MEDICAL innovation has a profound impact on public health.
However, before it is adopted in the mainstream of clinical practice, it has to go through stringent assessment, verification, validation and approval.
The United States Institute of Medicine reported in 2001 that it took almost 17 years from the inception of a medical innovation to its implementation.
This lengthy adoption process is to protect the public interest and ensure patient safety. However, the pandemic underscores the need to be flexible in care and treatment to quickly respond to public health emergencies.
In the US, the Emergency Use Authorisation law enables the Food and Drug Administration (FDA) to give faster approvals to manufacturers in times of sudden and immense public need. For example, last year, the FDA approved 625 novel medical devices, 20 times more than the 29 novel devices a decade ago.
Generally, medical device companies can start selling devices sooner when the right exemptions in regulations are leveraged.
Exemptions related to Covid-19 have been issued around the world. The most notable one is Singapore's exemption of certain devices, such as surgical masks, thermometers, particulate respirators, and protective gear from registration requirements.
The regulatory authority concerned would still perform a risk-benefit analysis to determine whether authorising the device would ensure patient safety.
They would also determine whether there is an alternative option that has already been cleared, and whether there is still a life-saving need before the approval of a device can be justified.
To drive medical innovations and accelerate commercialisation, consider these four suggestions.
First, organisations should promote a culture of innovation. Research suggests that collaboration should be forged across the whole organisation in developing new innovations. This is because silos hamper the innovation process from obtaining synergy from inter-unit collaboration.
Innovation is a complex ecosystem which has many loops.
As part of the innovation culture, businesses should create an "integration hub" to manage the flow of knowledge during the innovation process. This will require multi-stakeholder engagement.
Organisations should, therefore, forge a tripartite partnership between healthcare providers, academia and industry as early as possible in the innovation process.
Second, health-related organisations should keep the patient in mind throughout the innovation process, as the raison d'etre of their existence is to make a difference in the lives of patients.
These organisations should work with patients and clinicians to define the healthcare need early. They should keep this need central throughout the process and not be blindsided by engineering design, commercial interests, or manufacturing limitations.
Notwithstanding, clinical engineers should be at the heart of things. Teams have to be developed to support this engineering function if the innovative technology is to be successfully adopted by healthcare systems.
Third, it is never too early in the innovation process to implement a health technology assessment system.
Human factors, health impact assessments and health economics will be vital to the successful development of a product.
An organisation should not leave these issues to the final stages of the process, but initiate them early to ensure maximum beneficial impact on patients.
Fourth, access to adequate funding is critical.
A scheme that taps public and private sources would allow early-stage funding for clinicians to innovate with academics and companies.
The pandemic is an opportune time for medical innovation to make a substantive contribution to patients afflicted by Covid-19.
However, innovators should be mindful of the challenges ahead and crossing the gap from product evaluation to its adoption requires time, effort and resources.
Hence, organisations should leverage a well-planned strategy and a risk-preferent culture to drive innovation in the healthcare sector.
Nevertheless, whatever the technological innovation, nothing should replace the human touch in health services delivery.
The writer is Associate Professor and Dean, Faculty of Allied Health Professions, AIMST University Malaysia