A select group of medtech industry stakeholders calling themselves the Minnesota Medical Device Alliance (MMDA) have made their concerns known with the FDA over potential changes to the regulatory approval process. The group, comprised to a significant degree of venture capitalists with current or pending interests in medtech companies, met earlier this month w's Dr. Jeffrey Shuren, the director of Center for Devices and Radiological Health.
Their concerns center around the FDA's perceived inefficiency and unpredictability, which they expect will worsen if the FDA follows through with plans to change, in particular, the process of approval for products that would fall under the classification of 510(k) approval, the "substantially equivalent" consideration that has historically been a method of minimizing the need for clinical data due to the presumption that products of this classification are sufficiently like currently approved products to piggyback the original product test results. With the changes at the FDA coming under the new director, Margaret Hamburg, including a review and potential overhaul of the 510(k) process, precipitated in no small part by high profile device failures (defibrillator leads, defibrillators, stents, artificial hips, etc.), the outcome of the regulatory process reform is likely to be higher hurdles and greater costs, borne primarily by the likes of venture capitalists such as those in the MMDA.
The group points out that the average approval time under 510(k) has already stretched from 90 days in 2006 to 140 days currently. Some in the industry also like to point out that investment in medtech by venture capital has recently declined 34%, from $3.8 billion 2007 to $2.5 billion in 2009, with the suggestion that the uncertainty in the FDA's approval process is a significant factor in this (conveniently overlooking or deemphasizing the unrelated financial market meltdown in 2008, one presumes).
There should be no doubt that the challenge for gaining regulatory approval is big, even under 510(k). Developing products is costly and adding the cost of clinical trials to the process can sometimes determine whether a company can survive. Disc Dynamics has been cited as a company that ultimately had to close its doors due the overwhelming cost of providing the necessary regulatory data for approval of its products. Another company, Atritech, with $90 million invested to date, is similarly struggling with the cost as it develops products for atrial fibrillation and stroke, having initially gained approval by an FDA advisory panel only to be told that more data is required to prove safety and efficacy.
The concerns of medtech investors and, indeed, medtech companies about the increasing demands of the regulatory process are warranted. The process is not efficient or effective given that approval times are increasing while, simultaneously, serious lapses in the process are resulting in device failures, injury and death. But in this statement is the crux of the matter — that if companies cannot financially survive the approval process, important and life-saving products may never reach patients, but simultaneously products must not reach patients until the potential benefits of their use have been reasonably assured to be greater than the risk of their failure.
A word from medicine comes to mind that analogously applies here — homeostasis. This is the body's dynamic method of maintaining balance in its multitude systems to keep a steady state which ideally is a state of health. Homeostasis is often disrupted when a fundamental change in variables has occurred as in the introduction of a new outside force (e.g., trauma or disease) or even a change in an internal force (age) and the body must rebalance itself to restore that state of health.
Applying this to the regulatory debate is rather obvious, since the variables of medical device regulation have clearly changed; externally through the establishment of a new director at FDA and, internally, through the erosion of the regulatory process in 510(k)'s ability to ensure that safe and effective devices reach the market in a timely and commercially viable manner.
The medtech-regulatory organism is healthy enough, with enough interested principals, to restore homeostasis, but it is clearly a dynamic state that will need to be not only maintained, but monitored regularly as the variables intrinsic to the process change.