Page 24 - Safety Risk Management for Medical Devices

CHAPTER 2

Why Do Risk Management?

Abstract
There are many good reasons to do risk management. In addition to making safer products, risk
management can help reduce the cost of design and development by identifying the safety-critical
aspects of the design early in the product lifecycle. Risk management is a legal requirement in
most countries, without which it would not be possible to obtain approval for commercialization of
medical devices. In the unfortunate situations when people are injured by medical devices, the first
place that lawyers would look is the risk management file of the device.
Keywords: Legal; Regulatory; risk-based; recall; field corrective action; moral; ethical

Whether you are aware of it or not, you are constantly managing risk in your daily
life. For almost every action that we take, we internally evaluate the benefit of that
action versus the risks (or cost) of that action. If we believe the benefits outweigh
the risks, we take that action. Else, we don’t. Consider the simple action of driving
to work in your car. You consider the benefit of comfort and speed of getting from
home to work, versus the risks of getting injured or killed in a car crash. In general,
the chances of getting into a serious accident are fairly small, compared to the
benefit of commuting in your car. But now imagine you are in a war-torn country
where there are explosive devices buried in the roadway. Now the calculus changes.
The risks are higher than the benefits, and you would likely choose to walk off-road
instead.
The medical technology (MedTech) industry is required to evaluate the potential
risks due to the use of a medical device against the potential benefits of that device.
Regulatory approval of a medical device requires demonstrating that the risks of the
device are outweighed by its benefits. Rather than making a subjective judgment,
formal and systematic methods are used to make this determination.
Another very important reason to do risk management is the progressive shift
in the industry where more and more decisions are risk based. Risk-based decisions
are rational and defensible. In many aspects of product development, e.g., design
choices, or sample size determination, risk is a good discriminator and basis for
decision making. Moreover, the European Medical Device Regulation (EU MDR)

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00002-7 All rights reserved. 3