Creating home medical devices

May 1, 2011

When it comes to designing products for home healthcare,
challenges are universal.

Peter Brady

Home healthcare in the United States, the fastest-growing sector in healthcare, reduces costs by moving the point of care from high-cost, clinical centers to the home, where devices are used by patients and caregivers.

The shift towards home-based care challenges product designers to ensure these devices are safe, effective and easy to use. Working with St. Jude Medical, Sagentia helped develop Housecall Plus, a monitoring system to transmit complex implantable cardioveter defibrillator (ICD) data. Operating in real time over standard telephone lines directly from a patient's home to a medical professional's office, the product enables physicians to manage their ICD patients more efficiently.

Designing complex, critical-care devices for home use presented Sagentia's designers with challenges that are universal when it comes to designing products for home healthcare.

Key issues all designers must consider: ensure products are appropriate for all users/patients and suitable for the home environment; add the right intelligence to instruments for clinical decision support; choose the right approach to communications and connectivity; and ensure products are current with regulatory changes.

Creating products for the general population, including those with impairments, designers need to consider the demands a product places on users and their capabilities in each of the following areas: vision problems, hearing problems, cognitive processes, communication skills, locomotion impairments, reach and stretch impairments, and dexterity impairments.

Once demands and capabilities are assessed, any areas of weakness in product design can be identified and addressed.

The home environment

The home environment — including ambient lighting and noise levels, humidity, etc. — can also create hazardous situations. This environment, in contrast to a hospital, is much less controlled in terms of temperature, humidity and electromagnetic interference sources. These issues can affect the performance of a device. Single-use, disposable devices and consumables are unlikely to run out in hospitals where stocks are managed, whereas the risk of a home user re-using single-use, disposable items because they are misplaced or supplies need replenishment is much higher, significantly increasing infection risks and associated complications. Additionally, children and animals can also introduce an element of unpredictability.

By making devices easier to use, the devices themselves may have to make clinical decisions under certain circumstances (e.g. alerting emergency services). Because of the importance of these clinical decisions, significant levels of confidence in a device's software will be required for regulators, doctors and patients to sufficiently trust the next generation of intelligent machines. However, real products with this intelligence are emerging. This technology is likely to be a prerequisite for more complete, widespread use of medical devices in the home.

Similar to the Housecall Plus, many medical devices being used in patients' homes won't exist in isolation and may connect to control centers where patients and devices can be monitored. Land lines disappearing from homes in the developed world at an incredible rate (the current estimate is for the last landline in America to be disconnected sometime in 2025) introduces new challenges for reliable connectivity, particularly in areas with poor mobile network coverage.

Peter Brady is a managing consultant and
part of the critical care team at Sagentia.
For more information on Sagentia solutions:

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