I work for a pharma company that wants to expand its product portfolio with combination products. Iāve never worked in the device industry. What is the best way to get started in terms of overcoming the knowledge gaps between disciplines?
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pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Drug-device combination product 10123 August 2016 at 12:43pm Last edited: 23 August 2016 at 12:46pmBlazing new trails between pharma and medical device is intimidating, particularly when it comes to reconciling the different drug and device product registration requirements. Most pharma people I meet comment on how complicated it seems to get approval on a device. (My reaction is the oppositeāI canāt image the complexity of working towards a drug approval!) There is information out there if you know where to look. The FDAās Office of Combination Products is a great place to start.
If youāre trying to obtain approval on a drug-device combination product, the consensus from the FDA is that the product should satisfy the higher regulatory requirement, which is pharma. So, you would want to develop an appropriate cGMP quality compliance strategy that is pharma-based, i.e., 21 CFR 210/211 compliant, with device requirements (21 CFR 820.30) built in.
For the device portion, donāt reinvent the wheel. Start researching like devices, competitors and existing 510(k) applications/approvals on the FDAās 510(k) Database. Social media is another great information source. Medical device interest groups on LinkedIn and other social channels host lively discussions about device-related issues, including combination products. You donāt have to share trade secrets or design specs, but thereās no harm in obtaining clarification on data thatās already out there.
Alex Butler, MasterControlās Medical Device Segment Manager