FDA's Voluntary Improvement Program

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP).

This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Maturity Model Integration (CMMI) to push medical device companies beyond compliance, towards excellence. Kaplan elucidates the history of VIP, its benefits, and how it aligns with the FDA’s vision for a more innovative and quality-focused MedTech industry.

Interested in sponsoring an episode? Click here to learn more!

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key Timestamps

• [00:00:30] Introduction of Kim Kaplan and the Voluntary Improvement Program
• [00:05:00] Explanation of CMMI and its adoption in the medical device industry
• [00:15:45] Distinctions between CMMI and other quality methodologies
• [00:25:30] In-depth discussion on the specifics and benefits of the Voluntary Improvement Program
• [00:40:00] How companies can implement change based on VIP insights
• [00:50:00] FDA’s perspective and regulatory opportunities tied to VIP participation

Key Takeaways

Links:

• Etienne Nichols on LinkedIn
• Kim Kaplan on LinkedIn
• FDA’s Final Guidance on the Voluntary Improvement Program
• ISACA's overview of FDAs Voluntary Improvement Program (VIP)
• Regulatory opportunities of the Voluntary Improvement Program (VIP)

Memorable quote:

• “Organizations that are compliant aren't necessarily avoiding the types and numbers of issues faced by non-compliant ones.” - Kim Kaplan
• “CMMI focuses on the 'what' to do rather than the 'how,' allowing for a framework that compliments existing processes.” - Kim Kaplan
• “The Voluntary Improvement Program isn't just about compliance; it's about embracing continuous improvement as a culture.” - Kim Kaplan

Practical Tips for Listeners:

1. Engage with CMMI: Consider how CMMI’s framework could complement your company’s existing quality and project management processes.
2. Explore VIP: Assess your organization's readiness and potential benefits from enrolling in the Voluntary Improvement Program.
3. Continuous Improvement: Embrace continuous improvement, not just for compliance, but as a cornerstone of your company culture.

Feedback:

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

Transcript

Etienne Nichols

00:02:05.180 - 00:02:16.780

Hey, everybody. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. We're at MD&M West in Anaheim, California.

And with me today is Kim Kaplan. So glad to have you with us today. How are you doing?

Kim Kaplan

00:02:17.100 - 00:02:18.620

Doing well. Excited to be here.

Etienne Nichols

00:02:19.580 - 00:02:37.250

So, I wanted to have you on the podcast to talk about the voluntary improvement program. I almost called it the VIP program. We talked a little bit about how that p is redundant if. If the in the VIP.

But can you tell us a little bit about the history of this program and what it means for the industry?

Kim Kaplan

00:02:38.130 - 00:03:56.710

Yeah. So, VIP is part of the larger case for quality initiative, which came from a 2011 study that FDA conducted.

And essentially that study demonstrated that organizations that were compliant were facing similar types and numbers of issues as organizations that were not compliant. So, they wanted to look for other mechanisms to evaluate and help organizations to close those quality gaps.

And that's where the case for quality was born.

Now out of that, FDA worked with the Medical Device Innovation Consortium, or MDIC, to have a safe space to collaborate with industry on tackling these important issues. They have a number of initiatives and one of them was looking at existing maturity models that could be leveraged in the medical device industry.

So, MDIC actually contracted Deloitte to do a study of 22 different maturity models.

And they identified the CMMI, or the Capability Maturity Model Integration, as the best fit for the case for quality because of its wide global adoption and its flexibility to be fit to purpose. So, we launched some proof-of-concept pilots in 2016. They were successful and ultimately, we designed the VIP pilot in 2017.

Etienne Nichols

00:03:57.750 - 00:04:08.109

So, you say the CMMI. Can you tell us a little bit more about, about CMMI and what that means, that it's globally adopted?

I, I'd just like to learn a little bit more about it.

Kim Kaplan

00:04:08.109 - 00:05:18.000

Yeah, of course. So, the CMMI was developed in the late 1980s, early 1990s. It was originally an initiative by the Department of Defense.

So, they were working with a number of software vendors and having hit or miss quality, so they wanted to understand how they could better vet their vendors in order to make sure they were getting the right software, because lives are at stakes.

And so, they worked with Carnegie Mellon University to conduct a study of industry, all of industry, thousands of organizations, to identify which behaviors, when present, would actually increase the likelihood that their projects would be delivered on time, within budget and of high quality. And those behaviors became the Foundation for the Capability Maturity Model.

Now this was originally for software, but since then it's grown, it's evolved, it's expanded to services acquisition, cybersecurity, data management, people management. So, it's wide, it's industry agnostic, and it can be adopted at any level of an organization.

So far, we have over 10,000 organizations that have adopted the CMMI framework in over 100 countries around the world.

Etienne Nichols

00:05:19.370 - 00:05:37.930

So how, how is CMMI different than some of the other initiatives that are out there?

I, I think about maybe a manufacturing facility that maybe they're trying to initiate Kata or an Agile concept or 6M, all those different methodologies. What is the differentiator here for CMMI?

Kim Kaplan

00:05:38.250 - 00:06:21.950

Yeah, so great question. The CMMI focuses a lot on the what to do and not so much the how to do it.

So, it's less prescriptive and it works really well with other existing frameworks that you have.

The other nice thing about CMMI is many other Frameworks that are out there are more of a compliance-based framework in that you either meet the requirements, or you don't.

With the CMMI, you can actually do a gap analysis and see what degree of capability you have within your organization and develop a clear roadmap to improve that capability over time rather than just saying I've done it and now I'm done trying to improve.

Etienne Nichols

00:06:22.830 - 00:06:48.540

So that being said, with that spectrum of capability, I guess if I'm allowed to use that word, yeah. Are there specific niche industries?

This might be an off the wall question, but I'm curious, can you say, if you looked at trends, orthopedic manufacturers versus neuro or software, I don't know, with an AI component versus this other software in a medical device, are there certain industries that struggle more than others or do you have that kind of data? Feel free to punt.

Kim Kaplan

00:06:49.500 - 00:07:08.670

That's tough to answer because I think the way CMMI has generally been used since it was developed is as a compliance tool to achieve a certain level of capability or maturity within your organization in order to demonstrate to government agencies that you're a high-quality vendor that they should consider contracting.

Etienne Nichols

00:07:08.670 - 00:07:09.150

Yeah.

Kim Kaplan

00:07:09.230 - 00:07:48.770

However, we have learned that when you use the CMMI as a compliance tool, it actually drives unwanted behaviors where organizations will hide certain issues that may be underneath the surface, or they will put on a front. They'll get all the right paperwork to show auditors that they're doing everything right.

And then once they pass that inspection, they go right back into their old behaviors. So, it's hard to say what are the industry trends.

However, what I can share is that there are certain areas within our model where we see the medical device industry having strengths and where we see they're having gaps.

Etienne Nichols

00:07:49.090 - 00:07:51.730

I'd love to hear more about that if you could share some of that.

Kim Kaplan

00:07:54.610 - 00:08:55.950

Sure, yeah, absolutely. For example, something like product integration or technical solution. So those are two different areas of the model.

They're the most affiliated with developing a product. So technical solution would be designing what is the solution you're trying to create.

And then product integration is actually putting the components together in a way that makes sense and reduces the likelihood of defects. And so those are two areas that are highly regulated in the medical device space.

And so, we see that organizations are generally very capable in those areas of the model.

However, when it comes to things like planning, monitoring and control, estimation of work, things that are more project management functions, that's where organizations tend to struggle in the medical device space, especially around operations that aren't specifically in the QMS but might be indirectly supporting those departments that can have an impact on quality that often goes unnoticed.

Etienne Nichols

00:08:56.470 - 00:09:38.890

That's really interesting. I'm specifically.

So, I was a project manager in the medical device space, and I saw that and I anyway, I won't go too far down that rabbit hole, but that's really interesting and I'd love to hear more about that.

At some point I did want to go before we go too far down the rabbit hole of specific strengths and weaknesses medical device, because I'd love to hear more about that. I do want to circle back and talk about the voluntary improvement program. So, what is we.

We talked about the history and how it came about through the cost of quality, but what is that specifically? What is the voluntary improvement program and how is it a benefit to companies and maybe who should be involved? And that was multiple questions.

Let's start with what it is specifically.

Kim Kaplan

00:09:39.370 - 00:12:31.990

Sure. Yeah. So, it is facilitated by the Case for Quality Collaborative Community.

So, this involves stakeholders from FDA, MDIC, the industry, and my company ISACA, which functions as the third-party provider of appraisal services. So, when an organization enrolls in the program, they have to demonstrate a history of compliance.

So, no official actions indicated that are open specifically and either some kind of FDA inspection or an MDSAP inspection in the past. Once they enroll in the program, we will provide, we being ISACA, will provide an overview and onboarding for those customers.

We'll sign a contract so that we can deliver services to them and then we work with them to understand, okay, what does your organization do? What products does it manufacture? What's the history? How are you actually organized by departments? What are your objectives?

What are your pain points? What do you hope to accomplish from participating in the program?

And then based on that, we assign them an appraisal team leader, and they will build an appraisal plan.

So that includes who are we talking to, what products, projects, work activities are we going to sample from what you do that are representative of the majority of work done? How do we push that to include aspects of the QMS, but also go beyond the QMS to those indirect touch points? How long is this going to take?

Which days? And building in interview sessions, tours, executive overviews, things of that nature. So, the whole plan, this process usually takes about 60 days.

And then the appraisal itself, which is a gap analysis, is usually about five days on site at the organization. So, there's a very common schedule Monday through Friday.

And what we do is we talk with the individual contributors at your organization because one, we don't want this to feel like an audit. It's not an audit.

One of our primary goals with our very first time working with your organization is to build a trusting and transparent relationship with your organization.

Because if we just start by looking at your SOPs, oftentimes what we find is that what is documented, that is supposed to happen isn't always what actually happens. And so, we want to understand what's actually happening and where things are not working as expected or as they should be.

So, we have those conversations, we compare what we hear against our framework of best practices and then we identify opportunities for improvement and explain why not addressing these will cause future pain or why addressing them will actually resolve an issue that you've identified.

Etienne Nichols

00:12:32.790 - 00:12:33.350

Okay.

Kim Kaplan

00:12:33.350 - 00:12:35.190

Yeah, that's. Sorry, that's a little in the weeds.

Etienne Nichols

00:12:35.270 - 00:13:21.550

Fantastic answer. And I'm think I'm just listening to you. You mentioned it's not an audit.

I am curious if I'm a company and I'm gonna have a company come into, and forgive my layman's terms, but essentially evaluate my company on all these different metrics that have been determined through CMMI. What's. What I can see the benefit from a business perspective. I wanna be efficient.

I wanna work through these different, these different problems so that I'm working where I should be working in a way that I should be working. But how do I overcome the. I. I feel like the employees themselves might not want to volunteer that information.

And also, as a company, why would I want to volunteer or open up myself to, to this kind of review from another organization? Does that make sense or.

Kim Kaplan

00:13:21.550 - 00:14:22.460

Yeah. Yeah. So let me talk about the protections we have in place first.

So, confidentiality and non-attribution are two key components to any successful appraisal. What this means is that what we hear doesn't get shared.

And any outcomes of the appraisal are not attributed to any specific individual or department or team. So that no one can point back and say, I heard Joe say, blah, blah, blah. Right. So those two are in place to begin with.

Also, when we're doing interviews, we don't include individual contributors and their managers in the same conversation so that they can feel free to share. And then I'll also say one other protection is this information. The details do not get shared back with FDA.

Instead, we send a summary of the high-level results that really give FDA more of an indication of how industry is doing on whole and where there are areas where perhaps additional guidance is needed to support the industry in being successful.

Etienne Nichols

00:14:23.340 - 00:14:44.350

Okay, so you're segueing into the next question I wanted to ask, which is what does the FDA do with this information? You already alluded to guidance documents and the potential creation of those, which is really interesting. Might want to get more into that.

The other. But the thing that I'm also curious about, so as a company, what is this data going to benefit me from my relationship with FDA? How does that work?

Kim Kaplan

00:14:44.750 - 00:16:18.890

Yeah, so I think what FDA is looking to see is organizations that are already compliant committing to a process of continuous improvement that goes above and beyond what compliance requires. So, using compliance as a starting point rather than an end goal. And so that's, that's what they want to incentivize.

They want to encourage organizations to have the space to innovate in a way that isn't confined by the typical burdens of compliance. That the regulations haven't really changed much in the last 40 plus years and they're not always able to keep up with advancing technology.

So, in order to encourage that innovation, FDA is offering some regulatory opportunities to participants who commit to continuous improvement and engaging in the program.

Those include things like being removed or waiving the FDA inspection, preapproval inspection, post market things like streamlining the submission process for 30-day change notices. So typically, those might take even more than 30 days with some of the wait times and the transferring information back and forth.

Typically, we're seeing those get completed around 10 days, things like site transfers. So maybe you're trying to design a new product, you want to move it from that design location to the distribution center. That's usually 180 days.

Through this program, we've seen that be completed in an average of 25 days.

Etienne Nichols

00:16:18.970 - 00:16:19.450

Wow.

Kim Kaplan

00:16:19.610 - 00:16:25.290

So, it's saving lots of time to get those new better products into the hands of patients.

Etienne Nichols

00:16:25.770 - 00:16:30.970

That's fantastic. Do you have a resource that shows the comparison of the benefits somewhere?

Kim Kaplan

00:16:30.970 - 00:16:33.290

We do. Maybe you can link it in the show notes.

Etienne Nichols

00:16:33.290 - 00:16:37.050

Yeah, that sounds good. This is not your first rodeo, is it?

Kim Kaplan

00:16:38.180 - 00:16:39.740

I like to listen to podcasts.

Etienne Nichols

00:16:39.740 - 00:16:48.100

I actually really liked your, your wording there because that, that just showed me how professional you are. They offer some regulatory improvements.

Kim Kaplan

00:16:48.260 - 00:16:48.860

Opportunities.

Etienne Nichols

00:16:48.860 - 00:17:12.620

Opportunities, yes, that's a better word.

If I was a company listening to this, I think I would be interested in knowing, okay, I get the time improvements, but how much does this program cost versus an FDA inspection? Just going the traditional route because we're used to the traditional route and a lot of times it's not so much. The good is the enemy of great.

But what are your thoughts there?

Kim Kaplan

00:17:12.780 - 00:18:27.200

Another great question.

So, we actually asked a lot of our early adopters to do a comparison of the amount of money, time and resource hours that it took to complete this process versus a typical inspection. Now, I will say one thing is that a lot of companies have told us we are really good at inspections. We do this all the time.

We have it down to a science. Right. So, there is a little bit of getting uncomfortable in something unfamiliar.

But what we have seen is that organizations have typically saved something like a thousand resource hours. Because we only need about six hours of time from the individuals we speak to during the week.

We aren't stopping production; we aren't disrupting the lines nearly as much. In terms of the number of people, it's typically much fewer. We don't use a back room and a front room.

So, there isn't like 70 people sitting somewhere waiting to help distribute that flow of information. So that's really helpful.

From a cost perspective, we've heard it's typically less, sometimes even half the cost depending on how large your site is and how in depth the inspections are. So, from those perspectives, yeah, that makes sense.

Etienne Nichols

00:18:27.920 - 00:18:58.620

Even not having the front room, back room, that's a. Maybe it's a necessary evil at times, but it seems like a huge inefficiency.

Maybe the CMMI model has an opinion on the front room, back room, I don't know. But can we talk a little bit more about the medical device specific issues and maybe, I mean, the project management side is really interesting.

I am a big proponent of going to other industries, looking at how they're doing things and bringing those learnings back. And it sounds like the CMMI model has the potential to really do a lot of that for the medical device industry. Would you agree?

Kim Kaplan

00:18:58.700 - 00:20:35.030

Absolutely. Yeah. So, the model itself I think I mentioned is industry agnostic. So, these are behaviors that really can apply to any organization.

In terms of some of the other specific challenges we've seen, I won't necessarily list them all.

I'll try to encourage people to maybe sign up for a white paper we're going to be putting out soon here where we're analyzing all of the data and sharing insights. I think we're going to try to do that on an annual or semi-annual basis to start.

But one of the areas where we see quite a few challenges is actually in managing performance and measurement. And specifically, it's in the idea of operational definitions. What are you measuring? Why are you measuring it? Who's measuring it?

How are they measuring it, when, how often, where is it located? So, all of this kind of metadata about the data.

This is an area that organizations don't have well defined and that people within an organization is often measuring the same data differently so that their numbers are not actually apples to apples.

Or it might be multiple sites within a larger organization that are measuring things differently and so they cannot actually see how the sites are comparing to one another. So, this is one of the big areas where we help organizations get aligned on.

You might be measuring a thousand things, but maybe only 10 of them are actually important and actually matter.

So how do you get it down to those things and make sure everyone understands what they are, where they are, how they're being measured, who's measuring them and so you can compare.

Etienne Nichols

00:20:35.670 - 00:20:52.980

Very interesting. When you were talking, it made me think, is there a size of company that this is best suited for?

Or maybe at this point it doesn't really make sense to do it at. Is there a maturity level that's built in the CMMI? But what are your thoughts is when is the best time to start pursuing something like this?

Kim Kaplan

00:20:53.620 - 00:22:27.560

That's a tough question because I want to say, everyone, come on in.

I think maybe it's challenging for a startup organization who's still trying to secure funding, still trying to get registered with the FDA, get their product off the ground, prove that it's viable. We're not really here to help yet. We're not yet here to help organizations get FDA registered and get off the ground.

Now I will say I do think the model could help prove out the sustainability of some of these companies, help them increase the likelihood that they'll be here to last.

But I would say really any size organization, we work with some companies that are only 17 people, and we work with some that have over 6,000 people at one location.

We work with multinational organizations, we'll even do things called multi-site appraisals where it might be, you have one site that does the R and D, another site that does the manufacturing, another one that does the packaging, labeling, distribution. You want to see the full product lifecycle. So, we'll include all three and they might be like one in California, one in Ireland and one in China.

So, we'll go to each one and do one appraisal that's less than the cost of three individual appraisals, but more than the cost of typically one location. So those are some benefits for larger organizations that really want to get that broader view across their company.

It's especially helpful if you've recently acquired an organization and trying to align them in with your broader Company culture, learn what works well from them that you might want to borrow and things that maybe you want to change.

Etienne Nichols

00:22:28.040 - 00:23:01.630

That's fantastic.

So, the companies that start doing this, I can see the benefit of understanding where you've been and the trends and the, the good, the bad and the ugly. It sounds like you'll get a. And maybe we could talk about the actual reporting or how, how that information's fed back to the company itself.

What do the companies, the best-in-class companies do with that? How do they actually implement that? Change management? Because change management is one of the hardest things in my experience to really make happen.

How do they actually apply some of those learnings?

Kim Kaplan

00:23:01.790 - 00:25:24.090

Yeah, absolutely. We provide them with all of the data back, obviously de-attributed.

So, we share a heat map where we show, hey, these are the practice areas and then these are the individual practices within them. And we give a red, yellow, green indicator to show, hey, this one is good. You're doing everything that's expected. This one could use some work.

And this is completely. Not even at your organization may want to consider that. So, we share that.

And then for each yellow or red, we provide what's called an opportunity statement. And so that's like the specific details of what we found and why addressing it will be of value to your organization. So that's the starting point.

After that, we help organizations do what's called an impact prioritization.

And one of the things I didn't mention about the key differences between an inspection and an appraisal is that we don't see the results as a corrective action list. You're not expected to address every single thing we find and bring it into green state.

So, what we want to do is figure out, okay, if we've identified 10 opportunities, which ones are going to have the biggest movement in your organization be the biggest bang for your buck. And maybe it's two, maybe it's only two things, and maybe one of them aligns with an existing project you're already working on.

And this sheds additional insight as to the direction you might want to go with that project.

So, after we do that, our lead appraiser will meet with your organization, usually someone who is sponsoring the appraisal, so someone who is at a higher level of leadership and can actually have the authority to provide funds and resources to support ongoing efforts.

So, we'll meet with them and usually some other project managers or leaders within the organization on a quarterly basis to how much progress have you made? What's the status of your projects? Do you need any additional education? Do you need some assistance? Do you need some consulting?

Here's what we're seeing. Working with other organizations in the industry. Would that be helpful to you?

So, we do a little bit of hand holding on a quarterly basis and that's a minimum. Some organizations want to meet on a monthly basis.

So, we meet them where they are and then after a year we come in and see what progress they've made.

Etienne Nichols

00:25:24.490 - 00:25:51.760

That's really cool. Going back to the FDA then if we go full circle, how does the FDA take that information? Because you said the regulatory opportunity.

I'm going to try to use the phrase correctly. The reg.

One of the regulatory opportunities was to forego an inspection, but I would assume that the FDA is only going to do that if you're at a certain level. Is there a threshold appraisal level that you need to be at in order for that to happen or what. What does that look like?

Kim Kaplan

00:25:51.760 - 00:26:53.560

That's a great question. That's a common question I get actually. And no, there is no minimal score you need to achieve to get access to these regulatory opportunities.

You're already compliant. And anything we find is not actionable by the FDA because it's not coming through one of their official inspections.

No, what FDA is looking for is engagement. And that's something.

If we see an issue where someone is not responding to an email, they're not showing up to their checkpoints, they're not taking action on anything because they don't think anything is of value, then that might create an escalation where we say, okay, you know what's going on? And sometimes leadership turnover. Right. Maybe we've had issues where during the pandemic companies had to completely shut down their operating lines.

Take a pause from everything. So, there are exceptions where we understand we give the, we give organizations the time and space they need to recuperate.

But if someone is just not in the program for the right reasons, then that would be a cause for to maybe escalate and say, is this really the right fit for your organization?

Etienne Nichols

00:26:55.320 - 00:27:07.880

Really good answer. This really interesting. Where can actually before I ask you the question, where can people find you and so on, I.

There's an FDA guidance that recently come came out. Can you speak to that just briefly?

Kim Kaplan

00:27:08.200 - 00:27:15.840

Yeah. FDA released draft guidance May of 22 or excuse me, 23. Was it 23? I'm losing track of my day.

Etienne Nichols

00:27:15.840 - 00:27:16.880

The years are running together.

Kim Kaplan

00:27:16.960 - 00:27:26.720

Final guidance came out September of 23 though. You can find that on FDA's website. You can just search FDA final guidance. Voluntary improvement program and it should show up.

Etienne Nichols

00:27:26.720 - 00:27:31.440

Okay. We'll put a link in the show notes as well. Where can people find you and learn more about this?

Kim Kaplan

00:27:31.920 - 00:27:51.980

Kimberly Kaplan. If you search that with ISACA or VIP, I should come up. Yeah, that's probably the best way to reach out to me.

If you have any questions, you can also go to our website, itaca.org, MDAP, which is the tailored version of CMMI, the Medical Device Discovery Appraisal Program.

Etienne Nichols

00:27:52.220 - 00:27:52.740

Okay.

Kim Kaplan

00:27:52.740 - 00:28:01.100

We don't really use MDAP as much in common vernacular now because we're trying to refer to the whole program, but that is the link.

Etienne Nichols

00:28:01.260 - 00:28:04.140

Okay. And ISACA being ISACA.

Kim Kaplan

00:28:04.460 - 00:28:05.020

Correct.

Etienne Nichols

00:28:05.180 - 00:28:17.880

Okay. All right, we'll put a link in the show notes as well.

For those of you listening, thank you so much for coming on the show, Kim, and we will let you get back to it. Those of you listening, you've been listening to the Global Medical Device Podcast. Thank you and we will see you next time.

Kim Kaplan

00:28:17.880 - 00:28:18.840

Thanks for having me.

Etienne Nichols

00:28:20.280 - 00:28:28.880

Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never.

Done that before, but if you're listening. On the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I. I read and respond to every. Message because hearing your feedback is the only way I'm going to get better.

Thanks again for listening and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.