Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 1:5:1268010.
doi: 10.3389/fdgth.2023.1268010. eCollection 2023.

A comprehensive roadmap for MedTech innovations uptake into the public healthcare system in India

Affiliations

A comprehensive roadmap for MedTech innovations uptake into the public healthcare system in India

Prakamya Gupta et al. Front Digit Health. .

Abstract

Background: The burden of communicable, non-communicable diseases and reproductive maternal, newborn, child & adolescent health in India, reflects the necessity to develop tailored solutions. The plethora of MedTech innovations has provided healthcare facilities with more effective, affordable and accessible healthcare for people across the country. However, in spite of the Make-in-India scheme in the country, the indigenously developed healthcare technology is far from making an impact on the healthcare system.

Objective: To present a roadmap for MedTech innovations for their successful deployment into the public healthcare system.

Methodology: In addition to the literature review, recommendations were included from several stakeholders such as innovators, manufacturers, policymakers, subject matter experts, funding organizations, State health officials etc.

Results and conclusion: The journey of healthcare innovation from need identification to ideation, to prototyping and validation has paved the way towards the de novo design that caters to unmet needs. Innovations at the advanced technology readiness level (TRL 7/8 and above) demand a holistic and multidisciplinary approach which includes clinical validation, regulatory approval and Health technology assessment. The deployment of healthcare technology into the public healthcare system must consider resources (e.g., time, staff, budget, investment policies), ethical concerns (privacy, security, regulations, ownership), governance (policy, accountability, responsibility etc.), and Skills (capabilities, culture, etc.). The technologies are considered for field trials before the uptake in the public health system. Technology can be a key tool in achieving Universal Health Coverage but its use has to be strategic, judicious, and cognizant of issues around privacy and patient rights.

Keywords: healthcare innovation; low and middle income countries; medical devices; medical technology (Med-Tech) innovations; public health.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The “Valley of Death” highlighting the various challenges faced in transition from ideation to successful commercialization of the product. TRL, technology readiness level; PoC, point-of-care.

References

    1. Ministry of Health and Family Welfare. National Medical Device Policy 2023 (2023). Government of India. Available at: https://pharmaceuticals.gov.in/sites/default/files/Gazette%20Notificatio... (Accessed November 29, 2023).
    1. NASA. Technology Readiness Level. (2017) Available at: https://www.nasa.gov/wp-content/uploads/2017/12/458490main_trl_definitio... (Accessed February 13, 2022).
    1. Neugebauer EAM, Rath A, Antoine SL, Eikermann M, Seidel D, Koenen C, et al. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials. (2017) 18(1):427. 10.1186/s13063-017-2168-0 - DOI - PMC - PubMed
    1. Versi E. ‘Gold standard’ is an appropriate term. Br Med J. (1992) 305:187. 10.1136/bmj.305.6846.187-b - DOI - PMC - PubMed
    1. Ministry of Health and Family Welfare. Medical Device Rules, 2017 (2017). Central Drug Standard Control Organization, Government of India. Available at: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medi... (Accessed November 29, 2023).

LinkOut - more resources