Digital health products played a prominent role in addressing the COVID-19 pandemic and in helping caregivers and patients navigate their care in the past year. Going into 2022, remote monitoring, wearables, sensors, and other mobile health (mHealth) products are taking center stage in defining the future of medicine.

“One of the clearest areas of excitement now and into the future is the sector of healthcare products referred to as wearables. These are devices like fitness trackers, heart monitors, and other devices that record in real time and communicate biometric data either directly to the user or to a connected platform for a variety of purposes, including coaching, intervention, analysis and even within clinical trials administration,” notes a recent report from contract manufacturer Jabil, St. Petersburg, FL. The report, “Digital Health Technology Trends,” finds that “the top three solution categories providers are developing or plan to develop are in patient monitoring, diagnostic equipment, and on-body or wearable devices (see Figure 1).

DIGITAL DIAGNOSTICS, BETTER HEALTH OUTCOMES

As digital and mHealth capabilities have become an integral part of many medical devices and diagnostics, they have enabled a more agile and flexible healthcare system to emerge in the face of COVID-19. These products will continue to improve access to patient care.

Digital transformation of healthcare is not just about adopting new digital technology, notes a recent position paper from medtech giant Philips. It’s about reimagining healthcare for the digital age — using the power of data, artificial intelligence (AI), cloud-based platforms, and new business models to improve health outcomes, lower the cost of care, and improve the human care experience for patients and staff alike.” This outlook is driving a new era for healthcare companies and the products they develop.

“Digital health products have opened many new avenues for improving public health. These types of products will continue to improve their functionality while offering a more personalized experience. Digital health products will become more tailored to the individual, providing more intuitive interfaces and improved human factors,” says Ken Bragança, vice president of operations at Designs for Vision, maker of specialized optical surgical and dental products in Bohemia, NY. “Software will continue to adopt this approach,” he says, “providing analytics and predictive modeling to paint an overall picture of an individual’s health.”

Bragança predicts that such devices will become smaller and more powerful, allowing wearables and handhelds to create a distinct advantage in the market as technology blends with the human element. “This personalized approach will alter the way medical professionals and patients perceive health and medical technology, allowing for quicker and more accurate decision making,” he says.

Jabil’s report finds that nearly four in 10 developers of health solutions have a plan in process to create and deliver digital solutions, although there are some differences based on solution types. Those developing infection detection and monitoring, diagnostic equipment, and pharmaceutical equipment are more likely to believe they are fully capable, whereas makers of other device types are working to execute on their plans.

“We anticipate an increase in the use of wearable diagnostic devices and that this trend will accelerate throughout 2022 and beyond,” says Kevin Young, vice president of corporate development at Web Industries, a contract manufacturer headquartered in Marlborough, MA. The company specializes in assembling COVID test kits and is a converter of PPE used in the medical industry.

“The earlier you diagnose an illness, the better chance there is to treat it and improve recovery. The second part of that is that it reduces costs to insurance companies. They’re especially interested in early diagnosis to cut long-term costs for illnesses that could have been prevented or at least treated before becoming acute. We’re also going to see more point-of-care and at-home test devices, as we have with COVID-19,” says Young. “The migration of testing from a clinical setting to the home will continue to proliferate, not just for COVID but for many other maladies. We see companies gearing up to facilitate more home testing, especially for early detection.”

Philips predicts that telehealth and remote patient monitoring will become a “mainstay of healthcare” and says that other digital and mHealth platforms are on the same trajectory.

Michael Muchin, general manager, North America, Avery Dennison Medical, also says there that has been a lot more acceptance of digital technologies in the healthcare space. “This change has been driven by the inability to go into a doctor’s office or hospital setting. Viable remote monitoring wearables and other solutions existed before the pandemic, but they weren’t always trusted and/or accepted,” he says. “Now, with the challenges of going to receive care in person, there’s much more openness and understanding that remote monitoring and digital health solutions are reliable.”

Muchin says he also sees growth continuing for remote monitoring. Avery Dennison Medical develops solutions for the interface between the wearable device and the skin, plus construction layer materials to hold device components together. These technologies keep people safe and allow them to get on with their daily lives without having to be in the hospital or a doctor’s office to be monitored, he says.

“The phenomenon of self-tracking with technology and the community of users and makers of tools who are focused on ‘self-knowledge through numbers’ will drive technological advancements,” says Justin McMath, director of corporate development, healthcare and medical technologies at Molex, a maker of electrical and electronic connectivity systems based in Lisle, IL. “The result will deliver real-time consumer health diagnostics that keep followers at peak performance, requiring seamless data capture and results exchange among devices and equipment tracking health-related vectors.”

THE TECHNOLOGIES DRIVING THE TRENDS

Noninvasive monitoring technologies will grow using things like acoustic and ultrasound, says Jorg Lorscheider, marketing director for Omnica, Irvine, CA. And emerging technologies such as AI and machine learning (ML) will be used to make sense of the data as well. Advances in integrated circuits (ICs), battery technology, and the Internet of Things (IoT) will drive many of the improvements in digital health products.

“ICs have been steadily advancing, decreasing power demand while increasing performance and capabilities. These advances will drive technology into smaller and more embedded applications, allowing digital health products to perform more tasks with greater complexity,” says Bragança.

“Battery technology is being driven by the current focus on the electric vehicle (EV) market. Improvements in energy density should allow for batteries with smaller footprints and more customizable formats. These batteries will help to improve the capability and size of wearables and handheld devices. IoT technology is constantly being employed in a wide range of medical products. As more devices become connected, the pool of available data will continue to increase, allowing for new applications and instant access to healthcare data,” he says.

THE IMPACT OF AI/ML

FDA has identified 10 principles designed to guide device manufacturers in the development of medical devices that use AI and ML. FDA says that these technologies have the potential to transform healthcare by “deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day.”

“Nearly every wearable will provide data that would benefit from AI and ML technology,” says Lorscheider. “It’s amazing what these tools can do to recognize illness long before a doctor could. With AI, we can see things that we could not before. For example, simple heart rate or blood pressure monitors could reveal much more than they have currently been used for. So existing technologies will benefit from digital advances first.”

AI and ML will become commonplace in any device that can benefit from pattern recognition and predictive analysis, notes Bragança. But, he says, these technologies can also be applied to the vast quantity of healthcare data that is already available. “This will allow manufacturers to gain insights and make predictions that can help define product requirements and allow for more personalized interfaces,” Bragança says.

“While AI has been leading medical innovation, we will continue to see the impact of artificial intelligence in the proper diagnosis and in processing of healthcare data to reduce back-end errors and improve overall care,” says Hari Prasad, CEO of New York-based Yosi Health.

THE COVID-19 EFFECT

COVID-19 altered the course of medical technologies and the types of medical devices that are being developed. The pandemic has compounded both the mental health crisis as well as the opioid crisis, urging the demand for cutting-edge research and new technologies in this space, says Prasad, whose company develops patient engagement platforms. He says that there will be an amplified need to help identify, combat, and treat at-risk patients, as well as modify treatment plans utilizing technologies such as mHealth and wearables.

Another major impact of COVID-19 is that it has accelerated an already progressing trend of patients’ comfort with and reliance on technology, explains Bragança. “As people become more accustomed to technology in everyday activities, medical devices will evolve to become more individualistic. Digital health products will trend toward more personalization, offering better physiological and psychological compatibility,” he says.

Wearable and handheld devices will capitalize on this trend and begin to dominate the digital health market. To succeed, manufacturers will need to accommodate for evolving technology and customer demands as designing for individuals will require a greater attention to customization and product life cycle.

Lorscheider adds that being able to monitor patients and get real-time data is a huge asset to healthcare. “It has also assisted in allowing us to monitor nonambulatory patients at home or in senior living centers,” he says. “It has accelerated the adoption of these technologies.”

Muchin also points to the rise in remote diagnostics. “The technology was in a good place prior to COVID, but after the pandemic hit, there was a greater reliance on these solutions,” he says.

“It’s similar to how so many of us have adapted to working from home and using technologies that allow us to do that. Digital health solutions rapidly became something that people could trust and count on to monitor their health,” Muchin says.

“COVID-19 has accelerated the adoption rate of rapid tests, especially antigen diagnostic tests,” says Young. “If COVID-19 had not occurred, we would have seen a slower rate of patient testing moving from hospitals, doctors’ offices, and urgent care centers to walk-in clinics and at home.”

FDA has said the Center for Devices and Radiological Health (CDRH) plans “to engage with test developers to establish generic templates for commonly anticipated pathogens that may be adapted for potential future outbreaks. The agency also plans to develop a framework for conducting appropriate validation under different circumstances, to speed the availability of future in vitro diagnostic (IVD) devices. Further, it has urged the U.S. government to establish the capacity to independently evaluate test performance before outbreaks occur so that evaluation can be performed quickly during an outbreak.

“COVID test development investments by medical device researchers and manufacturers have positioned rapid testing for a whole horizon of maladies,” says Young. “We are seeing rapid tests being developed for cancer, HIV, tuberculosis, renal disease, and malaria, for example. Intense efforts are being made to lower costs and ensure the equitable distribution of these tests to low- and middle-income countries.”

Young also believes that COVID-19 has quickened the integration of device connectivity, including remote monitoring and data collection. “Databases need to be updated, and information must be delivered to primary caregivers. Connectivity is especially needed in low-and middle-income countries where good medical care is not always readily available,” he says. “So, the more connectivity of devices and information, the better. We expect the connectivity field to grow,” says Young.

Similarly, he says that telemedicine will also continue to enjoy acceptance and adoption going forward. “The pandemic has made telemedicine highly acceptable by both the medical profession and patients. It is even now covered by private insurance companies. You can talk to your doctor over a Zoom call, take a home test, and send in the results. This is a large step from going to a clinic, hospital, or doctor’s office. We see telemedicine as a major growth area.”

MORE ON THE MHEALTH HORIZON

Medical technology is evolving at a faster rate than ever before, says Bragança. “Product life cycles will shrink as manufacturers adopt new technology to maintain a competitive edge. Manufacturers will need to be nimbler in the market, pivoting designs as technology evolves. This environment will favor manufacturers that design and produce close to their intended markets,” Young says.

“One of the big concerns, however, is that we are creating silos of information that if taken together, could reveal even more and help to avoid illness much earlier in the cycle,” says Lorscheider. “This collaboration is not even framed well nor is there a method to share. FDA needs leadership to define things so that patient data can be shared with other sensors to achieve a more comprehensive picture of a pa tient’s health,” he says.

To help make digital and mHealth happen, automation will transform the future of healthcare. “Medi cal facilities are employing solutions that enable immediate access to patient information and continuous collaboration among healthcare professionals. This automation will aid in analyzing patient data and operations data to improve quality of care with augmented engagement,” says Prasad.

Article source: Medical Design Briefs