“Instrument quality in an ocean of confusion.”
Our President and CEO, Matthew Gudeman, had the honor of being on the “Beyond Clean” podcast to discuss design controls with Hank Balch, Justin Poulin, and Michael Matthews. Read the transcript of the conversation below or listen to the whole interview here.
Matthew: I think quality sometimes comes with this connotation of a “delight factor”; it just feels right in my hands, or that clicking sound the device makes when I turn the rotation just sounds like quality. That’s nice, and it’s our job to delight our customers as much as we can, but Acceptance Criteria can be different from a “delight factor”. Acceptance Criteria are measurable specifications.
Announcer: Beyond Clean offers a creative look into the inner workings of a healthcare industry committed to getting it right, every instrument, every time. Join us every week as we explore the hidden world of one of the most important aspects of safe surgical care.
Announcer: And now, your hosts, Michael Matthews, Hank Balch and Justin Poulin.
Justin: This week on Beyond Clean we speak with Matthew Gudeman, President and CEO of Endoplus. Endoplus is a privately-held medical device manufacturer with distinct competencies specific to class 2 laparoscopic medical devices. Removing cost and complexity from the laparoscopic value stream is core to their mission. Endoplus is registered with the FDA and holds multiple 510(k) and patents for laparoscopic devices.
Justin: Gentlemen, this is going to get a little bit into the weeds. It’s an area I’m definitely involved in pretty regularly. It’s something that with all of the FDA updates that have been coming out recently, I know we’ll talk about that with Matthew as well, but with all of that talk and that chatter and really leaping off the interview with David Anbari, this will be another good episode for people that are fans of manufacturing and third-party repairs.
Michael: Yeah, and this is definitely new territory for me. I’ve moved out of the frontline end user world and into the third-party repair/vendor world. So learning about this whole other area that’s out there that we’re going to be discussing today is really exciting.
Hank: It really is one of those things, from the user perspective we hear the FDA is coming out with new documents, we know there’s buzz in the industry, like Justin said in regard to David Anbari’s episode that we did on the-right-to-repair. But there’s still a lot of confusion, a lot of questions. Hopefully, on today’s episode we can get some clarity from Matt to kind of bring it down to a level that’s accessible, and make it real for sterile processing technicians to walk away from this episode with some real knowledge on what impact these changes will have on their everyday life in sterile processing.
Justin: All right. Well, before we get started, just a reminder, you can follow Beyond Clean on Twitter, @BeyondCleanInfo. Go to Facebook.com/Beyond Clean Podcast, LinkedIn.com/Company/Beyond Clean. Find us on Instagram: Beyond Clean Podcast. We’re posting pictures anonymously, pictures of difficult-to-clean instruments, key points of inspection. We want you to be all part of that. So if you do have a picture for us, or maybe you’ve got a recommendation for a future topic or guest on the show, you can send us an email to Info@BeyondClean.net.
Justin: We’ll be right back with Matthew Gudeman, President and CEO of Endoplus. Joining us now is Matthew Gudeman, President and CEO of Endoplus. Matt, thanks for coming on the show. I know we had a chance to meet at IAHCSMM. Great event for us. I’m sure you had a great time as well. Excited to have you on the show.
Matthew: Thank you very much. I appreciate being brought on.
Justin: Yeah. And I know we’re going to talk about design controls and third-party repairs and really the changing FDA conversations in the industry today, really leaping off, I’d say, on an interview that we had with David Anbari several months back, and the FDA obviously taking a position on third-party repair recently. I’m sure a lot of our listeners have had a chance to see the FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. I think by the time this airs it’ll be a couple of months since it came out. But I kind of was hoping you’d set the table and tell us a little bit about design controls, what that term means and how it relates to the work you’re doing at Endoplus.
Matthew: Sure, I’d be pleased to. First, my paradigm, unlike that of David Anbari’s, is that of an OEM manufacturer which is not exempt from General Controls. We’ve (Endoplus) been designing and manufacturing laparoscopic instruments since the ‘90s. My review of both sides of this right-to-repair debate is certainly shaped by my experiences leading a medical device company that embraces General Controls.
Because the “Design Control Process” can seem intimidating, I think it helpful to normalize it by describing it as being about common sense. The Design Control Process is the intentional use of common sense. To understand it is to embrace it.
Michael: Along with the decision that just came out, well, by the time this airs it will have been a couple of months after the FDA made their decision, what might be the impact on industries such as yours on the larger conversation about third-party repairs?
Matthew: Well, in my opinion, some expectations were telegraphed in FDA’s report.
- Promote the Adoption of Quality Management Principles
- Clarify the Difference Between Servicing and Remanufacturing
- start gathering the evidence or data which the third-parties should then use to assess the quality and safety and effectiveness of medical device servicing.
I believe it hands the third-party repair industry an opportunity to be proactive, to independently begin taking steps to follow the CDRH, the Center for Devices in Radiological Health, who’s mission, which I think is a great mission, is to protect public health.
It appears the 3rd party repair industry has been given some expectations and a head start.
I’m paraphrasing terribly, but it seems as if FDA is saying, “Here, we’re going to give you a little time. Now you guys go out, and without us enforcing it, start taking steps to help us meet our mission, which is to protect and promote public health. In my experience, as an OEM whose facility and Quality Management System has been audited multiple times by FDA, the CDHR is true to this mission.
I’m not sure if I answered your question.
Justin: No, you did. And, Matt, I think … I’m looking at this report and you actually sent us some information to brush up on before the interview, and I know you were just kind of alluding to this a little bit, but I’m going to read the quote from the report: “Numerous definitions have been used and proposed for key terms associated with servicing, including refurbishing, reconditioning, rebuilding, remarketing, and remanufacturing.” Then, they gave us some working definitions as part of a public workshop from October in 2016. I know, really, you wanted to focus a lot on design controls relating to those definitions. I think that’s a great place to kind of segue to that third-party and take that dive there, because it’s a great point: there have been a lot of different definitions. I kind of liken it to decontamination. It’s not necessarily meaning disinfection, so it’s one of those general terms. I think what the FDA is trying to do here is provide some structure and context to the conversation.
Matthew: Mm-hmm (affirmative), yeah. I’m going to take a go at design controls by putting it in the context of a tree swing. I think every one of us probably as a kid has played on a tree swing.
I started by saying that design controls is really a process about being intentional to use common sense.
So the design control process asks and captures some fundamental questions like, “What are the user’s needs?” In our case, reusable laparoscopic devices must withstand repeated cleaning and sterilization if we are to claim it is a reusable laparoscopic device. Some more of the types of questions are “What are the intended uses?” and “What are some specified requirements?” So it (the Design Control Process) leads you to ask specific questions which forces you to think through things that you would want to know.
Some fundamental activities of design control that I make it so powerful are design verification and the design validation. So, design verification is where you confirm that the design … that the outputs meet the inputs. If, for instance, I say it needs to do X, does it? Then, design validation is where you put your arms around that whole project at the very end and you say, “Guys, can we prove that this device does what it’s supposed to do?”
Matthew: Really simple concepts…there are details within those processes which can get complex, and that is OK, but the overall concept is really good. Endoplus doesn’t resent this regulation on us as a medical device OEM, but rather we’ve embraced it because it is the right way to do business. From my perspective in this conversation on right-to-repair, it would seem that a robust Design Control Process should be pre-requisite for performing repairs to medical devices.
Hank: So, Matt, bringing us down to the customer level then, I’m seeing these documents come out from the FDA and I’m seeing this intermural debate between OEMs and third-party repair, and I’m sitting here as a customer wondering, “What does all of this have to do with me?” I know it sounds like you’re supportive of at least the mission and the direction of some of these documents, but I’m still unclear exactly the impact this is going to have to frontline technicians in the field.
Matthew: Well, that’s a good question. I had begun discussing design controls in the context of a tree swing. So I’m going to hit a few more points about design controls using this example.
You’ve got design inputs. The example is a tree swing would be reusable. The swing shouldn’t leave splinters in the kids’ hands, and let’s just say we’re planning on a swing to withstand the weight of 12 eight-year-olds when there’s a birthday party and all 12 of them decide to get on it. So you’ve got a weight load of say 1,400 pounds. So starting this design project you could start out with a hazard analysis, which is very high level. You’ve going to document what could go wrong with the tree swing. In the interested of time, here might be a few examples, “One, let’s say if you put the swing on too weak of a branch, the branch could break and fall and it could injure, or worse, could kill a child. There is also design failure mode and effects analysis. This is where your team thinks and documents as many possible failure modes of each component you can conceive. You break it down to a component level. You’ve got your building material, your prints. You think of anything and everything that could go wrong.
Here’s an example. The UV light from the sun could cause the rope to fail prematurely. Who would have thought of that? Then you go to process failure mode and you document all of the processes, all the possible failure modes in each manufacturing and assembly processes that could go wrong. So we’ve got a seat on this thing. We’ve got a 12-inch by 6-inch by 1-inch-thick slab of oak that we’re going to make into a seat. Well, we said we don’t like splinters, but do you think that our sanding process could maybe compromise the structural integrity of the seat? If we sand it too much will the board get so thin that it breaks? So you methodically move on through this whole process. You’re documenting the whole time, you’re coming up with inputs and you’re coming up with things that’ll mitigate the risks you’ve identified.
Then, you get into design verification. By this point, you’ve got your prints, you’ve got some components, you’ve either bought them or built them, now you’re comparing your print dimensions to the part dimensions. Then, you get into process validation, which is saying, “Okay, we said that it could be a problem with this sander. Let’s actually do it. Let’s actually sand some seats and see if the controls are good on this process for putting out seats on our swing that are not going to break, that we don’t ever over-sand or under-sand seat, so seats are not too splintery and strong…that everything works.”
Then, finally, there’s the design validation. That’s where you say, “Can we prove that this finished device performs as designed?” You make a test, you provide data which proves that the swing is reusable, you design a test that proves that the swing won’t leave splinters in their hands or their bottoms, you prove that this swing will repeatedly support 1,400 pounds of swinging humanity.
Those are some fundamental, very high level aspects of a design control. Now how does that apply to a repair? So in our situation, the question I would have if we go back to these definitions that you mentioned, the FDA specifically said, “Hey, let’s get some clarity on the difference between servicing and remanufacturing.” So part of that servicing definition says, “Service includes refurbishing, reconditioning, rebuilding, repairing or remarketing, but not manufacturing.” Remanufacturing on the other side, FDA gives that a little bit more of a weighty definition, and they seem to be saying that is what you’re doing if you renovate, restore or any other act done to a finished device that significantly changes the device’s performance.
Here’s my point: as an OEM, we go through all of this work to make sure that we produce something that’s not going to fail, and if there are failure modes, that we’re mitigating them. There’s no reason anyone repairing a device can’t follow the design control process.
Part of my angst is seeing devices coming back to Endoplus that have clearly been modified by a third-party where liberties have been taken which make the device less safe. Does that make sense?
Hank: It does. Let me follow up on that then so we can stick with your swing analogy. So I’m the consumer, I buy this swing, and it’s been vetted in all of those ways that you’re talking about, I’ve got a buddy who is a great woodworker and I say, “Hey, would you cut some holes in this swing so my kid can be a little more aerodynamic?” And he’s like, “Oh, sure, I can do that.” Then, it breaks and I send it back to the manufacturer to say, “Hey, I got a faulty swing. What’s going on here?” Is that similar to what you’re saying there where you’re seeing modifications that perhaps have not been vetted in all those ways that you’re referencing, compromising what would otherwise be an original product with all the original safety built in?
Matthew: Yeah, there is. But I think it begs the next step in the progression. Rather than us just sitting here and arguing with each other, the OEMs saying how stupid the third-parties are and all that, and going back and forth, what is the next step?
I say don’t assume that companies in the repair space can either be compliant or productive, but not both. Compliant or profitable, but not both.
So I actually consider the third-party repair industry to be our customers. We work with several of them. Increasingly, I’m coming to them and saying, “How can we help you?” More so than just providing components, but how can we help you to come up with solutions across the board that will meet the interests of the CDHR to provide devices that are going to be safe? And a critical tool that accomplish this, in my opinion, is design controls.
Michael: So, Matt, along kind of those same lines then, I guess the question … it really kind of comes down to a question of quality. Along with that is, you know, when we talk about quality in the manufacturing or the repair of a product, are we talking about just an individual’s preference? Or are we talking about an objective standard? And if we’re talking about an objective standard, who’s measuring it and how are they measuring it?
Matthew: Yeah, that’s also a good question. I think quality sometimes comes with this connotation of a delight factor, you know, it just feels right in my hands, or that clicking sound that it makes when I turn the rotation just sounds like quality. That’s nice, and it’s our job to delight our customers as much as we can. But Acceptance Criteria can be different. Acceptance criteria are measurable specifications.
So, with regard to Quality vs. Acceptance Criteria, I’m not saying Quality is not important. I am saying that Acceptance Criteria is very important and here is an example of why: If changes are made to the design of a lap instrument, which is exactly what happens when a repair company replaces OEM shaft insulation with a different type of shaft insulation, don’t you think that repaired medical device should meet the claims made in the Manufacturer’s IFU? Manufacturers can’t make claims they can’t support, which is a reason they validate. Continuing with this example, if a Manufacturer’s IFU contains a written warning not to exceed maximum output voltage of 2,000 volts, and if the replacement shaft insulation on the repaired device can fail at 1,500 volts…is that OK? OEM specifications are important.
Justin: Yeah, that’s a great point, Matt. What’s the true possibility of getting conformance here? And what are the barriers from that vendor perspective of obtaining conformance?
Matthew: The CDHR has a pretty good mission to protect and promote public health, and I can say from experience that compliance with the CDRH’s regulations, including but not limited to design controls, produces good results.
The FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices says “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system
So, it would seem to me that the writing is on the wall.
Generally speaking, It is my observations that OEMs who have had regulation imposed on them have figured out how to be profitable and productive while producing some pretty effective medical device solutions, so it obviously can be done, and I’m aware of no good reason why third-parties should continue to be exempt from operating under the same regulation as OEMs. Endoplus is an OEM with capabilities, competencies, and capacity to do the right thing.
Justin: Well, and I know, and I’ll just piggyback off that as we close, but I know there are some states that make it law that those specifications are made available. And I know it’s not national. I know it’s not dictated by the FDA, but state law, I think it’s two states, but I know of at least one that requires the specifications be made available. A lot of that I think came from biomed departments. Not really surgical, maybe not the surgical instrument industry, but a lot of bigger capital equipment pieces and how much biomed ends up servicing that at different hospitals. And they knew that there’s a way to control costs and also maintain patient safety by making that a state law.
So maybe if that continues to be a common practice around the country you won’t be necessarily as alone in your stance on that as a manufacturer. Working for a third-party service organization, I’d say thank you very much for taking that angle.
Matthew: You’re welcome and, by the way, I really have to commend you on doing your research for this podcast. For you to go and get your appendix out prior to this recording just so that you could better understand the customer experience of a laparoscopic surgery…I really applaud you for doing that.
Hank: Hey, my pleasure. Put a couple extra dollars in the healthcare industry here in the US, yep.
Matthew: You got it. Well, our pleasure to be a part of this conversation, and perhaps a part of the solution. It is an honor. After all, we get to work in an economy which is the envy of the world. We enjoy great healthcare, and I think it is incumbent upon us to do what we can to figure this out.
Justin: Excellent, Matt. Thank you for coming on the show today.
Matthew: Our pleasure. Thanks for having me, guys.
Justin: That was Matthew Gudeman, President and CEO of Endoplus, talking about design controls and why they matter in the surgical instrument industry. I think it’s always helpful, especially with topics like this that can get a little bit into the weeds, and obviously Matthew is an expert, knows his business, but it’s great when we can get some sort of an analogy to really illuminate some of the key points in the discussion for the listeners.
Justin: Hank, Mike, I definitely am interested to keep an eye on this whole FDA and their involvement in third-party repairs, and also, kind of what I mentioned there at the end, but just state legislature about making the specifications available to biomed and third-party servicing organizations.
Hank: Yeah, Justin. It’s such a different world on the other side of the fence from the sterile processing, surgical professional side of things. We see the product come in our doors and we see it come in new, we see new innovations come out. Then, to hear a little bit more about what actually happens on the front end, and then how that impacts, as we brought out in this conversation, how it impacts questions about third-party repairs.
Hank: I really liked the specific highlight that he talked about in terms of objective quality; that it’s not just a look or a feel, but it’s something that can truly be measured and then measured against. I really found that to be helpful.
Michael: I think what it really all boils down to for our listeners who are sitting in their departments trying to figure out what these things mean is that it gives us tools to be able to interact with manufacturers and repair services and really try to distinguish between who is doing very good quality work and who is just out there trying to make a paycheck.
Michael: Anytime we can have some more ammunition to try and sort through the different qualities that are available out there it’s going to have an impact on our ability to run departments.
Justin: You know, Hank, I thought we were going to get through that show without mentioning your personal experience recently having your appendix removed, but Matthew had your number on this episode. That was kind of funny.
Hank: Yeah, that’s right. I was actually thinking as we got started with that episode, as he’s talking about laparoscopic devices and I’m sitting here, you know, in my own article that I wrote in reflecting on my appendectomy, I was a patient and I was sitting there with all the thoughts coming out on the sterile processing side of things that I could be concerned about. But it also hit me with the same reality that every other patient feels, is, “Well, I’m here and I need to trust the process and trust the quality,” not only in the hospital setting, but it goes back into this specific conversation that we had with Matt, is, “I need to trust the manufacturer, I need to trust the repair vendor, whoever that is for this facility,” all kinds of levels of trust that our patients either knowingly, like in my case, or unknowingly trust the system. So many lives depend on us getting it right.
Hank: So every episode that we do on the podcast is so important, not only for us to grow as an industry, but also to keep patients like us safe.
Justin: Yeah, and Bob Marrs also shared a similar, well, experiences on his interview. So if anybody on that theme wants to hear the voice of somebody who’s been through what Hank’s been through, but also has been in the positions as a manager and a sterile processing leader, that Bob Marrs episode is an excellent one as well. But that is going to do it for this week’s show.