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The Internet of Things and Medical Device Product Development: Practical Strategy Suggestions

Mon, 03/31/2014 - 2:21pm
Joe Kreidler, Director of Electrical and Software Engineering, and Joe Wascow, Principal and CMO, Optimal Design

With an astonishing 25 billion devices predicted to be connected to the Internet by 2015, the Internet of Things (IoT) stands to become a multi-trillion dollar market by the end of the decade. Wireless sensors are being used on everything from cattle, transmitting health data that lets the farmer know when a cow is sick, to refrigerators that let you know when you’re out of milk.

When applied to medical devices, IoT has the potential to completely transform the way patients and physicians interact with each other. This presents a huge opportunity for medical device manufacturers, too. But there are risks as well. To fully capitalize on this emerging industry, manufacturers should understand the unique challenges of designing and manufacturing Internet-connected products can bring.

Less Time in the Hospital, Reduced Costs
A large component of healthcare today is tied up with the need to hold patients in the hospital for monitoring. Internet-connected medical devices allow this monitoring to happen anywhere – at the patient’s home or workplace, for instance – allowing for greater patient convenience and fewer resources expended by the hospital.

Additionally, these devices can be developed to measure just about any vital sign that is relevant to the patient’s condition. Obvious measurements might include blood pressure, heart rate and so forth. But devices can also be developed to measure more subjective yet equally critical factors, such as speech patterns and changes in vision, depending on the nature of the patient issue.

For example, Optimal Design has recently been involved in the design of a medical device that analyzes a patient’s movement. The device will be used with patients recovering from physical injuries, such as a broken ankle or a torn ACL, as well as with elderly patients experiencing reduced mobility. The device uses multiple camera sensors and processors to record and analyze data in real time; that data is then uploaded to a secure cloud-based system. The healthcare provider can remotely access the patient’s data from the cloud for further analysis and progress tracking.

Devices like this can bring huge benefits to the entire healthcare system. Healthcare providers will be able to improve patient care and patient satisfaction while simultaneously reducing the duration of patient hospital stays and overall hospital operating costs. In today’s competitive healthcare environment, these will be critical gains.

Design Challenges and Obstacles
However, it’s very easy for manufacturers to get carried away by the sheer potential of the IoT – and ignore the very real obstacles that might prevent them from obtaining the best ROI on their product. There is, after all, a cost to developing and producing these devices. Smart manufacturers will take the time to understand the challenges they may face, so they can proactively identify and develop viable solutions.

We suggest companies consider the following issues when developing their own development strategy for Internet-connected devices:

What value will this device provide to the end user?
Manufacturers should be careful not to jump into the IoT just for the sake of IoT itself. Don’t fall prey to Shiny Object Syndrome! Instead, keep a focus on the value that your Internet-connected device can bring to the market.

In the case of the device that remotely measures patient movement, the benefits are many. Healthcare providers gain access to both real-time data and longer-term analytic capabilities, which improves the quality of information available to the provider and empowers the provider to fine tune the patient’s treatment as required. Additionally, the patient does not need to be tethered to wires to obtain the data, which improves the ability of the patient to move about more freely, further improving the quality of the data that is measured. And because the patient does not need to travel to the provider’s location, there is a huge gain in patient convenience and satisfaction.

How will the device connect to the Internet?
The manufacturer must be aware of the environment in which the device will be used. For instance, if the device will be used in a hospital, the device must be compatible with the hospital’s wireless technology and must not cause interference with other devices.

Machine-to-machine communication technologies include radio-frequency identification (RFID), Wi-Fi, Bluetooth, Bluetooth low energy (BLE), near-field communication (NFC) and cellular – just to name a few.  Manufacturers should assess their application requirements early in the game to determine which technology provides the right mix of coverage, power consumption and service costs.

How will battery power be managed?
Reliable power is a major concern with medical devices. Manufacturers must design the device to address charging, weight and battery life from the perspective of dependability and performance. The design must also consider power system redundancy.  Internal diagnostic capabilities can allow the device to self-monitor and send an alert if the power supply has become compromised.

As technology advances, new alternatives will become available; for instance, scientists have recently developed a commercially-viable nanogenerator – a flexible chip that uses body movements to generate electricity. Working with an experienced design partner can help device manufacturers gain access to the latest knowledge and industry insights.

How will the device ensure security?
Although security is a factor for any IoT device, it is mission-critical for medical devices. It’s not just about the protection of sensitive personal information, either; breaches in device security can have life and death consequences. If a medication management system were hacked, for example, the consequences could be terrifying. Manufacturers must therefore be prepared to address this very real problem.

Amidst growing public and governmental concern over the security of wireless medical devices, the FDA recently published official guidance on the subject: “Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff”. The guidance applies to all medical devices that incorporate RF wireless technology. This provides important clarity for manufacturers on the need to incorporate user authentication controls into device design, provide sufficient wireless security information to device users, be prepared to take corrective action if a malfunction occurs, and maintain documentation of the device’s security design features, production specifications and quality control analyses.

Ultimately, the point is that manufacturers must be prepared to ask the right questions – and find the right answers – before launching the design of an Internet-connected medical device. A well-thought-out strategy will allow manufacturers to integrate the most reliable, flexible and cost-effective solutions for their products. This will help ensure that the devices they introduce will bring real cost savings, real benefits and real value to the market – and to their bottom lines.

For more information, visit Optimal Design.

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