The FDA is implementing new programs that encourage innovation and speed up device approvals within the US. An entire day at the Transcatheter Cardiovascular Therapeutics (TCT) conference was dedicated to this and related topics, as thought-leaders within the field discussed and debated the impacts of these reforms.

Why is there a need for reform?

Currently, there is a fear that innovation in the US will dry up. Companies have had to move initial clinical testing of novel devices to sites in Europe and other countries, and as a result many of these devices are available in Europe long before they're available in the US. This is a concern for society in the US, and by extension the FDA, for two reasons. First of all, the delayed access to novel devices in the US carries a human capital cost, especially for patient populations that are undertreated or have certain specific unmet needs why should the burden of disease ever be higher than it needs to be, especially when technologies exist to even partially alleviate that burden? A second concern involves manufacturer operations. If innovative operations move outside the US, economic growth will occur in these markets as opposed to the US, and new jobs will be created in these countries as well. There are also concerns from the medical device industry. For US-based manufacturers, especially startups, the cost of having to move early clinical testing outside the US can be prohibitive. Even for large companies, the process of doing clinical research in the US has been a daunting task. Dr. Chuck Simonton, Chief Medical Officer of Abbott Vascular, mentioned during the session that a lack of consistency and understanding in terms of clinical data needed from IDE trials was a big hurdle even for a large company like Abbott.

Why does this problem exist?

There are several reasons for the current problems within this area. Dr. Mitchell Krucoff and others during the session agreed that the site-based research system was broken because it was built separately from the current clinical system. A lack of effective communication going both ways between the FDA and device manufacturers was also an oft-cited reason for the current state of affairs. Infrastructure development outside of the US has been significant over the past few decades, and as a result many of those countries have caught up or surpassed the US when it comes to novel medical device development.

Ok, I understand the problem. What's being done about it?

Several measures are being taken to address the innovation gap and device access lag within the US. First of all, the FDA is rebranding and repositioning itself to be a partner rather than a police officer. One of the measures that is being taken is that the FDA is allowing Early Feasibility Studies (EFSs) for novel devices that do not require as much nonclinical data. Additionally, the FDA has a been a partner in the Clinical Trials Transformation Initiative (CTTI), the mandate of which is to promote efficient clinical trial practices to create an efficient patient-centered clinical trial system in the US. Another partnership is the Medical Device Innovation Consortium (MDIC), which involves input from both the FDA and the medtech industry to facilitate clinical trial innovation and reform. The promotion of patient registries and the use of that data in randomized clinical trials is also a practice that the FDA can follow to reduce the total cost of clinical trials. In fact, the very first trial that followed this method, SAFE-PCI, was hailed as a breakthrough trial for this very reason and was featured on the first day of TCT. Several other measures are also being implemented to incrementally decrease the cost and increase the certainty surrounding clinical trial execution in the US.

This is all well and good, but what's the impact on the medtech industry?

We all know and recognize that there is often a device lag between certain markets. Typically, a device will receive CE mark in Europe and become commercially available there long before it reaches the US. The emphasis by both the FDA and the medtech industry on bringing innovation back to the US through clinical trial reform means that we may begin to see shorter lag times between device approvals, and as a result companies will be able to realize US revenues faster, which should be invested back into the companies to bolster growth. The attitude during this session was extremely positive, both from the representatives of the FDA and the medtech industry. The prevailing question of the FDA town hall session was, How safe is safe enough, and how fast is fast enough. The FDA finally appears to be on its way towards answering that question, and the US medical device industry will be better for it.

[Editor's note: Read more thoughts from MRG on the innovation crisis here. And also...Happy Halloween!]

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