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Developing medical devices for home use

Published by Isabella Greenock, Medical Device Paralegal on

The concept of ‘at home’ medical devices is certainly not new – medicine spoons, first aid kits and personal assistive products such as wheelchairs and hearing aids have been used in the home environment for decades. However, more recently there has been a trend towards the development of consumer friendly versions of devices which traditionally would only have been found in healthcare settings. Examples include cholesterol test kits, blood glucose meters and sleep apnea monitors. The drive for these types of devices stems from a desire from both patients and healthcare providers for more convenient and inexpensive healthcare.

These at home devices present new challenges for manufacturers. In this post we discuss some of the main considerations when developing at home devices.

Development challenges

It is important that at home devices are able to accommodate a wide range of users. Some may be professionals, such as physicians, nurses and social workers. However, many will be lay persons, including family members of the patient or the patient themselves. These users typically will not have received any medical training and may have chronic illnesses or disabilities that impact their ability to operate equipment.

The home environment is also less controlled than healthcare settings. Environmental factors that can impact the use of devices include the level of cleanliness, lighting, extremes in temperature and electromagnetic interference from other pieces of equipment (such as computers and games consoles). There are also fewer resources available in the at home setting to help identify and rectify any errors that do occur through use of the device.

These are all factors which manufacturers should take into account when developing devices which are intended for at home use. To ensure their devices are safe, measures should be taken to eliminate or reduce any risks associated with the potential environment and users. These measures may include, for example:

  • alarms and alerts to notify the user of any issues
  • large buttons and controls which are clearly labelled
  • backlighting on displays which is suitable for darker rooms
  • instructions/user manuals which use plain language that is easily understood.

Ultimately, it is up to manufacturers to determine what measures are needed for their devices. Manufacturers that do not have in-house expertise should consult with external experts (e.g. human factors experts).

Regulatory challenges

At home devices also present a number of challenges from a regulatory perspective, particularly in relation to qualification and classification.

Qualification is the process by which manufacturers must determine their regulatory product type (i.e. medical device, medicine, general consumer good, etc.). The qualification of at home devices may present difficulties as such products are often presented as being more casual and capable of seamlessly fitting into the user’s everyday life. This can make it difficult to determine whether the product should be regulated as a medical device or as a general consumer good. 

Qualification is further complicated by certain at home devices carrying out a variety of functions that may bring them within the scope of multiple regulatory regimes. For example, an app which uses indicators such as the user’s body temperature to monitor their fertility window (this is a medical function), in addition to providing a platform for the user to log information about their menstrual cycle (this is a non-medical function). Manufacturers need to think carefully about whether or not their product has a medical purpose (i.e. the diagnosis, monitoring or treatment of a disease or injury) which would bring it within the scope of the medical device regulations.

The classification of at home devices can also be challenging. Classification is the process by which medical devices are categorised based on the level or risk they present. The device class then dictates the applicable regulatory requirements, with high risk devices being subject to the strictest obligations. The at home nature of a device should not directly affect its class in the UK and EU where the classification rules are primarily based on how the device functions as opposed to its intended environment/users. However, in other jurisdictions (such as Australia) the fact that a device is to be used by lay persons rather than healthcare professionals may result in a higher classification. Ultimately, manufacturers need to be aware of the different classification rules in each of their chosen jurisdictions and how this impacts the regulation of their device.

How we can help

Regtik, our healthcare regulatory explorer tool, can help you navigate this legal maze by walking your product through a series of simple questions designed to determine whether it qualifies as a medical device and, if so, what class it falls under. It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.

If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.