View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
March 23, 2022

Ageing Population and Medical Devices: Regulatory trends

A pressing need in upcoming decades will be ensuring that older adults, who increasingly constitute a significant percentage of the population, can function independently, and maintain an acceptable quality of life. Addressing the unmet care and support needs of the ageing population and designing services and solutions centered around what they require is therefore becoming an urgent public health priority.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

Listed below are the key regulatory trends impacting the ageing population theme, as identified by GlobalData.

Authorisation for home use

The US Food and Drug Administration (FDA) has changed some of its enforcement policies so that home care devices such as physiological monitors, oximeters, spirometers, apnea monitors, electrocardiograms (ECGs,) and others—which were previously cleared or approved for marketing to hospitals—can be marketed for home use without additional submissions.

The relaxed regulations also allow hardware and software changes to be made to existing cleared devices to increase the ability of these devices to be used for remote patient monitoring (RPM) without seeking additional approval. The FDA has stated that these relaxed regulations will only remain in effect during the Covid-19 pandemic, but there are calls by the US administration and regulators for some of these changes to be made permanent.

RPM reimbursement

Until recently, it was challenging for healthcare providers to charge and receive reimbursement for RPM technologies and telehealth. Existing Current Procedural Terminology (CPT) codes, which are reimbursement codes used by the Centers for Medicare and Medicaid Services (CMS) for the US federal healthcare delivery programmes, were limited to RPM technologies and telehealth before 2018. Since then, an older CPT code (99091) and four newer CPT codes (99453, 99454, 99457, and 99458) now allow for the reimbursement of services that include training a patient how to set up and use RPM technologies, reviewing remotely collected RPM data, and consulting patients regarding their RPM data.

These changes strongly suggest that regulators anticipated RPM technologies and telehealth to be a growing part of healthcare delivery before the Covid-19 pandemic. As hospitals and care providers look for ways to manage a rapidly aging population with complex chronic health needs, the evolution of RPM reimbursement presents a unique opportunity for the elderly care market.

This is an edited extract from the Aging Population and Medical Devices – Thematic Research report produced by GlobalData Thematic Research.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network