How ‘Ollie the Biomed’ Is Reaching HTM’s Next Generation 

Keri:

Hi. Welcome to the MEDQOR Podcast Network. This is Keri Stephens, the chief editor of 24×7. Thank you for joining me for this podcast episode. I’m so excited to have Wayne Moore with me today to delve into the right to repair. Wayne is a CEO of Acertara Acoustic Laboratories and the 2022 Chair of the Ultrasound section of MITA as well as a 2022 chair of the Service Committee for MITA. Wayne, thank you for joining me today.

Wayne:

Thank you, Keri. It’s good to be here.

Keri:

Yeah, no. We’re really happy to have you, and to start I want to talk about how you have a very unique perspective in regards to the right to repair, and can you talk about that a bit?

Wayne:

Sure. We’re kind of at the intersection of the right to repair issue in that we are a third party service repair company, Acertara is, so we’re unique in that respect that we’re a third party service repair company and we’re simultaneously chair of the Service Committee for MITA, which is primarily an OEM based advocacy group for medical imaging, and so we are also in the regulatory sphere in that the FDA is a customer of ours.

Wayne:

The OEMs are customers of ours, hospitals, third party service providers, so we get to see this whole issue kind of play out from multiple perspectives. Then we have our own perspective on it as well, so I think that certainly puts us in a very unique position and I get asked to give a lot of presentations on right to repair from various entities like regulatory as well as OEM as well as third party groups. We get to hear all the stories and participate in them, so I think that puts us into a really unique category with regard to that.

Keri:

Absolutely, so what do you think about it? What is your perspective?

Wayne:

I have the advantage of being old enough to have participated in the first right to repair activity that occurred back in the late 1990s, and that’s when I was starting in Sonora, and I think we started Sonora about the same time you guys started 24×7.

Keri:

1996.

Wayne:

Yeah, 1996. At that point there was a lot of discussion about remanufacturing and third party service providers being regulated by the FDA, and it caused a lot of commotion like it has this time as well. Finally the FDA basically just said they were going to punt that and not do anything about it at that particular time. Well, they punted it and it was the longest punt I’ve ever seen because it didn’t resurrect again until six years ago, 6 1/2 years ago, so that 15-yard punt, or 15-year punt. That’s pretty good.

Wayne:

I came into it understanding the historical background, what the issues were at that particular time, and here we are 6 1/2 years later since the second round of the right to repair issue and third party service issue with the FDA commenced and we’re still no farther down the line than we were 6 1/2 years ago. The FDA still hasn’t come out with its remanufacturing guidance, et cetera, and there’s been a lot of misinformation, a lot of misunderstandings that have been going around that have colored this into kind of a zero sum game, and we don’t see it like that. As a third party service provider, we see ourselves partnering with OEMs, partnering with hospitals, partnering with regulatory groups.

Wayne:

There is a way to do it. There is a right way to do it, and so we don’t look at it like that. We don’t get into the name calling exercises that unfortunately taint this whole discussion and kind of put it as a Hatfields and McCoy feud rather than hey, let’s work together to see what we can do to make this thing actually benefit hospitals, benefit biomedical engineers, third party companies, remanufacturers, and the manufacturers. That’s where we stand and that’s why I have been such an advocate in trying to bring all of these things together, and some success and some not so successful.

Keri:

Yeah. I know for us especially, whenever we talk about the right to repair it is such a contentious issue and I don’t think anything gets people as mad. Anytime we have an article on right to repair there’s always such different sides and that’s why I wanted you on the podcast because you bring such a unique perspective to this because yes, you are working with MITA, and you are a third party provider, service provider, so it’s these two different views, but I mean, you talk about working together for the good of the patient, coming together. How can we come together on this, because it is so contentious?

Wayne:

Well, that’s a great question. I think the first thing is is for everybody just to sit down, take a deep breath and say look. We’re all working for the same thing. This is about lowering the costs that hospitals pay, overall costs, not just a transactional cost. I mean, anybody can go in and do a service call for 50 bucks less than the next guy, but is that a long-term successful strategy that’s going to help the financial issues that hospitals face right now? It’s not clear to me. I’m not convinced of that, that that can happen. It takes what’s the life cycle cost of repairing that system, and I just can only speak to medical imaging devices, the real high-tech devices like MR and CT, NukMed and ultrasound, of course, which I’m primarily vested in.

Wayne:

But there’s a lot more that goes into calculating what the cost of ownership is over the life cycle of the product than just a one-off repair thing that might happen, a break/fix kind of an issue. I think it’s the realization of let’s really talk about how we can save hospitals money, how we can alleviate some of the apprehension of having unregulated repair providers going into hospitals and performing repairs that may or may not be in the best interests of the patient in the hospital, and also the regulatory issues.

Wayne:

Until we can get to that, so the one side that I’m on, the third party side, unfortunately too often says that the OEMs are only in it for the money, which that’s of course absurd. It’s just not accurate and it causes consternation for sure. Then they say the OEMs are against third parties. Well, that’s kind of odd because I’m a third party and I’m the chair of the service section for MITA, so if they were against us I’m not sure why they’d put me in as chair of that. They’re interested in the same things everybody else is.

Keri:

Does that ever feel weird, though, to be working with MITA and then have such a differing perspective from most of the industry? That must be interesting. I want to hear about that.

Wayne:

Well, it is interesting, especially when I see some of the conversations going on back and forth. Some people may say well, the OEMs are in some dark, smoke-filled room cutting deals with Congress and stuff like that. Well, I’m in on every meeting and I’m yet to be in that dark and smoke-filled room where all the real deals are getting cut and stuff like that. Everybody’s working really hard. OEMs have congresspeople that they work with. Third parties have congresspeople they work with, and so we’ve got to calm down, I think, on the rhetoric first and the blaming and stuff like that because I see the OEMs operate, on a weekly basis we have a meeting for MITA and the service committee, and they have the utmost respect for service providers who are 13485 certified and doing the right thing, and have that good history.

Wayne:

They use them, right? But the OEMs go through, in the absence of any FDA guidance, when the OEMs contract with a third party service organization like us, they come in and they go through our quality management system with a fine tooth comb before they will allow us to do any of the work for them, because after all, at the end of the day it’s their name that’s still on the machine or still on the ultrasound probe, and they want to make sure that their brand isn’t injured as well. OEMs have never said that they’re against third party service. I defy anyone to show me that sentence.

Wayne:

What they’ve consistently said and what I’ve consistently been part of was they are against unregulated third party service. I am too. I’m against that. I think that it’s in the best interest of the patient that companies have full transparency with their quality management system and they adhere to it, and so that’s kind of the perspective I bring from them. I see the other side too from third parties. Sometimes it can be very difficult to work with an individual OEM, for sure. Not all OEMs are willing and ready and able to just turn over all of their service stuff at basically cost to third party service providers without any kind of accountability. That’s just not going to work.

Wayne:

There’s still got to be a lot of give and take between the two entities, and then I put on my regulatory hat and I see the FDA just basically throwing up their hands and saying they’re going to be damned if they do and damned if they don’t, no matter which way they go. They’re going to be yelled at by somebody, right? It’s that kind of a situation that we find ourselves in. It’s going to be very difficult to get out of that situation, and I think it’s going to take something like an act of Congress or enforcement by the FDA to really break the stalemate. That’s my opinion where we’re at right now.

Wayne:

I think it will not be handled with handshakes. They tried with the collaborative community and that didn’t work for a lot of reasons. If you ask the third parties it was the OEMs’ fault. If you ask the OEMs it’s the third parties’ fault. If you ask the FDA they go we don’t assign blame, but we still have to get back to that kind of a situation where the organizations can come together and say okay, here’s the way it’s going to be, and everybody agrees on it. Of course the other thing that got thrown into the mix at the very beginning is somehow, and I’m not sure exactly when it happened, the HTMs started thinking that somehow the third party service applied to them, which it doesn’t.

Wayne:

An HTM, who works directly for the hospital, as everyone knows in contract law, there’s two parties to a contract, party of the first part and party of the second part. We’ve heard that on TV for 50 years, right? If you’re an employee, full-time employee of the hospital, you’re already party to the contract that exists between the OEM and the hospital, so they’re not third party servicers and the HTM, if the hospital tells their employee we want you to try and fix this, they can do it. There’s no law against them doing that. The issues come if they break it or if there’s a patient event. Then that invites the scrutiny, obviously, of the FDA inside the hospital, but as long as they’re repairing their own equipment and not returning it back into interstate commerce, then they are acting as the second part of that contract. But the HTMs have been very instrumental in certainly the last few years in being advocating for third party service repair.

Keri:

Yeah, and one thing I continually hear, just on the flip side, to be devil’s advocate, a lot of our readers have said this is the OEMs trying to get money. This is not about safety. This is about money. What is your reaction to that?

Wayne:

Well, like I said, everybody has to make a profit. Show me a third party service company that’s not charging for doing their service. Everybody charges for doing their service and I can’t speak, nor would I even attempt to speak for all the OEMs, but I can tell you from a MITA perspective, which is only the imaging devices, so infusion pumps or patient monitors I have no understanding of how OEMs treat everybody regarding those devices. But from the OEM perspective, these people have family. They have family that gets treated for medical conditions. They go to oncology and they get MRIs and they get ultrasounds, et cetera like that. They’re not in it to bankrupt the hospital.

Wayne:

Their strong motivation, certainly from an engineering perspective, and I’m an engineer, used to work for Siemens, and from the engineering perspective it’s about creating new and wonderful technologies that can be used to detect disease earlier. That’s what motivates a lot of the OEM personnel, for sure, the employees, to get out of bed every morning thinking they may be part of developing the next system that will diagnose cancer at the cellular level and allow treatment. That’s what gets people going. They’re not checking their stock portfolios every morning to see if they can carve another two pennies out of a product. Yeah, they make a profit off of service just like third parties do.

Keri:

Earlier in this you mentioned the FDA collaborative communities, which we wrote about several years ago, I guess maybe two years ago, and that was the thing. Help solve the contention between the right to repair and just make everyone happier, maybe Kumbaya, I don’t know, but that was definitely the vibe it was giving off in the beginning, and why do you think it didn’t work?

Wayne:

That’s a great question. Again, this is my own opinion, but the reason I think it didn’t work was the FDA did not take a leadership position in the collaborative community. I mean, it’s like tying two cats’ tails together and throwing them over a clothesline, right? There’s going to be a lot of fighting going on, more fighting than Kumbaya moments. With the FDA not taking a leadership position, in my view it was doomed from the beginning, okay? Because any time, if you read anything at Harvard Business Review, anywhere, about collaborative communities, without strong leadership they’re always doomed. Companies fight each other. That’s the way it goes, and without somebody in there in a strong leadership position, driving toward an end result, had no shot.

Wayne:

The OEMs are very process driven, at least I can say for the OEMs I am familiar, very process driven. They take a long time to make decisions. When they do make a decision, they stick with it for a long time as well. Third parties, I’m an entrepreneur, we like to make decisions in a few minutes, and that’s how sometimes we run our business and create new business, is by making decisions in a very fast manner. When you have people that want to get something done right away and others that are being guided by the upper management within an organization to take a slow, methodical, let’s get it right process together, it makes one company, or one entity, look like they’re dragging their feet and the other one like they’re way too quick to pull the trigger on something.

Wayne:

Again, without that central leadership position from the FDA, that’s what we found ourselves in. The third parties said the OEMs can’t get past the processes and the OEMs were saying decisions can’t be made that quickly because they’re the producers. They got to go back and implement all this within a massive organization and get it socialized within the organization, get it integrated within all the processes and procedures. It’s not limited just to the United States, but it has to go throughout the world, certainly with the imaging devices. The same kind of issues with CE labeling and other regulatory issues that occur in different countries.

Wayne:

The local service organization like me, I might worry about a particular market segment just in the United States, but Siemens operates in 161 different countries around the world with a lot of different regulations and everything. To take what we do here and to just integrate it into that doesn’t work. It takes a lot longer for OEMs to make those kind of decisions and see how they’re going to integrate it into their aggregate business. I think it may not be possible, but if you could limit it to North America or just the United States, I think it would be a lot easier, but that’s really not how it works within large OEMs.

Keri:

For a final question, what else do you want to tell 24×7 listeners about the right to repair, and just your unique perspective or any misconceptions from the MITA perspective that you want to clear up?

Wayne:

I think what happens is, at least, again, from my perspective, it still gets back to the rhetoric and these seminars that are held at various regional and national meetings for biomedical engineers and only having one perspective talked about up on the stage or the presenter or if there is a couple of presenters, and not hearing about some of the issues that the OEMs have to face as well and get that put out there.

Wayne:

Some of them, unfortunately, some of these meetings that I have attended have been “let’s bash the OEM,” and I think that’s what stirs up even more kind of resentment and alienation between the two groups. If we can get that toned down and maybe have equal representation on some of these talks so that people can hear both sides of the equation. It’s famous in the legal profession, you know, that there are three sides to every story: your side, my side, and the truth. If you’re only getting one side of the story then you’re missing out on the other two-thirds of it. That’s what I would like to see happen, and I think it would go a long way to bringing the groups back together again.

Keri:

That is a great statement. Well, thank you so much, Wayne. We really appreciate what you’ve shared with us today, and we hope it’s really informative for our listeners. To check out the latest of 24×7, please visit 24x7mag.com. Until next time, take care. Thank you.

Wayne:

Take care.