Title: Contribution of statistical quality control to research innovation and commercialisation in biomedical industry

Authors: Erkan Karaman; Nada Boukhari; Mustafa Özilgen

Addresses: Department of Biomedical Engineering, Yeditepe University, Istanbul, Turkey ' Department of Biomedical Engineering, Yeditepe University, Istanbul, Turkey ' Department of Food Engineering, Yeditepe University, Istanbul, Turkey

Abstract: Contribution of statistical quality control to research innovation and commercialisation in the biomedical industry has been discussed by following the same approach with Bayrak (2022) via elaborating the fundamental keywords. Half of these keywords were related with the statistical distribution models, like Gaussian, binomial, Poisson, z, t, F and chi-square distributions. In addition, use of the process related keywords such as hazard analysis critical control point (HACCP) failure mode, effect analysis (FMEA), feedback control, six-sigma concept, confidence limits, attributes control, critical and manufacturing control points and C-charts were also discussed. We also demonstrated the use of the operating characteristics curves, destructive and non-destructive quality control, average outgoing quality and average outgoing quality limit concepts, military 105 D and Dodge and Romig sampling plans in the biomedical industry by referring to the biopotential electrode production and robot assisted surgery. Our assessments are strengthened with presentation of some numerical examples and referring to the concepts, like HACCP, barrowed from the other disciplines.

Keywords: statistical quality control; fundamental statistical distribution models; biomedical industry related calculations; biopotential electrodes; robotic surgery.

DOI: 10.1504/IJRIC.2022.129678

International Journal of Research, Innovation and Commercialisation, 2022 Vol.4 No.2, pp.133 - 157

Received: 22 Oct 2022
Received in revised form: 13 Nov 2022
Accepted: 24 Nov 2022
Published online: 20 Mar 2023 *

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