Electro-Mechanical Engineering Assessment of Intelligent Medical Device

Mansi Sharma
Clinical Researcher, Neurology; Hopkinton, Massachusetts, USA

Vinit Kakad
Managing Director; Marlborough, Massachusetts, USA

Shubham Thakare
Independent Researcher, Ohio, USA

Nitin Nagare
Quality Engineer; Newark, Delaware, USA

Rahul Uday Kawle
CQV Validation Engineer, Kyowa Kirin, Sanford, North Carolina, USA

Silpi Chatterjee
Associate Professor, Department of Public Health Dentistry, Bhabha College of Dental Science, Bhopal, India

Abstract

Background

Medication-related harm remains an important patient-safety concern across healthcare settings. Medication errors may occur during prescribing, preparation, dispensing, administration and monitoring, and may be influenced by human factors, workload and weaknesses in medication-use systems.

Although electronic medication-management and barcode-based technologies are increasingly used, their practical value depends on how well they address the challenges encountered by healthcare professionals during medication preparation and administration.

Objective

To describe a cross-sectional survey protocol for assessing medication-administration challenges, existing medication-verification practices, perceived limitations and user requirements for a proposed smart medication-safety device, MedDose™, among healthcare professionals in India and the United States.

Methods

A structured mixed-methods questionnaire is proposed for doctors, nurses, pharmacists and other eligible healthcare professionals in India and the United States. It will include demographic variables, five-point Likert-scale items and open-ended questions addressing medication preparation, administration, verification, near-miss experiences, workflow challenges and desired technological features. No primary survey data are reported in this protocol-oriented manuscript. A simulated dataset of 1,000 records is included solely to illustrate the planned descriptive and comparative reporting approach.

For a completed survey, quantitative responses would be summarized using descriptive statistics and country-level comparisons using tests appropriate to variable type and distribution. Qualitative responses would be examined thematically. The simulated values presented below must not be interpreted as observations from actual participants.

Results

The illustrative analysis demonstrates how participant characteristics, perceived medication-administration challenges and preferred device functions could be presented. All numerical results in this manuscript are simulated and are not empirical findings.

Conclusion

The proposed survey framework is intended to inform the user-centred design and development of MedDose™, a smart medication-safety device. Actual user requirements must be established through collection and analysis of real participant data before device specifications are finalized.

Keywords: Medication Safety ,Medication Errors ,Medication Administration ,Healthcare Professionals ,Medical Device ,Clinical Decision Support ,India; United States; Needs Assessment; User-Centered Design.