@Hospice_Houngbo. From safety perspective, there is no difference between the EU and US regulatory requirements. Though FDA believed that though approval time may be longer, thorough work has to be done to establish safety and effectiveness of these devices. Check out this related article for further information:http: www.medcitynews.com/2011/01/does-europe-offer-faster-better-approach-than-fda-on-medical-devices/
From my experience the quality requirements are needed, but to do the FDA approval process one has hire specialist(s) to handle all the submition papers and their content.
The language used is more like used for patents and all requirements are not clear. It would be nice to make that easier.
As I understand it, In Europe, a medical device needs to demonstrate it's ability to be safe while in the United States it must also be shown to be effective in treating a disease or condition. There is also a different reporting structure in effect. Third party agencies handle the approval in Europe whereas the FDA commands the approvals in the USA.
Do you think the FDA is too strict on medical equipment companies
@Kunmi, I dont mind FDA being too strict if it doesnt compromise on quality aspects. Just curious to know why companies get faster approval in the EU region than in the United States ?
The issue is that most medTech companies does not have much time to linger for approval on just one product line and if the approval time is delayed, many processes will be halted. These companies always put a lot of money and time into the process of approval and I believe they always want to get into the market as soon as possible. Whichever way it goes, it is obvious that healthcare delivery needs the contribution of electronic companies in order to meet with the current challenges.
Great subject! Medical device manufacturers have long-griped about the process for two basic reasons: the length of time and the clarity issue you mention. Yet, if the component world can succeed in the mil/aero market, there's no reason to believe it can't in the medical arena as well despite the landscape of protocols, documents and other traffic.
EBN Dialogue enables and encourages you to participate in live chats with notable leaders and luminaries. Not only editors and journalists, but the entire EBN community is able to comment and ask questions. Listed below are upcoming and archived chats.
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Thailand Stages a Comeback Join EBN contributor Jennifer Baljko on Thursday August 23, 2012, at 11:00 a.m. EST for a live chat on how electronic manufacturers in Thailand have shored up their supply chain to reduce the impact of future natural disasters.
Euro-Crisis: What It Means for High-Tech Firms Join EBN Editor in Chief Bolaji Ojo and Contributing Editor Jennifer Baljko on Thursday, July 12, at 10:00 a.m. EDT for a Live Chat on high-tech and Europe's economic difficulties.
Microsoft Surface: Potential Winners & Losers What are the implications for the electronics industry supply chain of Microsoft Corp.'s decision to launch its own tablet PC? Join industry veteran and EE Times' systems and OEM expert Rick Merritt on Tuesday, July 3, at 12:00 pm EDT for a Live Chat on this subject.
Join EBN contributor Jennifer Baljko on Thursday August 23, 2012, at 11:00 a.m. EST for a live chat on how electronic manufacturers in Thailand have shored up their supply chain to reduce the impact of future natural disasters.
Peter Drucker famously said "Trying to predict the future is like trying to drive down a country road at night with no lights while looking out the back window." Yet in the razor's-edge world of electronics—with a lean supply chain and just-in-time demands—the need to know the future is vital.
While no one really can accurately predict the future, we can take guidance from another Drucker saying which is the best way to predict the future is to create it.
You've heard the saying "the No. 1 supply chain risk is your people." That hasn't always been the case. But today's complex global supply chain requires a new type of multitalented employee. It's one who understands, finance, marketing, economics, is savvy with technology, graceful with relationships and can think analytically.
Where are these people? Are universities properly preparing the next generation supply chain professionals? How do train your existing workforce for these new, demanding positions?
Brian Fuller, editor-in-chief of EBN, will lead a 60-minute Avnet Velocity panel discussion that will ask and answer these and other questions swirling around today's supply-chain talent challenges.
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