its always a difficult process to execute but at the end this is actually to ensure safety. It is not a right way to point fingers at fda instead the organizations should work towards faster developments. As long it is similar regulations for all the companies it is still acceptable.
If I may add, it also increases the cost of healthcare delivery, which we all end up with. I still believe we can have safe medical equipments and supplies approved without so much red tape.
It may appear as a game plan but in reality it is not. It is just "Quality " based. Knowing fully well that the end users are patients in the sick bed. It is better to tighten up that loosen out, Safety and Effectiveness crown it all.
Part of the slow down in FDA approval will occur when a medical device must have what is called IFU documentation (Instructions for Use). This is where things get slow and laborious, particularly when you need to include specific instructions for the use and care of the device under scrutiny. If any part of that language is not clear, any part, your application gets stalled. You may be amazed at how specific the language needs to be. It keeps corporate legal and regulatory people busy for weeks at a time.
“It's getting even tougher to play in the area due to tightening conditions from the FDA and the realities imposed by the litigious environment in which companies serving the healthcare industry must navigate in the United States”
Kunmi, what are the challenges companies are going to face due to this tightening condition?
@Kunmi, thanks a lot for detailed explaination.That was really helpful. Do you think FDA will reassess its procedural norms so that it can catch up with its european counterparts ?
@Parser, it is both the lack of clarity and the lengthy paper trail that bogs down the process thereby delaying the approval process. Even with the specialists, the red tape makes the approval process cumbersome and frustrating.
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.
Archived Dialogues
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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