If a company has product innovation it must be a disruptive, it much make changes though out the process. The biggest misconception is that innovation cannot be a true process. The aspects of the development process is being abused are its all understanding company serves to the customer. The brain storming process is also misused which should have different approach to the prototype output. In process improvement you should reduce iteration in the development cycle and streamline. The Development should build upon, not go back and repeat the process of prototype after a risk or default is found. A pharmaceutical company will look at drug interaction, what company might fail to look at times is the device interaction with the body which they are capable of doing. Company should make a product which meets what a body wants and reflects that to make it acceptable to the costumer. The company will get results that directly achievable as they reflect what this body is trying to attain to overcome in resistance. Companies should not compromise what a consumer need or a body physiology wants for the techniques they are trying to deliver. Company should not focus on making the technique easier for a product development and good risk management.

Involving in risk analysis is a serious task, and often requires a large amount of personnel working simultaneously to properly analyze the associated risk. as such, workings in some companies if seen are those with computational modeling of risks and parameter values changing in stuff like survival analysis. Survival analysis is " Survival analysis is the analysis of data measured from a specific time of origin until an event of interest or a specified endpoint". And often times they use competing risk methods in their work. Lots of team members are needed and together they can make good work.

I have no experience with risk analysis, but i think there is no major difference between the medical device and pharma world. After doing a little research I found a website/pdf that broke down the quality risk management process which is very similar to the medical device. Those steps are:
1) Risk assessment
2) Risk control
3) Risk review
Within those steps there are sub points, the interesting thing is that they all link up to risk communication after each step are you communicating to update the risk.
https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/ireland/quality-risk-management---the-pharmaceutical-experience.pdf?sfvrsn=6

I think I may have to disagree with you a bit the brain storming process happens, but it is not as thought through are we may like on the outside looking in. Companies focus on making the technique easier because it’s a business risk doesn’t make them money, if they can produce a product fast what do they have to loose.

Usually the quality management system establishes the guidelines to periodically perform a risk assessment. This risk assessment is performed by people who are qualified to perform such activities; an engineer familiar with the device, a quality representative that performs CAPAs and NCRs on said device, and someone from the complaints department that is familiar with the device/complaints. Each person brings in a new perspective and information from what they've worked on through the year to brainstorm about new risks, existing risks, etc.

Periodically assessing risk ensures a good product and that the risk levels, as defined by the quality system, are maintained within control. If something breaks through the acceptable risk criterion, then there are internal actions taken that seek to mitigate the risk.

Although I don't have any direct experience with Risk Management, I would assume that people in risk management must be able to consider all possibilities and look very far ahead in terms of the outcomes of the product. That being said, I think if there were miscalculations and some risks were overlooked, I would like to believe there would be some sort of contingency plan in order to deal with those unseen risks. After all, the risk management team should be well-equipped for worst-case scenarios.

- Saad Ali

I never had the chance to sit down in a risk management meeting but as working as quality intern, I did have a chance to read an FMEA. They are very very long and there are numerous revisions. Each new revision is longer than the previous due the new risks the team has come up with. But if you have the chance to read an FMEA, you can see the very very small risks are written down and they are calculated for how severe they are. These meetings take very long time. I think coming up with risks for our project will be interesting to see what we can come up with.

The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry. Secondly, Medical devices have different efficacy dynamics to pharmaceuticals.The effectiveness of a medical device depends upon many more variables – the care setting, individual patient characteristics and the skills and experience of the clinician ‘applying’ the device. Finally, Research and development (R&D) models are different
Most medical devices cannot be evaluated using randomised clinical trials due to ethical and practical issues in the choice of comparator

I would like to point out that no matter how creative and methodical you are, there will be risks that you will not be aware of until something goes wrong. The Failure Mode and Effects Analysis tool is a live document in that its gets updated repeatedly to include new failure modes or corrective/preventive actions which mitigate new or old risks. Something like an FDA audit may uncover new risks which you did not think of before and so you need to figure out a way to prove it is under control. The project team would then have to brainstorm procedure changes or protocols which can be executed to determine the severity, occurrence, and or detection of such a failure. As Dr.Simon pointed out the team also needs to determine if it is a failure in the manufacturing process or the design of the product as those are two completely different documents, at least in my company.

I haven't had the opportunity to work with a risk management team, but I've noticed that brainstorming is the most used tool. Has anyone used the fish bone diagram? If so, how effective was it?

The risk assessment process for medical devices can go all the way back to design stages of medical device development. In this phase a lot of medical research is done in order to think of all possible consequences can be reversed and prevented. I have combed over more than 300 reports and science documents only to use 30 relevant ones in order to cover all possible angles of risk. It all depends on the severity of the device and how much time and resource analysis teams are willing to take.