The Post Pandemic New Normal Will Be a Better Normal For Patients and Those Who Care for Them

Audrey Sherman

Division Scientist at 3M

Learning Objectives

Disruption of the pandemic has been creating even more opportunities in remote patient monitoring. There are many ways that this disruption creates a ripe time for invention and creativity. I will discuss the science of skin and its influence longer-term wear of remote monitoring wearable medical devices. The benefits to the patients and the care providers to enjoy better compliance are big drivers that are changing the way healthcare will take place in the future.


"What really is true is that inventions need to be useful to lead to commercialization."

Audrey Sherman

Division Scientist at 3M

Transcript

Hi, everyone, I’m Audrey Sherman. I’m a Division Scientist with 3M Company. And I’m so happy to be here today to talk to you about what kind of opportunities a disruption, like a pandemic, has led to in the healthcare industry, particularly in the area of wearable devices. And we’ll get a little bit in on the science of skin. So let me share my screen.


I’ll talk a little bit about the pandemic healthcare disruptions, how what opportunities leads to remote patient monitoring with wearable devices. And then of course, because they’re wearable devices, what that has to do with skin and how three 3M looks at the science of skin. So first of all, you know, disruption does definitely create havoc, and havoc is a perfect opportunity to invent and be creative, find ways to get out of that current situation. So producing the invention itself could actually be considered the easy part. The larger obstacle may be the customer’s ability to utilize your invention. That’s why this pandemic has afforded so much opportunity in the health care area is simply going to happen now that we do have the right idea at the right time. Most everyone knows the story of the internal combustion engine invented long before we actually could purchase a vehicle and use that as our mode of transportation. Mostly that was because the public really was happy with what they had, they did not see the need to change.


So some would argue that inventions the mother of necessity, it creates needs we’ve never seen before. But what really is true is that inventions need to be useful to lead to commercialization. So the disruption of COVID in the healthcare industry was seen almost immediately. It definitely had a negative impact on elective surgeries, surgeries were being canceled. Cancer surgeries were being postponed or delayed. And there were definitely some opportunities where trauma surgeries were actually not able to happen. deferred cancer treatments have a huge impact on patients’ lives. As well as did undetected chronic problems, people actually did not just go to the doctor or the dentist for that matter to so live was really put on medical hold unless it was COVID related. So the trends because of this interruption in our general health care, accessibility, how we interacted with our physicians when we chose to have elected opportunities for surgery or diagnostics has definitely changed. There was an increase in the virtual care no longer Was it the office visit, it was the video visit. There were quite a few digital products to monitor and observe as opposed to your doctor, listening to your heart in his office, taking in your blood pressure in his office. And the consumable wearables, healthcare digital area was actually been optimized at this time. So the pandemic has really allowed creativity to be unleashed in this area. World Class Manufacturing was just thrown into gear to produce protective equipment that we needed, oodles of and couldn’t get enough of. There was rapid, rapid expansion In the new developments and point of care testing, whether it be Pulse ox, diabetic testing, even rapid COVID testing was needed as well. And then there was much, much much expansion into the remote monitoring of the medical wearable devices. So people began to utilize these devices to actually check in on their well-being in between these visits that they were unable to have with their physician. There were lots of wristwatches, there were lots of devices to monitor respiration, there were rings that some of the professional teams were using to monitor temperature, and sleep. And so you really saw this explosion happening because of the loss of the chance to be in person with your physician. So as healthcare services, you know, went to the safety of patients homes, you know, it


 


doesn’t quite


 


provide the same opportunity for everyone. Certainly, when it goes to the patient’s home, you definitely need to at least have connections, okay, you need to have that remote access, as opposed to the patient coming to the to the physician’s clinic. So this surge of medical technology really is a catalyst for all of this interconnectivity, and digital transfer in the healthcare industry. Lots more monitoring and self tracking their wars sites where you could record your temperature every day, you could take surveys about how you were feeling people were checking in on you on your device. Consumers really wanted to manage their own personal health and wellness. After all, the gyms, you could not get to your gym anymore, there was an uptick in online fitness programs that you could participate in. And then the wearables really do allow the patients though, to get a much more understanding of their own chronic illnesses. I can speak personally for my husband who went to a wearable glucose monitor. And he had never seen his a one C in better control, then during the pandemic, and that wasn’t because he was exercising better or taking better care of himself. It was his own understanding and ability to see what was happening on a hourly, if not even minutely basis now, and that certainly was not true. Before he is wearable device. So wearables again, like any emerging technology, there’s a lot of challenges coming along. Okay, so we’re going to run into the the areas of false alarms and and end up with alarm fatigue. Just like people who get cell phone, you know, they can’t hear their cell phone anymore, because it’s just such a normal tone. So you just kind of tune out to it. That’s a possibility that’s going to happen. And then we need to balance this the clinical testing that has to go on with these devices, versus interrupting our patients daily lives. So if you’re going to do clinical testing, with a device that monitors a patient, constantly, how is that clinical going to be set up so that the clinical isn’t? The patient isn’t stuck, they’re monitored, being monitored constantly. So those challenges, I’m confident we’ll be able to work through them. It’s just that they’re just new. So we hadn’t thought of them before. So there’s, I want to talk now and switch modes to to what I do at 3am. And what we do in this industry, you know, we can bring 50 core technologies, we’ve been sticking things to the body for over 60 years. We have tons and tons of knowledge on consumer designing of products, whether it be sand paper, or whether it be office supplies, or diapers. And I think we can also loan our expertise in how we can approve performances of biosensors as well. And really bring these solutions that will get us going in this wearable area. In this new post pandemic healthcare industry, three of our design missions at the company revolve around these pillars. And so I’m going to speak a little bit to each of these coming up here. So the first one is skin itself, you know, having your device interact with the body is critical. That’s why we call it a wearable. And it’s a help. So you bring all the health issues in regulatory, and that, and then on top of that, you pull in the challenges of adhering to skin. These are typically placed by the consumer. So you may have a contaminated surface, you may have differing surfaces


 


in


 


their texture, and elasticity, skin is definitely considered a low surface energy. And then not only that, skin is your largest organ. So it’s growing, it’s alive, it’s breathing, it’s shedding off dead cells as you live. So these are all factors that come into consideration when you’re thinking of adding a health monitor to the patient’s skin. So typically, there’s many ways that the medical device gets put together, something to protect it something to hold the protective layer to your assembly, something to shield your electronics, now, there has to be batteries, there has to be antennas, another layer of adhesive to assemble that. And then finally, you definitely have to have your stick to skin adhesive. And so how can the creators of these devices, make them wear longer, without compromising the skin safety of their wearer, you want something to stay on? As long as you need it, but come off, right at the time you need it and look like it was never there. So the considerations for designing these devices, again, were time, the longer you need to wear it, the stronger your adhesive may need to be and what is the risk of the skin injuries? Have you really selected the best options as you try a little long in your medical device? And did you involve your stick to skin patient early enough? So oftentimes, you end up with the device that then at the end at the very end Oh yeah. And it has to adhere to skin. It it that may be such a challenge that if you don’t have that last link in the chain, you It probably won’t work. And then did you avoid design decisions that affect your performance? And then again, how do we extend that understanding from laboratory out into the wild, where it’s not as controlled as as it is in the laboratory. So let’s look at the science of skin from 3pm. And before we talk adhesives about sticking to skin, this is really something that I think you really have to understand. This is different than adhesion to stainless steel. I often tell my colleagues that the Man of Steel actually has no need for medical devices. So stainless steel simply doesn’t play a role in these type of adhesion properties. So what do you really need to think about when you think about skin, skin is an organ, it’s an elastic organ, it’s it’s our interface to the world. There are physical, chemical micro changes, microbial changes in the skin, it protects us from the sun, it’s actually involves one of our senses of touch of cold, of heat of moisture wet, and it has all the receptors in it for that. It’s also self repairing, it is alive, it’s growing, and it regulates our body temperature, our and ions and salt regulation upon sweat cools us off, it’s really one, we have to begin to remember it is an organ in our body.


 


So the skin structure looks like this, there’s multiple layers. And I like to think of this as kind of an escalator. things grow from the bottom up to the top. So as we go through the various dermis layers, to all the way up to the epidermis in the stratum corneum, where the skin cells are shedding as they die there, this is a continual renewal process. And of course, in there you can see some of the others substructures. So moisture management is one of the wonderful things that our skin does. And you can see that since the body is made up of so much water, we do need to maintain our water inside, but we also sweat. And so there’s that equilibrium from the deep inside out to our skin have moisture constantly coming off of our organ, then there’s the fact that we age. So our organs age along with us. Aging reduces that skin functionality. epidermis thins, you know, there’s fewer dendritic cells down there, there’s a decreased cell turnover starting to slow down, there’s that decrease in natural moisturizing. And so it can reduce skin functionality. You don’t sweat as much there’s reduced collagen synthesis, there’s shrinking of the collagen. And the last is and and the blood vessels themselves become more fragile. So all of these factors, again, reduce that wear time, they affect that skin adhesion. And we need to dig a little bit more deeper. We can get into the microbiology of the skin. Well, we cannot sterilize our skin. The bacteria grows back, it’s in the follicles. There’s a complete recolonization of the surface bacteria within 18 hours. And so we need to ensure that the micro organisms are at the surface so we don’t get local infection. So there are a few choices of adhesives that are used in medical products. natural rubber was the very first adhesive introduced, for the most part because of the latex allergies that can happen from those proteins in those natural rubbers. Those have pretty much left the medical area for attachment to skin. And related he serves have been much more accepted since the 1960s. And they tend to be very, very hypoallergenic, although there still can be some skin sensitization to those act relates and so recently what has been introduced Now are silicone adhesives. These can be thought of as the new class of gentle adhesives. And they are particularly suited for patients with the most at risk or fragile skin. So one thing that you really need to consider is, who your target audience is, and what type of shape would their skin be in through the lifetime of your device.


 


So there are some simple tests that we use to perform these adhesion tests, there is the the tack, or sometimes they call it the quick stick. So this would probably come most into play, when your devices first going to be applied. There’s the adhesion, which is will it peel fall off, get bumped off by taking off clothing or rubbed off. And same with the shear is this going to be under a lot of area in in on the body, that’s going to get a lot of rubbing in shear. So you really need to take into some regular pressure sensitive adhesive testing, but in the mold that your device is going to see. So these three adhesives that I talked about, definitely vary in their performance, and particularly over time. So the synthetic rubbers of the of the early days really held on very well for short periods of time. As time went on, those adhesives did not perform as well. And they also have the added problem with the latex sensitivity. Err grillades, on the other hand, may start off a little bit lower in adhesion, but they tend to build adhesion through time. So the longer and the longer that you are on the scan, the higher and the higher the adhesion builds, that tends to be something that sounds attractive, but you have to remember, there’s going to be a day in the future when you’re going to remove your device. So if that adhesion is constantly building, you could be setting yourself up for when you need to remove it. silicones are very interesting and coming onto the market now because they have typically a very flat profile as their adhesion to skin goals. So they may start off a teeny bit low, but they reach to where they’re going to stay very quickly. And they stay at that level. I’ll be it a little bit lower than an acrylic but they do not build to that potentially skin damaging levels, even over great amounts of time. And the reason we worry about those skin damaging levels is medical adhesive related skin injuries, Marcy, it is definitely a patient safety concern in the healthcare industry. They are as the name implies, adhesive related, and they can vary from skin stripping to the dermatitis that I was mentioning, particularly with the latex mask duration, if they stay too wet under there, you can get attention injury or blister, even up to the skin tear or even some just mild allergic contact dermatitis as well. And there’s a lot of different factors that go in to Marcy as well. Is their underlying illnesses. What are the skin changes if there’s exposure to sun if you’re going to be worn for 24 seven people are going to be living their lives they will be out and about. And then are they in a you know is that Oregon in a condition of immunosuppression that matters as well. Again, the extremes of age from the very very young were skin is still developing to the very very old where the skin now is very aging and having reduced functionalities as opposed to healthy midlife skin. And those all fall into what would be your choice of adhesive for your device. These considerations I just cannot say enough about because these risk factors for marsi are what will affect your wear of your device. And in this pandemic, one thing that everybody has has definitely got on their mind now is they are watching what is happening to them to themselves, they understand that you need to take care of you. And so when they are choosing what devices they will be looking at in the future, there’s no way that the pandemic is ever gonna get away from the fact that we now really care about ourselves. So I’d like to thank everyone, and just remind you to definitely think about 3am. We have many, many technologies in the company that we share back and forth. I’ve highlighted a few that we really rely on when it comes to skin, skin adhesion, and particularly in these wearable device areas. And so let me know as soon as you’re ready to collaborate, because the time to do it is now there is definitely the opportunity.


 


The consumers are ready. And so I’m just so excited for what the future holds in the area of health care. Thank you so much, everyone, and have a great life.


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