Advancements in wearable medical devices, now and into the future

The global wearable medical device market size is projected to grow at a 19.5% compound annual growth rate from $17.4 billion in 2020 to $56.6 billion by 2030, according to a report by Market Watch. The evolution of home healthcare and remote patient monitoring devices, as well as a focus on wearable devices for fitness and healthy lifestyle purposes, is anticipated to influence this growth at an increasing pace.

Why wearables, why now?
In an article called Wearable Health Devices- Vital Sign Monitoring, Systems and Technologies, Duarte Dias and João Paulo Silva Cunha, note that, “Wearable health devices are increasingly helping people to better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to clinicians with a potential for earlier diagnostic and guidance of treatment. The technology revolution in the miniaturization of electronic devices is enabling design of more reliable and adaptable wearables, contributing to a world-wide change in the health monitoring approach.”

A beneficial function of wearables, as well as implantable devices, is that it’s possible to design them as smart devices to provide digital health data and facilitate telemedicine.

Technological features in wearables enable patients and doctors to more easily monitor vital signs, physiological and biochemical parameters, such as glucose levels and physical activities. Additionally, wearable drug delivery devices provide a reliable means of drug therapy without requiring administration by trained personnel. These capabilities create higher efficacies in patient diagnostics and therapies, not only providing a better patient experience, but also helping to reduce healthcare costs.

Reliance on the data provided by these devices will make it imperative to have a dependable way to collect data, which, in turn, is stimulating demand for biocompatible and implantable material solutions that have functionalities such as conductivity, tracing, adhesion, and lubricity.

Challenges associated with wearables
Human factors, such as patient comfort, ease of mobility in daily life, fool-proof use, and error-free operation to ensure patient safety, pose the most significant challenges for wearables.

From the device designer’s and manufacturer’s perspectives, these issues translate into new challenges, such as incorporating much smaller devices and more functionalities into less space. Risk mitigation takes on new dimensions as there may no longer be trained personnel, such as a doctor or nurse, involved in the application of a device. In addition, when designing a wearable device, engineers must consider not just design for functionality and human factors, but also Design for Manufacturability (DfM.)

Selection of suitable materials is key in mitigating the risk of tissue irritation, inflammation, infection, and, in the worst case, rejection. Silicone is the preferred elastomeric choice thanks to decades of proven results and consistent advancements in antimicrobial and anti-inflammatory solutions in response to the demand for wearables. 

The industry is also making great strides to address the trend toward reusable versus single-use devices and components. Reusable wearables require materials that prevent bacterial growth and perhaps withstand multiple sterilization routines. Synthetic materials are playing a major role in medical devices due to their continued development and innovation to meet increasingly stringent demands.

At the onset of the COVID-19 pandemic, the Emergency Use Authorization accelerated actions in the healthcare and medical industry in the United States. Other countries took similar actions to secure more capacity for products and devices such as masks, gowns, gloves, and test kits.

As the industry shifted its focus, the main challenge for wearable drug delivery devices was to ensure that production stayed steady, so people with chronic conditions could continue their normal at home treatments. Wearable device manufacturers also had to maintain production while portions of their workforce quarantined, or their factories temporarily shut down altogether.

In wearable smart devices, the need for data and patient privacy protection has added a whole new level of complexity. Device manufacturers struggle to keep up with regulatory requirements and the constant stream of changes, such as by the FDA or via the new Medical Device Regulation (MDR) 2017/745, ISO 13485, in terms of risk mitigation in the supply chain, or ISO 10993, in terms of the biological risk of devices, or control standards for chemical substances and other regulations. Regulative scrutiny is increasing at all tiers of manufacturing and in the complete supply chain of such devices.

Innovations and solutions
Innovations and solutions for wearables are occurring at the technological levels of devices, in their materials, and in manufacturing. When it comes to device technology, innovations are happening in telemedicine and patient-centric therapies that collect information to make data driven actions for the patient. For example, leveraging sensors, devices are collecting information and presenting it to patients, physicians, and care givers so that pro-active decisions can be made based on real-time data. Additionally, wearables are moving from being purely mechanical to operating as small computers that treat patients wherever they are. In manufacturing, device companies are working to make devices smaller and more complex so they can solve new challenges. For example, a wide variety of drugs (in both powder and liquid form) are being incorporated into small, silicone-based delivery devices, which can release the drug directly at the required site with fewer side-effects. Also, companies are looking to make implantable devices more bioresorbable.

In terms of materials for wearables, older technology is used due to the highly regulated nature of the market, high cost of change, and adversity to change. This, in turn, creates a need for customization of materials, chemicals, and additives to accommodate increasingly specialized applications and heightened regulatory compliance. Additionally, we can expect lower volatile organic content (VOC) and bioresorbable materials to make further inroads in wearables and implantables.

At the manufacturing level, innovation revolves around the need for customized and robust solutions in individual applications and devices.

The manufacturing of wearables is evolving in two main directions. The first is combining multiple materials and/or components into one. In a wearable drug pump, for example, multiple functions and requirements need to be integrated into a small space and must meet tolerance constraints. To accomplish this, device designers work with specialized manufacturers to incorporate multicomponent Liquid Silicone Rubber (LSR) parts with silicone materials that are tailored to the specific needs of both the application and process requirements.

The second innovation in wearable manufacturing is the microsizing of devices. Manufacturers are challenged to come up with new manufacturing technologies, systems, tools, and equipment to produce devices and components that can fit into a 5mm³ space, with a weight of less than 0.02g, or which have features of less than 0.5mm.

Setting up for success
Many of the challenges in the development of wearable devices can be overcome by partnering with an experienced healthcare and medical components manufacturer that has expertise in all aspects of engineering from early concept development to high volume serial production, including prototyping, product and process development, material selection, processing, toolmaking, quality, validation planning, scaleup, and automation.

A manufacturing partner in the healthcare and medical industry must have a robust quality system with cleanroom facilities and demonstrate good manufacturing practices for the application at hand. Expertise in medical device regulations, such as the US FDA or the European MDR, is fundamental in supporting the device validation process.

Conclusion
With telemedicine and patient-centric healthcare on the rise, the demand for wearable medical devices and their components will continue to increase. Patients and healthcare providers expect wearables to be minimally restrictive, comfortable, and error-free. Therefore, manufacturers must focus on making these devices smaller, more efficient, and robust. Many challenges related to manufacturing wearable medical devices can be overcome by selecting a partner that is knowledgeable in all aspects of process and materials engineering and has the resources and quality systems to react to changing market conditions.