Designing safe and effective medical devices for home use, Blog Post by Andres Dumas

June 6, 2025

As healthcare increasingly shifts beyond hospital walls, more patients are managing their health from the comfort of home. From blood pressure monitors to complex respiratory devices, home-use medical technologies are becoming essential tools in everyday life. But designing devices for this setting comes with unique challenges and opportunities.

What Makes a Device “Home Use”?

According to the FDA, a home-use medical device is one that is labeled for use outside of professional healthcare facilities. This includes, but is not limited to, houses and apartments, as well as schools, vehicles, shelters, and retirement homes. If a device is intended for use both in professional healthcare settings and in other environments, it still qualifies as a home-use device under this definition.

Unlike clinical settings, the home environment can vary widely and so can the people using the devices. Most home users are not trained healthcare professionals. That means safety, ease of use, and reliability must be built into the device from the start.

Common Types of Home-Use Medical Devices

Home-use devices span a range of categories, some of the most common include:

·        Durable Medical Equipment: items like hospital beds, lifts, and toileting aids that assist with daily living.

·        Meters/Monitors: devices for tracking vital signs and health data, such as glucose meters, pulse oximeters, and wearable sensors.

·        Respiratory Equipment: including CPAP machines and nebulizers for conditions like sleep apnea and asthma.

·        Medication Administration Equipment: tools such as inhalers, insulin pens and other drug delivery systems.

·        Telehealth Equipment: Devices that collect and transmit data to healthcare providers for remote monitoring and virtual care.

Unique Challenges of Designing for Home Use

Designing medical devices for home use requires rethinking how devices function in unpredictable, everyday environments. Home settings can expose devices to dust, moisture, pet hair, household chemicals, and rough handling. These elements can all interfere with the device's performance and cleanability if not accounted for in the design. Robust sealing and durable construction are essential to protect devices from liquid, solid, and airborne contaminants.

Home users are typically not trained healthcare professionals, so devices must be intuitive and easy to operate and maintain. This includes minimizing steps, using clear visual indicators, and providing straightforward instructions. It’s also important to consider that users may have reduced strength, limited mobility, sensory impairments, or cognitive challenges. If a device is hard to use, understand, or maintain, the risk of misuse increases.

Make Maintenance Simple and Accessible

Most homes don’t have access to specialized cleaning or sterilization tools, so medical devices must be designed for maintenance with everyday household supplies. Cleaning and upkeep should be simple, with clear guidance provided in the labeling and instructions for use (IFU).

This should include:

·        Clear cleaning and maintenance instructions, including required supplies and where to get them

·        Guidance on when professional servicing or reprocessing is needed and how to arrange it

·        Contact details for technical support, servicing, or replacement parts

At SteriLabs, we help ensure your home-use medical device is safe, effective, and compliant. With extensive experience in Cleaning, Disinfection, and Sterilization Validation, our team can help you address the unique challenges of home healthcare with confidence.

 

REFERENCES

FDA 2014 Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff. Available from: https://www.fda.gov/media/84830/download

National Research Council (US) Committee on the Role of Human Factors in Home Health Care. The Role of Human Factors in Home Health Care: Workshop Summary. Washington (DC): National Academies Press (US); 2010. 8, Medical Devices in Home Health Care. Available from: https://www.ncbi.nlm.nih.gov/books/NBK210047/

Andres Dumas

Biochemistry Scientist & Cleaning Validation Study Director

Andres Dumas is a skilled Biochemistry Scientist with 4 years of experience in the medical device and biotech industries, specializing in medical device cleaning validation and the development of biochemical analytical assays for the quantification of residual analytes. His work ensures compliance with Health Canada and FDA regulations. Andres collaborates with clients to validate cleaning processes, meeting stringent regulatory standards. His contributions include device classification assessments, test method selection, detailed risk assessments, and comprehensive documentation to ensure that devices meet the highest safety and cleanliness benchmarks. He holds a Master’s degree in Biotechnology from the University of Guelph and remains committed to staying at the forefront of industry trends and regulatory developments, helping SteriLabs offer innovative and precise solutions to its clients.