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.

The Internet of Things is a network of objects, usually connected wirelessly.

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

The IoT is well suited to healthcare because it facilites data collection and communication.

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
  • Sensors
  • Energy solutions that can optimize or extend device life
  • Printed electronics

Using Additive Manufacturing

With 3D printing, devices can be made that exactly match a patient’s anatomy.

Additive manufacturing, also known as 3D printing, is a process that creates a three-dimensional object by building successive layers of raw material such as plastic or metal. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a computed tomography (CT) image. The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices precisely matched to a patient’s anatomy.

Devices from shoe insoles to eyeglasses, and from hearing aids to prosthetics, can be customized for optimal fit and function. Examples include a 3D printed vertebra to replace a patient’s cancerous vertebra, and a 3D printed ventilated hand cast to replace heavy, occlusive plaster or fiberglass casts.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. As of December 2015, the U.S. Food and Drug Administration (FDA) had cleared more than 85 3D printed medical devices.3

As a replacement for traditional plastics and composites processing, particularly injection molding, additive manufacturing offers major benefits, including avoiding the high cost and extensive time required for designing and building mold tools. Although traditional injection molding operations are actually faster than 3D printing, molding requires lead times of several weeks for tooling. The competitive sweet spot for 3D printing is manufacturing up to 100,000 items a year.

Additive manufacturing also allows faster prototyping and simplifies aesthetic and physical customization (fitting devices to the patient). Additional advantages of this technology are cost-effectiveness and flexibility when creating devices used in clinical studies, where quantities are small and design changes are often required after evaluation.

In some cases, 3D printing allows device companies to produce structures or forms that are simply not possible using injection molding due to technical constraints such as an inability to demold parts with complex geometries and intricate interior structures.

Using 3D printing technology for high-volume production requires general manufacturing competence, understanding of material properties and performance, and access to digital factory facilities that offer systems for transferring and managing input data, processing, and yields.

Mastering Multiple Technologies to Create Wearables

IDTechEx analysts estimate that the wearable technology market will be worth over $30 billion in 2016, growing to over $100 billion by 2023.4 Wearable medical devices range from fitness and wellness monitors to clothing with integrated sensors that can track vital signs and detect issues with various body functions.

Although they may appear simple, wearable devices contain sophisticated technologies.

Because wearable medical devices involve so many different types of advanced technology and processes, it is very difficult for companies to prototype and produce them without assistance from a manufacturing partner. For instance, a fitness band looks simple on the surface, but contains sophisticated miniaturized technology. Such bands are challenging to manufacture because they require facilities capable of automated, high-volume production, and a deep understanding of flexible materials, such as thermoplastic elastomers, and how to integrate electronics into the polymer.

Manufacturers must possess experience, infrastructure, and technical capabilities in these areas:

  • Complex molding
  • Electronic circuits, including flexible circuits
  • Miniaturization
  • Batteries
  • Low-power wireless connectivity
  • Sensors, including conductive biosensors, gyroscopes, magnetometers and barometers; optical sensors; wearable electrodes; chemical sensors; flexible stretch, pressure, and impact sensors; temperature sensors; and microphones
  • 3D printing
  • Materials and textiles

Benefits of Partnership

Many device companies and consumer product companies that wish to enter the connected health market lack expertise in complex electronics that will enable and support remote connectivity, data collection, and data analysis. They may also face the hurdle of building manufacturing infrastructure for their specific device and finding experts in technologies such as additive manufacturing. This approach can cause delays, require heavy capital outlays, and present serious risks.

One solution is to partner with a provider that offers knowledge and technical expertise in the design and manufacturing of electronics — particularly consumer electronics — as well as medical devices. These providers not only have extensive, advanced manufacturing capabilities and global supply chains, but can also advise device companies on different material, technology, and process options that can control costs and accelerate time to market. Further, these companies offer extensive regulatory expertise to help ensure approval of novel devices.

References

  1. “The global medical devices market will reach $398.0bn in 2017” predicts new Visiongain report. News release.
  2. Growth of IoT means business worth billions of dollars for verticals: IDC. Posted May 13, 2014.
  3. 3D Printing of Medical Devices. U.S. Food and Drug Administration. Updated May 12, 2016.
  4. Wearable Technology 2016-2026

This article was written by Ralph Hugeneck, Senior Director of Technology at Nypro Healthcare, a Jabil Company, St. Petersburg, FL. For more information, Click Here 

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Medical Design Briefs Magazine

This article first appeared in the October, 2016 issue of Medical Design Briefs Magazine.

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