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Point of Care

Creating home medical devices

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


ome 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 implant- able cardioveter defi brillator (ICD) data. Operating in real time over standard tele- phone lines directly from a patient’s home to a medical professional’s office, the

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

product enables physicians to manage their ICD patients more effi ciently.

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 prod- ucts 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, includ- ing those with impairments, designers need to consider the demands a product places on users and their capa- bilities in each of the following areas: vision problems, hearing problems, cognitive processes, communication skills, locomotion impairments, reach and stretch impair- ments, and dexterity impairments.

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

The home environment The home environment – including ambient lighting

and noise levels, humidity, etc. – can also create hazard- ous 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 replenish- ment is much higher, signifi cantly increasing infection risks and associated complications. Additionally, children and animals can also introduce an element of unpredict- ability.

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

By making devices easier to use, the devices them- selves may have to make clinical decisions under certain circumstances (e.g. alerting emergency services). Because of the importance of these clinical decisions, signifi cant levels of confi dence in a device’s software will be required for regulators, doctors and patients to suffi ciently 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 com- plete, 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 chal- lenges for reliable connectivity, particularly in areas with poor mobile network coverage.


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