Originally Published MD&DI September 2009
PRODUCT DEVELOPMENT INSIGHT
Leveraging Documents in Medical Device Development
How to apply organizational knowledge to new product development.
Alpaslan Yaman, Biotech, Pharma & Device Consulting LLC
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Alpaslan Yaman
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In the development process of any new medical device, time to market is a key variable. Navigating through the design control process, it is likely that some aspects of a new product can leverage research that has been done in the past. Unless the platform is completely new, most products are designed within the areas of a company’s core competency. Leveraging knowledge of the organization and its previous work minimizes redocumenting known technology.
However, the company needs to fully understand what aspect of the leveraged document applies, and also how it applies to the specific project under development. The term leveraging documents means that concepts or studies that were executed for a previous like product, whether in design, development, or verification and validation phases, can be applied to the next project of similar or like design.
Another interpretation of leveraging may be using knowledge from previous studies or experiments in a sort of “lessons learned” approach. However, that more-general approach, even though it may be an expected and a welcome part of any development or business growth, may not be applied to a specific document.
Reinterpreting Documents
Merely referencing (leveraging) like-titled documents, based on subject or sameness of the device, creates a state of being outside of the design control system.
A document may be leveraged in one case for which it was a viable application, but that document now takes on a different interpretation of the original document’s foundation. As the next project is completed, the documents that were leveraged need to be at a minimum, updated in the design history file, with descriptions of how they were leveraged and whether any of their final conclusions may have been affected. If such a process is not done accurately and consistently, then subsequent projects that use the leveraged documents will be yet another level removed from the original documents.
For example, assume that a company has a product line that has been on the market for several years. The products have always had a basic structure, both in design and materials of fabrication. This product line has always been terminally sterilized using ionization attack. All of the sterilization validation, including product integrity, has been completed some years ago. Every subsequent project leverages the original sterilization cycle development and validation data without reassessing the assumptions and conclusions from the original work. Now a project from this existing platform is being progressed into another new product, but one of the key materials of fabrication is slightly different than those from the past. An assessment is done to show that the standard (midpoint) sterilization cycle is acceptable for this new product. Thus the company decides to leverage the existing sterilization cycle development and validation without more-detailed assessment.
A further review of the original sterilization cycle work would show that the operational range goes beyond the standard cycle midpoint that was used in the assessment of this new project. So, would the leveraged data from the original qualification, including the product shelf-life study, apply for this new product’s operational range? Without a comprehensive study to show whether the product is viable for that same range, one could not say for sure, and thus the project may acquire a serious deficiency.
Even more problematic, within this file would now be a leveraged document and a tie to an unconfirmed conclusion. And the next project, which is a slight modification of this new product form, would be leveraged against this interpretation and may further weaken the position of the original study.
Another situation to avoid is using a conclusion from a report or study without understanding how the data were analyzed. It is imperative to understand how the study data were acquired, whether the method used may have been changed since that time, or whether the method is still in use. Data acquired by an alternative method may not be equivalent to the original method; an equivalency analysis can determine how the data can be comparable.
During the planning phase for a project, at its onset, and at the initiation of each design phase, it is essential to review all documents being considered for leverage to confirm their suitability. Reviewing what can be leveraged is typically part of the design control process. That does not mean just a cursory review of the title and perhaps the summary and conclusion of the documents. It means a thorough read of the objectives, the assumptions, and the acceptable criteria of the documentation. It also includes a technical assessment by subject matter experts. They can determine the viability of technical leverage to a particular project.
Documents that are being leveraged as a whole should include a cover memo that summarizes exactly what aspect of the document applies and how it applies. If such a memo is not attached, then there’s a possibility that during a review of the project, the reviewer may conclude that all aspects of the leveraged document apply. If the leveraged data and documentation do not explicitly apply, the gaps that exist create a condition of potential nonconformity and noncompliance.
Having a validation master plan for a project helps the process go smoothly. If the leveraged document is for a product that shares a similar process but is not exactly the same as the previous one, then the summary review document should discuss the differences between the leveraged validation master plan as well as how the leveraged document does apply. If there are significant differences between the two products and processes, then review of the leveraged documents may prove to the development team that it may be more time-efficient and cost-effective not to leverage. It may be better to prepare a new document for that project.
Medical Device Leverage
Leveraging documents can be prudent in the area of medical device manufacturing. Multiple products may share the same process, and in performing the installation qualification, operational qualification, and performance qualification for that equipment, the worst-case approach is employed. If a new product fits within that assumption of worst case (i.e., the product does not present a new worst case) and the work that was previously performed can appropriately be leveraged. A simple, short memo to the file should state that the new product uses the same process and falls within the original worst-case scenario qualification.
If, however, the new product does not fit the original qualification in some way, then the areas of disparity need to be addressed through original documents. It could be in the form of a study protocol and report addressing those critical areas. Consider requirements in every phase of development for the new innovative product.
Another example of leveraging documents may be in the case of failure mode and effects analysis (FMEA). If an official FMEA plan exists for a specific product platform the project development team may decide that the work done in the past is sufficient to be leveraged. But a truly new product is not likely to be identical to a previous one. The new product should be assessed against the same caveats or assumptions used in the first FMEA exercise before deciding that the original conclusions apply as well to the new product.
Conclusion
One cannot assume that leveraged documentation and technical knowledge is adequate to pass a new product through the design control process. An independent review may conclude that leveraging such documents was erroneous. Even if this rejection does not halt design development, it may cost the company time and money. A project may have to go back into a preceding development phase to redo or initiate work that had not been anticipated. That could cause a delay to the eventual filing and commercialization date.
If a company chooses to go forward with a project that may have a qualification gap, assuming that the situation will be fixed after filing or commercialization, it will have to consider more than a possible delay. Such behavior could cause a loss of good faith on the part of the regulatory establishment.
Regardless of the path taken, the key to any project development approach is to know what risks are prudent for a project and which are not. This is ultimately dependent on the technical experience and knowledge of the company. Having the knowledge to determine what documents or parts of documents may be leveraged for a particular project at a particular time is a key to improving cost-effective and time-efficient product development.
Alpaslan Yaman, PhD, is a principal consultant for Biotech, Pharma & Device Consulting LLC (Parsippany, NJ). He is a certified black belt and has a PhD in pharmaceutics with a minor in physical chemistry from the University of Missouri. Contact him at ayaman@biopharmadvice.com.
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