But I can relate. I can relate to the driving example as a father of two teenagers, who are both drivers. I chuckled a little bit, as you talked about being compliant. My children went through similar experiences and I'm still waiting for their quality to improve but... [laughter] But that being said, I mean, you talked about some practice areas I don't wanna delve into that a little bit because on the surface, when you first... When you first or rather when I first learned about the appraisal program and these practice areas. To me, it kind of sounded like, "Oh this is like an audit, but like a different flavor." What do you think, I mean, is this like an audit? I mean, how is it different from an audit How is it the same?

George Zack: Yeah, so, there certainly are elements that are similar in that there's, when you... I perform both, right? I have performed for other businesses, and they actually hired... They've hired me or they've hired Two harbors and we all know, we've hired consultants out there to play the auditor. And sometimes they even say, "Hey, we want you to come and play the Tough Guy auditor. Really ask us the really hard questions." And so you're going in and you're... What's similar is that there's a framework, when you do an audit, you're... You maybe that's 820 or 803, or 806 and 807 or 1345, whatever it is. And you are asking questions to understand how they are meeting the intent of those regulations. And it's similar regarding assessment, where we are certainly asking questions to understand how they're meeting the intent of the practices that we're looking at within... The CMMI appraisal, the areas that we've scoped with the MDIC and the agency and the industry partners that are in there. But I would say that's essentially where a lot of the similarities end, and that there's a lot of things that are very different. Now, I'll give you a couple. But I'll also suggest on that... People hearing it from me as a consultant...

Jon Speer: Yeah.

George Zack: They might, you know, "Okay, whatever." We've also with MDIC we've had a few webinars where we've had participants come back and speak to how they perceive they... The difference from an assessment and the CMMI assessment, to be very different than a typical audit from the FDA. And so, I think their words are gonna be much more golden, if you will, so go back... I can share the links with you and I'd say go back and listen to those things where you can hear it from big industry partners, as to how they perceive it's different.

George Zack: But essentially, what I would say is since we're moving from just a compliance, like how did you meet the intent of the regulation? And we're asking more broadly how can you continuously improve and how can you achieve higher levels of quality outcomes. That shifts the entire tone and it... Frankly, it takes some time for the participating businesses to get that. We're speaking directly with people that are performing the work we're asking for an open dialogue that's very different, we're all familiar with that when we train people to go through audits or inspections. If you're asked, "Do you know what time it is?" Your answer is, "Yes." You don't give the time in an audit or in an inspection. And so, in an assessment, we're actually working to get people to go beyond that and to speak to us as to how the work is actually being performed maybe even beyond what's actually written or not written in their procedures. So we're moving beyond just looking at documents. We don't start with document review we might use that to support our activities, but we're really talking to the people and doing that in a way that's very open and transparent, so that we can learn how to improve the organization.

George Zack: This changes a lot of things and you'll see that the backroom is not necessary, the typical audit backroom that might be staffed by 10s or maybe even some cases, dozens and dozens of people. Crap is not necessary with that organization asked us, "Hey, how can we prep for this and what is it that we need ahead of time to study for? And we say that... "Just... No don't, don't prep and study, instead tell us how you actually do the work," and other things that are different as an example is... As we come... As we work with an organization of the week we come back, and we say, "Okay these are the things that we've heard, these are your appraisal results. Is this, right? Because we want you to be able to own this set of results, not fight them and say, "Oh that's not really a finding," but that you can look at that and say, "Yeah, that's an area that improvement, that's something we need to work on, that's a value add to us." And when this appraisal team is gone, we can understand it. That's obviously very significantly different than what you get in a 43 or a warning letter as the result of an inspection. So there are a lot of areas that are different, those are a couple... And I'd also suggest that people go back and check out what they can hear from industry colleagues if they're interested, as the kind of thing that they could do different.

Jon Speer: Yeah, well and folks, we'll get those links and share them with the text that accompanies the podcast so they can hear from yourself. But a couple of things, thoughts, there I mean I... As I'm sure maybe many of those listening. We've been a part of audits, I've been in this industry for over 20 years now, and being "audit ready" is something that you always... Especially those on the quality area, try to make sure that their companies are prepared for it. And it's almost become, I would say in my experience, that we as an industry, it's like we've been conditioned to be compliance-minded. And I think that if I were to analyze some of the comments about... That I've heard from Dr. Sherrin Cisco Vicente and some of the case-for-quality messaging, it's almost like there's a reprogramming effort under way. And I know you've been a part of that with the appraisal program.

Jon Speer: So I think one could say, "Well, how did we get here?" Well, I think it has been, because we've been so focused on, "Did we meet the regulation?" And we start to structure our processes and procedures in a way that demonstrates that compliance, that sometimes we've lost the bigger picture. We are in the medical device industry, we are helping save and improve the quality of life. So for me, this program has been extremely refreshing. Because just to dive into some of the comments that you made, it's really about understanding how the business operates. And I guess you've done what, probably dozens and dozens of appraisals by now, both within and outside the med device industry. So I guess, maybe share a moment where there was a light bulb or something, an epiphany that happened with one of the companies where you did the appraisal. How they suddenly saw that, "Oh wow, this is a different context."

George Zack: Sure. The CMMI practices that we're looking at are not... They're not necessarily specific to the medical device industry, they are applicable to to all industries. Even in my own consulting firm, we periodically go back and we'll look at the CMMI model and say, "Okay, are we doing these particular practices?" So...

Jon Speer: I'm sorry, I just wanted to chime in. So you've mentioned "practice areas" a couple of times, maybe if you can give a couple of examples of a few practice areas that people could kinda wrap their head around.

George Zack: Right, right. A classic one is... There are in this program, there are 11 in-scope, a set of practice areas in-scope within those 11 practice areas. And those are things like technical solution and product integration and configuration management and planning and monitoring control. There's others that are out of scope for this particular program at this time for initial appraisals, but they would be brought in as the participating organization sees appropriate and a value-add to them. So that could be things like incident resolution and prevention, supplier agreement management. A classic one that organizations... No surprise here, I'll give you two that they often struggle with not just in the medical device industry, but more broadly, is requirements development and management and configuration management. So, I know from a configuration management perspective, we've all dealt with that spreadsheet or that document or that project plan or that SOW, whatever it is, that ends up getting emailed around and then the... You're making edits to it, I'm making edits to it, it's on somebody's desktop, and it's not necessarily controlled.

George Zack: Maybe from a medical device perspective, that's not... That type of document is not necessarily needing to be controlled, but how you manage the things that need to be under appropriate levels of configuration management can have an impact to your business requirements development. So often, you'll see organizations, particularly young organizations, struggling with, "How do we collect in requirements? How do we manage our particular cue of those things? Are those stories, are those features, is that an SRS? Are we taking that in from our complaint too as well? How do we consider that from a risk perspective?" And the model itself represents a set of practices that gives you an organized way to consider how to, at a very simple level, "Hey, let's record our requirements." And then as you get to higher levels of capability and maturity, how are you considering those requirements by involving all the necessary stakeholders? How are you considering your requirements with your supplier? How are you considering that with other systems that you might need those requirements with other systems that you need to interface with?

George Zack: How are you gonna validate those particular requirements? So, the light bulb goes on for organizations when... Typically by going through an appraisal, I make the analogy that going through an appraisal itself, it doesn't necessarily create the process improvement, but it's like going to a doctor and then they're saying to you, "This is the state of your health. This is what your BP is. This is what your BMI is. This is your blood, the blood markers, levels that you have." And then from there, you can start to identify what's the appropriate plan for that patient or for that organization as to how they can improve on those particular things. And there are certainly are some commonalities. I mentioned requirements management there and configuration management, but all the organizations have their own sets of struggles maybe it's in how they size their particular efforts in terms of cost and effort or how they deal with incidents or how they're coming up with designs, while there's commonality across the areas of the practices in the framework each organization has it's own unique profile in terms of their capabilities. Did that help Jon?

Jon Speer: Yeah, that helps a great deal and folks I just wanna remind you, I'm talking with George Zack. George is with Two Harbors Consulting. George has been very involved with the medical device appraisal program or in-depth program which is a part of the Case for Quality initiative and just as George was talking, one of the things that I want to remind all of you as well, that we at Greenlight Guru we've built an e-QMS software platform specific for the medical device industry and our mantra is about true quality. And so when I learned about the in-depth and case for quality initiatives it was like for me a light bulb went off because it's like, "Yes, finally there's an awareness or an initiative that's out there to help companies shift from just being compliance-minded and really start to focus on managing their business in a way that results in the safest most effective medical device as possible." So I encourage you to check out George and Two Harbors Consulting and you could go to their website at www.twoharborsconsulting.com. Actually let me back up. I think it's even simpler than that. I think it's a twohc.com and you could go and learn more about Two Harbors Consulting and of course you can learn more about the Greenlight Guru eQMS software platform by going to www.greenlight.guru. So George, you talked about the companies who participate in the pilot program and I guess first the pilot program it's mind to saying, it is continuing throughout 2019, correct?

George Zack: Yes, that is very correct.

Jon Speer: Alright, so I know the...

George Zack: Current new cycle, I think we're all... The day you're recording this, we're all trying to figure out what's going on with the FDA and where it is going in 2019.

Jon Speer: Yeah, and as we're recording this too, I believe the government is still on shut down so obviously FDA is part of the government. So there's trying to figure out if, what, when and all that sort of thing, hopefully there's little impact to progressing through this program in 2019. But some of the things, you talked about the regulatory benefits to participants in the pilot program in 2018 and I know a lot of those regulatory benefits the obvious of... Most obvious of those was that needing or having to go through an FDA inspection as long as they're involved in the program but there was some other regulatory benefits predominantly for PMA class III devices or advanced review times and cycle times and things like that. Can you maybe elaborate a little bit on some of those regulatory benefits for the 2018 participants?

George Zack: Yeah, sure, so the most basic that you mentioned is that routine inspection. So the inspection that I think that people are expecting where the FDA comes in, knocks on your door and asks for a cup of coffee and a walk through your facility and then maybe wants to camp out for a few days to go through documentation and talk to people, that routine inspection activity gets waves. And for some people, that alone is a benefit enough. Now, certainly for organizations that are participating in MBSAP they may say that that's not really something that is of great value to them, but to organizations that can often get tied up with an inspection that can tie them up in that backroom and maybe impact production significantly for days or maybe even a week or more we've had different numbers on that. We've had some organizations say, "Hey, we value the removal of that at a $10,000 benefit and we've had other organizations tell us that they value it at a half a million dollar benefit because of the lack of interruption."

Jon Speer: Well, hang on, just wanna pause there 'cause that's pretty significant, whether it's 10,000 or half a million dollars. I've been in those even for small companies going through an FDA inspection. You're probably tying up at least two or maybe three FTEs for a solid week and then if you don't have that kind of interruption that an inspection tends to bring that could be pretty significant so... Yeah, go ahead.

George Zack: Right. One of the MBIC case for quality form, a leader from one of the large medical device manufacturers showed a picture of the back room that they had for their MDSAP inspection and it was manned by close to 50 people.

Jon Speer: Holy cow.

George Zack: So you can do whatever you want from a run rate on that for those people across the course of that, that five days and what the cost of that would be and again... And then she did a comparison of that too there was nobody essentially in the back room for the team of my appraisal activity because we strive for it to be as non-interruptive... Obviously, we're taking up time, people have to do planning doing interviews but to be much less interrupt-driven, so there's certainly benefit with that. Another one is the 30-day change notice. And this one's a little... What's really interesting to me about this is initially I thought that this would be... That the benefit would be... Okay, we have an engineering change if we can implement that more quickly and the FDA streamlines that from 30 days down to five days or two days. Hey, we're getting that change in faster and particularly if we're running different production lines, say for the US versus Europe, we can now implement those changes at the same time and that's really where our benefit would be. One of the things that I'm... We're hearing from organizations is that with such a streamline process your engineers, your problem solvers are more likely to bring problems or engineering changes that would be of benefit to the organization, to the table where in the past they may not because it's a... There's all these submission paperwork. It's too much, I'm not gonna even bother trying with it...

Jon Speer: Oh, wow, that's really interesting. So let me elaborate on that for...

George Zack: So, I don't know about...

Jon Speer: Yeah, just let me elaborate on that for some folks. So in the US, if you have a class III PMA device, and you identify that you need to make a change, it is not a trivial exercise as it stands in a traditional model, there's a change notification process, that you need to engage FDA on making that change. And so, what George is pointing out is that... And a lot of organizations, because of these hurdles we'll say, perceived or a real... But hurdles that are in place for making changes a lot of times the changes wouldn't happen, they would go into the queue and maybe never gonna see the light of the day. But what George has observed is that, wow, with this appraisal program that now engineers are more likely to bring these changes to the surface, which that to me all by itself is pretty profound, because you wanna talk about... The reason that... I'm an engineer, I solve problems, the reason I would make a change, is to make an improvement to something and if I'm bearing the opportunity for improvement because of the regulatory hurdles that I have to go through, then no kidding, no wonder my device isn't as safe and effective as it could possibly be. So this is a... This is a wonderful discovery.

George Zack: Yeah, we're really excited about that. I think initially the feedback that we were hearing was that, with the stream, you can certainly do the math and say, "Hey, something that was taking me 30 days. Here's the cost associated with that, and here's the cost savings that's associated with that." If it's taking five. I can implement those changes faster, but just, I don't even know how to put a number on the value of like, "Now we're gonna bring more... " You don't have a kick for that to say, "Now, we'll bring in more ideas to bear." Additionally, one of the things that came out is there was a large medical device manufacturer that did some analysis and with the number of changes that they were submitting to the FDA separately, they were essentially tying up the equivalent of an FTE at the FDA, with the number of changes they were submitting in a year. There wasn't this one person sitting there waiting for the changes...

Jon Speer: Right, right.

George Zack: Towards that medical devices, but essentially it added up to that. And so with the streamlined approach where they can also combine multiple changes in this streamlined approach the FDA is also saying, "Hey look, we don't need... " they're seeing benefit perhaps the listening audience is less concerned about FDA benefit [chuckle] and... But they're seeing benefit and they're saying, "Hey look, we don't have to tie up resources in that same way with the streamlined approach." So they're improving and learning, and they're able to reallocate those resources to other activities to bring other devices to the market more quickly or to inspect firms that maybe are not necessarily in compliance, so. They're looking at some benefits as well.

Jon Speer: Well that's important, I mean, we're in an ecosystem for sure, and so FDA is... One way looking at it, it could be a customer of ours as a medical device company, but they certainly hold some decision-making power in that process too. So we have to be cognizant of... Not only resources in our organizations, but also those third-party regulatory agencies. I mean, that's pretty significant. But I guess for those listening, and you kind of putting a wrapper on this podcast, it sounds like a lot of the benefits in the 2018 were... I'll say skewed more toward class III PMA-type device companies. And what do you see coming in 2019? Is this gonna be more geared towards companies of all shapes and sizes, all device types or is there a certain type of company a certain device type that you see being more beneficial in the 2019 version of the pilot?

George Zack: Yeah, so before I answer, where I think some of the regulatory benefits are coming in 2019, the size of the company, we've had the biggest of the big... All the big names that you're familiar with in this program, we've also had a handful of smaller organizations. I think the smallest organization that we had participate in this pilot was 17 people. A software development shop that had 17 total staff in it and privately held, not publicly traded. So the program itself, at this point is... It's not just for large organizations, we dealt with small, medium, and large class one, class two and class three organizations. To your point about where the benefits are going, it's very much a hot topic with... Within the working groups that we have as a part of this program. So in addition to the organizations participating that getting an appraisal, we are also asking us... We're asking those organizations to come back and help us improve this program and one of those is what are the regulatory benefits that would make the most sense for you?

George Zack: And it's probably no big surprise. Everybody's looking for something streamlined in the 510K space and that seems to be very much aligned with what we're hearing out of the agency in terms of how they're trying to shift their thinking on predicate devices and the age of predicate devices and where they're going with their Safety Action Plan. And one of the working groups that we have formed with our participants and the agency is to get the right representation from industry and the agency in a virtual room and discuss through what that looks like.

George Zack: So right now I would say that's probably the hottest ticket to go in the class two space. And we're really hopeful that by way of those conversations, we can define something that would be helpful in that space. I think it's also aligned with... What I would expect is it's outside the Case for Quality. But I know that you've also spoke on this podcast about the digital health pre-certification program. I know that the software is a medical device manufacturers are really interested in benefits in that space. It would seem to me that while there probably be... There will be some SAM D devices that may bubble up to a Class III. It seems to me like a lot of them would be in the Class II space. I feel that whatever is defined in this program is probably also gonna have some spill over into that program in the 510K space as well. So I think that's an area... This program striving towards that but there's also other initiatives that are all driving us towards some sort of shift or modification or whatever you wanna call it, in the 510K space.

Jon Speer: Yeah, thanks, that's really helpful. And folks, George and I are just really skimming the surface of the MDDAP program, the Medical Device Discovery Appraisal Program, and would encourage you all to learn more about George Zack and Two Harbors Consulting to twohc.com, and of course we'll provide additional supporting information about MDIC, the CMMI Institute and the appraisal program. Because in my opinion, it doesn't matter your shape or size of your organization, understanding how your business functions and operates and getting into this mindset of continuous opportunity for improvement is really the right way to go. And I've had some candid conversations with George about ways to implement the appraisal methodology within our business here at Greenlight Guru. And I think it's just... It's really a great mindset, especially for those of us in the medical device industry, because remember we are improving the quality of life with the devices that we're developing and manufacturing so to enable changes, to enable opportunities for improvement is something that we should all be mindful of, and something that we should try to enable within our particular organization. So George, thank you so much for being my guest on the Global Medical Device podcast.

George Zack: Thank you Jon, again really honored and like I said, I've really enjoyed listening to your podcast in the past. I probably won't listen to this one 'cause it'll be like listening with my boys. [laughter] But the work that you guys are doing here in this podcast, I think is leading in terms of sharing this information as to how this space is changing and it's a really interesting time. So, thanks again for the opportunity to speak and be happy to speak with you at any point in future about where the program's going.

Jon Speer: My pleasure. Folks, once again, George Zack with Two Harbors Consulting and you've been listening to the Global Medical Device podcast.


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