Unmasking the Current Scenario of Indian Biomedical Devices Industry: Ventilators being the Heart of the Discussion

  1. Sheersha Pramanik
  2. Sucheta Karmakar
  3. Shreyas Mukherjee
  4. Indraneel Dhavale
  5. Rohan Shrestha

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Abstract

Background

The Indian Biomedical Device Industry has been growing at an unprecedented rate, but several hindrances need to be acknowledged in offering access to quality, budget-friendly medical devices in India. This article explores the current loopholes of the Indian biomedical device industry along with the proposal of various innovative solutions, with emphasis on ventilators.

Methods

An online survey with the help of Google forms was conducted from 1 st November to 25 th December 2020, addressing the problems of the Indian medical device industry (MDI) along with probable solutions. The survey also provides a glimpse into the complications aroused from the frequent use of ventilators during COVID-19 outburst, along with possible measures.

Results

According to the survey, 51.6%, 46.5%, 55.7%, and 47.5% of respondents have agreed to ‘Stringent laws and implementation,’ ‘Safety testing and strict regulations,’ ‘Unfavorable duty structure,’ and ‘Reducing tax rate on domestic manufacturers,’ as a possible solution to advance the implementation of ISO 13485 and ISO 10651, implementation of ISO 14971, the probable cause of limitations of Indian MDI, possible measure to overcome limitations of Indian MDI, respectively. 46.7%, 47.5%, 46.2%, and 44.6% of respondents have agreed to ‘Surgical decompression,’ ‘Nebulized and broad-spectrum antibiotics,’ ‘PEEP,’ and ‘Adopting lung protective ventilation strategies’ as possible solutions to treat various ventilator complications, respectively.

Conclusion

The study briefs about the people’s perception of the Indian MDI as well as on the ventilator complications. The results complied with our hypothesis as the majority of the respondents have agreed with almost all the probable solutions in both the sections given by us as options.

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    SciScore for 10.1101/2021.02.26.21251720: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data analysis: IBM SPSS Statistics Version 26.0 for Windows (IBM Corp., Armonk, NY, U.S.) was utilized to execute the analyses to address the research-based questions.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

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  2. Version published to 10.1101/2021.02.26.21251720 on medRxiv