Hello Viraj: I see you are interested in the identification of risk and its prioritization; me, too. Never had experience dealing with medical device risk analysis. And you are right “Managing risk early is the best way to avoid issues later”.

Discussion on this topic so far has been quite enlightening; for example,jtl27 posting code 1377 remarks that “a risk is a risk” if it threatens a company wellbeing. When a risk enters a major disaster level and customer suffers major harm in the process, the company could be sued and claims could be heavy enough to threaten the company’s existence especially when the company’s life is at its infancy.

If I may suggest, perhaps one of the best approaches to understanding how to identify and deal with risk is to study the concept of CAPA. It’s documentation and analysis should include:

i) – any prior risk scoring of the procedures covered by CAPA, as well as any prior risk mitigating
efforts such as Failure Mode Effects Analysis (FMEA)

ii) – Any related regulatory risk reduction such as Serious Reportable Events

iii) – Discussion of metrics to measure forward – any early warnings that similar problems are developing

iv) – Circuit breakers to prevent cascading failures – true catastrophes usually start small and then
snowball into disaster

v) – Specific documentation updates and changes to procedures and processes together with data monitoring
plan

No CAPA is complete without risk mitigation and risk mitigation never happens by chance.

One of the best tools available to risk analysis and mitigation is the Bow Tie analysis – a highly structured analytical process used to address high risk processes.

More so, one of the important ideas Dr. Simon emphasized early on in his lectures is the need to avoid re-inventing the wheel.
If a company has existed for a while it will have acquired documentation on risk analysis; hopefully by device design. It is always a wise idea to take a pick at records of previous projects the company handled as may be related to the project at hand. This may throw in some ideas on precautions taken, as safeguards.

Customer input, as always, – may be, with the help of a prototype – should always be the source of initial medical device design input. Not only will this provide valuable ideas on what the customer wants, but also on intended usage which will give added knowledge on what precautions to take in designing the medical device.