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Medical Device Development: From Specification through Validation

Controlling Product Data Electronically

The medical device validation process

Medical Device Development

Medical device manufacturers are heavily regulated organizations and rightly so. Manufacturing a potentially life-saving device should not be taken lightly. It can take years to get a product to market given the required research, development and rigorous testing that takes place. This article addresses how medical device manufacturers can leverage electronic systems to document and control the product information generated during the entire development process, culminating in successful verification and validation.

Medical device products are categorized by a class type (class 1, class 2 or class 3). The classification is based on the level of risk that a device failure could pose to an end user and therefore how much regulatory scrutiny should be applied to the device development. The class also determines the level of design control, testing and documentation required by the FDA to obtain clearance to market the product.

Validation example for class 1 product

Introducing a new medical device to market means the manufacturer has tested the product against all product requirements. The final device must be verified to meet engineering specifications and validated to meet product specifications.

Take for example a class 1 product, a waterproof band-aid. The product requirement document might state the following, “The bandaid must be waterproof during long distance ocean swims.” The related engineering or design spec might state “The band-aid should stay affixed to skin for at least 6 hours when submerged in 65 degree water temperature for a continuous time.” The company would conduct tests to confirm that the band-aid met these requirements, and document these tests with data and test reports. The design history file would include the initial specification, design specs related to the product spec, test protocols, results and reports. If in testing, the band-aid did not meet the product requirement, the company would head back to the drawing board for more design iterations. The engineering testing, verification and validation processes would be repeated as necessary. But as the ramifications of band-aid failure are minor, the regulatory body may not actually need to see all the validation documentation in order to approve the product for sale. In this case, where the product is a low risk class, the company may instead be able to submit documentation which explains the product, and perhaps compare it to a similar approved product.

Validation example of a class 3 product

In the case of a class 3 device, an aortic cutter, the product requirement might state “The aortic cutter must pass through the aortic wall, and stop before impacting other uninvolved tissue.” The consequences of failure to meet this type of requirement would certainly be more severe than the consequences of poor band-aid adhesion. In this example, the company would still have a product specification, a design or engineering specification and related test documentation proving that these specifications are met, but the level of detail of this documentation would be significantly greater than that of the band-aid. Furthermore, statistically significant bench top, in tissue, animal tests and human clinical trials would be conducted. The preponderance of evidence required to both define the requirements carefully, and prove that the requirements are met would be appropriate to the level of risk associated with device failure.

Controlling data during the medical device validation process

A medical device will be tested against each and every product requirement. Each product requirement may have one or more associated engineering requirement. Thoroughly testing each and every engineering and product requirement and carefully tracking all this data together is a must. Not to mention filing this information appropriately. And depending on the type of paperwork, it may need to be related back to other documents, reviewed by other members within the company, or signed off on to allow development to move forward. Documentation throughout the medical device product development is crucial. When it comes time to meet with an FDA auditor, a medical device company must be able to demonstrate all reasonable tests were performed to reduce risk.

Electronic systems help manage medical device validation paperwork

As the verification and validation test paperwork piles up, a medical device organization must consider how this information will be stored and managed. Will collecting and storing paperwork in colored folders and file cabinets be an efficient process? Will those who need product documentation have access if files are stored on a network drive? And when the meeting with an FDA auditor is scheduled, how time consuming will it be to gather and cogently present all the product information?

To manage all the paperwork generated during the medical device development process, particularly during final verification and validation stages, medical device companies can leverage an electronic solution. Using electronic change management software means revision control functionality, better control over protocols, procedures and test documentation, and easy association between related objects. Documenting requirements, protocols, test case results and sign off events during the verification and validation phases electronically will make for smoother processes and ultimately a smoother audit experience.

Is an electronic system right for your medical device company?

An electronic system enables medical device companies to streamline and document device development, verification and validation processes in an organized manner. In selecting an electronic system, medical device companies should consider if the system or software can be validated. Medical device manufacturers have enough to do validating their device designs — they don’t need the burden of additional validation overhead for software tools.

Arena QMS provides connected quality and product processes to meet FDA regulations. Arena Validate further helps medical device companies achieve process efficiencies without the I.T. overhead of on-premises software solutions.