I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.
In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.
The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?
In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.
Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.
This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.
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.
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.
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