Home Healthcare Equipment
As the delivery of healthcare services shifts from clinical settings to the home, the market for home healthcare equipment is expected to grow exponentially over the coming years. However, manufacturers face a series of unique challenges in supplying equipment that is both more effective and safer.
The shift to home healthcare is one of several strategies to reduce the increasing costs of delivering healthcare services. As a result, manufacturers are redesigning medical devices and healthcare equipment so they are no longer exclusive for hospital use, allowing patients and lay caregivers to use them in home environments. This dramatic shift in the delivery of medical services is creating new opportunities for manufacturers of home healthcare equipment.
Placing healthcare equipment in the home, however, introduces some complications: Manufacturers are attempting to address the unique issues associated with the use of their equipment by untrained users outside of controlled clinical settings. At the same time, government and insurance regulators, industry groups and independent standards organizations are focusing on developing, marketing, regulating and surveilling home healthcare equipment to ensure that devices perform as intended and are as safe as possible for patients and caregivers to use.
This white paper examines the current and anticipated regulatory landscape for home healthcare equipment. It offers an overview of the current and future market for this equipment and discusses some key issues manufacturers might face when developing products for use in home environments. The paper then provides a review of applicable standards, a summary of the guidance issued by the U.S. Food and Drug Administration (FDA) on design considerations for medical devices intended for home use and implications of other FDA guidance documents — specifically those related to human factors engineering (HFE). The paper concludes with a preview of future considerations for manufacturers of home healthcare equipment.
Download our white paper to learn more about home healthcare devices standards, risks and challenges.