In 1983, Sting wore a Casio calculator wristwatch on his "Wrapped Around Your Finger" album cover, an early “tech wearable.” Today, the world is seeing those once-trendy gadgets driving the delivery of human medicine, to the tune of $13 billion a year1 and growing. Amid the quantum shift from clever to clinical, what is happening in the medical wearable devices (MWD) industry, and what design considerations should be incorporated into the development process?
Medical Wearable Devices and Auto-Delivery Medicine
For starters, there are two functional categories of MWDs: diagnostic/monitoring and therapeutic. Right now, diagnostic and monitoring MWDs are capturing a large market share, though both are rapidly evolving. Within the functional categories, infinite differentiators will present themselves based on each individual concept and its purpose.
Diagnostic/monitoring wearables use technology to perform clinical measurements—from taking vital signs to heart monitoring and reporting electrocardiography (i.e., ECG or EKG), or managing diabetes. Additionally, diagnostic MWDs show promise for early disease detection, such as cancer. I worked with one monitoring product that was an electronic transdermal patch that had a computer/PC board on it to monitor the amount of medicine being administered. How about using a smartphone to read a scannable glucose monitoring patch? There is no end in sight to the innovation we are seeing in the market.
Therapeutic MWDs treat medical conditions, chronic or acute, whether through delivery of biologics or some other form of technology. For instance, I’ve worked on a migraine medication and delivery system that is unique because the drug is separate from the device. The device is only worn for about 30 minutes—the time needed to deliver the drug, based on the person’s size and weight. The user puts the drug into the device and then puts it on, just like that.
Autoinjectors are not quite in the same club as MWDs but are a hot trend that is even surpassing wearables at the moment. Medications are becoming more potent, increasing the need for precision metering and management. But it's got to be do-able and easy-to-use without going to the doctor.
Emerging delivery methods are hot, too. Consider a traditional nasal spray. You spray, but some of the medication is bound to go down your throat. Now, imagine a two-part vial, where you put the spray part in your nose and the other part in your mouth. As you spray, you simultaneously blow into the device, keeping the medication in the nasal cavity. This is a current delivery method for migraine medication for which I’ve customized packaging.
Guiding Infinite Options into Effective Innovations
The vehicles for MWDs and injection delivery are evolving as fast as the scope of their use. These include transdermal patches, pumps that meter drugs into the body on demand, autoinjectors, air injectors, even cancer-treating headgear.
Medical wearables may be implantable, externally worn, hand-held, or a combination of technologies that work together. Autoinjectors, pens, and other portables are still in the family; it may not be “stuck” to you, but it is with you.
I typically work on the packaging, with the device and device developers. Often, the customer arrives with the package engineering, device engineering, or marketing team. They have an understanding of what they need and are working to identify its optimal form and delivery system. With the device itself, the biggest challenge is communicating to the patient how to use it. It has got to be simple, even foolproof, to use. This means starting with the most basic approach possible. What is old news to us is inconceivable to the patient. The device must give a high comfort level. Packaging becomes just as much a part of the process as the device itself.
There are many questions to ask to determine the device details, such as:
- Is it a long-term or short-term delivery system?
- Is it an alternative to a shot or an injectable?
- What are some of the different ways to get drug products into the body? (i.e., the newest nanoneedles! These have a small pouch similar to Velcro that slowly meters the drug product into your system.)
- What is the most effective while the least invasive?
- What materials are available?
- What technologies are required to support the full process of monitoring or treatment?
- What is the primary user demographic, and what are their abilities to interact with the product?
- What must be communicated to the user that is intuitive to us?
- Does the product require strict scheduling or specific timing to be effective? (An example is Hepatitis C. The cure medication offers one shot to get it right. There is a 99% chance you will be cured, but if you mess it up, that’s it, you can’t do it again.) How can we make sure this happens correctly?
As I am a healthcare packager, my perspective must be end-to-end. This means more questions that support use as intended, and compliance, including:
- Does this need large print? Pictures?
- Can color-coding help explain the how-to?
- Does the user understand the application and what it does?
- What language barriers need to be considered for global markets?
- What resources can be created to reinforce education and compliance?
- Will video help the user more effectively than another method?
The fact is, communication is hard, but it must be a primary and ongoing part of the design process.
Communication by Design
From a packaging perspective, particularly with MWDs, instructions (and their ease of use) are the foundation of communication. It’s very challenging because everyone wants to take everything out of the box and then look at it. We try to create the packaging so a patient would actually use it when opening the device. A lot of times, the first thing the patient would see now is a big STOP sign to make the patient stop, read the directions, and watch a video or other supplemental education. I think we all know from our own behavior that people still don’t always follow directions. By using packaging to help control the order in which they encounter and ultimately administer the product, we have an opportunity to improve safety, adherence, and effectiveness.
Good communication is also one of the reasons I am a strong proponent of physician demonstration kits. Demo kits show the patient or caregiver exactly how to use the product, what to expect, and why. The product rep will first present the demo to the physician and team, so that they can do the same with patients. And just as physicians often have medication samples for patients to try, consider patient starter kits that come with just a few doses for them to practice with and get started. The bottom line is, effective communication tools ensure that the medical team and patient/caregivers are educated and working from the same page for remote, telehealth, and hands-on family medical management.
We Have Lift-Off. The Voyage Begins
I’m only at the tip of the iceberg here. There are ingestible technologies, robotic textiles, smart fabrics, adhesives, implantables, and the external reporting and recording technologies that go with them—smart medicine.
I haven’t even gotten to the drill-down levels of this market. What about specific demographic considerations for the elderly? This growing population stands to reap significant benefits from MWDs, yet these patients may not be equipped to manage the technology on their own. Or, what about those with serious mental health conditions like schizophrenia? Monitoring and delivery systems can change their lives by ensuring medication regime adherence when the illness itself may discourage it. There are at-home chemotherapy injectables on the way, improving quality of life for cancer patients and easing stress for families facing pediatric allergies, chronic conditions, or disease?
The state of MWDs and autoinjectors cannot be contained in a single story. I hope my passion for what all of this means in our work is contagious. I am energized to be at the forefront of this field and share our findings as we bring it to life.
- "Wearable Medical Device Market Size, Share & Trends Analysis Report By Product Type (Diagnostic, Therapeutic, Respiratory), By Site (Strap/Clip/Bracelet, Handheld), By Application, and Segment Forecasts, 2020 - 2027," Grandview Research, Grandviewresearch.com/industry-analysis/wearable-medical-devices-market
- "Wearable Healthcare/Medical Devices Market Size, Share & Analysis, By Type (Fitness Trackers, Body Sensors, Smart Clothing, Smart Glasses, Wearable Camera, Others), By Device Type (Diagnostic And Monitoring Device, Therapeutic Devices), By Application (Sports And Fitness, Remote Patient Monitoring, Home Healthcare, Emergency Medical Care, Others), By Region, Segment Forecasts To 2027," Reports and Data, https://www.globenewswire.com/news-release/2019/02/27/1743565/0/en/Wearable-Healthcare-Medical-Devices-Market-To-Reach-USD-27-49-Billion-By-2026-CAGR-18-5-Reports-And-Data.html (Diagnostic and monitoring devices expected to occupy significant market share, breast cancer diagnostic patches)
- "Packaging Innovations For Medical Wearables," Samtec blog, https://blog.samtec.com/post/packaging-innovations-for-medical-wearables/ (general confirmation of tech/medical wearables conf 2018)
- "Wearable and Implantable Sensors for Biomedical Applications," Hatice Ceylan Koydemir and Aydogan Ozcan, Annual Reviews Annals of Chemistry, https://innovate.ee.ucla.edu/wp-content/uploads/2010/03/Ozcan-Group-Annurev-Anchem-Wearable-Implant-2018.pdf (general confirmation of tech/medical trends/smart textiles)
- "6 Things to Avoid When Developing Wearable Medical Devices," Christine Park, StarFish Medical blog, Blogarithmic Thinking, https://starfishmedical.com/blog/developing-wearable-medical-devices/ (general confirmation of understanding)