The QSE UPDATE

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Design Control Process Questions

By Richard Bliss, QSE President

QSE was recently contacted by a new client asking for consulting support in harmonizing their Design Control system.  This particular firm, like many companies in the medical device industry, is growing not only organically but also by acquisition of new and innovative technology.  They are expanding their product line in diverse areas including new materials for permanent implants; biologic materials used in combination devices; robotics and software applications for improved surgical techniques, etc.  As they continue to make these acquisitions, they have recognized and are addressing the significant business challenges in maintaining an effective Design Control process throughout all areas of their growing business. 

Consider that many of the companies that have developed much of this new and innovative technology are small, start-up firms with limited resources.  As such, it is not uncommon for some of these smaller firms that are the target for acquisition to have less than fully developed and/or effective quality systems, including Design Control systems.  We see this situation more frequently than we would like to as we conduct due diligence audits on behalf of our client companies.  The following excerpt is unfortunately a typical finding in a due diligence audit report –

The design history file (“DHF”) for the company’s sole medical device, Product X, does not allow for the traceability from design inputs to design outputs and then to verification and validation results. The DHF does not appear to be compliant with the U.S. Quality System Regulation, § 820.30 Design Controls, in that device design and performance claims have not been appropriately verified or validated. Software validation practices do not provide full assurance of device performance.

The old adage of “buyer beware” is important to the larger firms when considering the acquisition of a smaller company.  For the price being paid, typically tens of millions of dollars, what is the acquiring firm getting for their investment?  Will they obtain a safe and effective device, fully designed, verified, and validated demonstrating that user needs and intended uses will be achieved?  Will this new device being added to their portfolio of products and bearing their company name on the labeling be one that the medical community and patients are eager and willing to use?  Will the device further enhance the reputation and brand name of the acquiring company? 

Or will this newly acquired device be one that is the subject of ongoing complaints and potential Medical Device Reports, reflecting both patient and user dissatisfaction?  Will the money spent on this acquisition be matched by even more money spent on product recalls and/or product liability claims?  Will additional cash be required in trying to identify and solve product problems that could have and should have been addressed in the initial design activities for the device?  And finally, will these design control failures do more, in the long run, to damage the reputation and good will of the acquiring firm and ultimately lead to declining market share as practitioners and patients take their business to your competitor? 

Unfortunately the grim picture I have painted has been a reality for many firms that did not approach product or company acquisitions wisely.  It is good to see therefore that this particular client has given much thought to expanding robust Design Control practices uniformly throughout their business as they grow it.  With this aspect in mind, let me share some of the questions that clients have asked us to work with them to resolve.  While these are not the only questions to be addressed, they are a great start for this firm.

1. How do we make a global Design Control process that is flexible for all sites to use but addresses the needs of the major stakeholders in the process?  What can we do to make one overall process that addresses the requirements for very different products, e.g. implants, biologics, software, etc?  Can the same basic Design Control forms be used across various company sites?
2. What are the expected requirements for Design Transfer?  How do companies typically achieve and document a successful Design Transfer? How is Design Transfer addressed when Design Control responsibilities resides at a different site or outside entity?
3. Can you provide suggestions for making the Design Control process lean?
4. Do you have suggestions on how Design Control can effectively interface with manufacturing and QA activities, e.g. manufacturing transfer, QA plan?
5. Do you have suggestions on integration of the overall Product Development process currently used in the company with Design Controls?  How are business processes to integrate with Design Controls?  Should Business documents reside in the DHF?
6. Should user needs be integrated into the Design Input document or does another user need form need to be created?
7. What are your suggestions for including inputs from product complaints or CAPA into Design Control?
8. Do you have suggestions for control of changes?
9. What constitutes an effective design validation?
10. What about automated Design Control and Risk Management software? Do you know of any good software options available on the market?
11. What are the expectations for the Design Plan?  How do companies typically address this requirement?
12. What is a good way to include Human Factors into the Design Control process?
13. Have there been any recent FDA or EU regulation changes that impact Design Control?  Are there any new regulations on the horizon of which we should be aware?
14. What are your views on separate Design Control processes for implants and instruments, i.e. different product classifications?
15. Should the procedures directly reference the regulations, pros/ cons?
16. Why does FDA place so much weight upon defining essential Design Outputs?
17. What constitutes acceptance criteria as related to Design Outputs vs. Design Inputs?

If you have questions regarding your Design Control process or want to fully evaluate the Design Control process for a targeted product or company acquisition, please do not hesitate to call us to discuss your needs.