Where device investments once hedged biotech portfolios, because of the relatively short product development cycles relative to drugs, now regulatory and reimbursement risk mean that it can take eight to 10 years for devices to get to the market. Indeed, the FDA process is a major risk factor for medical device investors, not only in terms of uncertainties surrounding 510(k) reform (the regulatory pathway to approval for 90% of devices), but also because of increasing demands around clinical trials that are difficult for small companies to meet.
Regulatory risk is often mentioned as one of the biggest challenges facing companies and their investors today. Many companies in the middle of development have been asked by the FDA to conduct new or longer trials for which they can't gain funding support, stopping them dead in their tracks. This was the case for drug-eluting stent company Xtent Inc
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?