Launching a Critical Care Medical Device Startup
If there is one thing I enjoy it’s hearing how someone came up with an idea to solve a really important problem. That’s what Marie Pavini, MD has done by launching a critical care medical device startup and I was thrilled when she agreed to join me on my podcast.
Marie is a critical care physician and the Founder of Healthy Design, whose flagship product is Exersides™. Exersides™ is a restraint alternative for sedated or confused patients who have vital lines and tubes to protect.
Marie came up with the concept for Exersides™ by watching her patients and their families struggle with PICS (Post-Intensive Care Unit Syndrome) after being released from the hospital. New research has shown that the accepted practice of restraining sedated and delirious patients in the ICU can lead to ongoing psychological trauma. Marie created her device as a a way to give patients more freedom to move, and thereby reduce their agitation – all while protecting the lines and tubes keeping them alive.
In this podcast interview, Marie and I discuss:
- How Exersides™ brings patient-centered care to the ICU by addressing PICS and mobility
- The complexities of the market research phase, so necessary before launching a new medical device
- The Phase One clinical trial process, which is a critical step for any medical device startup
This is an episode of the Leading with Health podcast, formerly titled “Healthcare Lead Generation.” In this podcast, healthcare IT disruptors, innovative healthcare providers and health sector company leaders join host Jennifer Michelle to discuss growth strategies and navigating change.
Jennifer Michelle, MPH, EMT is a marketing consultant specializing in the healthcare sector. President of Michelle Marketing Strategies, she has a Master’s in International Health & Epidemiology and currently volunteers as an EMT. Her unique background allows her to bring unexpected insight and depth to every interview.
Launching a Critical Care Medical Device Startup with Marie Pavini, MD of Exersides™ (Podcast Transcript)
Jennifer: 00:03 Hi, everyone! I’m Jennifer with MichelleMarketingStrategies.com, where I specialize in helping healthcare IT and provider organizations get more leads. Today on Healthcare Lead Generation, we are talking with Dr. Marie Pavini of Healthy Design. She is a critical care physician and the Founder of Healthy Design, whose flagship product is Exersides™. It’s a restraint alternative for sedated or confused patients with vital lines and tubes to protect. Marie, welcome.
Marie: 00:31 Thank you, Jennifer.
Jennifer: 00:33 It’s awesome to have you here. I believe I didn’t mention your website. Everyone listening, it’s Exersides.com. And, of course, that will be in the podcast description. So today’s topic is critical care, PICS and better outcomes for ICU patients. Marie, why don’t you, before we jump in, give us a little overview of what PICS is, for people who maybe are listening and don’t really understand what that means.
Marie: 01:00 Sure. PICS is Post-Intensive Care Syndrome, which is basically like post-traumatic stress. It’s sort of little known, really, that if you end up on a breathing machine in the ICU, on a ventilator, that you might be so sick that you have tubes and lines, feeding tubes tied to all kinds of IVs. Because of that, you’ll be tied to the bed with these restraints and, because you’re tied to the bed, you’re going to be pretty, pretty agitated. And, because you’re agitated, you’re going to then be sedated. So now you’re a sedated, immobile patient having hallucinations and delirium and that’s not very good for healing. That’s Post-Intensive Care Syndrome. It’s what happens to you after you leave the ICU, because of what happened to you in the ICU.
Jennifer: 01:54 Wow, let’s talk about that. We have two big healthcare trends – we have an aging population, which is its own healthcare niche. And we also have this move towards patient-centered care. How are those impacting this new focus on PICS? Because I think there was a time where people really weren’t concerned about mobility of patients in the ICU or the response they might have afterwards.
Marie: 02:25 That’s definitely true. It’s so new even now that a lot of people still don’t know it and I’m embarrassed to say there are actually still some physicians that don’t even really understand the importance of early mobilization and cognitive therapies.
Jennifer: 02:40 How did people start talking about it? What made it suddenly something people became aware of? Was it the trend towards patient-centered care, or was it something else that brought it to a head?
Marie: 02:51 I think it’s just that some of us noticed. Probably about 10 or 15 years ago, I can remember going to the international conferences and there’d be just a handful of us, sitting in a big lecture hall, all alone in the front seat and just talking about these things. Saying, doesn’t it not make sense that if the patient doesn’t move there, they’re not going to get better? And you can’t really have any discussion with them about what they’re feeling and what might be going wrong and they’re getting pressure injuries and they’re getting muscle wasting and they’re having delirium. That doesn’t make sense, does it? And so we just started talking and now you can’t get into those lecture halls. It’s standing room only and there’s tons of people. Fortunately, the people that I was talking to are all great researchers and academicians. So they’re doing some great research on early mobilization and delirium prevention and Post-Intensive Care Syndrome. So now the word is really getting out. There’s even an organization called Thrive, which is part of the Society of Critical Care Medicine. They’re trying to make the word get out there and you’re right about that. The aging population is important because those people are at more risk, if they get extra sedation, that they’re not going to be able to come out of it. That delirium that they experience in the intensive care unit stays with them when they finished the ICU, and it can even turn into dementia.
Jennifer: 04:30 I’ve heard about this. Just as an EMT in a rural area with an aging population, there’s always this feeling when older people get hospitalized, they don’t always come back in the same state they were the day before they went in. I never really knew that that was a syndrome.
Marie: 04:49 Exactly, exactly.
Jennifer: 04:50 Before we dive into some more of this, just to get everyone on the same page, tell us a little bit about Exersides™, which is the device that you have created through your company, Healthy Design, to help people in this situation.
Marie: 05:05 Sure. So the current restraints are basically these pretty little soft bracelets that tie you down very tightly to the bed. And the Exersides™ restraint alternative is a little bit larger than that because it has you able to move your entire arm at the shoulder. So, you can lift your arm, you can have full range of motion for the shoulder. You have a little bit of bend at your elbow, you can move your wrist, you can hold things. The only thing that you can’t do is bend the elbow enough to get to the breathing tube, feeding tube and IVs, but you can move all around instead of that. This way you’re not tied down to the bed, unable to move at all. And this, of course, means that there’s much less agitation so you’re not nearly as upset about being like this. So you don’t need all that sedation and nobody’s keeping you pinned down and immobile.
Jennifer: 06:05 Oh my gosh. You can just imagine what it must be like to be in a disoriented state and unable to move but sense that you’re tied. You can see that a human being would not react well to that. That’s excellent and you’re saying they can’t pull out their tubes, they can’t really do any damage to themselves, but they can feel comfortable and shift. And I’m assuming that helps reduce pressure sores, as well, because they can do the natural shifting that their bodies, if their bodies are able to move, would be able to do.
Marie: 06:34 That’s exactly right. And there’s also mitt restraints, too. Mitt restraints look sort of like boxing gloves and what patients do, if they’re not tied to the bed, they use those boxing gloves to just squish them around the breathing tube, or feeding tube and then yank it out. With the wrist restraints, what they do is this thing called the Houdini maneuver where they kind of slide their head down to their hand because the hand is tied to the bed. So they just move their head to their hand and then pull the tube out. So Exersides™ does offer that extra safety.
Jennifer: 07:10 All unconscious, they’re doing this?
Marie: 07:12 Yeah. Subconsciously, a survival instinct is saying they have to get out of here and this is what’s wrong. If I could just get rid of this feeding tube, I’d be fine.
Jennifer: 07:24 Well, you’ve got to give them an A for effort, right? So, tell me, with things like this, you’re also dealing not just with the patient, you’re dealing with families who are dealing with caregivers, how are they coming in now? I know we have more social media, people sometimes inform themselves a little bit before going in. Is that making a difference to the kind of care they’re asking for or the kind of questions that they’re bringing in, is that part of what motivated you? I’m trying to get a whole picture vision here.
Marie: 07:37 Sorry, Jennifer, somebody was trying to call in right when you were asking that question and I didn’t hear any of it.
Jennifer: 07:37 No, no, no, that’s okay. I’m saying, when we talk about these greater trends, I know one of them is that, in this case you have your patient, but also their families and caregivers who are probably more likely to be on social media trying to figure out what they need to know. Is that helpful in this? So that they’re excited that there’s more that you can offer them when you talk to them about Exersides™? How is that impacting the family’s response?
Marie: 07:37 It’s so new that there’s not really too much out there except for patients who have already had their experiences. There are patient support groups now and different hospitals like Vanderbilt, Brigham and Women’s have support groups. But this is sort of after the fact. Really, what we’d like to happen is for people to have a place to go to before it happens to them or while it’s happening to them, so that they can get information. So you’re right that it’s the family or caregiver that is really in the position to do something about it. I mean, if you’re the patient, there’s nothing you’re going to do while you’re hooked up to that breathing machine, but your family member can certainly go onto social media and try to get a few tips and learn about what to ask for and what’s happening to their loved one. Right now, there are websites that you can go to. There’s myicu.org, which is the Thrive organization from the Society of Critical Care Medicine and there’s really not much else. So I think we really need to work to get information to people because it’s not anything you really prepare for. It’s not anything that you think is going to happen to you. And when it happens to you, it’s sudden, it’s severe. It takes up all of your time and all of your mental energy. So you’re not thinking about, “Oh, let me go on Facebook” or “Let me just send out a tweet here.” It’s not occurring to you.
Jennifer: 10:05 I think I had heard something – probably from our first conversation – about PICS also affecting the families. That there’s a syndrome there, as well. Is that right?
Marie: 10:15 Exactly. And it’s not just that the Post-Intensive Care Syndrome is going to happen to the patient, it’s affecting the family because they are the caregiver having to deal with that patient. There’s actually PICS-F. The F is for family. It affects the family member in the same way that it affects the patient. In other words, the family member is actually going to go home after the ICU stay and have nightmares and not be able to focus and their memory is going to be reduced and they’re going to become a social introvert and they may lose their job. All those same things that affect the patient can affect the family member because they’re really going through the same trauma. They’re in the ICU room and so they’re trying to figure out what to do next and they feel helpless and hopeless. So that has its own kind of trauma.
Jennifer: 11:15 I bet. Wow. That’s amazing. I think this is one of those things where people just go merrily along in their lives and don’t even realize it’s going on until it happens to someone that they care about. I’m delighted that you guys are moving forward with the different kind of approach to it. Now, with Healthy Design and your product Exersides™, whenever you try to bring something like that to market and – yes, this is a healthcare lead-generation podcast – let’s talk about the process of that. Because there needs to be some market research to find out if people are going to be interested, to find out who you would even approach about it and how it would be purchased. What are the procedures and supply chains? What was that like for you learning about that and doing that research for this?
Marie: 11:50 Well, it was very long. I have to say. I don’t know if you all use the same terminology, but there’s the Valley of Death and that’s kind of inbetween. You have the idea or the basic research for your product. Then, what’s after that but before you deal with the marketing, there’s this whole product development process which is really onerous and there’s a lot of research about who the end users are and to try to figure out the supply chain and whether there’s even much of a need. Sort of where you’re going, how big your market is and whether you should keep going.
Jennifer: 12:57 I can imagine. I’ve been with companies that worked in the healthcare field, but were like, “Oh great, I’ll go do this” and then you’re left going, “Well, who’s going to make that and where are we going to source it?” I remember I did that with my clothing company. I had a clothing company many years ago and just finding a pattern maker … I couldn’t find a single pattern maker who was willing to work with me. They had just had babies, they weren’t working in that state, they were full up. It was crazy. It took a solid year to make this little piece of exercise clothing. So I can’t even imagine.
Marie: 13:28 It’s crazy. There’s so many regulations. I started listening to myself because I knew what I wanted. I knew what the need was. That’s step one. And then after that, I went out to the major academic medical centers that were around me. And this was on the advice, by the way of the Small Business Association, the Small Business Dvelopment Center, a guru who helped me along the way. It was really worthwhile. They said you’ve got to go and you’ve got to talk to hundreds of people and find out this and find out that. So I talked to lots of people, found out what they wanted, what they didn’t want, what the problems were, what they needed. And then I found out there’s a need here and so how would I get it to you? I ended up talking to Purchasing Departments and Value Analysis Committee members and Restraint Committees.
Jennifer: 14:30 There are Restraint Committees?
Marie: 14:34 Yes.
Jennifer: 14:36 What do they do? Every single time I think I know something about the healthcare world, there is some other thing. So, do they decide who’s doing well with restraints and what kind of restraints are okay? What is their purpose?
Marie: 14:53 It’s born from the fact that restraints are almost legal issues. So there are medical devices and restraints are in a special little category of these medical devices because of that situation. It’s because of that, that the FDA and the Center for Medicare and Medicaid sort of mandate that hospitals really keep a close control over it. So that’s why the Restraint Committees are formed. They generally try to decide whether we’re being humane, whether we’re keeping the patient safe, whether we’re overdoing it, what type of restraints are being used, are restraints being minimized, are they being documented properly and frequently enough? And those processes change constantly because new rules are always coming out. So we have to dance around whatever new rule has come out.
Jennifer: 15:57 I guess there’s a fine line between restraining someone for their own health and false imprisonment, so it is probably very good that you guys have that much focus on it. I just didn’t realize. What you’re describing to me is the stuff that I get very excited about because, whenever you’ve got any product that you want to bring in, the first thing you want to do is talk to the people who will be using it and talk to the people who will be buying it. In healthcare, as you just described, there are the people who will be using it, the people who will be putting it on, the nurses. There’ll be the Value Analysis Committee that has to decide if they’re going to purchase it, the Restraint Committee has to approve it. So, at each step of the way, you get different questions, you get different concerns. And what I’m always trying to find out is what are they interested in, what gets them excited, what would they like to see, what would help them? Was that the kind of stuff you were able to find in that process?
Marie: 16:52 It was. I just always thought so naively that they just wanted the best thing for the patient and, ultimately, that’s still the case. You get, “I’m worried about keeping the lights on in the hospital” so you have to pay the bills. Or else there’s not going to be a hospital. There are people who were just concerned about the money that the hospital makes to be able to stay alive, to take care of the patient, to do the best thing for the patient.
Jennifer: 17:28 Right.
Marie: 17:29 So there’s lots of different things that different people are focused on.
Jennifer: 17:34 So they asked you about budget is what you’re saying? Well, of course they do, of course they do. That is very important, that’s a huge part of marketing, but it’s not usually the only factor. This is one thing that I always find, people get this idea that marketing is about finding some magical way of talking about something so everybody wants to have it. And my feeling, especially in healthcare, is that good marketing is finding out what people want and, if you have a product that fits that, talking to them in the words that they would use so they know that you have what they’re looking for. Now that it’s a lot easier to do and it takes that whole manipulation thing down to a reasonable level of just trying to put your best foot forward, which is the kind of marketing I prefer to do. But what is interesting here is you’re introducing a device that is not a new version of something they have. It’s a really different version. It’s almost its own new category. It falls into “restraints,” but it’s very new and I’m wondering, were they able to see the value of that or was there some education that you needed to do as you were going through that?
Marie: 18:46 Fortunately, the regulatory bodies that are out there are realizing that there are these different things that need to be addressed more than just a money, but they have to sort of link it into money. So patient satisfaction is now a big deal and you actually get reimbursed or penalized. Now you can use that. Their customer satisfaction. So, there are several layers. One layer is that the patient is going to be more satisfied, the family members are going to be more satisfied and I believe that the nurses will be more satisfied because this allows them to sort of titrate restraints just the same way …
Jennifer: 19:31 What a great way of putting it.
Marie: 19:34 Exactly. So the doctor writes an order and it says to keep the sedation level between three and four. But the nurse knows that, if they try to do that, all kinds of problems are going to happen. They are the ones left to juggle everything. You can’t keep a patient tied down to a bed and then wake them up. You can’t keep somebody really sedated because then the doctor’s going to be upset. So now they will be able to say, “Okay, I’m just going to turn this dial up a little bit on the restraint, turn this dial down a little bit on the sedation” and then they become much more in control.
Jennifer: 20:12 Wow. I bet the they like that they do have that control over it because they can manage it better. It makes their job easier. That’s fantastic.
Marie: 20:20 Right. Nurses are definitely in a position to ask for what they need. So you’re right, this is a very different type of a device. It’s a restraint alternative. It actually has three levels to it. It can be tied to the bed, if you need to emergently. It can be allowed to be free and there’s also an intermediate level, sort of a bungee type of a strap, so that a patient who’s confused and agitated and might hurt themselves, or hurt the staff member, you can put this bungee strap on. So there’s really like three levels of restraint so that you can give the least restraint necessary for any patient that they need along the way. But if the nurse likes that idea, and so far they have, they can ask for it. So there are nurse leaders who will ask for it. So there are two routes that we can get champions from. There’s the nursing route, so that they feel more empowered to do what they need to do. They’re the boots on the ground all the time. And there’s also the physicians who know that they will be able to get the sedation level that they’re supposed to be getting now – because our new guidelines are always coming out , the PAD guidelines, pain, agitation, and delirium guidelines. So we have our mandates and our standards of care and we’re writing orders, so if we know that this device will help us get those orders met, then then we’re going to want that, too. So I’m hoping that we get the champions from both of these groups.
Jennifer: 21:49 That’s very interesting to hear. What you have there are two audience segments and when we talk about that in marketing, that’s always about how are you going to approach this to both groups? Because, as you just described, they have very different interests. But this is not only something that will be helpful to both of them, it’s something that they both need. It’s not just a want. It would be useful for both the doctors and the nurses. So I think that makes it very exciting. And hat’s one thing I love about healthcare, that there all those nuances. What is the doctor going to want to know about it? What is the nurse going to want to know about it? What is the Value Analysis Committee going to need to know? Now I know that the Restraint Committee is also going to need to know things, so I’m learning. Now, I know that you were in the middle of doing a clinical trial for Exersides™ and I know that’s a pretty common phase of bringing a medical device or some new product to market. Talk to me about where you are and what that’s been like. What that’s like to go through while you’re still in, as you described it, the Valley of Death, about getting your idea into action.
Marie: 22:51 So, I’ve already been through a little bit. I made the first prototype and then I got a sub grant, a sub award from a company that helps with business development and prototype development. They have a design engineer. So I got the first prototype, I did a small pilot study and all that went very well. The patients liked it, the families liked it, the nurses, the physicians, the therapists. With that, I was able to talk to the people at larger academic institutions who were also interested in it. And together we formed a 10-person investigative team that’s, really, these other people, not me. But these other people are just phenomenal. They’re really world-class people who have done a lot of real good for people. Together, we put in a proposal for the NIH and we were award a $1.86 million grant to do a three-year study with this device. Currently it’s Phase One that we’re doing now. Phase one is basically a better pilot study and it will be out of my hands.
Jennifer: 24:06 Which is how you want it done so that the results can stand?
Marie: 24:12 Exactly. And so that’ll be a very small study of the eight patients. It’ll take a year or less and that will look at safety and efficacy to be able to do the larger trial.
Jennifer: 24:24 Just out of curiosity – I’m an epidemiologist by training – what are the outcome measures you’re looking for? Is it a level of PICS? Is it certain things like nightmares or is it the whole syndrome? What are you measuring as a result there?
Marie: 24:39 So Phase One is just safety and efficacy. Phase Two will be sedation-level mobility and agitation. So I would love to be able to look at PICS-type symptoms but that will take years. So those are long-term outcomes that we don’t have.
Jennifer: 25:00 So really what you’re looking for is, does it work at this point and is there any harm that we’re not gauging?
Marie: 25:07 Right. Phase Two will show whether a patient moves more and whether they’re as agitated, whether they’re as sedated because those are our guidelines right now. To have sedation minimization and reduce agitation and to increase mobility. Those outcomes have already been shown to help patients to reduce morbidity and mortality. So if we can get those things happening, that they’re less agitated, less sedation and more mobile, they may have fewer ventilator days, fewer days in the ICU. Now, with some of the long-term outcomes research coming in, we believe that they will have less PICS.
Jennifer: 25:45 Makes a lot of sense that they would. So, agitation, is that a scale at a standard or do you set up the scale for measuring that as part of your study?
Marie: 25:52 Right. There’s a Richmond Agitation Scale and there’s the Sedation Agitation Scale that we use. Typically, an order is put in for say propofol or whatever sedation you’re going to use and you say titrate this to an SAS level of three to four. And that means kind of calm and awake. So part of that scale is agitated and part of that scale is good.
Jennifer: 26:20 Well, it’s the ICU so these things are going to be a range. Now, I know you mentioned the FDA regulations that you had to learn about in this process. Just for anyone out there who might also be dealing with the process that you’re going through, any words of wisdom on that to share?
Marie: 26:38 So, the FDA is interesting. It’s going through a lot of change right now. Um, there was actually a recent documentary about the FDA and medical devices. So I think it’s even coming into the mainstream more now. So Exersides™ is a Class One device (and it was Class One to Class Three). So Class One is the least invasive, so it’s not like an implantable defibrillator. But as I had mentioned before, restraints are like a special kind of Class One. There are five devices that go into this special category. I think latex gloves is another one, but restraints have more regulations that are placed on them. So just a few more hoops that we need to jump through.
Jennifer: 27:24 Was it easy to work through that process and find the information you needed so you can make sure you hit those specs, or was it a very convoluted process? When you say government you assume that it won’t go smoothly. That doesn’t sound likely, does it?
Marie: 27:45 I know. Well, the thing is that it actually ends up a little bit more simply than it starts off. The reason that it’s so convoluted that you are not sure where you fit in and what applies to you and what doesn’t and how to get what you need. So there’s just a lot of research and some documents look the same but say different things, so there’s just a lot of time that you have to put into it.
Jennifer: 28:09 Do they have consultants or people who are like Program Officers that can help with that? Or do you just have to deal with that on your own and dig through the regulations?
Marie: 28:19 You can purchase a consultation with them and you can get other consultants who have been through the process before. In my situation, I’m bootstrapping this company so I’m trying to hold onto the money for all these other things that I need to do. So for me, it’s leg work. But I’m happy about that because I’m really learning what I need to about all these different areas as the company starts. So later on I’ll know what everybody’s doing,
Jennifer: 28:51 It sounds like you have such a passion for it! And I think that’s why I love talking with founders because it’s not just some random widget. You care about this and you can tell that you’ve seen the pain it causes and you created this amazing idea and here you are putting in all this work to make it a reality and test it and help people. I think that is beautiful.
Marie: 29:10 I really am passionate about it. And that was always the thing that bothered me since day one of being a physician. Going on rounds and seeing people strapped to the bed and not being able to move. I almost had my own Post-Traumatic Stress.
Jennifer: 29:23 Yes, it would be hard to watch. But look what it led to. You’re going to help so many people.
Marie: 29:27 Right. That’s another really interesting point. Because it’s kind of new and a little bit different, I mean it’s really coming out a lot now and so the bigger companies are really paying attention now. Even two years ago, they really didn’t know much about it. So it would’ve been great for me to just have this little napkin sketch and go to a company and say this is going to be powerful. This is a really good thing and I think it’s going to make you a lot of money. I think you’re the right people to get this out there quickly. Nobody really understood where it was going to fit in for them and what it was really all about. So I kind of was left to either scrapping it or developing it myself. I was kind of thrown into that position. But you’re right, I wake up every morning, early in the morning and I think about what needs to be done and then I get going.
Jennifer: 30:17 And I bet it’s a lot easier dealing with your patients who are still using the old restraints, knowing that you’re in the process of making that better.
Marie: 30:24 And I love to hear when the nurse is telling me this person could really use your new restraints.
Jennifer: 30:29 Exactly. That tells you that you’ve really hit a need. That’s fantastic. Thank you so much for coming on this episode and just talking with us. I know I have learned a ton about critical care and mobility and I think everyone listening has probably, as well. For all who have been kind enough to join us and are listening, please know that you can learn more about Marie’s work at Healthy Design and the Exersides™ restraint at Exersides.com. Marie is a critical care physician and the Founder of Healthy Design and Exersides™ are their flagship product. It is a restraint alternative for sedated or confused patients who have vital lines and tubes to protect. And I am your host, Jennifer Michelle. I’m with MichelleMarketingStrategies.com, where I specialize in helping healthcare IT and provider organizations get more leads. Thank you all for joining us. Marie, again, thank you so much. It was just a pleasure talking with you.
Marie: 31:27 Thank you, Jennifer.
Jennifer: 31:28 Thanks. Bye, everyone!