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Articles from 2020 In September


Wearable Medical Devices

Wearable Medical Devices: What Do Design Engineers Need to Know?

Image by artinspiring – Adobe Stock wearable medical devices

Interest in wearable health technology continues to rise significantly, according to many reports. Health and fitness monitoring continue to drive demand, and emerging needs such as remote patient monitoring, home healthcare, and drug delivery could add to such interest. To help medtech product designers meet these needs and more, MD+DI asked a group of medical device engineers about the latest developments in wireless technology, battery life, data and security concerns, user needs, and more. The following questions were discussed and collectively answered by a team of engineers from StarFish Medical. These engineers are Kenneth MacCallum, principal physicist; James Jackson, principal industrial designer; and Nigel Syrotuck, mechanical engineering team lead. Also contributing are John Turner, software manager; and Ash Luft, embedded software engineer. Read on for their insights on wearable medical devices.

 

How has wearable medical device usage increased in the last five years?   

Fitbit, Apple Watch, and insulin pump usage have all increased in popularity and usage. The insulin pump, hearing aids, ECG, and continuous glucose monitors are on the market and are considered wearable medical devices. Diabetes wearables are going to become very common when glucose monitors and pumps are added to the mix and provide a level of constant care. 

We saw a big increase in client requests for wearables a few years ago. Recent projects include pain cessation, insulin delivery, and post operation follow-up. 

 

How will fitness monitoring shape the global wearable medical devices industry?  

Fitness monitoring is more popular than ever. As a result, a lot of people are learning how a wearable works, setting the stage for medical devices. Apps are also more ingrained in everyday life, like the Apple Watch monitoring cardiac arrhythmia, cardiac arrest, and general health. Healthcare professionals are beginning to tap into apps for constant monitoring and emergency monitoring to determine [whether a patient is] having a heart attack. They're not there yet, but the long game is to make fitness monitoring devices and apps into regulatory accepted medical devices.  

One obstacle to overcome is that although Fitbits initially seem very cool, the value they deliver to their users is pretty limited. People buy them, use them, and then get bored. In our opinion that’s because right now they are more about serving big data than the individual, although their hope is to also improve lifestyles and provide users with biometric feedback via ECG monitoring, blood O2 monitoring, and the typical IR sensor. Fitbit is working to add clinical indications to their devices as well as experimentally aggregating data broadly among their user population to draw medically relevant conclusions. Until they provide direct clinical value to individual users, it is unlikely that adoption will jump up a level. In the meantime, being able to read texts on your wrist is probably more useful and more reason to wear a device than seeing if you walked more than 10,000 steps in a day.  

background image by artinspiring – Adobe StockKenneth_MacCallum.png

 

How can diabetes care applications challenge the wearable medical device industry?  

Diabetes care applications are a very big market for wearable medical devices. We see a big uptake on them. People want them. They wear them. You see them all around now on both kids and adults. It's a real medical device, really wearable, with real benefits, and being used and improving the quality of life in many ways.  

 

How are current wearables adhering to customer needs and wants? 

They're combining things to promote adoption. A smartwatch has to have things like text messages for people to really like it. The purely pseudo medical part is often not so compelling. Wearables is a very buzzy topic, but it feels like killer applications are few and far between in the medical space. 

Currently, the most adoption is in the performance fitness stuff—the people who ride their bikes a million miles a day and want to track their heart rate over six months to see how they're doing. Apple is not just looking at the Fitbit side. They want more integrated health. Their Apple Health app is primed for a lot more than just being a step counter or tracking peak and resting heart rates. 

If we can broaden wearables to include things like phones, then a bunch of interesting things are happening with apps. Particularly with COVID and all the COVID apps that people have on their phones. 

Contact tracing is being used in Europe and trialled in North America. It's a wearable, but just monitoring where people are. Ironically that's the sort of data that if Google or somebody similar said, "Hey, we just happen to be tracking you and noting whenever you show up near one of our other customers," it would be creepy. But now, suddenly it is acceptable, even appealing. 

The COVID tracker is very relevant in the times that we're living in now. And those times are way different than they were five months ago or six months ago. That's a wearable medical device of sorts. Finally, a compelling use case for a wearable. The implications are obvious. The technology is not insurmountable. You have to be beside somebody for five minutes and you have to be within two meters for five minutes for it to work.  

Another example can be seen in orthodontics. The daughter of one of StarFish Medical’s engineers uses an electronic device that she sticks in her mouth for a number of minutes every evening. It helps make her teeth move and the orthodontist says, "if you don't do it, then it may take longer and cost more." The upside for the patient is “faster and costs less if you do these things.”  

Also, there's a big issue with incorrect dosages or incorrect medicines being given. Wearables can help for insurance reasons and also prevent the wrong medication being given. Apple Health enables you to take a picture of a drug or a tablet and find out what the drug is and how many milligrams are in the tablet. Your phone can take a photo of pills that are about to be administered and give you a second line of assurance, thereby reducing incorrect dosage incidents.  

A similar device is the pill tracker. A number of phone apps are connected with special pillboxes to help simplify complex medications. They ensure pills are taken at the right time. And they don't forget. The clinician gets to see how well the patient has been taking medications and can make a proper diagnosis. 

The Holy Grail of medical device wearables is a combined insulin pump and monitor, because monitors currently send us a fingerprint every now and again. Real-time monitoring of what's happening with fidelity through the day in a combination version that will dispense insulin in more of a considered way will dramatically improve healthcare for diabetes.  

Long-term blood pressure monitors that you can wear for 24, 48 hours or a week are the thing now. There's one for estrogen as well for pregnancy, for monitoring the menstrual cycle and identifying the optimal time to fertilize the eggs. Several monitors based around estrogen are coming on market for all the reasons above. 

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What technology has made the biggest leap for wearable medical devices?  

Every wearable now interacts with, and usually uses, the cell phone as the hub of all communication because everybody has one. If it's a smartwatch, it talks to your phone, Glucose pumps have an interface on your phone. As phones and other wearable tech march forward, wearable medical devices are going to build on them and benefit immensely. 

Another area is sensors. For example, integrated directly into the knee, a prosthetic can monitor temperature, position spaces, and rehabilitation. The bend sensor can show a physiotherapist whether their patient is actually holding to their rehabilitation regime. Or, the sensor can indicate that if there is an infection. They communicate directly back through a phone. Often the rehabilitation system is designed to gamify the experience in order to encourage compliance. This system enables a health provider, which is essentially the insurance company, to confirm that a patient is actually doing rehab.  

 

What are the current limitations of technology for wearable devices? 

Battery life is a limitation. There hasn't been a huge step forward in battery tech for a while. The amount of energy you can jam into a given volume has been the same for a few years. We’d love to see that jump forward a bunch. A lot of battery development is currently going on for a variety of reasons. Maybe we'll see a big jump in the next decade. 

 

How can recent wireless trends for wearable medical devices benefit healthcare providers?  

Everybody has a phone. The more people who use a wearable connected to their phone, the more data available to collect either anonymously, or with permission, on a person-to-person basis.  

The cell phone is a bridge between a medical device and the cloud. One can link a wearable monitor to the clinician through the cloud. There's no IT problem to solve to allow that to happen because the Internet is available all the time.  

A cell phone is useless without wireless, as apps on it allow communication to the cloud and capture of data, but then, of course, it's got to have a short haul wireless like Bluetooth, which allows you to go to sensors.  

If the patient is wearing a device, there's a more longitudinal measurement of whatever parameter their wearable might be monitoring. Rather than taking punctuated tests, providers get a whole bunch of data. Although not much is on the market yet, the industry talks about the potential of long-term data.  

We don’t know yet if the COVID tracker is effective, but everybody seems to think it's worth trying. Perhaps that's just because we have a phone in our pocket and can do these types of things. It is definitely a benefit for healthcare providers who can track contacts much better.   

More efficiency and patient access to health records are also a benefit. A phone can scan bar codes either on patients, on the drugs, or both. Wireless communication between a phone and other wearable devices empower and streamline information and workflows for providers and patients. 

On the compliance side, healthcare providers can make sure their patients are doing the things they are supposed to do. However, there is a potential downside that insurance providers could make decisions that aren't best for the patient based on data that they receive from wearables. 

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How are wearable devices benefiting patients?  

There are two aspects to wearables that could benefit patients. One is removing decision-making from the clinician, allowing the cloud to make that decision. The other is monitoring people to make sure they're doing what they're supposed to be doing.  

It's a double-edged sword. The upside is, we're all human and mess up periodically. Wouldn't it be great if we had this little angel overlooking over our shoulder and saying, "Not that one—take this one?” Let's face it, it's usually the stupid things that we fail at, not the complicated things. We pay attention to the complicated things. 

Patient benefits are empowerment and the ability to see what's happening in their bodies in a way they’ve never been able to see before. Professionals may have been able to see what's going on in patient bodies, depending what the patient is hooked up to, but this is the first almost real-time monitor on what's happening. The ability to put his or herself under a microscope is quite an interesting patient benefit.  It can enable more adherence to plans while removing the veil of what's in the doctor's chart. It gives more clarification about "what professionals are writing down."  Add in the gamification when the patient can see their chart, they can go, guilt or gamification.    

Patients are able to monitor their progress and see that they're progressing. They can also see how altering their routines might help them more. It's a long-term understanding of what they're doing and how it's working (or not). The healthcare provider can contribute to this effect if they have access to the data and can advise the patient on what is working and not working and then adjust accordingly.  

 

What are the wireless trends? 

Bluetooth through phones is a big trend. Wires don’t plug into phones much anymore. The same thing is happening with medical devices. The phone app for a glucose monitor or insulin pump uses Bluetooth. Wiring a link to a phone to be able to control a device would be really irritating. People don't want big and bulky wearable devices, because their phone has an awesome portable, wearable, rich user interface already.  

A common or known interface back to an Android, Apple, or other platform and being able to integrate into that holds a lot of benefits. They are known interfaces comfortable for users which other design guides are asked to uphold. That commonality reduces error and increases adoption. It's a much richer interface for developers to develop on compared with building and supporting new hardware.  

Hearing aids and cochlear implants now use phones as an interface to tweak their parameters. Five years ago, to change the parameters of a hearing aid, users had to go in to a clinic. That was partly the business model, but now hearing aids allow users to tweak devices and change the settings to adjust to the environment—TV mode and things like that. Users pay a monthly subscription instead of a clinic visit fee.  

 

What are the most reliable forms of wireless communication for wearable medical devices?  

Bluetooth and Bluetooth LE are both good options. Every smartphone has Bluetooth capability so we can connect that way. Some cell phones have near field communication (NFC), although it's not super useful for wearables. The phone itself has Wi-Fi and cellular data to communicate up into the cloud where the data can be passed on to clinicians in an appropriate way.  

 

How have wearable medical device designers handled limited power sources? 

Bluetooth LE is good because it is low power. Mostly, designers trade bandwidth for power. If users do not need to send much data and send it infrequently, then a skimpy battery is great. Aggregating data and sending it up in small little bits rather than a massive unprocessed data stream can be a way to handle limited power sources. Sleep modes and reduced functionality are additional options. 

Batteries are getting better, but there hasn't been any step change in power densities since lithium, lithium ion, and lithium polymer. They are the most energy dense, most readily available power sources. There other battery technologies such as mercury batteries, silver oxide etc., but lithium chemistries are by far the most prevalent for wearables. Lithium ion batteries have safety issues around them, but there are lots of standards to keep it safe.  

 

How have technological advancements impacted wireless communication for wearable medical devices?   

Technological advancements have focused on a very small number of mechanisms, lower energy communications, higher energy density batteries, and in particular, the cell phone. Everybody has a cell phone. A decade ago, designers might have considered putting an SMS transmitter-transceiver in a device to ensure that connectivity. But with Bluetooth on most phones, designers can pretty much assume the phone can get any comms that are needed.   

There may be cases where somebody doesn't yet have a smartphone but needs a medical device with connectivity. It’s likely they will need a loaner device. Communicating through a phone is so compelling because it is so available for most of the population. 

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How do wearable medical devices transmit and receive data from controllers or smartphones?    

Bluetooth LE is certainly a way. There are more proprietary methods to communicate through tissue. But mostly the jump to a phone is done with Bluetooth. NFC is about the only other way to transmit and receive data, but not every phone has it.  

 

How do you balance security and utility in wireless wearable medical devices? 

It would be great to send all sorts of great data across all these wireless links, but the more data, and specifically the more patient identifiable data that you send, the more care you have to take to not let the data get away from you and to not let it get outside of your control. 

Another balance is ease of use. If you want the process to be simple for connecting and throughout its use, the solution often leads to less security. Ensuring a lot of security often means lots of hoops to jump through, such as passwords to type in or biometric biometrics or whatever. The balance is ease of use versus keeping data secure. Fortunately, technology is marching on. Cell phones now have fingerprint sensors and lots of apps now use the fingerprint sensor as a security feature. If everybody has this on their cell phone, that removes the need to type in an onerous password and write it on a Post-it on your fridge or something like that.  

A lot of data breaches happen with people getting into the server at the facility, not by getting into a phone. Why not get 10 million hits instead of one at a time? Regardless of whether there is a secure link to get the data into the repository, or kept the link to the database secure, somebody can hack into the database and get tons of data instead of data for just one person.  

 

How has security technology for wearable medical devices changed?  

In the past 5-10 years, we have seen an unprecedented explosion of connectivity integrated into technology including wireless and wearable medical devices. Ensuring clinical environments have secure networks has already been a major issue for health delivery organizations historically. With the shift towards wireless wearables, more devices are operating on consumer home networks or even public Wi-Fi. Increased connectivity means that devices may be exposed to unknown or unsafe networks, which may significantly impact risk. 

People are taking it seriously. There have been enough instances of things being hacked, whether they are pacemakers or insulin pumps or another device. These hacks demonstrated how insecure wearable medical devices were. The industry and patients now understand security is something that they can’t ignore. That's a big change. We have got to worry about cybersecurity. It will be very public if you don't pay attention. A number of medical device manufacturers have become quite public regarding how they've been hacked or discovered a vulnerability.

If you look back far enough, some wearable devices didn't use wireless technology. They didn't need security because it was just one person's data on an old school pedometer or an insulin tracker. Security concerns might have been a little bit different. But now, we want wireless data, constant connectivity, and telemetry. We want a cell phone app. Wireless security is valuable to the company that makes the device, consumers, and healthcare providers.  

The challenge is to provide patients and clinicians with the richest interface, the most useful data presentation, with the least amount of passwords required, and then making it secure so nefarious actors can't come along and hack a pacemaker, turn it off, or grab health data that they can use negatively.  

 

What security implementation challenges does the wearable medical device industry face? 

One class of challenges stems from security industry solutions being designed for hardware independent software or non-safety critical systems. For example, standard security tools and protocols that work well to assess modern web applications or traditional networks often aren’t appropriate for embedded devices and product life-cycles that include hardware-dependent development. We need to create custom solutions to address the security requirements for each device which can be resource intensive. 

background image by artinspiring – Adobe StockAsh_Luft.png

 

If you were creating a wearable device, what you raise as key considerations and why?  

Fitting a wearable onto a user is always a huge thing. And that's not just the size of the wrist, but how hairy their arm is and how loose their skin hangs. What impact will the wearable have on their day-to-day life that may cause them to either use it, or not use it, or use it improperly?  

On the projects that have a wearable aspect, those are the big challenges we have to get through. We can leverage a lot of the wireless communication from consumer electronics. But to make it fit onto a person, into a person's life, and interface with them in a way that makes it, is going to continue to be a big challenge.  

Sensors are part of that. There is no sensor out there that can be bought off the shelf for a reasonable price that will actually work for most people every time. Maybe it skips a couple heartbeats or whatever, and the data gets thrown off. We can try to fix it with an algorithm, but things are a little wishy-washy. Sensor technology is good, but not great across the board.  

How these wearables are worn is a challenge. There is some stigma as well. That's always been the challenge. A shortsighted view is "make it look like an Apple thing." People with IBS don't really want to be going around with anything, regardless of how nice it looks. Other concerns are how and where it adheres to the body, comfort, and lots of problems with temperature. If you're down in South Carolina wearing one these wearables around your midriff, you are probably very uncomfortable.

And then there is the issue of acceptance—are people psychologically comfortable wearing these things? That's why fit people don't wear Fitbit. There's a lot of psychology involved with wearables. We don't fully understand that yet. What's going to work? At the moment wearables are kind of like the Apple Watch, your Fitbit for their kind of things that can't be seen. How that will playout in the public psyche is going to be very interesting. Is it something that will be, "Oh, look, what I've got." Or is it something that people will be more quiet about wearing.   

The difference between a smartwatch and a wearable medical device is that a medical device represents a condition. There's an issue that you're trying to solve or detect, and that's why you're wearing the device. Whereas, a smartwatch could be just a cool fashion accessory. You might like people to see your smartwatch. You probably don't want them to see your colostomy bag.  

 

What stood out for each of you after all your discussions on wearables and wireless?

Syrotuck: Perhaps it's a little pessimistic, but I think there's been no fundamental shifts in the way wearables and wireless work in the last five years. It's definitely a lot of work. Anyone who thinks that tossing a pedometer in a phone or a watch and sending the information to a Web site or an app is easy is missing some of the key technical challenges that come with medical devices. A. It's tougher than you think and B. There's nothing too new and exciting happening.  

MacCallum: Really compelling medical devices are few and far between—insulin pumps, hearing aids, ECG-like applications. Not many of the Fitbit and fitness trackers are turning out to be a real thing as far as medical devices are concerned. A lot of people thought, if I designed an awesome sensor that I could “medicalize” and hook up to the cloud, then people will beat a path to my door. But they're not. It seems like everyone is waiting to have that little epiphany of a new intended use that needs a wearable. 

Syrotuck: Or one that works so seamlessly and requires so little of your mental effort. Like, if I could wear a watch that gives me data throughout my entire life and I knew that, in 40 years, I could take it in to my doctor and s/he could say, "oh, when you turned 60, that incident was nothing. But, you know, when you turned 40, it looks like you had a little heart attack." That's good to know. There's also a hump of usability where if we can make things seamless and show positive effects over the long term, that's the place we should go.  

Jackson: This is kind of a looking glass into oneself with all the psychological responsibility that will bring. Constant tracking, being able to look at what's happening with yourself instead of a doctor writing down something on a medical record, and you not knowing what's there. Or not really understanding what they are saying about your blood pressure and every few months going in and talking again. This real-time information may empower people to actually take more care of their health. We'll have to wait to see what actually happens, but I think that's somewhat of a possibility.  

MacCallum: Various healthcare schemes all over the world will need to adapt a lot to make that work. Unless the preventive-style care happens, not many healthcare systems are set up to really leverage that data. Nor does the way that clinicians get paid mesh well with some of the ways that we imagine wearables could be useful. If there's no money in it, and they can't recognize an immediate cost savings or an immediate revenue stream, it doesn't matter how good a wearable might be for humanity—it will have a little bit of a hill to climb to get on the market.  

Syrotuck: The day my doctor asks me, "Hey, are you wearing one of those bits yet?" Or maybe there is a screening question in the doctor's offices, "Do you have any health tracking wearables?" will be the day that I think they are adopted and they are useful. That will be the day we've gotten there.  

MacCallum: Especially if your doctor recommends, “Oh, you should get a smartwatch because, that'll help me.”

BD Set to Launch 15-Minute COVID-19 Test in Europe

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Companies are quickly filling the demand for more rapid COVID-19-related diagnostics. BD is the latest firm to do so with the availability of its point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System in Europe.

The Franklin, Lakes, NJ-based firm said the new test delivers results in less than 15 minutes and that it has been CE marked to the IVD Directive.

“Availability of the SARS-CoV-2 assay on the BD Veritor Plus System in Europe builds on our molecular test on the BD MAX System that has been available since March,” Roland Goette, president of BD EMEA Region, said in a release. “The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of COVID-19.”

The test uses the BD Veritor Plus System, which is already in use across Europe to test for conditions such as Group A Strep, influenza A+B and Respiratory Syncytial Virus (RSV). The BD Veritor Plus System is slightly larger than a mobile phone.

The test has had emergency use authorization from FDA since July. Earlier this week, Cepheid received emergency use authorization for a molecular test that can detect viruses causing COVID-19, flu, and RSV infections.

The Sunnyvale, CA-based company’s diagnostic comes at the beginning of flu season, a time when these tests will be in high demand. As companies are still rolling out diagnostics the pandemic continues to rage on. To date, more than one million people have lost their lives to COVID-19, according to data from www.worldometers.info.

Medtronic's Buying Spree Continues with Avenu Medical

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Medtronic is set to acquire Avenu Medical, a company that would give it the ability to support procedures across the dialysis vascular access care continuum. The Dublin-based company did not disclose the sum of the tuck-in deal, which is the latest in a series of acquisitions to further the medtech giant’s plan of refocusing during the pandemic. The acquisition is set to close this month (October).

San Juan Capistrano, CA-based Avenu is focused on the endovascular creation of arteriovenous fistulae for patients with end-stage renal disease undergoing dialysis. To that end, the company has developed the Ellipsys Access Vascular system.

Avenu’s Ellipsys Vascular Access System is a single-catheter, ultrasound-guided device that inserts a catheter percutaneously (through the skin) into the arm to create a durable AV fistula. The procedure can be performed in the hospital outpatient department, ambulatory surgery center (ASC), or physician’s office. Ellipsys was cleared by FDA and has CE mark.

“AV fistulae are like lifelines to patients undergoing dialysis. Until recently, the only option to create a fistula was through invasive surgery, which is associated with high failure rates,” Jeffrey Hull, M.D., director of the Richmond Vascular Center and co-founder of Avenu Medical, said in a release. “The Ellipsys system has shown durable outcomes out to two-years and has the ability to shorten procedure times and potentially reduce costs. Unlike open surgery, sutures are not required after the procedure and the patient leaves with just an adhesive bandage.”

‘Tis the Reason for Medtronic’s Acquisitions. But Can the Company Break Boston Sci’s 2018 Deal Record?

Medtronic’s revenue took significant hits because of the pandemic. During its most recent earnings call, Medtronic CEO Geoff Martha said the company was going through a revamp of sorts and for investors to lookout for a new Medtronic.

One of the most tangible aspects of this proclamation is the rate Medtronic is going after these tuck-in acquisitions.

The medtech giant announced six companies it had signed definitive agreements to acquire and all are tuck-in deals. During Medtronic’s most recent earnings call, Martha, said the tuck-ins would keep occurring but there was little to no likelihood of a massive deal.

“The focus is on the tuck-ins,” Marta said according to a transcript of the call from Seeking Alpha. “And the tuck-ins can get up to billion dollars or low billions. But that's the focus. That's the focus.”

Martha pointed to the Companion Medical deal as being a significant part of the tuck-in-deal puzzle. The deal was for an undisclosed sum.

Medtronic acquired Companion because it gave it access to the smart insulin pin device, which further simplified diabetes management and improved outcomes by optimizing dosing decisions for the large number of people using multiple daily injections.

“See, Companion is just one more example of how we're going on the offensive as a company through an increased cadence of tuck-in acquisitions,” Martha said of the acquisition, according to a transcript of the earnings call from Seeking Alpha. “In fact, in addition to Companion, we've done two other major tuck-in acquisitions this calendar year, with Digital Surgery and Medicrea. Combined, these three deals totaled approximately $1 billion in total consideration.”

Medtronic is going on a buying spree that could mirror or even surpass Boston Scientific’s efforts two years ago. Recall in early 2018, the Marlborough, MA-based company’s president and CEO Mike Mahoney said the company had a lot of cash on hand and was hungry for M&A. The result was a year that ended with 10 announced deals.

MD+DI Editor’s picked Boston Scientific as company of the year in 2018 because of the wide breadth of deals it had under its belt.

Medtronic has a few more deals to go before it surpasses Boston Scientific’s 2018 numbers – but there is still a lot of time left on the 2020 clock.

Wearable Medical Devices

Wearable Wireless Medical Devices: Signaling the Future of Healthcare

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Jeanette Numbers, co-founder and principal for Loft, who will be speaking during the upcoming BIOMED Digital event in the session,  “Wearables with Purpose: The Future of Healthcare.”

Wireless devices are already transforming self-care for the consumers who wear them. But can wearable medical devices impact patient outcomes? Jeanette Numbers, co-founder and principal for Loft, sees such potential, but only if wearables can do more than just monitor and report patient data. 

Numbers has focused on creating visually compelling, human-centered design solutions described as “rooted in purpose and driven by research.” She's led teams in strategic design thinking, digital and physical product design, and final product commercialization, in a wide variety of industries.

Numbers will be speaking during the upcoming BIOMED Digital event in the session,  “Wearables with Purpose: The Future of Healthcare.” MD+DI asked her a few questions about wearables ahead of her session. Read on for her insights, and don’t miss “Wearables with Purpose: The Future of Healthcare” on November 5.

What is wearable technology in health care?

Numbers: Wearables are miniaturized technology intended to be worn on the body. They can provide information about the person wearing them or information about the person’s surroundings. Personal information could be anything from monitoring heart rate and ECG, glucose levels, hydration, even migraines. Providing information about the external environment could include something like a food-based allergen sensor or even a fentanyl detector that could give you real time-information.

Because of their intimate relationship to the consumer (they are worn directly on the body, providing unprecedented access to personal data) and the momentum behind health tech, wearables are in a prime position to be a huge player in the healthcare space.

 

What do consumers want from wearable wireless medical devices? 

Numbers: Up until very recently, wearables did not do much for the end user. Take the Apple Watch, for instance: it counts calories, monitors heart rate, and receives text messages. Handy, yes—but from a health perspective, does it actually solve any real problems for you? What if instead of just taking in your data and sensing the needs of the body, wearables actually acted on them, by delivering interventions such as micropulses, heating, cooling, and more? In my work at Loft, I have become very focused on the idea of “proactive wearables”—wearables that go beyond the obvious to serve a real purpose for the end-user. Or in healthcare terms, to drive positive patient outcomes. As the healthcare industry looks for options outside of pharmaceuticals and surgical intervention, the idea of a wearable that has prime access to your biomarkers is really enticing—there’s a near future where wearables have the opportunity to prevent, detect, manage, and even treat symptoms.

 

What will be the impact of the popularity of fitness monitors on the outlook of the wearable medical devices market?

Numbers: Fitness trackers are paving the way for users to be more willing to wear a device consistently, day-in and day-out. For the average consumer (or patient), fitness trackers are an easy introduction to the idea of wearing something on your physical body everyday that is not for the sake of fashion or utility (comfort, protection from the elements, telling time, etc.). By being connected to your body 24/7, devices can learn your habits and routines and start helping you make actionable improvements.

 

What factors will contribute to making wearable wireless medical devices mainstream?

Numbers: Making them proactive—having them give more than they take. In other words, the wearables of today have to go further than just tracking steps and giving you data. They have the ability to provide interventions in the moment that can create positive outcomes, from helping you manage your anxiety to sensing seizures before they happen. From a medical device perspective, we need to elevate wearables out of the “fitness tracker” space in order for them to be widely adopted and worn consistently.

 

What are the health benefits of having wearable wireless medical devices be mainstream?

Numbers: By providing interventions, wearable wireless medical devices can prevent negative health outcomes and treat symptoms. I’d argue we need to go beyond mainstream to make these devices accessible to all—wearables currently exist in the realm of “discretionary purchases,” and people usually buy them out of pocket. We need to make devices that are accessible within the current health payer system. Furthermore, by making these devices more ubiquitous, we reduce the stigma that people with more serious conditions may feel from wearing a “medical device,” as it becomes no big deal.

 

How can healthcare providers utilize wearable wireless medical data from next-generation devices?

Numbers: Great question – and thankfully a problem that I am not tasked with solving. I am watching the debate around this question rage on with wariness. My primary concern is maintaining privacy and transparency for the end users that wear the product long after I design it.

 

How will healthcare evolve with the introduction of the next generation of wearable wireless medical devices? 

Numbers: It really comes down to those interventions that happen in the moment, and the degree to which we can personalize this care. We can also imagine a near future where instead of referencing a year-old chart at your annual checkup, your doctor reviews data from your wearable device.

 

What challenges are faced by wearable wireless medical devices in healthcare settings?

Numbers: There are several hurdles that I see as barriers: First, protecting patient information is paramount, and I don’t think anyone is doing it perfectly yet. Secondly, compliance and consistency—in order for these devices to actually work, they need to be worn regularly by the users. Lastly, and something I am particularly passionate about: there are people and groups being left out of the wearable device development process and the pitfalls are painfully evident. For instance, heart rate monitors intended to be worn across the chest often do not take into consideration female anatomy, rendering them useless for 51% of the population.

 

How is wearable wireless technology impacting hospital settings?

Numbers: To be honest we’re not really seeing the impact yet, mostly because wearables are still locked in this “fitness tracker” space. My hope is that adoption of proactive wearables will lead to less hospital visits and faster diagnoses for patients who can provide their doctors with comprehensive data thanks to their wearable device.

 

What challenges will healthcare face with the next generation of wearable wireless medical devices?

Numbers: The next generation of wearable medical devices will have a significant amount of data to process in order to truly add value. Making sense of all that data is a big hurdle I see for the future of medical wearables.

From a more abstract perspective, I think the challenge is that we’re limiting ourselves by thinking of wearables as data collection devices and trackers. I see the potential for wearable devices to go so much further, but it requires us to stay creative—which can be difficult in the healthcare space where there is such a focus on process, procedure, and safety.

 

How can future fashion collections adopt medical technology as a basic characteristic?

Numbers: Fashion companies and medical device developers need to talk early and often in the development process. One cannot be sprinkled on top of the other. That being said, the benefit of making wearable medical devices look less… medical, is that they will be easier for users to adopt and wear. And the more comfortable users get with wearing something on their person everyday, the more benefit the wearable can provide. Going sleeker, going smaller—these are two ways to make a wearable more wearable. We’re doing it with clients Embr and Allergy Amulet right now, and we’ve had a great response from our user surveys.

Why Consider X-Ray Sterilization?

Image courtesy of Avery Dennison Medical ADMD_TapesFoamSCPeelWhtOL_web.jpg

With evolving news headlines about COVID-19, the mention of supply-chain shortages in the medical industry brings to mind surgical masks, protective equipment, and virus test kits. Yet since this time last year, there also have been headlines about supply-chain risks of another kind—those related to temporary or permanent closures of ethylene oxide (EtO) sterilization facilities. Several large EtO sterilization facilities in the United States have shuttered or temporarily halted operations due to environmental concerns about potentially dangerous air emissions. As a result, the U.S. FDA has been monitoring supply-chain interruption risks for devices that would typically be sterilized at those facilities. At the same time, medical device manufacturers and their extended supply chains have been prompted to reconsider their sterilization methods. According to FDA, more than 20 billion devices sold in the United States annually are sterilized with EtO, or about 50 percent of devices requiring sterilization.1

Sterilization Basics

One of the last steps in the supply chain, sterilization usually takes place after a device has been manufactured and packaged, before it ships to a storage or end-use destination. The purpose of sterilization is to eliminate all living microorganisms on a device so that it is free from any contamination. By killing all microorganisms, sterilization helps prevent any potentially harmful ones from reproducing and spreading infection when the device is used on a patient or in a healthcare setting. Most device makers outsource the sterilization process to large contractors with specialized equipment and facilities.

This article focuses on sterilization methods, including EtO, gamma irradiation, and X-ray, that are viable for use on devices containing plastic films, papers, and nonwoven materials, including medical-grade pressure-sensitive adhesives. Such materials are commonly found in disposable medical products, wound care dressings, ostomy appliances, surgical drapes, wearables, and patient monitoring devices. Many polymer resin-based devices like these products cannot withstand hot-steam sterilization, a popular method without the risks of some other processes.

The Issues with EtO

EtO gas kills microorganisms on contact. EtO is classified as a human carcinogen by EPA. Facilities using this sterilization technique must meet stringent environmental standards to protect their workforces and surrounding communities.

A number of EtO operations closed in 2019 given concerns about emissions. Announcements were made that some plants would not reopen, whereas others would be building EtO emission reduction equipment or making emission-control enhancements. 2,3   Some operations reopened under an FDA Emergency Use Authorization or a pandemic-related emergency order. 4,5

Beyond the emissions risks, EtO sterilization poses additional challenges to device makers when they go to prove that their products have been successfully sterilized. They must not only provide evidence that EtO gas has killed all microorganisms, but they must also confirm there are no toxic EtO residual gasses trapped within the device and its packaging. A process called off-gassing is used to eliminate these residual gasses, but it still can be difficult to validate a successful EtO cycle for some products. Moreover, if there is an impermeable release liner protecting an adhesive material, there can be concerns about whether a device’s adhesive surface, the one that ultimately will touch the patient, has been effectively sterilized.

Image courtesy of Avery Dennison Medical.ADHC_SilverInciseDrapeRet4web.jpg

Medical devices such as ostomy appliances, wearables, wound care dressings and surgical drapes usually contain polymer-based materials, which can be damaged by some sterilization methods. These materials typically can tolerate X-ray irradiation, an alternative to ethylene oxide treatment.

 

No Method Is Perfect

While EtO environmental risks and related supply-chain interruptions are currently in the spotlight, it’s important to note that every sterilization method has pros and cons. The hot-steam sterilization process poses low safety risks, but its high temperatures and moisture levels are too intense for most plastic and paper materials.

Another sterilization method, gamma irradiation, can be used on polymeric materials, but it is harsher than EtO treatment. The ionizing radiation can degrade the materials, sometimes causing them to become yellow and brittle. The gamma irradiation process also consumes the radioactive material cobalt-60, which is in short supply globally and highly regulated and poses environmental and health risks if not managed properly.

X-ray Sterilization: Another Option

Given short-term and long-term concerns with both EtO and gamma irradiation methods, X-ray sterilization, also known as X-ray irradiation processing, has emerged as an alternative method. It is gentler on polymeric materials than gamma irradiation, and it does not have the emission dangers of EtO.

“The commercial use of X-ray irradiation began around 20 years ago. However, due to the low power output of the accelerators used, the technology was generally overlooked as a viable sterilization method,” according to STERIS Applied Sterilization Technologies, which provides a variety of contract sterilization services, including X-ray. “Now, with the introduction of high power, high energy accelerators, we are able to offer X-ray irradiation technology at a commercial level equivalent to traditional sterilization methods.”6

With the latest X-ray technology, sterilization contractors can achieve better penetration than they could with gamma irradiation with less impact to product materials, according to STERIS. One reason is that there is a shorter exposure time required to kill microorganisms. High-energy X-rays can be used to irradiate large packages and pallet loads of medical devices, STERIS reports.7

While there are no air emissions or residual waste products from this sterilization method, there are some barriers to entry for X-ray irradiation processing. Contractors looking to use this method will need to make significant capital investment in a high-power electron accelerator, conveyor systems, and other equipment. As a radiation-based sterilization method, X-ray irradiation also requires biologic shields to protect workers from damaging rays. There is a very small possibility that X-ray radiation could induce radioactivity in medical products, but this risk can be mitigated by careful control of energy levels.8

Conclusions

Medical device sterilization methods will continue to evolve as the industry develops new standards and solutions that are economical, environmentally sustainable, safe, and effective. In fact, FDA has launched innovation challenges to encourage the development of new and improved sterilization methods.

During material selection, product development, manufacturing, or any point in the product lifecycle, it’s important to have a proactive dialogue about sterilization with all suppliers. Advanced medical material suppliers should be prepared to discuss how different sterilization methods affect their products. Some may be able to supply laboratory test data to show how materials across their product range maintain properties and performance after treatment with X-ray irradiation.

With close collaboration, partners across the medical supply chain can ensure materials used today and developed for future devices are compatible with next-generation sterilization methods.

 

References

  1. “Statement on concerns with medical device availability due to certain sterilization facility closures,” U.S. Food and Drug Administration, Oct. 25, 2019.
  2. Ethylene Oxide Sterilization Facility Updates, U.S. Food and Drug Administration, Jan. 28, 2020.
  3. Ethylene Oxide (EtO) Safety at BD, including “BD Statement on Agreement with State of Georgia to Maintain Availability for Patients,” Oct. 28, 2019.
  4. “Medical device sterilizers ask to use EtO to boost hospital mask supply; activists call for FDA to block it,” Cook County Record, April 17, 2020.
  5. Latest on Sterigenics plant situation. Cobb County, Ga., government website, April 8, 2020.
  6. X-ray Irradiation Processing, STERIS Applied Sterilization Technologies website, accessed March 11, 2020.
  7. “X-ray Radiation Processing,” STERIS Applied Sterilization Technologies presentation, February 2019.
  8. A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products,” International Irradiation Association and Gamma Industry Processing Alliance white paper, Aug. 31, 2017.

Medtech Unfiltered: Learning to Coexist with the Big Bad Apple

News Editor Amanda Pedersen talks about the competitive pressure of Apple, FitBit, Google, and Amazon's increasing presence in medtech.

Cepheid to Cut Through the Flu Season Clutter with New Test

Michail Petrov -images.adobe.com IMG_Sep292020at40858PM.jpg

Cepheid has received emergency use authorization for a molecular test that can detect viruses causing COVID-19, flu, and RSV infections.

The Sunnyvale, CA-based company is designed for use on the GeneXpert system, with results delivered in about 36 minutes. The combination test is set to begin shipping the U.S. this week. However, Europe will see availability of the molecular test in November.

The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patients in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine.

"Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus," said David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid, in a release. "The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system."

Cepheid’s parent company Danaher has been deep in the fight for COVID-19 detection. Beckman Coulter, another Danaher company, obtained EUA for an antibody test in late June.

Smith & Nephew to Buy Integra Unit for $240M Cash

Image by MQ-Illustrations - Adobe Stock Integra

One company's challenge is another company's opportunity. Integra LifeSciences is hoping to offload its extremity orthopedic business to Smith & Nephew for $240 million in cash.

The sale is expected to close around the end of the year and includes Integra’s upper and lower extremity orthopedics product portfolio, including ankle and shoulder arthroplasty, and hand and wrist product lines. The business being divested generated revenues of $90 million in 2019 and about $32.7 million dollars during the first six months of 2020.

"While the multiple on the sale is not as high as investors would have hoped, we like the divestiture from the perspective that it should allow [Integra] to focus on areas where there is actually the potential to drive meaningful growth," said Ryan Zimmerman, a medtech analyst at BTIG. "Investors had long questioned why [Integra] continued to participate in the extremity orthopedics market given it was sub-scale and lacked navigation and pre-planning technology, and as pure-play companies continued to iterate and take share."

The analyst noted that Integra made efforts to enhance the portfolio with acquisitions and development agreements.

"But in removing this business, we think the OTT portfolio can get back to [high single digit] growth driven by regenerative technologies where [Integra] is a top five share company," Zimmerman wrote in a report Tuesday.

Integra President and CEO Peter Arduini said Smith & Nephew's strong focus in orthopedics will enable the business to expand its reach and scale, while allowing the team to thrive in a new environmet. As for Integra, Arduini said the divestiture will increase the Princeton, New Jersey-based company's focus in neurosurgery, surgical instrumentation, and regenerative medicine. The sale will also move Integra closer to achieving its long-term growth and profitability targets, he said.

The transaction includes the sale of Integra’s upper and lower extremity orthopedics product portfolio, including ankle and shoulder arthroplasty and hand and wrist product lines.

Why Not Online Medical Device Usability Testing in the Face Of COVID?

Image courtesy of Medi-Vantage Online usability Testing 082520[2]web.jpg
A patient prepares for online usability testing while reading the IFU on the screen of his computer in front of him.

When COVID-19 hit and the lockdown occurred, there was an almost immediate economic recession triggered in our industry that trickled down from hospitals to medical device suppliers. While our primary work at Medi-Vantage is to help medical device, diagnostics, digital health, and drug-delivery companies with strategy research, we also heard from several clients about human factors research they had planned with us. One client had been planning to start summative usability testing two weeks after the lockdown. He called to explore options since he was due to submit his 510(k) package to FDA.

Medical Device Usability Testing Still Needs to Be Done During the Pandemic

In the COVID-19 age, medical device development teams must continue to use robust processes to maintain their product development deadlines and this includes human factors usability testing. Most usability testing will ultimately continue, but under a different set of processes, unless your device falls into the category that can utilize online usability testing.

Below, we share our process for human factors usability testing in the era of COVID-19. If it is unclear which category fits your medical device, call us to discuss the specifics. At Medi-Vantage, we have performed human factors usability testing for a variety of medical devices and understand that not all products can fit into an online process.

Healthcare Providers Want an Alternative to F2F Usability Testing

Healthcare providers, one of the most important resources we have in medical device usability testing, have seen the agony caused by COVID-19, and most will not risk further exposure by participation in face-to-face testing at usability testing facilities. No one, including me, wants to go to a usability testing facility in person and risk being infected. In the early days of COVID-19, Medi-Vantage didn’t want to stop innovating and delay getting new products to the patients that need them. The way I saw it, in March 2020, we had three options for continuing human factors usability testing. 

  1. Continue at usability testing facilities—not an acceptable situation. 
  2. Cancel all studies, causing delays and loss of revenue for clients due to postponed commercialization.
  3. Perform usability testing online.

After some creative thinking about how usability testing is done, Medi-Vantage developed Option 3.  One of the fundamental requirements of medical device usability testing is the ability to video the end-user using the product, without showing that end-user’s face or other distinguishing characteristics. We knew we could get the technology to work for us, and we decided to pivot to online usability testing.

While researching options for our client, we performed multiple online searches to see how other usability testing companies were coping with the restrictions of the pandemic. We learned that many were not doing usability testing online, since the audio and video recording requirement could not be met appropriately. Audio and video recording is an absolute requirement to see and consistently monitor the errors and successes of end-users, to complete the entire human factors process.  We needed to come up with a pivoting strategy, so that we could make clients happy to move forward with their timelines, make end-users happy so they didn’t have to come in person to  a usability testing facility and risk infection, and, importantly, ensure that FDA would get the results it needed and the high quality of work expected.

New Intellectual Property

Medi-Vantage created a new IP to address all the concerns about the testing requirements needed and the logistical challenges that we found along the way. We use web tools to make it work.

There Are Two Categories of Medical Devices When Considering Online Usability Testing

Not all medical devices fit the online usability testing methodology.  As a company with extensive, demonstrated experience in human factors usability testing, Medi-Vantage has developed a robust process to identify which products to recommend for online testing in the age of COVID-19.  Our goal is risk mitigation, in terms of study execution.

Many types of medical device and non-medical device studies can migrate to online usability testing. These methods can provide the insights needed to accurately link critical use errors to their root causes. Online usability testing enables end-users to assess products from their homes, while communicating with researchers. When using the Medi-Vantage methodology, usability researchers can see exactly what end-users are doing with full video capture of their interactions with the device. Examples are:

  • Drug Delivery.
  • Packaging.
  • Software UI.
  • Imaging UI.
  • Wearables.
  • Formative Research. 
  • Contextual Inquiry.

This methodology provides an opportunity for medical device development teams to develop a deeper awareness of testing methods outside of usability lab-based testing. Many human factors challenges encountered in contextual inquiry, formative, and summative studies can be mitigated early in device development by researching early-stage medical device concepts currently in progress and work with human factors professionals to adopt from a tool kit of  new testing methodologies. This reduces your company product development cycles and reduce expenditures that can often occur with late-stage user testing.

The Brave New World of Medical Device Human Factors Usability Testing

We have all had to change our lifestyles and strategies in the face of the pandemic. In human factors, this can only happen with significant expertise to increase medical device safety, avoid product development delays, and reduce user testing costs.

A Timeline of Key COVID-19 Testing Milestones in 2020

Image by ronstik - Adobe Stock COVID-19 testing

COVID-19 testing