In late June, CDRH hosted the second in their series of town hall meetings to review their 2010 Strategic Imperatives. These priorities include -
- Priority 1. Fully Implement a Total Product Life Cycle Approach
- Priority 2. Enhance Communication and Transparency
- Priority 3. Strengthen Our Workforce and Workplace
- Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
As I reflect on the session, a few major points come to mind.
First, a lot of concern was expressed by industry professionals on the perceived increased timeliness for approvals for new products. As we all know, innovation is the lifeblood of device companies and many speakers underscored this point. Thesy provided specific examples of where they felt the American public did not have access to the best possible healthcare due to the increasingly long approval cycle for many devices. Some raised concerns that this could stifle competition, as start-up companies find it more difficult to take a new product through commercialization. It’s important to note that these observations are based on the current law, though upcoming changes to the 510(k) process will undoubtedly bring change in the coming months.
Secondly, companies expressed a lot of frustration about the increased uncertainty in the industry. Companies just don’t know how long it will take to get things approved, or how much the changing healthcare economics will impact their business model and they are looking for more transparency from the FDA to at least know if companies are heading in the right direction.
Lastly, it occurred to me that the fundamental struggle stems from the FDA’s charge to serve the public good by balancing safe and effective products vs. innovation in industry. In my opinion, however, the political climate is such that product issues are judged as failures in FDA oversight. It seems to me that is putting FDA in a very difficult spot, as there is no way to eliminate all risks, and companies are attempting to bring new products to market that are better than what is currently available, the risks are being held to a higher standard. Think about that – there are new products that are better than existing ones (safer, more effective, etc.) but are not yet on the market - and in fact it's unknown if/when they will be approved due to higher public scrutiny of every decision the FDA makes. That very statement was a central point of the feedback that industry was providing during the session.
So where does that leave industry? Are we "victims" of these circumstances and now need to batten down the hatches to reduce costs across the board? Stop investments in R&D due to changing reimbursement policies? I would counter that the industry should instead follow the advice that many of us were given as children – focus on the things you can control and understand those that you can’t. Now, more than ever, companies need to invest in the things they can control – the people, processes and technology needed to improve their internal operations to create a competitive advantage and weather the uncertainty. The successful companies will be even better positioned for growth and increased market share as we all navigate these uncertain times.