Risk analysis

Risk analysis is a term often mentioned in relation to risk management and medical devices. The most relevant place for a medical device company to look for an explanation to this term is in the standard ISO 14971, that deals with risk management for medical devices.

This standard states that risk analysis is:
“Systematic use of available information to identify hazards and to estimate the risk.”
This means that risk analysis is the process that aims to identify hazards and consequences of the hazards and risks related to them. Often, however, the word is used to mean risk management documentation, or sometimes the entire risk management process.

Typically, one attempts to determine the following steps in risk analysis:
– Hazards
– Reasonably predictable events or combinations of events
– Hazardous situations, and
– Harm


FMEA stands for Failure Mode Effects Analysis and is the denomination of a method that aims to increase the reliability of products or processes (P-FMEA). The method of FMEA is documented in the standard IEC 60812:2006. The term is sometimes used in place of risk analysis or risk management within the medical device industry. It is important to note that the FMEA, as it is known in the literature and in the standard, cannot be said to meet the requirements of risk management found in the Medical Device Directive.

The FMEA is based on how a component can fail and what consequences the failure will lead to for the system as a whole. Since the components are being analysed, the components of the product need to be known, i.e. construction should have progressed quite a bit before it makes sense to start the FMEA.

Let’s use an example. We have constructed a boat that has a propeller. The boat has a seal on the propeller shaft. In the FMEA, we specifically study the seal and try to identify how it may fail, so-called failure modes. A failure mode that we find is “breakage”, i.e. the seal breaks. The purpose of the seal is to prevent water from leaking into the boat, which it will if the seal is broken. The local effect is ingress of water. For the system as a whole, it means that the boat might sink, which may be considered a fairly serious systemic effect on a boat. If the probability is extremely low, we may not do more with this problem, but if the probability is slightly higher, then we may take action, such as e.g. have double seal, make checks or purchase seals with a high safety factor against breakage. All such measures are also suitable in the FMEA.

FMEA is usually documented in a table. For every line you write, you get an RPN number, a Risk Priority Number, that is used to compare risks and indicate which risks should be dealt with first. FMEA typically does not contain a limit between acceptable and unacceptable risk.

Project management

The word project, and hence the term project management, is both broad and somewhat abused in the sense that the words are used to mean many different things. In some organisations, there is a “project manager” and a “project” as soon as something is done, no matter how small it may be (when it is really more a question of someone having been given a task).

A more traditional and suitable sense of the word can be taken from A Guide to the Project Management Body of Knowledge (PMBOK): “The application of knowledge, skills, tools, and techniques to project Activities to Meet the Project Requirements.”

Definitions are not what makes a project succeed, but in this case one can understand a few things; that the project manager if he/she is going to lead a project must have the knowledge, skills and tools to do it. At least if one is to meet the requirements of the project.

Project management for product development and medical device is often about developing a new product or improve/change an existing one. It is almost always urgent to develop the product, and resources are almost always limited. The major challenge for the project manager is to meet the requirements on the product as quickly as possible, using as little resources as possible.

With a realistic plan, skills, knowledge and processes in the organisation, this is possible. Another essential component is that the steering committee must function with the roles and responsibilities they have.