Dan:
Karen, welcome to the show.

Karen:
Oh, thank you. Thank you so much for having me. I really appreciate it.

Dan:
I know we've had some fun conversations in taxi cabs around conferences and things. So it's good to get you on the show. Karen, why don't you tell the audience a little bit about yourself and a brief history of your innovation work?

Karen:
My background is critical care nursing. So I started at the bedside and there I did a year in med surge and then went right into critical care and absolutely loved it. And so I imagined that I would stay in critical care. But at the same time I was always really interested in product development. And of course there's no place in the hospital that has more technology than critical care. So I was always playing and tinkering. And back in the days when I was in critical care, there were a lot less rules and regulations. So it was much easier to work with industry right at the point of care and bring products in to test and to try to give feedback on.

Karen:
And so I was doing a lot of work with patient monitors in our intensive care unit. I was a clinical nurse specialist at the time at Baystate Medical Center. It was [inaudible 00:00:56], it turned out to be Philips, but initially it was Hewlett Packard who then got bought by Phillips, asked me if I wanted to come in to their company and be the business development person for a new product line for which I had been working on. And actually turned out I had more requisite knowledge than pretty much anybody just because we used it. It was obviously why they wanted me.

Dan:
That sounds familiar.

Karen:
Yeah. They said, "You want to do business development?" So I said, "Well, I'll have to get back to you on that." And so I told my husband, I said, "I don't even know what business development is." And he said, "Well, they must think you know, so go for the interview." So I did, and ultimately I got hired. And what I really learned, and which has really changed the whole trajectory of my career is, what I had been doing in the ICU and playing with products and giving feedback was fine, except that I had no idea of the whole regulatory system and the risk class.

Karen:
And so what I didn't realize was anything that myself or our nursing staff, or actually any frontline staff would provide, any information, was not likely to see any changes in the product for probably three, more like five years. And so what I really enjoyed about being into Philips Healthcare and then subsequently other companies, was that we could build a nursing perspective in the product from idea to commercial and then bring it out to commercialization. So from a blank piece of paper or the first meeting in a conference room are the perspective of the end user could be built into the product. And that's really, I think it makes a huge difference.

Dan:
Yeah. That's one of the complaints. I mean, you've heard it and I've heard it as well around, from nurses on the front lines it's like, "Who design this thing, and why aren't nurses asked? It's always the physician that gets kind of that credit and things." And so do you see more nurses in product design and planning? Or is that still kind of a relatively obscure place for nursing talent to be?

Karen:
Probably obscure is a little strong, but it's certainly not where it needs to be. And I think it's really important for people to realize, nurses are the nation's largest group of healthcare professionals. They're the only ones that have access to patients 24 hours a day. And as a result, nurses really have a uniquely practical and care sensitive perspective on healthcare delivery. They also touch more products and are a part of more services than anyone else. So they're really the ideal connections to address everyday problems in healthcare. Because most other healthcare professional groups, while they are at the point of care, don't understand the full scope of these everyday problems and their impact on workflow.

Karen:
So I think that's what the nurses, that's the perspective that they come with when they say that who designed this? Ask questions like who designed this product. And also nurses are really part of patient care in every conceivable setting where patient care is delivered. And I think the whole COVID situation has really brought that to line, because a lot of the innovations that you see popping up are being led driven, or nurses are part of the healthcare team. Hopefully that will help sort of speed up the obvious need for nurses to be an integral part of healthcare innovation and improve in healthcare.

Dan:
Yeah. And I know in our network we know a lot of nurses that have developed products or advised on products, we had Joey and Taofiki from Frontier Health who built these really amazing seizure pads that are self-inflatable. I know we've worked with Lindsey Roddy on masks and her ICU cord products as well. And so what are some other examples of really prominent nursing driven product design?

Karen:
Well, first of all, I listened to that episode with Taofiki and Jeff, and that was awesome. And that is such a perfect example of frontline caregivers that see a relatively easy to solve problem. What was really interesting about that is Taofiki in particular, sounded like he had a lot of high technical expertise. But really that's great, but most of what's needed at the bedside doesn't require that. And sounded like that was an aha moment for him.

Karen:
Also, I'm actually working with Lindsey Roddy, she's done the face mask, which you know, in '95. But she also has another product called the Medical Tube Organizer. And I actually met her when I went to the Ohio State Innovation Conference last September and we hit it off right away. So since then have put in an NIH SBIR grant, which did not get funded, but are now working on a National Science Foundation grant to fund further work on that area. So hopefully we'll get to see that. But the neat thing about that product as the N95 is that they're designed to really address specific problems that nurses and frontline caregivers deal with every day.

Karen:
Other things that people may or may not know, like the crash cart was developed by a nurse. Sanitary pads and the absorbent material that are used were developed by nurses. Disposable baby bottle liners were developed by nurses, the ostomy bag. So those are some of the older ones in addition to the new things that we just talked about.

Dan:
That's awesome. Yeah, nurses always have, they have their ways of getting like the most impactful things out into the world I think. They're just natural innovators. You know, as nurses are looking to potentially get into developing solutions to the things they see every day, what's some advice them? And I did this, when I was looking for a new role, I was searching Microsoft, Philips, Google. There's not a lot of job descriptions that say nurse wanted to help build something. They're kind of these obscure, like business development roles that you would never think as a nurse, without that knowledge kind of searching. You wouldn't think that's a job that you should go for? Do you have any advice for nurses to kind of figure out how they might connect with these opportunities?

Karen:
Yeah. That's really interesting, because most of the jobs, industry jobs posted for nurses are specifically, like clinical support jobs, field positions to support products versus product design jobs. And so I would say, first of all, just to your point, don't rule yourself out just because it says business development. One of the things I found really helpful, and in fact I really felt like I had to do it was go back and get my MBA. This was after being at Philips for seven years. So I'm not saying nurses should all get MBAs. I don't think that's necessary at all.

Dan:
Or MHIs.

Karen:
All right, or MHIs. Although, not that I'm saying they should. However, you do definitely need some of that knowledge. So there's lots of ways you can go, Coursera. You can just, you'll work with somebody that has it, but in order to ... First of all, you have to be passionate about what you're doing, which certainly nurses have plenty of passion for a lot of the things that they do. But you also have to really get outside your comfort zone, learn some skills. You can't get too far without understanding a little bit about how market needs for your product. Because if you have a good idea or what you think is a good idea, you have to be able to sort of test that in the market.

Karen:
Oh, you have to, I would say reach out to your interdisciplinary colleagues. First your current users, but very shortly or various stakeholders and interdisciplinary colleagues. And you have to get some business skills to at least be able to assess the financial opportunity, the value you'll might be able to create or the return on investment if your product were successful. But those are all things you can do on your own.

Dan:
You need to have that acumen, even financial acumen and those types of things just to speak the same language. Because, and ultimately, and this was something that I didn't realize. Everything ends up being some sort of sales, even if it's not your kind of quintessential sales guy picking up the phone and cold calling. You have to convince people of your idea at some point along the way. And so you need to have some basic understanding of just building those relationships, building that trust, communicating effectively. And then have the business side and the numbers on the back end so that you can make the case. Otherwise it just becomes an idea and people don't see the validity in it moving forward.

Karen:
Yeah, no, that's exactly right. You do have, you have to be able to speak the language. And you have to figure out if your product, even if it's the best idea, if there's not an economic value statement or argument to be made. I mean, that could be able to really be success.

Dan:
What are you working on right now? I know you've got your hands in a lot of cool stuff. So like what's going on on your end?

Karen:
It's funny. So I spent, everything now in my career as an undisclosed number of decades. So I spent an undisclosed number of decades in clinical practice. And then I worked for a variety of companies, small, medium, and large. Loved the startup world. That was so fun, but I did get tired to get laid off and having my equity equals zero. But the learning was priceless. I knew that at some point I'd want to be in academia. I actually went back and got my PhD in later in life. And it wasn't because I thought life would not be whole without a PhD. It was really completely pragmatic, practical reason.

Karen:
I was still in the clinical environment that I was still at Baystate Medical Center as their clinical nurse specialist, doing a lot of technology research. And kept bumping up against my own limitations of being able to design and execute a decent study. But when I went back I realized how much I really enjoyed the learning environment, especially as a older student. So now I've made the jump in 2017 to academia. And what that allows me to do is really focus on my own research while mitigating, or at least minimizing, I still work with a lot of companies too. But mitigating the commercial influence, because I can work on what I want rather than what I'm being paid to do.

Karen:
So my two main areas of research are non-ventilator hospital acquired pneumonia. That's actually the number one since the last CDC survey, point prevalence survey is actually the number one hospital acquired infection, non-ventilator. And so one of the things that's pretty simple and completely nursing driven is, if you think about pneumonia, most of the things that cause pneumonia, the germs that cause it come from the mouth.

Karen:
And so we really have, I put myself and a group of my collaborators, have a program or research around comprehensive oral care and just basically keeping your mouth clean as a method of source control. And so we have a fair amount of research that we've done in that area, so we've scoped out the problem. I just finished with a group of collaborators, a small cluster randomized trial, because most of the research has all been pre-post. So we just finished a small cluster randomized trial, where we had to batch medical and to match surgical units to test the intervention.

Karen:
And now I want to use that as pilot data to apply for an NIH, or I may do a PCORI or AHRQ. I have a couple of different mechanisms that I'm sort of targeting. Because we still need to answer it in a better way, but I think we've done a pretty good job of building the data for that. And in the meantime, interestingly enough, with the whole COVID thing, obviously COVID is a virus. But in previous outbreaks, the death rate is really highly related to not just the original viral infection, but the associated secondary bacterial infections that develop. And so non-ventilator hospital acquired pneumonia is actually very applicable to the COVID patients. We're starting to see literature saying exactly that where oral cleansing, decontamination, not just for patients, but even for healthcare workers as a possible mechanism to test reduce transmission.

Dan:
Oh, wow. Yeah, that's really interesting. I know early on in China they were saying that a lot of the deaths were occurring because of the secondary pneumonia infection and then the damage to the lungs. And it makes total sense that reducing those risk factors would potentially improve outcomes moving forward.

Karen:
Yeah. And oral care is there's nothing more nursing. It's really basic fundamental care. So it's very low tech, is very low cost in the grand scheme of things, but you do need better oral care supplies, which most hospitals don't have, because they don't realize how important it is. So we're also working with a couple of different product manufacturers to try to get better quality toothbrushes, better quality toothpaste and oral rinse that is actually antiseptic into hospitals in order to be able to do better oral care. And then that's very interdisciplinary because we sure need our dental colleagues to help us there, because they have more domain knowledge in that than any of us. And so we work pretty closely with dentists.

Dan:
Yeah, that's really interesting. One of the projects that I'm still working on with Kaiser's med school was, or is interprofessional education and the Dean has been very adamant to partner with dental colleagues to bring them in as interprofessional learners with the medical students. It's been interesting, because it's been hard for us to find where in the curriculum to place them, because oral care in medical school is like almost not existing. I mean, they talk about the mouth and the GI tract. And that's about what you learn about it. In nursing school I know there was probably a lecture or two on it, but it still wasn't a focus. The task of oral care may have been, but the kind of the concept of the bacteria and all that kind of stuff's not there. It seems like an element where we need a really a stronger connection between dentists and oral care practitioners and then medical professionals within the hospital setting.

Karen:
Oh, we absolutely do need that. We really need to use their domain knowledge to help. And in fact, interestingly, talk about interdisciplinary. There's a professor, Frank Scannapieco, he's at University of Buffalo actually. He's done a lot of work in this area of microbiome and identifying and also making the connection between what's in the mouth and ends up in the lungs as pneumonia. Since we've been working together, now he's invited myself and another one of my nursing colleagues. So we're actually writing a summary article for a special issue in a dental journal. So that's kind of cool.

Dan:
Yeah, that's awesome.

Karen:
So that's one. And then my other area that I really like, and this actually came as a result of working in a startup is improving the usability of IV smart pumps, large volume IV smart pumps, which are the workhorse of the acute care system. I focus on my research on large volume infusion pumps, which are the workhorse of the U.S. acute care healthcare system. So they deliver more than 90% of patients in hospitals have an infusion pump, or have an infusion, most of which are on pumps. So it's really ubiquitous and it's a part of every nurse's workflow, and not the easiest part sometimes. Because most of the technology out there was designed long time ago. So it sits on old technology and user interfaces that are not particularly intuitive.

Dan:
I would argue it sits on like a DOS operating system and they may call it smart. But I don't know if there's a lot of brains behind IV. I feel like they haven't ever changed. I mean, there's been like three vendors in the entire world that have ever created IV pumps and none of them really work all that well, in my opinion. Although I've been away from the bedside for a little bit, I just remember how frustrating Baxter pumps were and then they got all recalled and then you moved to Alaris. And then there was one other one I think, and they were all just really, really hard and didn't really mesh with the nursing workflow. So I'm glad you're working on that. Because it seems like there's a big room from improvement.

Karen:
There really is. And I'm clearly not going to design a new IV pump. That's a huge multi gazillion year job. But what I can do as a nurse and an end user, or working with nurses and end-users is really point out the usability issues from the end user perspective so that that can help inform future design. So, that's really what I try to do. And interestingly, when I first started, I got into the literature and I'm like, "Well, there's got to be some nursing research on this." And what I found was there wasn't, there was very few programs looking at it at all. And the ones that existed were human factors engineering, which is great. Because we certainly, we absolutely need our human factors engineering colleagues to help us, but they don't have the same perspective as an actual end user.

Karen:
So I decided to actually go back, I did a postdoc and what I focused on was grant writing skills and also IV infusion device usability. During my postdoc I really focused on that, and have been doing it ever since. So myself and a small group of researchers that we're starting to build have done a lot of looking at usability and publishing. Right now what I'm doing is, also doing some flow rate studies. Because some of the ergonomics, actually the whole way secondary medications for example, are administered requires us an ergonomic setup. That's actually not even achievable. You know, you have to drop the primary bag and the secondary has to be insert. Well that's actually what we found through some of our observation studies. In fact, we have one in press right now.

Karen:
It's not even possible in a lot of settings because of the physical limitations in the environment. All the flow studies that are submitted to the FDA and that are part of the whole labeling for the product are based on the ideal configuration. And that almost never happens. So we've now moved on to actually some flow rate accuracy studies. And so we're going to use actual setups that we observed that are not manufacturer recommended and see what that's actually doing. That I think will have a lot of application in the clinical setting.

Dan:
Yeah, no, that is a huge issue. And one of the vendors that I won't name had an issue with an organization I worked with in the past and it was around secondary flow. Like either the bag would completely dump in in minutes, or it would never go in and the primary would backup. And this is despite it being set up correctly. And we went back to the vendor, they kept telling us, "No, the nurses are doing it wrong. They need more education. The nurses are doing it wrong." And we actually brought the executives in and said, "Show me what's wrong with this? What did the nurse do wrong and it's going backwards?" So yeah, I think just more validity and research around that piece and the non ideal situation, because really there's very times where everything's ideal. And so to have that leeway, it needs to be built into the product, otherwise you're going to have error increase, I think.

Karen:
That's right. And what's happening, now first of all, that's a perfect example, to system issue. Because this product does not work in the environment in which it's being used. So it needs to be redesigned, not just this product, but actually the whole linear peristaltic flow technology, which is what most of the market uses. That's why you have to drop the primary bag. So that really needs to change. So I see my sort of research is pointing out what the real practical issues are with that. And then letting companies and vendors come up with the technology solutions, that's what they do. But we need the data to support why that has to be done and what that relationship is to infusion safety. And now that with COVID with nurses moving pumps outside the room, because they really have to, it's a couple of not great choices.

Karen:
If you have PPE shortage and you have pumps that beep constantly, you physically cannot go into the room every time it pumps because it takes too long to put this PPE on, plus it's shortage. Plus what if it's an emergency situation? It's just really, it's really a hard choice. So anyway, we're actually going to do some flow studies in my lab, which is now going to be my garage with COVID. I have pumped in my garage already. I've got supplies on the way so that we can mock up solutions with actual pumps and put them at different configurations and see what the flow rate of different medications, or fake medications in this case would actually be.

Dan:
How hard is it for you to convince hospital leadership to allow you to do this type of research? Is there like zero resistance? You have to convince them to say, "Hey, let me play around with your nurses in the middle of a COVID or not COVID?" It seems like that's always an uphill battle. How has that been for you?

Karen:
It is an uphill battle. And that's actually been interesting. Some hospitals are really, the ones that are probably high reliability organizations that are willing to pull back the covers in the name of safety. Those hospitals are pretty easy to work with and they'll be really good partners. Other ones are like, "You want to do what? You want to publish, you want to study and publish that no one's doing the right thing?" But that's how, we have to really be honest about where the problems are.

Karen:
And a lot of times we'll collect the data, but we won't name the hospital. So I think it's all over the map what people will let us do. With the flow rate it's obviously "I'm going to be doing it in my garage and then I could," but then we can make, if then we know by observation that certain configurations are common, then we can at least start to make the connection that you're probably having medication errors that are completely undetected. Which if you think about secondaries, what's the most common medication given by secondary? It's antibiotic.

Karen:
Well in any bacterial infection, and now COVID with secondary bacterial infections. One of the most important and mortality reducing interventions you can do is get them their antibiotics as ordered. And that may or may not be happening in the way that we think it is, just because of some of these flow rates issues.

Dan:
And then all we have to go by is what was observed and charted. And it's all clear liquid at the end. And so you really have no idea what went in when and how, and that's a huge issue and not to mention, sepsis and all these other things that are on nursing sensitive indicators and reimbursement tables for CMS. I mean, these are all really huge things that have real financial implications and outcome implications?

Karen:
That's exactly right. So we basically need a pump that runs itself and doesn't need a nurse. And then no matter how the nurse puts it, it works.

Dan:
Yeah. That's the dream. You've just now defined the dream of all nurses everywhere, I think.

Karen:
That's right, my client.

Dan:
I wonder if that thing beep, they like sings the patient to back to sleep or something.

Karen:
Yeah, that'd be nice to deep clean on it.

Dan:
Well, you mentioned that you're moving your research into the garage because of COVID. What other things have you seen in the industry around product and innovation that COVID has either negatively or positively impacted?

Karen:
Well I think one of the things that's done is, it's really made it obvious that we need to be innovative in anything remote or anything that can be done from a distance. The FDA has been a little bit leery about doing those sorts of things. And telemedicine certainly hasn't had the track record of reimbursement for example that it could. But I think this has sort of put us in the fast lane for really reconsidering a lot of how we deliver healthcare. And a lot of maybe our preconceived notions about what's safe and doable and what's not. So I think that part's been good. It's unfortunate that it had to happen this way, but I think that's been good. And then also the vital role that nurses have been able to play as the frontline caregiver in most cases to be a really active part of that.

Dan:
So as we, well, who knows when we'll come out of the peak of the U.S. infections. But as we kind of look back and learn from what went well, what didn't go well, I've told nurses on social media and everything they ask, "How can I innovate in a time of crisis?" I said, "This is the perfect time to innovate. Start taking notes on what's broken, and let's attack it one by one after." How can nurses take those notes and actually do something with them? What is some advice for them?

Karen:
Part of the advice goes back to, you have to be able to engage your stakeholders. Really be honest about the scope of the problem and be disciplined in trying to study it. If you don't have the business skills, just find someone that does and partner up with them, a marketing person, an engineer to help with some design ideas. A marketing person to help you figure out the value. So those are things that they could do now.

Karen:
But on a more bigger scale, I think we really need to start moving forward and creating an environment where nurse innovation is really supported. I think that can start at the academic level or even when we give, we should give nurses coursework, and maybe not ... And just innovative design thinking. Or build a couple of classes into their schedules that are interdisciplinary with either business engineering or preferably both.

Karen:
So that from the very beginning, when they get out of their undergraduate degree, they're starting to think and look at things differently. And then clearly the clinical environment has to support that, and support, not squash those types of ideas. So I think it's both systems, some systems could change to be more supportive. And the nurses also have to feel like they have the power and the capacity and the support to openly innovate. Because right now it's all one off workarounds and those are such the raw material that innovation, we should be celebrating that stuff and trying to do it in a way that's safe so that we could actually then turn it into solutions that can be marketed widely if they work.

Dan:
Yeah, well, you know, I think Bern Melnyk just recently came out with a publication saying, "Nurse managers were the number one barrier to evidence-based practice implementation in a health system." And so that's that system issue. We got to train leaders better to be able to support nurses. But I wonder, you've done a lot of work with the Critical Care Nurses Association and been a member for a long time. How can the associations potentially help nurses in their ideas is, does AACN do that work?

Karen:
Honestly, I'm not really sure. I'd have to look to see what they're in. They're certainly supportive of it, but what they do to drive it from the organization level I'm not sure. Certainly the ANA has started to do that. I mean, now there's a, as you know, since we're both on the advisory board, they have the VP of innovation position and they have a clear stake in trying to help support nurses in that area. So AACN could certainly do that as well and be visibly doing that as well.

Karen:
We could have maybe trading programs. Maybe we could give some business training. I remember I worked with a nurse from Deloitte & Touche on a project a couple of years ago, and she had been at Deloitte for a long time and she offered to come in and teach nurses just finance for the non-financial person. So we can do certain things like that or give scholarships to help just really start to seed some of these that help people feel like there's a place to go with some of their ideas. And then there's some actual support as well.

Dan:
Right, and even just building the network of co-conspirators as I call them [crosstalk 00:25:43].

Karen:
Oh yeah, exactly.

Dan:
We had the same idea. And you can use that whole network effect to build out even better ideas and refine them and even move them forward into production over time.

Karen:
That's true. And I also have partners that you can talk to the same language. In fact, right after I listened to your podcast, I went and looked up the safe seizure product. I reached right out to those two innovators, because-

Dan:
Yeah, Joey and Taofiki.

Karen:
Oh, absolutely. Those are two people I think I would love to work with. We could put our heads together, because I love doing stuff at the point of care. And I like taking ideas from frontline nurses or frontline caregivers. It doesn't have to be a nurse. I just happen to work mostly with nurses since I'm a nurse. But people that actually know what it's like to deliver care at the point of care and can see where innovation is needed.

Dan:
Well, Joey and Taofiki are amazing. And if they don't reach out to you, let me know, and I will text them. They have been texting them [inaudible 00:26:33]. I will yell at them, but I started to see the nursing schools start to get into this space as well. So was over at Duke recently, and Duke had built an innovation lab in one of their SIM center rooms. And they were bringing in engineers, nurses, and medical students to look at problems. And they were looking, I remember walking through and they had IV lines with led lights in them, red and green. And they were testing out use cases related to that. So I think more and more, it's going to become the norm. And I keep pushing the nursing schools I work with to incorporate some of this innovation thinking and even just testing things out into the curriculum so that nurses can come out and be the change they wish to see instead of putting the passive aggressive Post-it Note on the IV pump.

Karen:
Exactly. Exactly.

Dan:
Saying, "This is broken, whatever."

Karen:
Yeah. And they just leave it at that. Yeah, I think you're absolutely right. Nursing schools of medicine, hospital systems, even more so probably, are definitely moving into the innovation space and braiding themselves and putting aside space. And in fact, I started at Northeastern when I first went into academia in 2017 and I actually loved it there. But I had no intention of leaving, but UMass Amherst was looking. They have a brand new, beautiful life sciences center, and it's all interdisciplinary. And they have faculty from all over the university that have joint positions there. So I have 50% in the life sciences center, 50% in the college of nursing. And they were literally looking for a nurse who wanted an interdisciplinary program of research, who also had product development experience. So it just felt like it was such a good match, and it's been absolutely wonderful so far.

Dan:
That's awesome. Well, we're coming up on time. So I wanted to wrap us up. And one of the things we like to do on the handoff is actually have our guest give a handoff of information to our listeners. That one nugget that sends them on their way that they can take action on as they go into their week. So, Karen, what would you like to hand off to healthcare leaders, nurses at the frontline about product innovation and innovating in healthcare?

Karen:
I would say, first of all, be passionate and follow your passion. Never let fear stop you. Always really support each other. Take every chance you can to mentor, be mentored and never miss the opportunity to celebrate the success of someone else. And finally, never take no for an answer. Well, practically never.

Dan:
Never regret. Yeah, practically never. I love it. Karen, where can we find you? If our listeners want to connect with you or learn more about what you're working on, where can they find you?

Karen:
They can find me at by UMass email address.

Dan:
Okay. And we'll post it so you don't have to say it, we'll post a link.

Karen:
Yeah. Yeah. And also I have, I do have a Twitter and an Instagram account, but I'm not particularly good.

Dan:
We will put all of that in the show notes so that you can connect with Karen. Karen, thank you so much for being on the show. I think this was some great insights for nurse leaders and for bedside nurses to move forward in innovation and get involved with designing the products they use every day. So thank you so much.

Karen:
Well, thank you so much for having me. It was good to talk with you, Dan.