In 1980, a graduate student at Carnegie Mellon University in Pittsburgh, David Nichols, was in the mood for a beverage. On arrival at the vending machine, David discovered that his colleagues had beat him to it, and the machine was empty. This was not the first time this had happened! David, with help from a few (thirsty) colleagues, decided to do something about this – with a few sensors and some clever code, David started monitoring the vending machine’s contents via the ARPANET (a precursor to the internet). By doing this, David inadvertently invented the world’s first Internet-of-Things [IoT] device.

In more modern times, the proliferation of connected devices has been considerable. One sector that has seen a huge uptake is medical devices. According to Deloitte’s Centre for Health Solutions, the market for connected medical devices is predicted to grow from $14.9 billion in 2017 to $52,2 billion in 2022, with close to 70% of all medical devices being connected.

A connected medical device is one that forms part of the Internet-of-Medical-Things [IoMT] ecosystem. The IoMT ecosystem facilitates the collection, analysis, and transmission of health data so aims to improve efficiencies, lower care costs and provide better outcomes in healthcare. But how exactly does this ecosystem work?

The anatomy of a connected device will typically include an ‘endpoint’ (the physical medical device), connected to the ‘cloud’ via some form of ‘gateway’. The physical device may include a sensor, for example an ECG to record the electrical activity of your heart. Hardware may be included on the devices PCB that allows for ‘edge computing’: the cloud has limited capacity to process the large amount of data being transmitted from a network of endpoints, and therefore some data processing needs to be performed on the device itself. The device will also include a transmitter, for example Bluetooth or ZigBee, which connects the device to a gateway such as a user’s mobile phone or router. The gateway forms a bridge between the medical device and the cloud. Alternatively, the gateway could be included in the device itself, for example a mobile network that connects the device directly to the cloud – this connectivity functionality is particularly important for users that do not have reliable access to Wi-Fi networks, for example in rural settings.

The data needs to be ‘translated’ to allow for different software applications to read and use the data. The ‘translator’ is known as an Application Programming Interface [API]. Once in the cloud, the data can be used in a variety of ways. For example, for remote monitoring and decision making by a clinician or neural network.

Connected medical devices create exciting opportunities to streamline clinical workflows and improve patient care. But what are the major challenges that exist in the design and development of a connected medical device?

Interoperability is the ability for different software applications to exchange and make use of information. There is currently a lack of interoperability between healthcare systems and technology. This is due to a lack of standards for sending, receiving, and managing information between healthcare systems.

The IoMT and its prevalence in the development of new medical devices is ever adapting, improving, and growing. If you would like to learn more about how Haughton Design can help your medical device development project(s), please reach out to enquiries@haughtondesign.co.uk

John Harverson 8 July 2021

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Get in Touch with John Harverson

Senior Design Development Engineer

Holding a Bachelor’s degree in Industrial and Product Design as well as certificates in Project Management and UX Design, John is an advocate of user-centred design and finding innovative solutions within regulated fields. With over a decade’s experience in the medical device industry from working as a Consultant helping companies develop innovative medical devices, to head of an Industrial Design company developing imaging equipment for early detection of breast cancer, John also manages our ISO 13485 & ISO 9001 QMS.

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