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Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

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Developing medical device technologies from users' perspectives: a theoretical framework for involving users in the

Syed Ghulam Sarwar Shah¹, Ian Robinson, Sarmad AlShawi

¹Multidisciplinary Assessment of Technology Centre for Health Care, Brunel University, Middlesex, UK. Sarwar.Shah@brunel.ac.uk

International Journal of Technology Assessment in Health Care

|October 23, 2009

Summary

This summary is machine-generated.

A new framework guides the involvement of diverse users, including patients and healthcare professionals, throughout medical device technology development. This ensures devices meet real-world user needs from concept to market.

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Area of Science:

Biomedical Engineering
Human Factors Engineering
Product Development

Background:

Medical device technology development (MDTDP) often overlooks diverse user perspectives.
Ensuring devices meet end-user expectations is crucial for adoption and efficacy.

Purpose of the Study:

To propose a universal theoretical framework for integrating various user types into the medical device technology development process (MDTDP).

Main Methods:

The study outlines a framework with distinct pathways, methods, and stages for user involvement in MDTDP.
It categorizes user involvement into end-user and professional-user streams.

Main Results:

The framework details user engagement strategies across the medical device lifecycle, from ideation to market launch.
It includes scenarios and examples to demonstrate practical application in developing simple to complex devices.

Conclusions:

Effective medical device development necessitates direct input from both healthcare professionals and end-users (patients, individuals with disabilities, caregivers).
A significant gap can exist between manufacturer/clinician perceptions and actual end-user needs, leading to device rejection.
The proposed framework aids manufacturers in strategically planning and executing user involvement throughout MDTDP.