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The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start their companies after personal (and occasionally tragic) experiences.
Nick Perrenoud is one of those entrepreneurs. He's the co-founder of HAI Solutions and led the development and patent for a solution to protect patients from the accidental or negligent contamination of IV anesthesia medications.
Nick learned the importance of protecting patients with sterile IVs, not only as a nurse anesthetist, but also when caring for his adopted son who required IVs for seven years and spent nearly three years in the hospital to, to central line infections.
He shares many useful insights for any medical device entrepreneur such as how securing patents has helped with fundraising, focusing on your purpose, and being patient-driven.
Robert Fenton: [00:00:21] Hi, everyone really excited to welcome Nick Perrenoud, co-founder of HAI solutions to the show today. Nick led the development and patent for a solution to protect patients from the accidental or negligent contamination of IV anesthesia medications. Nick learned the importance of protecting patients with sterile IVs, not only as a nurse anesthetist, but also when caring for his adopted son who required IVs for seven years and spent nearly three years in the hospital to, to central line infections. Nick's story is so inspiring. I really hope you enjoy this conversation.
So Nick, welcome to the show today. Really excited to have you join us and tell us more about your journey, where you're working on and sharing some of the lessons learned you've had from, the, I think five years now, or almost six years, you've been working on this.
Nick Perrenoud: [00:01:15] Yeah, no, that's right. It's been quite a journey. It's one of those amazing processes that you can't believe how fast time goes by.
Robert Fenton: [00:01:24] I know that feeling, unfortunately. So maybe, yeah, just for, anybody listening, who's not familiar with your business. Maybe you could tell us a little bit about, HAI solutions and what are you doing? How are you helping people?
Nick Perrenoud: [00:01:38] Yeah. So HAI solutions came out of, a personal experience, and we are developing products to help protect patients who are in the hospital from hospital acquired infections.
And we are in the journey of producing devices to do that. And in the medical space, particularly in the infusion, medication, administration space,
Robert Fenton: [00:02:00] how did you get into that? That sounds like pretty specialized.
Nick Perrenoud: [00:02:03] Yeah. My, background is in nursing and, years ago when I had my first job, my wife and I worked at a children's hospital and I was in the pediatric ICU there where we met my, to be soon adopted, first child. He was abandoned there because of his condition and, he had a central line. It's basically a vascular access, a catheter in his bloodstream in his chest that required infusions every day for nutrition. He had a condition that required a nutrition through his bloodstream.
And what kept him in the hospital for what ended up being 28 of his first 36 months was that the catheter was getting infected. what's called a catheter related bloodstream infection. And those catheters, are surgically implanted. And then obviously surgically removed. He had over 12 of them in those first three years.
So very complicated, medically fragile little guy. And my wife worked with him every day and she advocated while he was in the hospital and she came to me and said, we've got to bring him home. We've got to do something for him. His life is obviously limited, but even more so it's accelerated by these conditions that are happening in the hospital.
And so we brought him home and even despite knowing what I knew as a pediatric ICU nurse, we realized, that there was a lot to be learned about catheter access and what really it honed in our understanding of is that bacterial ingress or bacteria gets into the bloodstream through these access points.
And so when we had been taught at that time of bringing him home by, pharmacist, who said there was like three things and it was overridden by vigilance obviously, but three things. One you had to use, alcohol, or isopropyl alcohol you had to scrub these connections and you had to allow that time for it to dry and also time for it to be scrubbed.
So cleaning these connection ports to disinfect or sterilize these connections. So we did, we were very, vigilant. We did all what he had said. And on top of that, just extra mindful of his access. two years went by and he was growing and thriving, no infections. And so it just Trajectory changed for him. He started school and having somewhat of a normal life. And we ended up getting a couple of years, with that line and they wanted a larger line cause he was growing. And so we, saw how basically these techniques were so effective and my, career transitioned to anesthesia and in anesthesia, the work environment is so busy and chaotic at times anyways, that the medications that we were administering, we weren't following very tight procedures of these cleanings that we would obviously be doing at home, but we weren't doing, I wasn't seeing being done at work. And so the environment actually has exceptions where they are allowed to based on the emergencies of the situation, do what's needed to give medications, but the connection points were not being cared for like we were doing at home. And so I, I saw a need. I saw where there was this discrepancy between what was working for my son at home was obviously these pillars of information and vigilance though safety is a major aspect of anesthesia, this particular aspect of anesthesia, there wasn't a lot of attention to and it brought us to a point where we thought, man, I wish there was a tool I wish there was devices. I wish there was ways that we could help providers do a better job, at the hospital and, in a coordinated event of several things, it was just amazing how it all comes together.
My business partner and I, we, met over the device we were using at home for my son. I said, that we needed to use this. At the hospital, whenever my son needed to go to the hospital, I thought this, university children's hospital should have this device. It just, the connector was a special connector and we hit it off and we just started developing ideas.
Those ideas went from, sitting at a Starbucks over a cup of coffee on a napkin to filing patents and really pursuing this idea of creating something to help ultimately the providers protect the patients, in the hospital.
Robert Fenton: [00:06:34] So that's yeah. I'm sure the montage has more than, you met and the Starbucks, then the patent ride.
So I think that story is pretty common. So this started from a product that already existed that was, you thought had more applications. Is that a fair summary of some of the initial concept or did you completely redesign something?
Nick Perrenoud: [00:06:58] Well basically this Multiport delivery device was our first device and in the hospital, there's in these environments, like the anesthesia environment, there's multiple port devices that are in line of our IV fluid already.
And what we were seeing was that you could. Practically inject anything through them. There really was no safeguard for bacteria or particles or air. And so there are those in the market that had filtration, but that weren't integrated into the multi-port. And so we thought, let's draw it up. Let's create it.
Let's see if it's patentable. And it turns out it was. And so we put a pharmacy grade filtration and a Multiport delivery device. Have multiple channels because there's different applications in anesthesia that would require that and customized it for what we would describe as like the peri-operative area.
So interop is the, or, and pre is before and post is after, but even ICU and where those areas where you would be doing the same kind of infusions, but with a safeguard of having these pharmacy rate filters to capture. Yeah, those accidental contaminations.
Robert Fenton: [00:08:12] I can imagine how much impact that's made.
Now, maybe coming back to that moment, I always try and ask people and even friends, people I meet is, do you remember the moment you decided to start pulling on that thread so to speak,
Nick Perrenoud: [00:08:24] In the sense of that moment of inspiration, like this is,
Robert Fenton: [00:08:27] we've got to do it. I think we're going to do this.
Yeah. I think people can often remember that for a moment. You said I'm just going to dig in here and see what happens.
Nick Perrenoud: [00:08:36] Yeah. I remember actually being in the anesthesia work room, prepping for a case and sourcing these ideas, but not really being able to create it with what was existing. And yeah, I do remember that inspiration moment where it was, BA basically looking at how do I assemble this and it really wasn't available, but, That is, definitely a moment that has been, a moment that we reflected on before.
Robert Fenton: [00:09:05] Yeah. So you saw problems firsthand, personally, you had ways to solve that you identified that the current state of school wasn't quite exactly where it should be. You decided to drop some ideas with the person you'd met your business partner. Let's talk about what are some of the things that didn't work because people often see all the, at the end product, right?
Survivorship bias is you see what worked, and this is now a business and a product, but it's always fascinating to understand that like the missed shots that, got people there.
Nick Perrenoud: [00:09:35] Yeah. I think, I, one of the things that I, would say is that it didn't happen overnight. like I think that's what you're getting at is that it takes time and there's, the highs and the lows of, finding your way.
And we're still finding our way. I think that's one of the beauties of this journey is that it doesn't happen, accidentally, in the way of the things that I, the miss shots, I think, one of. looking back, one of the areas that I would have, it would have been maybe helpful is if there was a particular.
Program that would have been available. I know of them now, but time we forged our own way through creating a business, and bringing different, resources together and, trying to make it happen on our own. And I think one of the challenges is, from that beginning stage of having this idea to realizing that it's just, it's a huge undertaking.
It's a huge undertaking of raising funds. It's a huge undertaking of coordinating the multiple experts that are required to, especially on a device that requires FDA approval. So there's a whole regulatory side of things, the legal aspect of having a business legal aspect of filing intellectual property, maintaining those relationships is so complex.
And so it would be amazing if, I could have. Had one house, I guess you could say that had resources that would be able to have coordinated that ahead of time. yeah, I think we had a, this sort of trial and error of relationships and let's go in this direction, and realizing maybe that, maybe we're a little premature or maybe it wasn't the right fit.
And so you have to learn those lessons the hard way.
Robert Fenton: [00:11:31] a Lot of our, parity with our customers and where we help them. we have this bull mission of enabled teams, long-term scale life-saving products, And you fall, you're almost a perfect definition of one of those teams.
One of those products that have had such a tremendous impact on people and that complexity is often hidden because you see that. You see this problem, you conceive the solution. You might test it works, but then you have these other barriers to IP. One is an interesting one. The one we spend a lot of time with is the quality regulatory, side of it.
I'm curious. again, a question I always ask is everybody I meet is what was it like? How did you discover that regulatory pathway and what quality meant? And how did you get past those.
Nick Perrenoud: [00:12:19] Yeah. my, again, have learned this as we've journeyed along my business partner was and continues to be in the device development on the marketing sales side from a medical devices.
And so he had a network of people that he referred to in those early stages. So we thought, we got to make this device. So how do you get from this prototype that we've assembled to an actual device? So going through the network of a design house and then going to a basically a manufacturing premium manufacturing, house, then they would require, Oh, so what's your regulatory plan?
And we would say, Oh, do you have someone that you could refer us to? And so that kind of is how we did. Initially we worked with a regulatory, advisor, so consulted with him and, he had been in this space before with the infusion space. And so he said, this is the project. Plan, and this is how we have to execute it.
We have to take it to the FDA and get a pre-submission done. And so he had that roadmap already. And so with his expertise, we followed his lead and I got the pre-submission completed with the FDA, which then provided the roadmap to say, this is what we now have to achieve. And the FDA was at that point, supportive, if we could do what they had outlined for us.
Robert Fenton: [00:13:45] And not to get too nerdy, but what path did you follow it? Was it a five, 10 K pathway of repeating backed on something already? Their laws?
Nick Perrenoud: [00:13:52] Yeah. Yeah. That's right. Yeah. Yeah. We did a five, 10 K pathway with a predicate device that is without the filtration component, but has the multi-port and fluid pathway design that's similar. So we're following that.
Robert Fenton: [00:14:07] Yeah so much behind something so small, right? so taking a step back, any other lessons learned? So we spoke about some of the blockers, some of the challenges and what were the big lessons learned that you wish you knew? going back to when you started working on this
Nick Perrenoud: [00:14:23] Lessons, I, I, again, whenever I think about the challenges, I, will say what continues to fuel us is the results and inspiration of where we come from. So my son actually, we use the central line for over 10 years without an infection. Now it's unheard of, the reality of using the same catheter every day for this extended amount of time is sorta rare. Maybe more than rare, just exceptional.
So knowing that we could achieve something in our own home, that would then inspire us. To be able to achieve that on a grander scale, kept us focused. And so I think that was something that we always refer back to is that inspirational journey that has been proven in our own experiences. What has been really, I would say one of the most time consuming processes is, getting funding.
I think funding is, I wouldn't say underestimated, but it takes a ton of time to, in our experience anyways, to bring together individuals who can see your vision and can say, I totally see this happening with our support. A lot of people will say, great job. Great story. It seems to be a great idea. Why don't we talk some more about it, or how about you go to this angel group first? Or how about we do vet you through other channels? And so friends and family have been really what have kept us going up until this point. But angel groups are engaging with us now that we have patents. So we have assets that I think we can lean up against.
And so that would be one of the things is I think a lessons learned it takes time and patience and persistence, and, that applies to, this process as well for raising funds.
Robert Fenton: [00:16:20] To paraphrase some of what you've said is to all the fundraising takes a long time. It's difficult. And you mentioned that the work on like the patent.
So is it fair to say that securing intellectual property and the patent, do you believe there's going to be one of the levers to unlock the funding, to get you where you need.
Nick Perrenoud: [00:16:38] Yeah, thank you. That is the summary. That is the truth. Pre patent it was a lot of, great job guys, but let's wait and see, but I'll tell you the day that the first patent, because now we filed several patents.
We have a UV light. We brought in an engineer. Who's now part of our company who is a friend of our, my business partner. So now the three of us have collaborated in making an effort in other products within the UV space. And some other patents, which we have now also have, gotten approvals on the UV, IV sterilizing device.
But yes, to your point is that as we've gained traction, with intellectual property, the attention and the support has come, much, easier.
Robert Fenton: [00:17:23] So maybe the next question might, be, how did you navigate the path to patents? Was it like from the referrals? I'm curious as to how well the people can, shorten that learning cycle because it's complicated.
Nick Perrenoud: [00:17:37] It is complicated and picking your right, the right attorney and the right firm.
I would, I wish I had Oh yeah, this is the way to do it. I'll be honest. I was fortunate is that a roommate in college became a patent attorney for a, quite a large firm in Southern California. And so I called him on that napkin drawing and just said, is this even something we should pursue?
And he said, I think you should come in the office. I think we should sit down and look at it. And, that started it. So we have a big advantage, from a personal relationship, but I would say that having his support from the get go made, it made the difference. It
Robert Fenton: [00:18:18] Sounds like it. So the lesson learned for everybody has called up your former roommate
Nick Perrenoud: [00:18:22] and, I wish there was like a, Oh yeah.
This way or talk to that firm, but yeah, no personal relationships have been a huge part of our journey for sure.
Robert Fenton: [00:18:34] And everybody has some story like that because in anything you do here, because it's so difficult and it takes so long, it's you lose all these battles and you have these battles you win and you always find some, there's always something you typically find within your network, or you just so happen to know that helps.
I'm curious for anybody else are there, is there any other resources that would be relevant to help people, when they have debt? We were having a coffee, probably socially distance or at home right now. And have an applicant, And writing out the diagram over zoom call and I think, Oh, is this patentable, is there any kind of resources or places you think people could go to at least get some where along the journey without the median, the lawyer's office.
Nick Perrenoud: [00:19:16] Yeah. I think that's, there's government websites, there, we've referenced over the, I think public pair is one of them that posts patents. Google has a, search feature that you can look at what exists out in that space that you're interested in. we went through an accelerator group in our town that, in, Southern California, in San Diego, we had, an accelerator that
provided us resources. I think big cities typically are around universities have that as well. The university that I currently work at also has that in-house, if there's something where again, if you're in healthcare, like I am a lot of, providers are in that clinical space and that is their domain.
And so it's. They don't have all these resources and expertise. And so looking at it now, after all these years, the university I currently work for has that in-house, you bring it to them. Of course, there's a bit of sharing that ends up happening with that. You, hand off, in, exchange for their services.
So I guess my point is, that there's lots of different ways of approaching it. I think that, I have a friend at work that also in the non-healthcare space he has created or has filed a patent and he went on Yelp and he looked, what was, what's the best patent attorney in my area.
And he's had a mixed success. I think, I, don't know options.
Robert Fenton: [00:20:37] I think that's lots, that's something that I personally don't know a lot about. So I think that's really helpful.
Where's the business today?
Nick Perrenoud: [00:20:47] So currently we have, one product, that's in manufacturing that Multiport delivery devices, basically halfway through manufacturing it's in a, stage where we're nearly complete with the design freeze. If you want to say basically saying that the device is exactly the way we want it and it's performing the way that it's supposed to. There's a few tweaks that we're making and new year, probably the next six to eight weeks, we'll have that design freeze.
And then it kicks off this validation phase where we will then go through manufacturing for the next, six to nine months to be able to produce that final product. And so with that final product, and you can engage with the FDA and begin that journey of, vetting this device that it's ready for clinical use with all therequirements that the FDA has. So right now we're in manufacturing. We've been in manufacturing this phase for about six months and the next one will be an additional six to nine months as we get that device out of our hands and into the hands of the FDA and cliniciansafter that.
The second device is prototype.
We have to do on the UV device, bench testing, and the results surprised us. We were so excited how it performed that's part of that fundraising that we're trying to do right now is like acceleratethat device, same manufacturing pathway. It takes, about a year from the ideas going intomanufacturing, and then being able to be processed through to the end result.
Robert Fenton: [00:22:19] So fast forward a year, successful fundraising, one product in market, one product close to the market. Is that, the goal?
Nick Perrenoud: [00:22:27] Yeah. So FDA is going to be key. So we're hoping to FDA approval by end of year, we'll follow that pre-submission and based on that, we were hopeful that will happen.
And then yeah, the, just to the maybe first quarter or second quarter of next year, or I guess the following year 22, we'll have that second device ready to go. And they're very, different. They're in someregard complimentary synergism to them where one addresses the contamination sites, where we were using alcohol, or we're now looking at using UV light and then the downstream.
And we have that integrated filtration capability. And I think together, we, said, cheeky a little bit, but the like driving an automobile, we have the seatbelt, which is low tech, but very effective. And then we have the air bag, which is a bit more high-tech and together, you're, much more safe having both of them.
And so that's why we're excited about accelerating this UV light. We just feel like it will enhance what we're working on with the Multiport and achieve that together. I think that'sour goal in 2022.
Robert Fenton: [00:23:36] We'll Nick, a great story. I'm excited to watch your progress over the next year. And hopefully if I can help in anything you reach out and your story to get for you've gotten, I think is inspirational and I applaud you for the work you've done and the journey you're on.
I really appreciate it, sir. Thank you very much for joining us today. And, we'll if there's anything, any links that you have on patent offices or anything, you've got some insights from, we'll add that to the show notes and with that, sir, have a great day.
Thank you so much for joining our podcast today.
Nick Perrenoud: [00:24:08] All right, thanks so much. I really appreciate the opportunity.