The size of the global wearable medical device market is expected to grow at a compound annual growth rate of 19.5%, from $ 17.4 billion in 2020 to $ 56.6 billion by 2030, according to a report by Market Watch. The evolution of home care and remote patient monitoring devices, along with the emphasis on wearable devices for fitness and healthy lifestyle purposes, are expected to influence this growth at an increasing rate.
Why wearables, why now?
In an article called Wearable Health Devices – Vital Signs Monitoring, Systems and Technologies, Duarte Dias and JoÃ£o Paulo Silva Cunha, note that âwearable health devices are increasingly helping people to better monitor their health both at the level of activity / fitness for the tracking of health. ‘self-health and medical level providing more data to clinicians with potential for earlier diagnosis and direction of treatment. The technological revolution in the miniaturization of electronic devices enables the design of more reliable and adaptable wearable devices, contributing to a global change in the approach to health surveillance. “
A beneficial function of wearables, as well as implantable devicesis that it is possible to design them as smart devices to deliver digital health data and facilitate telemedicine.
The technological features of wearable devices make it easier for patients and physicians to monitor vital signs, physiological and biochemical parameters, such as glucose levels and physical activities. Additionally, portable drug delivery devices provide a reliable means of drug therapy without requiring administration by trained personnel. These capabilities improve the efficiency of patient diagnostics and therapy, not only providing a better patient experience, but also helping to lower healthcare costs.
The reliance on the data provided by these devices will make it imperative to have a reliable means of collecting data, which in turn drives the demand for biocompatible and implantable material solutions with features such as conductivity, tracing, adhesion and lubricity.
Challenges associated with wearables
Human factors, such as patient comfort, ease of mobility in everyday life, heavy-duty use, and error-free operation to ensure patient safety, are the most significant challenges for portable devices.
From a device designer and manufacturer perspective, these issues translate into new challenges, such as incorporating much smaller devices and more functionality into less space. Risk mitigation takes on new dimensions as there may be no more trained personnel, such as a doctor or nurse, involved in the application of a device. In addition, when designing a portable device, engineers should consider not only the design for functionality and human factors, but also Design for Manufacture (DfM.)
Selection of suitable materials is essential in reducing the risk of tissue irritation, inflammation, infection, and in the worst case scenario, 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 demand for wearable devices.
The industry is also making great strides in tackling the trend of reusable rather than single-use devices and components. Reusable garments require materials that prevent bacterial growth and may be able to withstand multiple sterilization routines. Synthetic materials play a major role in medical devices due to their continuous development and innovation to meet increasingly stringent requirements.
At the onset of the COVID-19 pandemic, emergency use authorization accelerated actions in the health and medical industry in the United States. Other countries have taken similar steps to ensure more capacity for products and devices such as masks, gowns, gloves and test kits.
As the industry changed direction, the main challenge with portable drug delivery devices was to ensure that production remained stable, so that people with chronic conditions could continue with their normal treatments at home. Manufacturers of wearable devices have also had to maintain production while part of their workforce was quarantined or their factories temporarily closed.
By mobile smart devices, the need for data protection and patient privacy 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 through the New Medical Device Regulation (MDR) 2017/745, ISO 13485, in terms of mitigating risk in supply chain, or ISO 10993, in terms of biohazardous devices, or chemical control standards and other regulations. Regulatory oversight is increasing at all levels of manufacturing and across the supply chain for these devices.
Innovations and solutions
Innovations and solutions for wearable devices occur at the technological level of devices, their materials and manufacture. When it comes to device technology, innovations are occurring in telemedicine and patient-centered therapies that collect information to perform data-driven actions for the patient. For example, by relying on sensors, devices collect information and present it to patients, doctors and caregivers so that proactive decisions can be made based on real-time data. In addition, portable devices are moving from purely mechanical to small computers that treat patients wherever they are. In manufacturing, device makers strive to make devices smaller and more complex so that they can solve new challenges. For example, a wide variety of drugs (in powder and liquid form) are incorporated into small, silicone-based delivery devices, which can release the drug directly to the required site with fewer side effects. In addition, companies are looking to make implantable devices more bioabsorbable.
In terms of materials for wearable devices, older technology is used due to the highly regulated nature of the market, the high cost of change, and the adversity of change. This, in turn, creates a need for customization of materials, chemicals and additives to accommodate increasingly specialized applications and increased regulatory compliance. Additionally, we can expect volatile organic matter (VOC) content and lower bioabsorbable materials to make further inroads in wearable and implantable devices.
At the manufacturing level, innovation revolves around the need for customized and robust solutions in individual applications and devices.
Wearable manufacturing is moving in two main directions. The first is to combine several materials and / or components into one. In a portable drug pump, for example, multiple functions and requirements must be integrated into a small space and must meet tolerance constraints. To accomplish this, device designers work with specialty manufacturers to incorporate multi-component Liquid Silicone Rubber (LSR) parts with silicone materials tailored to specific application needs and process requirements.
The second innovation in wearable manufacturing is the micro-sizing of devices. Manufacturers are challenged to come up with new technologies, systems, tools and manufacturing equipment to produce devices and components that can fit in a 5mmÂ³ space, weigh less than 0.02g, or have lower specifications at 0.5 mm.
Set up for success
Many challenges in wearable device development can be overcome by partnering with an experienced medical and healthcare component manufacturer who has expertise in all aspects of engineering from initial concept development to full production. high volume series including prototyping, product and process development, materials selection, processing, tool making, quality, validation planning, scaling and automation.
A manufacturing partner in the medical and healthcare industry must have a robust quality system with clean room 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 to supporting the device validation process.
With the rise of telemedicine and patient-centered healthcare, the demand for wearable medical devices and their components will continue to increase. Patients and healthcare providers expect wearable devices to be low-restrictive, comfortable, and error-free. Therefore, manufacturers need to focus on making these devices smaller, more efficient, and more rugged. Many challenges associated with manufacturing portable medical devices can be overcome by selecting a partner who understands all aspects of process and materials engineering and has the resources and quality systems to respond to changing market conditions.