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  • 1.  Organizational Structure

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2018 09:06
    This message was posted by a user wishing to remain anonymous

    Hi All

    I was wondering what kind of org structure has worked in your experience for device experts supporting combination products in the pharma industry.

    Would the typical device industry set up of having sustaining device engineers at sites work? Also having design assurance/pre market quality engineers and post-market quality engineers (supporting PMSRs, process validations, complaint/recalls, HHE etc.)?

    Currently seeing that to address combination product requirements (esp those with device constituents), some pharma companies are trying to make their pharma staff device experts and adding a few lines within pharma procedures to cover device requirements and this does not seem to work. This is leading to 483 observations and warning letter galore when CDRH investigators show up with CDER and CBER....

    Still there appears to be insistence that device regs are not so different from pharma regs and therefore they don't need to hire more people with device expertise. Any thoughts?

    Thank you




  • 2.  RE: Organizational Structure

    Posted 10-Sep-2018 11:40
    ​Hi Anon.

    Unfortunately, that bias (things aren't that different in area X and area Y) seems to be somewhat pervasive within all of FDA's regulated industry.  I have had it happen (and be said) to me more often than I can count from people who are all well-intentioned but who have not had enough exposure or experience in the two areas to truly understand what the differences are and how significant they might be.

    To me, any time that you have an area that requires specific expertise (so in your example engineers to deal with the device portion of the products and chemists to deal with the drug or biologic portion of the products) the best scenario is to bring personnel with the needed experience into the company.  Many companies are not willing to do that for whatever reason (costs, headcount bloating, etc.) but I think you are correct - when the regulator walks in they find the problems very quickly and then the problems multiply because you are almost "required" to make the changes you should have implemented in a much more rushed and tighter timeline than you really should. This leads to inefficiency and also to potentially some less-than-stellar fixes or hires that ultimately cause additional work later.

    Just my thoughts.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Organizational Structure

    Posted 11-Sep-2018 07:58
    ​Hi,

    While I agree that the way that Pharma addresses Device requirements when they have a Combination Product is less than optimal, grafting medical device experts is not necessarily the solution.

    First, although these companies are "developing" a combination product, given the broad scope of these product, most are not designing, nor manufacturing the device constituent part.  The pharma role in many of these cases is more of program management than device designer.  Many of the systems used, expertise applied and activities executed are by the device subcontractor (or device manufacturer for co-packaged or co-labeled products) with input and oversight by the pharma company. 

    With regards to quality and quality engineering, I fully agree.  These are concepts that are alien to many pharma companies, who are mostly staffed with clinical or commercial pharma quality experts.  This is also just the right expertise to help with integration of device systems (such as risk management and Human Factors engineering as well as others required by 21 CFR Part 4), to provide oversight of a device subcontractor during development and to provide support on an ongoing basis. 

    However, just because someone has device expertise, does not make then qualified in a combination product environment.  There are issues and elements that are unique when the drug and device are combined that must be learned by the device experts.  This also means, that some pharm experts can also be taught the tenets of device quality engineering.  One thing is certain, everyone must expand their outlook and go beyond their experience and training when both a drug and device are involved.

    Finally, I spend all of my time in the combination product environment and follow and review all Warning letters and other that one to Amgen years ago (which was more about not following procedures than anything else), I have not seen the "warning letters galore" that you cite.

    I would appreciate if you could provide a list of link to those as they would provide a great resource for learning for all in tis area.


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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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    Original Message


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