Page 242 - Safety Risk Management for Medical Devices

CHAPTER 31

Risk Management and Product

Development Process

Abstract
As technology advances, more sophisticated and more complex devices are produced to handle
difficult medical conditions. Many of these devices employ hazardous and potentially lethal sources
of energy such as gamma radiation and lasers, or dispense life supporting medicines into the
patients. The rise in complexity of these medical devices brings about both increased benefits and
increased safety risks. What safety strategies should a manufacturer adopt? How can risk manage-
ment be a value-added activity to product development? Can risk management help identify
Essential Design Outputs? This chapter explores answers to these questions.

Keywords: Safety strategy; essential design outputs; lifecycle; product development

As technology advances, more sophisticated and more complex devices are produced
to handle difficult medical conditions. Many of these devices employ hazardous and
potentially lethal sources of energy such as gamma radiation and lasers or dispense life
supporting medicines into the patients. The rise in complexity of these medical
devices brings about both increased benefits and increased safety risks.
The requirements of ISO 14971 [3,7] with respect to risk management apply to
the entire lifecycle of a medical device. This includes the product development part of
the lifecycle.
Considering product risks during the product development process, the safety
features of the System can be developed as an integral part of the product develop-
ment process and effectively integrated in the System architecture. This reduces the
product development costs and can reduce the product development schedule as well.
With advance consideration to safety, several characteristics should be considered
in the design. For example:
• The safety aspects of the System should be as simple as possible, with clearly
understandable design and operation.
• Functionality of safety-critical parts of the System should be kept independent
of the rest of the System, if possible.
• Interfaces to safety-critical parts of the System should be well defined.
Most medical Systems today are complex. It’s likely that some latent design flaws
with the potential for unintended behaviors would remain in the design. It is advisable

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00031-3 All rights reserved. 221