Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?
Traditionally, surgical wounds have been closed with sutures, staples, Steri-strips, Mastisol, or some combination thereof. There are multiple benefits to using these technologies, but new products are expected to significantly improve the way surgeons close wounds. Ethicon’s Dermabond Prineo mesh and cyanoacrylate-based skin closure systems, as well as Zipline Medical’s Zip Surgical Skin Closure, are new products that recently have become popular for surgical wound closure. This rise in popularity is cannibalizing older forms of wound closure, such as sutures, staplers, and skin closure strips.
Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.
By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.
Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.
On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.
Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.
Just two percent of the revenues generated by the top 200 medical device companies arise from emerging markets. To achieve greater success, medtech must look beyond the legacy approaches that led to success serving the billion richest patients in the world.
Despite a labyrinth of risks to overcome, the Mexican medical device market is primed for growth, and presents tremendous opportunity to medtechs that can navigate its pitfalls.
A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.
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