As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your device or product to go off market through an MDR.
Suppose you start a medical device company with a partner, how would you manage to understand the validation processes of the products or devices your company plans to launch on the market? How will you manage your employees and make sure they understand what the company you started wants as far as validation processes goes? Please share your experiences.
As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the validation depends on what type of medical device your company is producing, and it would depend on the the specification that was not verified, so it is now being validated. As Dr. Simon also mentioned in his lecture, performing 100% verification can be costly or can damaged the produced instrument. In most cases, the general validations include testing for sterilization, clean room ambient conditions, humidity/environmental testing, sterile package sealing, etc.
Its very important on the validation process to make sure that the output equal to the user needs!. Before your company start marketing for a medical device, a successful validation should be submitted to the FDA according to FDA 21 CFR part 820. For a successful validation you need to answer some question like:
- Does the device work for the user?
- Does it meet the specified user needs?
- Does the device work in the user’s environment?
- Is the device’s usability easy, clear, obvious, and evident?
- Is the device safe and effective for both the user and the patient?
- Is the device meet user satisfaction and acceptability ?
So, I think every employee should know the answer for those questions to reach a successful validation.
The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process is tailored to each device. The customer and user need to be complied with. The safety and outcome of the device need to be known and most importantly clarity of the thought and instructions. Learning and preparing the validation processes initially is the most difficult but protocol can be followed by a trained or new engineering with some mentoring. As a new employee, the best way to learn was to get some initial guidance from trained professionals and then to follow documentation yourself and learn through doing. Even though this was true for more manufacturing/testing part of the job, it can be carried to all aspects.
When starting a medical device company, it is very important that the validation processes for the devices are followed. As others have mentioned, it is key that the validation processes guarantee that the needs of the customer are met. There are specific regulations to follow according to the FDA for validation processes to ensure the best quality product is released. The validation process that is followed for the device should fulfill certain requirements specifically proposed for them. In addition, when validating the product, it is important to take the safety of the device into consideration. When improper validation processes are followed, there can be penalties when auditing is done. As a result, this could cause a setback for the product and the company, itself. The validation process accounts for any issues that may arise and makes sure the device follows protocols.
As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn the standards of the company through SOP documentation. There are general guidelines on how to go about the validation and verification process which can be found online. But an employee will need to implement those guidelines in the companies Quality System documentation for it to be used within the company. Safety should be placed as a high priority when validating a device because if an auditor comes and finds errors in the company’s validation of a device it can escalate into a major issue for the company itself. Any equipment requiring a validation also requires a specification document, an IQ/OQ/PQ based on the device and protocol as the bare minimum.
I think it's always good to validate. I agree with @bb254 about engineers being trained per the SOP's of the company and validating equipment. I think every employee, not just engineers should be made aware and trained in the validation process. To answer @tn58 original question about how to understand the validation process, I found flowcharts and checklists very helpful. Specifically, I found this flowchart from (samaras-assoc DOT com/quality DOT htm). It put all the necessary validation checkpoints in a timeline so you could have a better perspective of planning your validation process.
I think if everyone in the company is made aware of the seriousness of the validation process, they will be more wary, in general. Sometimes, there are unexpected issues that may not require a validation process but would benefit a lot from having one, then it's a good thing to do.
