Read the Full Video Transcript

Diane Newman: Welcome. I'm Diane Newman. I'm a Nurse Practitioner. I am Adjunct Professor of Urology and Surgery at the University of Pennsylvania, and I specialize in, when I say lower urinary tract dysfunction. I've been practicing in the field of urology since 1986, so well over 30 years. And I see patients who have bladder dysfunction. They may either have incontinence where they cannot control their bladder, or they may have something we call urinary retention, or incomplete bladder emptying where they need a device to actually empty their bladder because they cannot urinate on their own.

I'm very pleased today because I have with me a guest, Don Darais, who's the Associate Director of US Marketing for ConvaTec and I'm going to ask him to explain to us exactly what his role is within the company and kind of some current advancement in technology with his products. Thanks for coming, Don.

Don Darais: Yeah, thanks for having me.

Diane Newman: Tell us a little bit about yourself.

Don Darais: I've been with ConvaTec almost 11 years now. I'm the Associate Director of our US marketing for Continence Care. So we are a medical device manufacturing company. We manufacture intermittent catheters, ostomy products, advanced wound care infusion sets, I've had the privilege to wear many different hats throughout my career talking directly to end users, healthcare providers, our channel team members. ConvaTec's kind of going through a journey right now. So we've got a new emphasis on forever caring, and that really embraces everything that we do from when the patient starts their journey to when they end their journey with whatever they need in between, beginning to end. And any touchpoints that they may have as well with healthcare providers or another DME company.

Diane Newman: Well, I'm interested in the fact that, you say continence care, which is interesting as opposed to incontinence, and part of that continence care is bladder management, because you actually have some fantastic products as far as urinary catheters, for men and women who really can't empty their bladder. Who have maybe urinary retention and they may have to catheterize several times a day. Is that what we're talking about, intermittent catheterization?

Don Darais: Yeah, so you're absolutely right. There's a incontinence and then there's the continence side. And incontinence deals a lot more with diapers, pads, those types of things, which a lot of people are very familiar with. But we manufacture directly, so we have two intermittent catheter brands under the ConvaTec umbrella. So we have our Cure medical brand, which we acquired Cure in early 2021. It's been an amazing integration with Cure and GentleCath. And then we have our legacy brand GentleCath with our FeelClean™ Technology, and we continue to really focus on that and develop new products and really expand, not just in the US but in other markets as well.

Diane Newman: Advancement of technology in this area is very important, right? Because men and women use catheters for intermittently several times a day. And what we're seeing in this field is the fact that they're using it many, many years because we have such great medicine and technology as far as to make bladder management something that people can live with. But I'm interested in the fact that I think that you're now developing some new coding, and I want you to explain that a little bit because I have been practicing for many years, and it's only been probably the past few years, I've really understood what is in that catheter that I may be prescribing for an individual patient. So talk to me a little bit about... And our audience, about the technology, about FeelClean™ Technology.

Don Darais: Yeah, well FeelClean™. I'm super passionate about it because I actually do think it's the next generation of intermittent catheters. So years ago we saw an uncoated catheters, even prior to that, we saw a lot of red rubber latex catheters, and then we evolved into this more plastic clear product that patients had to lubricate themselves. And then we developed, which this was a breakthrough in the intermittent catheter technology back then, the coated hydrophilic catheters. So basically what a manufacturer would do is they would take an uncoated catheter and then they would have hydrophilic properties and they would either dip or spray that hydrophilic properties onto the catheter. And then what would happen is if the catheter touched water, it would become very, very slippery. But what we did is actually we took the hydrophilic properties, we were able to actually remove some of the properties in them, and we took the water-loving properties and embedded it or integrated it into the product itself.

So I think what makes it a big difference is the fact that a lot of people think that cathing is really just to drain the urine. You're halfway done at that point, you've got to insert the catheter, but it's just as important upon insertion as removal is, that the catheter is just as lubricious coming out as it is going in. So our technology is really here to protect that urethral mucosa and make sure that we're reducing any chances of urinary tract infections by reducing chances of microtrauma, micro tears, any type of trauma that's happening inside of the urethra.

Diane Newman: And you use the term lubricious, and what we're talking about is we want that catheterization to be smooth going into the bladder and actually smooth without any kind of difficulty when it's removed. Correct?

Don Darais: Right.

Diane Newman: And that's really a challenge, especially for someone who's doing it several times a day.

Don Darais: Right.

Diane Newman: Now, the other thing that I'm really fascinated with is you are really getting involved in patient education, right?

Don Darais: Yes.

Diane Newman: That's been more and more of a focus of ConvaTec, but also other companies that have intermittent catheters that they produce and of course have for patients. Tell us a little bit about those challenges with educating patients.

Don Darais: Well, we did a study years ago, and when we rebranded ConvaTec, where we talked to both healthcare providers and also end users. And we saw a very interesting similarity of what both of them are saying. Healthcare providers said that they wish they could spend more time with their patients and educate them more, but due to time constraints and just being overbooked, understaffed, really, it was a very big challenge for healthcare providers to provide the level of education that they want. And then on the other hand, patients also said that they need more information, they need more insights and education especially in the beginning when they're first starting cathing. 'Cause if you think about it, a lot of patients go through this journey where something's happened, something's changed in their day-to-day routine where they can't go to the bathroom or maybe they're feeling ill. So they go to the doctor and their doctor is explaining to them of all these things that's happening.

And then at the end of it, they kind of say, "Hey, you've got to use an intermittent catheter." A lot of times patients have this big obstacle that's put in front of them, and they have a really hard time thinking of, okay, how am I going to do this day to day? And just like you mentioned, a lot of them have to do it multiple times a day, anywhere from three to five, to sometimes seven times a day. So that can be a big barrier for patients to overcome.

So what we're really doing is developing education and resources so that way, A, we can help support the healthcare providers and their journey and their process of providing that extra level of tools, and information, and resources, but also giving that extra care to patients. So here at ConvaTec, we actually think it's important to have urology nurses on staff. So we have our me+™ program, which is an educational program that patients and healthcare providers can take advantage of. And a part of our me+™ team, we have a nurse, a urology nurse, and she's certified in pediatrics. She is just a tremendous resource. And so it's super important, I think that the industry really steps up and kind of helps fill the gap there.

Diane Newman: Now Don, your background, I think you started actually with a manufacturer as far as a distributor, that's where you started with, right?

Don Darais: Yeah.

Diane Newman: So you probably have seen it from the beginning as far as how to get that catheter to the patient as well as now as far as development of technology within ConvaTec itself, what do you find then? How many staff do you deal with? You know you have salespeople all over the country, right?

Don Darais: Yeah. So I mean, ConvaTec, we've got about 9,000 employees globally. Continence care, we actually are much smaller than that. I think we have around a hundred-ish globally for continence care as a business unit. But you're right, I started on the phones talking directly to patients, and that was really eye-opening to me. I make a joke all the time that if you would've told me 11 years ago, I knew this much about intermittent catheters, I would've asked what's an intermittent catheter? But I talked to patients and I really realized that there's not a lot of resources. They have so many questions, and when they're taught in the office and then they go home, those are two different settings. And a lot of times, even just in the maybe two hours between office teaching and they've got to do it at home, they forget a lot of information.

And then on top of that, they've been given a lot of news that maybe they didn't soak in all the information the doctor was giving them. So that was one of the things that really attracted me to the urology space and to the patients, because I really did feel like I got to have an opportunity to help people and really walk them through the journey. And during those setup calls, we would talk all the time, men talking about, this thing is 16 inches long, I've got to go to work, I travel, I've got dinner plans tonight. I mean, how am I supposed to conceal this product? So that was always a joy to brainstorm and really talk with them about ways that they could overcome that fear and live just a normal life again.

Diane Newman: Well, I know that, you listened to us as far as the nurses, that are teaching this and what our ideas about why we like or dislike a certain catheter. And then of course, you're listening to patients also, how long does it take, what period of time does it take before you have... For instance, let's take someone who's going to work every day, so they need more of a compact, right? A product that they can be discreet with so that everybody doesn't know that they have to catheterize. How long does it take to really develop these products, I guess in several years?

Don Darais: It can, yeah, it really depends, I think, on the product as well. But the product lifecycle journey can really take anywhere from 12 to 24 months. And then depending on the type of product, I mean even longer than that, this is a highly regulated industry as it should be because patients are using these products, they're putting them inside of their body. So it's extremely important that we get it right the first time, and that the products are safe to use every single time. So it takes a while. And I think what's also really important, and what I love about ConvaTec is that we actually take the time and the extra steps to listen to healthcare providers, listen to patients, to hear, okay, what obstacles are they facing right now with the current products they're using? How can we overcome those? What can we do and develop to make their lives easier? And again, I think that goes back to what we were seeing with healthcare providers of providing that extra care, even on an educational side. There's also a product development side that we can help with that too.

Diane Newman: Now, tell me, now, these products, they go to the FDA for approval, right?

Don Darais: Yep.

Diane Newman: Yeah. Now, so whenever we see the products, say in my urology office, that has been approved by the FDA?

Don Darais: Exactly.

Diane Newman: But it's because it's similar to another catheter. Correct. Do you have to then get new approval for, say, a new coating on the surface of the catheter? What is the process for that?

Don Darais: That's a good question. So we do submit them to the FDA. So if we are seeing them in the office, or if a patient's already seeing them online and available through their distributor, then they're approved by the FDA. So we go through the 510(k) process through the FDA since there's been a lot of other products there. So yeah, we're able to take advantage of the kind of legacy products and go through a 510(k) process through that. But it's reviewed and approved by the FDA, and we make sure that we've got all of the informational, the product descriptions, ingredients, all that stuff that it's provided to the FDA so they can make a good decision, well-educated decision.

Diane Newman: Okay. So say a clinician has a concern or something happens with a certain, say maybe it's one of ConvaTec's catheters or any catheter, what should they do? Should they contact the company? Because I always worry about that. How do we get that information back to the person who's really making these products?

Don Darais: That's a great question. So we take any type of potential product complaints or any product issues, even if it's just a user error or off-label use, we want to know about those as well, because that gives us an opportunity to learn and develop further products and packaging and informational leaflets. But it's great to go back directly to the manufacturer. So we have our me+™ team, handles any type of product issues or product concerns, both from really an HCP level, from inpatient level, but even a distributor or DME level. We can handle all of those, and it's actually handled by a nurse as well. That way we can really brainstorm and figure out, is this a product defect, is there an issue with a product? Or do we just need to go through some additional education on how to use it, how to open it, how to properly wash hands and things like that? But we take it very seriously and we log every product complaint. We make sure we submit it back to the FDA within the required timeline. So yeah, it's a pretty regulated industry as well.

Diane Newman: Now, the other controversy in this field that is really a worldwide issue, is the fact that historically these catheters have been reused by patients, and we've come to realize that that's not probably a good practice, that it probably is contributing to complications such as your urinary tract infection, perhaps even urethral complications like stricture scarring, that type of thing. Talk to me a little bit about, tell our audience about these are sterile products, correct?

Don Darais: Correct. Yes.

Diane Newman: And that really, whenever you produce these and distribute these, they're really for one time use, correct?

Don Darais: Exactly. Yep.

Diane Newman: So really, that individual should be catheterizing with that catheter and discarding it. Correct?

Don Darais: Correct, correct. You're absolutely right. And I think what's interesting is to take a look back as well. So years ago in the late 2008, 2007 period, Medicare, which is really the one that sets a lot of, you know, CMS, Medicare, they set a lot of the industry standards, both from a government insurance, federal and state, Medicaid levels, but also to a private insurance level. Medicare, they only covered a few catheters every single month. So patients were required to wash and reuse them. Those are the days, I think a lot of doctors really liked the red rubber catheters because they could be a bit more durable, they could be washed and reused. But you're absolutely right. Once you open that package and you use the product, that product can never get as sterile as it was from the manufacturing. In addition to that, I think you're right, Medicare changed their guidelines back then to where they went from just a handful of catheters every single month to now 200 catheters. So that way patients can get a sterile catheter every single time that they need to use one.

Diane Newman: And you brought up a really important point there, the red rubber, which is latex. And what we're seeing actually in hospitals and offices, urology offices, we use a lot of products and we're seeing latex allergies that are becoming a real issue. And what else we're seeing is acquired latex allergies, especially around nurses who have been dealing with products over years, and years, and years. So we've gotten away from that red rubber catheter, and I think that the material was important. Correct? As far as how the material that you make these catheters with, right?

Don Darais: You're right.

Diane Newman: And we have silicone and we have different types of material that's utilized. Can you talk a little bit about that?

Don Darais: Yeah, so there's quite a few different, there's PVC, there's [inaudible 00:16:14], red rubber and latex are still out there. Sometimes you've got silicone coated red rubber catheters. But you're absolutely right, and especially in the pediatric settings, patients with spina bifida, any type of condition where they're using medical supplies or devices very early on, just increases the risk of developing latex allergy as they age. And then I've seen numerous articles, to your point as well, of nurses that develop a latex allergy after decades of being in the industry. So it's really important that all of our products are not made with any latex. So that way any patient can use them, any healthcare provider can feel safe using them. And then addition to that, we've even taken the extra step to make sure that there's not any type of carcinogens or known carcinogens like DEHP or anything like that as well on our products.

Diane Newman: Yeah, I know there's some countries that actually have outlawed really, that no longer can use DHEP. Correct?

Don Darais: Right.

Diane Newman: Because that product is just really harmful to individuals. So I think also what our audience needs to know, especially if it's say a patient watching this, they need to know what that catheter is made from, right?

Don Darais: Right.

Diane Newman: And it's on the labeling, right?

Don Darais: It is. And some of the things that you buy from the store, sometimes you'll notice if you look on the back or notice on the corner of it, you'll see a Prop 65 warning. So the state of California passed years ago, this Prop 65, where it required any type of manufacturer that had a known carcinogen within that product that they had to label it. So there are still some products out there that have you look on the label that still says Prop 65 warning. And so that means it has DEHP in it. DEHP is a plasticizer just to make the catheters more malleable. But we've come so far now that there's so many other options out there that don't have DEHP that are much more safe to use.

Diane Newman: So I'm going to ask you a really hard question now. Okay. We are saying that we should use single use. So again, one catheter per catheterization, right? But all these catheters, we have environmental issues. And that's a big concern of course nowadays, and it's going to be concern future. I think one of the greatest things that's going on in this field, and it's to the fact that you have developed better and better technology that's helping individuals live longer and longer with this type of bladder management. What about disposable as far as maybe a catheter that maybe is biodegradable? Where do you think we're going with that? Is it going to ever happen in our lifetime?

Don Darais: Yeah, that's a great question. And honestly, it's one that that's very personal to me as well. I've got a personal passion around sustainability and the environmental impact. So the short answer is yes. I think it's extremely important that industry moves in that direction and that industry needs to be the ones really leading the way. But we're seeing also governments across the world start requiring any type of disposable products or anything like that, that they are either biodegradable or net-zero emissions, things like that. So ConvaTec is committed on that path of sustainability and identifying ways that we can make our products and the way that we make them more sustainable.

Diane Newman: So that's hopefully going to be our next new technology, maybe in the not too distant future, right?

Don Darais: Right.

Diane Newman: Well, thank you very much. Anything else you want to tell us about the work that you're doing currently? You're just US based, right?

Don Darais: Yeah, so I'm based here in the United States. We've got other teams out there. So we've got a team in the UK. We've also got team in France and then Italy. And our products are available actually in almost 30 other countries. So we're really excited about getting products out there to patients. Again, we have the third generation product of intermittent catheters, so we really want to talk a lot about it and get out there because the more and more data that we're seeing is that our catheters do actually reduce friction, especially upon removal. So it takes almost 40% less effort to start removing our calf catheters with feel clean technology. And so again, talking about that, back to that lubricity topic, it is really important that catheters are very lubricious going in while it's being drained, and then also coming out of the urethra as well, in and out many times a day.

Diane Newman: Well, thank you very much for sharing what you're doing and also maybe what we could look for in the future. But I think that we really need these catheters. I can tell you I've been doing this for so many years that patients lives have been changed with the fact that industry has kept up and listened to us, but really has listened to the patient and really try to meet their needs. So thanks so much.

Don Darais: Yeah, thank you. Always a pleasure talking with you.