Hello and welcome! This is the kickoff blog to RQS’s new daily blogging social media initiative. The purpose of this blog is to provide current, thought-provoking content about quality and regulatory affairs, life sciences and healthcare that impacts the Pittsburgh and Cleveland communities, United States as a whole and finally the entire world! This initiative aligns with RQS’s business model to becoming a national and international regulatory and quality service company in the future. Content in this blog will be posted daily by me (Jillian Walker) as well as Rebecca Spelich, Kristen Berger, Sherri Hall and Ryan Kasun who are all part of the Regulatory and Quality Solutions team.

So let’s talk about innovation. How has innovation in the medical device industry been prohibited or encouraged by different regulatory entities? What are current trends seen today by the major players in the device space? In the age of technology are companies afraid to be innovative because of the risks and uncertainties involved with getting approval?

Although there are certain programs and groups out there that aid companies in developing unique and innovative technologies, such as the NIH, I believe the general trend has been an overall decline in true innovation. Larger players in the industry are looking towards more acquisitions and partnerships than actual research and development. This changes how smaller development companies view their business and it also changes the development strategy. Large companies are eliminating their own developmental risk by acquiring proven technology. Smaller development companies are taking on the risks and costs associated with developing new innovations. This can be good and bad because on the one hand, once a technology has been developed enough to be acquired by a major player, it has the marketing and sales power to back it up. On the other hand, more of the smaller companies are failing because they don’t have enough funding to develop their technologies to the point of becoming appealing to those big players.

One report that I have read which focuses on the discussion of innovation was provided by the FDA in March of 2004 (see link below). However dated this article is I believe it’s worth a read!

http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm113411.pdf

Finally I would like to encourage readers to comment on the content that is posted here. This blog is meant for friendly open discussion and debate so let’s see some comments!

Jillian F. Walker --

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