Visiongain predicts the global medical devices market will reach $398 billion in 2017.1 To win share in this growing market, device companies need to stay out in front of manufacturing advancements so they can quickly integrate information technology (IT) functionality, accelerate time to market, and control costs.
A number of healthcare trends are increasing the importance of incorporating sensors, controllers, wireless connectivity, firmware, and remote monitoring into new devices. The transition of care delivery from acute settings to the community, patients’ interest in tracking their own health, an aging population with chronic conditions that must be managed, the rise of “accountable care,” and greater focus on prevention to drive down costs all have created strong incentives for designing devices built on the latest IT and getting them to market faster than the competition.
To capitalize on this opportunity, device companies need access to manufacturing resources — either in house or contracted — that can produce technologically complex products with speed, precision, compliance, and consistently high quality. Advanced capabilities that can facilitate the next generation of tech-enabled medical devices include:
- Connecting devices to the Internet of Things (IoT)
- Using additive manufacturing (3D printing)
- Producing wearable electronics such as “smart” clothing, skin-adhered sensors
As a practical matter, many device companies — which are often small startups — lack the knowledge, expertise, and infrastructure to successfully integrate IT components into their products, or to apply computer-driven manufacturing techniques. Instead, they often turn to manufacturing service providers with specialized capabilities.
For instance, because technology transfer from the consumer sector (think fitness trackers and smartphone-based monitoring) is so common in medical devices, the industry can benefit by partnering with manufacturers that have expertise in consumer electronics, including wearables.
A partner with the latest plastics manufacturing equipment, such as 3D printing technology, can help meet demand for faster throughput and lower costs. Finally, a manufacturing services provider that keeps abreast of the emerging IoT arena can help companies equip devices with Internet connectivity and sophisticated sensors that perform cost-effective, remote maintenance and support, as well as patient monitoring, data collection, and communication with clinicians or other IoT-connected devices.
Trends Behind IT-Enabled Medical Devices
IT can help the device industry design products that target a wide array of healthcare trends.
- Globally, the rise of the middle class in nations such as China and India means more opportunity for affordable yet technologically advanced devices.
- Patients are increasingly tech savvy and expect medical technology to offer the same functionality and features as their consumer electronics.
- Care delivery settings are shifting from the hospital to the home or extended care facility to save money and lighten the burden on providers. Managing patients — or helping them self-manage — in these settings is driving greater needs for remote diagnostic devices, monitoring via the IoT and wearables that can capture and transmit information on events and day-today health status.
- The healthcare reimbursement model is evolving from payment for performance to payment for outcomes. To increase the likelihood of positive results while keeping costs under control, providers need devices that can help them remotely manage, or even diagnose, their patients.
- With an aging population subject to chronic conditions such as diabetes and hypertension, providers need efficient ways to oversee patients without constant, burdensome office visits. This oversight includes ensuring patients’ compliance with various therapies by tracking when a medication is taken, how often, and at what dosage.
- The goal of connected health for populations depends on a network of linked devices and other objects collecting, sending, and receiving data about people, environments, and processes without human interaction or input.
Connecting to the Internet of Things
The IoT is a network of physical objects (things), including everyday items, equipment, and devices, that are connected to the Internet, usually wirelessly. Through the use of built-in sensors, these objects collect and transmit data, share information with each other, or control and manage a device or process.
The IoT is well suited to healthcare applications because it facilitates oversight and self-monitoring, streamlines data collection, and promotes communications between patients and providers. According to an IDC report, the IoT market for remote health monitoring will grow to over $12.4 billion in 2018.2 Many medical device manufacturers have started to prepare for implementation of this new business model, where the device is only one part of the solution. However, they often lack expertise in complex electronics that can enable and support remote connectivity, data collection, and data analysis for their particular device and use case.
The IoT presents many technical challenges for medical device developers. Transmitting, securely managing, and analyzing the vast amounts of data collected by sensors in IoT-enabled devices will involve many different technologies. Confidentiality of patient data makes this process even more complicated, requiring expertise in secure transmission over the network, and secure storage in the cloud or another repository.
Manufacturing capabilities needed for IoT-enabled medical devices such as glucose monitors, inhalers, infusion pumps, insulin pens, and cardiac monitors include:
- Device integration
- Connectivity using emerging standards such as ZigBee, a cost- and energy-efficient wireless network standard, as well as more mature systems like radio-frequency identification (RFID) and low-power Bluetooth connections
- Energy solutions that can optimize or extend device life
- Printed electronics