This is a blog written by Elemed expert guest blogger Michael Wetherington. Want to be a guest blogger? Email mathilde@elemed.eu for more info!
According to “Today’s Medical Development” website, the global home healthcare device market is experiencing rapid growth and is estimated to reach $60B by 2024. [1]
So if you are a #MedTech company or startup venturing out in the home healthcare device landscape, the following design tips will help you avoid costly mistakes and market entry delays.
It is important to note that the home environment imposes additional risks compared to a controlled environment such as a hospital or clinic.
In many cases, a device for use at home, the user becomes the patient. Children of varying age groups, the elderly, persons with disabilities, and pets may inadvertently come in contact with the device.
But before discussing the tips, as with any design endeavor, there will be some basic documentation that you will need to create before engaging in the design.
Start with a design requirements matrix followed by risk assessment in accordance with #ISO14971.
The risk assessment will assist you in determining the risks and unacceptable residual risks of your device. This, in turn, allows you to identify available standards and or other methods that you can apply to mitigate the risks. Examples of such standards are #IEC60601-1-11, IEC60601-1, and IEC60601-1-2.
So enough with my rambling, and let’s get on with the tips!
Here they are:
☑️ Avoid designs that will make your device irresistible to children. Do not make your device appear like a high-tech toy or a delicious mouth-watering treat. Sounds, colors, shapes, and lights can be an attention grabber for young children.
A warning statement or symbol on the device to keep out-of-reach from children and pets may not be sufficient as risk mitigation. We all know how we can easily forget and lay things around the home.
The idea is to first design-in safety and after you have performed your cost-to-benefit analysis and proves otherwise, you may use a lower form of risk mitigation such as the warning label example shown below that is affixed on the device and repeated in the instructions for use:
☑️ Small parts that can lead to choking hazards should not easily detach and preferably require a tool for removal or detaching a part. As examples, a battery compartment cover and changing of accessories. If removable by use of the hand, ensure that the force required is sufficient based on the intended user.
☑️ Design to withstand impact forces particularly for mobile, transportable, and body-worn devices.
☑️ Balance length of power and interconnecting cables and tubings with performance to avoid strangulation and tripping hazards.
☑️ Design ventilation openings to meet the articulated finger probe and test pin tests required by applicable standards. Optimize the airflow with small opening dimensions to prevent access to hazardous moving parts or uninsulated hazardous live parts.
☑️ Design your device for optimal electromagnetic immunity or susceptibility. Your device will be bombarded with interference from household appliances, electronic gadgets, and electronic toys.
☑️ Design adequate ingress protection (IP rating for solid foreign objects and liquid). If it is foreseeable that a body-worn device can be used in the shower or worn while washing dishes, design the enclosure with an adequate seal.
☑️ Do not rely on protective earth (PE) as one layer of means of electric shock protection since residential homes are known to have unreliable protective earth systems. Design to Class 2 electric shock protection instead.
A Class 2 design simply incorporates insulating material as enclosures that meet the dielectric properties and rigidity required under normal and expected abnormal conditions.
☑️ Design for worst-case environmental conditions including, altitude. As mentioned above, the home environment is less controlled; therefore, considerations to expected worst-case temperature, humidity, and altitude form part of your design requirements.
☑️ If you anticipate that either a transportable or body-worn home healthcare device can be used in an ambulance or automobile, there are standards that address the associated risks. The idea is for the device not to interfere with other electronic devices in an automobile such as its navigation and controls systems. The same applies to ambulatory use where your device may interfere with other medical devices within the ambulance.
In conclusion, the design of home healthcare devices needs careful safety considerations that are not typical in hospitals and clinics.
You must thoroughly apply risk assessment to anticipate all possible risks of a home healthcare device and use recognized standards and other known methods to mitigate the risks.
For additional information, watch the video here: https://youtu.be/P3VU9KwsFeI
Remember, risk mitigation by design then, if not possible, by information.
References:
[1] https://www.todaysmedicaldevelopments.com/article/medical-device-manufacturing-design-home-healthcare-market-2024-102615/
GIE Media, Inc.
About the author
Michael Wetherington
Founder of MedicalRegs.com
Michael Wetherington is the Founder of MedicalRegs.com
His is an engineer by trade and his background includes medical device R&D, Notified Body product expert, medical device product safety certification testing, quality management development, and regulatory affairs.
In his spare time, he enjoys playing instruments, singing, sketching, playing chess, and mentoring.
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