TECHNOLOGICAL DIVERSITY MANAGEMENT OF MEDICAL DEVICE ENTERPRISES

Authors

  • Shudipta Choudhury CEO Vigilenz Medical Devices Sdn.Bhd

Abstract

Background: Technological diversity management in the manufacturing of advanced medical devices is essential. The manufacturing industries of medical devices should act in accordance with the technical guidelines and regulations in order to ensure best practices with the use of devices in hospitals

Aim: To explore safety hazards, cost implications, and social and ethical standards to be considered during the manufacturing of advanced medical devices

Subject and Methods: A qualitative descriptive study was used. There was no targeted sample in the current study whereby secondary data were used to explore the research topic. Secondary sources were obtained from databases including EBSCOHOST, PubMed, ProQuest, Science Direct, and Google Scholar. Peer-reviewed articles, journals, books, conference proceedings, and other web publications were used to gather relevant data.

Results: The current study indicated that the technological diversity management of advanced medical devices is associated with safety hazards like security threats, integrity problems, and medical errors. The study also showed that high cost of standardizations, supply, and purchase of advanced medical devices is a huge burden faced by the manufacturers and users. The study showed that the regulation of the medical devices, certification, and post-market surveillance are essential social and ethical considerations during the manufacturing process of the new medical devices.

Conclusion: The current study explored the technological diversity of advanced medical devices. It is evident in the current study that technology diversity of medical devices is associated with safety hazards and cost implications. The study disclosed that taking into account social and ethical issues aid in manufacturing safe and high quality medical devices.

Keywords:

Advanced Medical devices, Technology diversity management, Social and ethical issues, Safety hazards

Downloads

Download data is not yet available.

References

Altenstetter, C. (2011). Medical devices: European Union policymaking and the implementation of

health and patient safety in France. Piscataway, New Jersey, US. Transaction Publishers.

Barakat, N., Sunny, N. & Hasan, M. (2014). Ethics of regulated biomedical device design: American

Society for Engineering Education. ASEE Annual Conference and Exposition, pp 1-9

Bolka, E. M. (2014). Medical device excise tax: An unfair burden. Indiana Law Journal, 89(4), pp

Billaux, M., Borget, I., Prognon, P., Pineau, J. & Martelli, N. (2016). Innovative medical devices

and hospital decision making: A study comparing the views of hospital pharmacists and physicians.

Australian Health Review, 40(3), pp 457.

Bitterman, N. (2011). Design of medical devices-A home perspective. European Journal of Internal

Medicine, 22(1), pp 39-42.

Burns, A. J., Johnson, M. E. & Honeyman, P. (2016).A brief chronology of medical device security.

Communications of the Acm, 59(10), pp 66-72.

Ciani, O., Armeni, P., Boscolo, P. R., Cavazza, M., Jommi, C. & Tarricone, R. (2016). De innovatione: The concept of innovation for medical technologies and its implications for healthcare policy-making.Health Policy and Technology, 5(1), pp 47-64.

Cleary, M., Horsfall, J. & Hayter, M. (2014). Data collection and sampling in qualitative research:

Does size matter? Journal of Advanced Nursing, 70(3), pp 473-475.

Colorafi, K. J. & Evans, B. (2016).Qualitative descriptive methods in health science research.

Health Environments Research & Design Journal,9(4), pp 16-25.

Dybczak K. & Przywara, B. (2010). The role of technology in health care expenditure in the EU (No. 400). Brussels: European Communities.

ECRI Institute. (2015). ECRI institute announces top 10 health technology hazards for 2015. PR

Newswire. Available at:http:// search.proquest.com/docview/1627687301? accountid=45049

El-Haik, B. & Mekki, K. S. (2011). Medical device design for Six Sigma: A road map for safety and

effectiveness (1st ed.). Ontario, Canada: John Wiley & Sons.

Feijter, J. M., Grave, W. S., Muijtjens, A. M., Scherpbier, A. J. & Koopmans, R. P. (2012). A comprehensive overview of medical error in hospitals using incident-reporting systems, patient complaints and chart review of inpatient deaths. Plos One, 7(2), pp 1-7.

Gadotti Martins, E., Pinheiro de Lima, E. & Gouvea da Costa, S. E. (2015). Developing a quality

management system implementation process for a medical device manufacturer. Journal of Manufacturing Technology Management, 26(7), pp 955-979.

Hagedorn, T. J., Krishnamurty, S. & Grosse, I. R. (2016). An information model to support usercentered design of medical devices. Journal of Biomedical Informatics, 62, pp 181-194.

Hilbers, E. S. M., de Vries, C. G. J. C. & Geertsma, R. E. (2013). Medical technology at home: safety-related items in technical documentation. International Journal of Technology Assessment in Health Care, 29(1), pp 20-26.

Holtzman, Y. (2012). The US medical device industry in 2012: Challenges at home and abroad. Available at: https://www.mddionline.com/us-medicaldevice- industry-2012-challenges-home-andabroad

Johnston, M. P. (2017). Secondary data analysis: A method of which the time has come. Qualitative and Quantitative Methods in Libraries, 3(3), pp 619-626.

Joung, Y.-H. (2013). Development of implantable medical devices: From an engineering perspective.

International Neurology Journal, 17(3), pp 98-106.

Kirisits, A. & Redekop, W. K. (2013). The economic evaluation of medical devices: Challenges ahead.

Applied Health Economics and Health Policy,11(1), pp 15-26.

Koch, A. (2011). Firm-internal knowledge integration and the effects on innovation. Journal of

Knowledge Management, 15(6), pp 984-96.

Kreis, J., Panteli, D. & Busse, R. (2014). How health technology assessment agencies address the issueof unpublished data. International Journal of Technology Assessment in Health Care, 30(1), pp

-43.

Kreiwall, T.J., (2008). Ethics of medical device safety. Long Term Effects of Medical Implants Journal,

(2), pp 167-74.

Lehoux, P., Gauthier, P., Williams-Jones, B., Miller, F.A., Fishman, J. R., Hivon, M. & Vachon, P.

(2014).Examining the ethical and social issues of health technology design through the public appraisal of prospective scenarios: a study protocol describing a multimedia-based deliberative

method. Implementation Science : IS, 9, pp 81-95

Neale, J. (2016). Iterative categorization (IC): A systematic technique for analyzing qualitative data. Addiction, 111(6), pp 1096-1106.

Polisena, J., Gagliardi, A. & Clifford, T. (2015). How can we improve the recognition, reporting and resolution of medical device-related incidents in hospitals? A qualitative study of physicians and registered nurses. BMC Health Services Research, 15(1), pp 1-9.

Ross, S., Weijer, C., Gafni, A., Ducey, A., Thompson, C., &Lafreniere, R. (2010). Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery. BMC

Medical Ethics, 11, pp 14.

SaniCln, L. (2013).Data collection techniques a guide for researchers in humanities and education.

International Research Journal of Computer Science and Information Systems (IRJCSIS), 2(3), pp 40-44

Shimanuki, S. & Saiki, T. (2012). Technological diversity management of medical device enterprises. Journal of Strategy and Management, 5(4), pp 420-436.

Simoens, S. (2009). Which barriers prevent the efficient use of resources in medical device sectors? Applied Health Economics and Health Policy, 7(4), pp 209-17.

Sorenson, C., Drummond, M. & Bhuiyan Khan, B. (2013). Medical technology as a key driver of rising

health expenditure: disentangling the relationship. Clinico Economics and Outcomes Research: CEOR, 5, pp. 223–234.

Thimbleby, H. (2013). Technology and the future of healthcare. Journal of Public Health Research,

(3), pp e28.

Ventola, C. L. (2008). Challenges in evaluating and standardizing medical devices in health care

facilities. Pharmacy and Therapeutics, 33(6), pp 348–359.

Wahlster, P., Goetghebeur, M., Kriza, C., Niederländer, C., &Kolominsky-Rabas, P. (2015).Balancing

costs and benefits at different stages of medical innovation: a systematic review of Multi-criteria

decision analysis (MCDA). BMC Health Services Research, 15(1), pp 1-12.

World Health Organization. (2010). Barriers to innovation in the field of medical device. Available

at:http://apps.who.int/medicinedocs/documents/s17701en/s17701en.pdf

Williams, P. A. & Woodward, A. J. (2015). Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem. Medical Devices, 8, pp 305–316.

Wong, J. & Kaiyu, R. T. (Eds.).(2013). Handbook of medical device regulatory affairs in Asia.CRC Press.

Zarmani, N. F., Ramli, M. A. & Shaikh Mohd Salleh, S.M.S. (2014).The ethical aspects of halal

certification of medical devices in Malaysia. Proceedings of the 15th Asian Bioethics Conference

(ABC 15) & 12th Asia Pacific Conference (APC12) ~ RCAPS, pp 303-306

Downloads

Published

02-01-2018

How to Cite

Shudipta Choudhury. (2018). TECHNOLOGICAL DIVERSITY MANAGEMENT OF MEDICAL DEVICE ENTERPRISES . Malaysian Journal of Medical Research (MJMR), 2(1), 71-80. Retrieved from https://ejournal.lucp.net/index.php/mjmr/article/view/252

Metrics