Innovations and Regulations in Healthcare

Bridging the Gap

Prasanthi Sadhu, Editor, Asian Hospitals and Healthcare Management

Healthcare systems around the world have been grappling with challenges of meeting the ever-increasing demand for better care. Innovation and technological advancements have played a key role in improving care. However, innovation does not necessarily limit to new products or technologies. More often than not innovation can happen around organising or executing things, aided by technology.

Healthcare systems around the world have been grappling with challenges of meeting the ever-increasing demand for better care. Innovation and technological advancements have played a key role in improving care. However, innovation does not necessarily limit to new products or technologies. More often than not innovation can happen around organising or executing things, aided by technology.

While care providers have continued to adopt new technologies in the form of modern medical devices and newer treatment approaches, innovation tends to be bogged down in this highly regulated sector. The gap between regulation and innovation needs to be bridged for innovation to flourish and help businesses thrive. The first step in driving innovation to succeed is clear and consistent communication across the organisation. People or teams responsible for innovation need to be in constant communication with legal and regulatory staff. If the regulatory and compliance challenges are understood and mitigated at the ideation or early stage of a project, there is a better chance of success. From an organisational perspective, healthcare technology innovators can look at some interesting examples. Companies like Intermountain Healthcare, Kaiser Permanente and Providence Health & Services etc. are known to have established innovation centres in-house to bring forth key ideas from the staffs that result in both operational efficiencies and improved clinical care, thus benefiting both service providers and consumers.

In some cases, delays in products reaching the patients could also be affected by the knowledge gap between innovators and regulators. Inorderto avoid such delays, regulatory bodies have to take certain measures. The FDA Center for Devices and Radiological Health (CDRH) has taken steps in this direction by establishing mechanisms to provide additional reviewer training via programmes such as the Experiential Learning Program (FDA, 2016b) and the Network of Experts (FDA, 2016c). It is also evident that these measures are not enough and FDA needs to explore new methods for evaluating and regulating products to make approvable products available to patients without any delays.

In the cover story of this issue titled ‘Regulation vs. Innovation - Are We Getting It Right?’, we look at how the regulatory environment has had a significant impact on the introduction of innovative new healthcare products.

Author Bio

Prasanthi Sadhu

Prasanthi Sadhu Editor, Asian Hospitals and Healthcare Management