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In the race to get new medical devices to market, companies encounter FDA speed bumps that slow down the process. But would we really be willing to accept the risks that would accompany fast FDA approvals?
In medical device development, challenging weaknesses early in the process can help an entrepreneur zero in on problem areas. Read more about this twist on the idea of fast failure.
Medical devices could get to market faster if regulators didn't have to test for both safety and efficacy of new devices. Read more about how the use of post-market studies could bring new therapies to patients more quickly.
Creators of new innovative medical devices need to know how to protect their ideas. Read more for tips on the best ways to do this.
The Institute of Medicine (IOM) released a report recommending the 510(k) process be scrapped. Read more about the medical device industry’s reaction.
Earlier this month, Johnson & Johnson pulled out of the heart stent market amid struggling sales of its products. Read more on how this move reveals the need for continuous innovation in the healthcare business landscape.
A disposable insulin pump maker has completed the biggest equity financing transaction this year, proving that fundraising dollars are not as scarce as some might think. But the company, Valeritas, has a lot of things on its side. Read more about the company's advantages.
Pharmaceutical companies are benefitting from partnerships with academic medical institutions, but can biotech companies do the same? Read more on clinician impact on medical device innovation.
Many would agree that surgeons are qualified to create innovative medical devices that may be superior to what is currently available. But the controversy arises when surgeons begin to profit by purchasing their own products for use in their patients.
The FDA has been sluggish in the approval of innovative medical devices. Read more on how delayed approval could endanger venture funding for medical device startups.
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