Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. There are many different functions to look at when it comes to creating your EURA’s such as Process, Design, and Application. Like you mentioned before brainstorming is key, so while there is the fear of miscalculating or misinterpreting a risk, there are other members on your team to assist you in making these calculations. Additionally, quality will also review your risk analysis to ensure you haven’t miscalculated any associated risks. Again, teamwork is key when creating any medical device and that is shown here as well.

-Tarek

Thank you very much for the interesting question. I would agree with Tarek that determining the risk associated with a project is a team effort. Each member of the team may be able to evaluate different risks with the device. A team is needed to not only identify each risk, but also be able to evaluate the risks as well.

-Andrew Nashed

The risk assessment can differ from various ways, they typically may have someone who is acquainted with the field but look an analyze the device from top to bottom, every inch to check from a technical side any associated risks, even risks like, how will this device react with the body, will it make a reaction or cause one. Also the use of mathematical and computational modeling is growing as a form of risk assessment.

In pharma risk analysis deals with biologics so all suggestions and concerns from the team are used to create the animal study. For example we recently were working on a drug and we feared it would have a certain side affect so during the animal study we paid closed attention to check for the side effect and it did appear so formulation had to go back and try again. I think it is important to make sure everyone is involved in risk analysis and that it is done early on in the products life.

Would you be able to share with us some of the differences you see between Medical Device and Pharma risk management structure and technique?

I haven’t had formal experience with risk analysis, but from what I understand of the risk methodology is that it incorporate all cross functional teams within the products development. Whether if it’s marketing or R&D Engineering, the concept of Risk insures that uncertainty will not impact business goals. All potential risks should be addressed and reduced. I know from my experience within manufacturing, all aspects are taken into consideration when introducing a new process or introducing new equipment,but sometimes there is the occurrence of uncertainty that was not taken into account, as a result I’ve had experiences when we changed process, which is used for multiple products, but it drastically effected one of the products in a negative way, as a result manufacturing was halted to resolve the issue regarding that one product.

Chris

I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated, scored, and placed in a hierarchy of “danger of risk” using a cutoff value to identify and assign risk mitigation candidates. Once this evaluation is complete, the team should then focus on risk control and risk reduction and implementation of risk control measure(s), sometimes taking into account risk/benefit analysis and risks arising from risk control measures. The team completes its effort by publishing a risk management report to be used as production and post-production information throughout the product lifecycle. This goes hand-in-hand with the widely accepted PDCA (plan-do-check-act) practices.

-Nicole

http://www.meddeviceonline.com/doc/the-what-why-when-and-how-of-risk-management-for-medical-device-manufacturers-0001

I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the company from spending too much time and money on a device or project to then deem it too dangerous or risky. As some of you have mentioned, these meetings and analysis are done by a team and not just one person, however, they do pull in feedback from different areas like clinical, marketing, development, etc. I have never had the opportunity to follow this process from start to end, but it's always interesting to see how companies handle certain risk.

I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many cases) are chemically based and therefore rely on your bodies' functions to break it down and utilize it effectively. There, the efficacy and risk of a drug is based solely on how it interacts with your body and how your body interacts with the drug. The drug does need to be administered appropriately, so that adds a level of risk but ultimately it is a relationship between your body and the drug. Medical devices on the other hand, are typically reliant on someone else, whether it be a surgeon or a doctor, to implant or place the device properly in order for it to function. There is a much higher risk of human error in medical devices for effectiveness of the product than with pharmaceuticals. Essentially, if a drug has proven it will work, then it will typically work for a large portion of the users. But, just because a medical device is proven to work, doesn't mean it will work if the surgeon doesn't implant the device properly.

-Kaitlin Connell

A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the risks associated with the project. Risk in pharma is certainly different than risk in a medical device company. Risk in pharma could be activating different cascades or signals that are not the intended target. Risk in a medical device could lead to failure. For risk to be identified, once would have to understand the project and know what the intended use and scope is. Having that understanding would help to go a long way in these meetings.

In the current company I work at, we identify risks through a PHMM or Product Hazard and Mitigation Matrix. In these meetings you have directors from R&D, Quality, Manufacturing, and the Medical director discuss the potential applicable product risk management plan. To maintain and organize the risks each description of the harm or hazard/hazardous situation is associated with a Hazard ID, along with the severity of the harm and if it is covered by a Standard. Then the matrix also contains the potential cause of the event that initiates the risk and the foreseeable sequence of events that may occur due to the risk. Next, includes the plan for mitigation on how to prevent the risk from occurring or creating a risk mitigation plan if the event is not preventable before but how to plan post-risk. Then also document if some risks are acceptable or unacceptable.

In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation there are several methods one can use to get to the root cause of the problem. This can include several different methods like the five whys, fishbone diagram analysis, ect. Once the root cause(s) is identified they must be addressed. In my company it is policy to use quality system documents to address these. We mainly look at the product Risk Management Summary, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis. These documents will usually identify all the possible related risks/failures and how they are mitigated. They use a rating system to identify the level of risk. This helps in closing the investigation and will point us in the direction of what type of corrective or preventative actions need to be taken.

Based on ISO 14971 outlining the risk management process for medical device manufacturers, risk analysis is the systematic use of available information to identify hazards and to estimate the risk. In order to do so, company may need to define the scope of their medical devices, to specify the intended use of the product and to identify hazards and hazardous situations. Once hazards and hazardous situations are captured, company may need to estimate risks.

Ideas are expands and gets build upon perhaps become unique enough to become a product development. Balancing an innovation is the risk aspect; risk management is about defining the risk, analyzing the risk and then mitigating the risk. A product can be demonstrated after the risk around innovations is defined, since it points out what we will be dealing with in the development process. Companies are technically used to doing risk analysis but in wide open space that they don’t quantify needed specifications. Company should build a much detailed risk profile to state and research what they are getting involved in and that will help in defining the actual product. The risk mitigating has to verve with best practice in product development. The risk assessment depends on the product and its development process.