A Regulatory Strategic Plan (RSP) used to bring a medical product to market requires solid regulatory knowledge married with scientific/engineering/clinical expertise using critical thinking skills. An RSP does not focus solely on the path to obtain regulatory approval or clearance but also links the approval/clearance to how the product is manufactured, promoted and how future product revisions or line extensions are introduced to the market. If done properly and maintained over the course of a medical product’s lifecycle a company will have a more predictable product development timeline that can be adjusted as new information becomes available and a product regulatory risk profile that can be actively managed during post market release. If implemented effectively, the RSP will result in improved operational process efficiency, reduced operational costs, and a reduction in time to market. If the results of product development or the experience after commercialization is not as predicted, the RSP will better position you to make adjustments and, unfortunately, make the difficult decision to cancel a development project or recall/remove a product from the market.
RSPs focus on the ENTIRE product lifecycle not just “getting FDA approval”. An RSP is not developed or maintained in isolation. It is
What are the consequences of an inadequate RSP or one that is poorly implemented? First of all, RQMIS is not one of those consulting firms or webinar companies that send out “alarming” emails that suggest a new area of interest from FDA that will sink your company if you don’t comply. We believe in providing ongoing advise/support that integrates an RSP within your business operations. This RSP will balance your operational culture with the regulatory/quality/clinical requirements required to gain and maintain product commercialization. You should never simply restate regulatory requirements within your company’s operations procedures. In the same vain, you should not simply take a set of boilerplate SOPs/WIs from a consultant and insert your company name (yes, I have seen this happen). Nor should you expect that testing required for a premarket submission 5 years ago will be the same for your product today. All of these approaches will likely get you into more trouble than you think.
The net effect of not preparing/implementing an RSP can result in frustrating delays, cost overruns and not meeting customer expectations. It can also result in more serious outcomes such as product disapprovals, warning letters, injunctions, seizures and legal actions. History is replete with failures directly linked to poor regulatory strategic planning. This history is typically linked to poor planning, lack of regulatory/quality/clinical knowledge/information, lack of information management/integration, and yes, at times, a company’s culture that encourages exceedingly liberal interpretations of regulatory requirements that affect one of the seven components of an RSP. Although RQMIS believes from experience that the last reason is not the typical reason medical product failures occur, we have seen it occur first hand and results can be disastrous.
RQMIS consultants have been directly involved with resolving import bans, warning letters, resurrecting premarket submission that were on the road to no where, PMA Not Approvable Letters, Clinical Study suspensions/restarts, Congressional Hearings, FDA Investigations, Product Recalls, Health Hazard Assessments , etc. all of which were a result of a lack of an RSP or one that was poorly designed or ignored. Our deep understanding in developing and implementing RSPs is founded on how we have seen companies fail to do them and how they have worked effectively.
Case Study on RSP Failure to:
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