Design Rationale for the Regulatory Approval of Medical Devices

297 Pages·2013·4.96 MB·English

by  Jeevan Sagoo

CRANFIELD UNIVERSITY

JEEVAN SAGOO

DESIGN RATIONALE FOR THE REGULATORY
APPROVAL OF MEDICAL DEVICES

SCHOOL OF APPLIED SCIENCES

DOCTOR OF PHILOSOPHY (PhD) THESIS

CRANFIELD UNIVERSITY

SCHOOL OF APPLIED SCIENCES

DOCTOR OF PHILOSOPHY (PhD) THESIS

SEPTEMBER 2012

JEEVAN SAGOO

DESIGN RATIONALE FOR THE REGULATORY
APPROVAL OF MEDICAL DEVICES

Supervisors: Professor Ashutosh Tiwari and Doctor Jeffrey Alcock

Academic Year 2008 to 2012

This thesis is submitted in partial fulfilment of the requirements for the
degree of Doctor of Philosophy

© Cranfield University, 2012. All rights reserved. No part of this publication may be

reproduced without the written permission of the copyright holder.

In Loving Memory of My Inspirational Father

Kundan Singh Sagoo
(1949 – 1993)

“We can't solve problems by using the same kind of thinking
we used when we created them”
Albert Einstein

Abstract

Design rationale is a methodology aimed at capturing and representing design decisions
according to a designated structure. Additionally, these design decisions and their
underlying arguments can be made available for examination at a later date. The
literature review identified that there is currently a lack of information describing the
use of design rationale methods and computational support tools with the medical
device domain. Furthermore, the review of literature has also recognised that there are
no existing guidelines available for medical device manufacturers and regulatory
authorities to follow in order to capture and represent the design decisions in the case of
medical devices.

Medical devices are instruments which are used for diagnosis, screening, monitoring, or
the treating of patients suffering from disease, injury, or disability. Medical devices are
products that require rigorous regulation before they can be placed onto the market. If
problems are encountered with a device once it has been placed onto the market, the
device is recalled by the relevant regulatory authority. Device recalls can often result in
the device manufacturers having to evaluate the design decisions that were made during
the product development stages in order to address the reported problems and
implement a solution. As a result, medical device manufacturers can incur unexpected
rework and/or redesign costs, and in even more severe circumstances, incur high
litigation costs.

This research; reviews the state-of-the-art in design rationale and identifies its key
capabilities, analyses design rationale’s feasibility for use with the medical device
domain, identifies the regulatory approval processes for medical devices and compares
them, analyses the possibilities of utilising design rationale with the regulatory approval
of medical devices, and develops a set of guidelines. The guidelines detail the necessary
steps that are required to capture and represent the design decisions for medical devices.
The utility of this contribution has been verified through the process of validation with
experts and researchers.

i