Neurosurgeons interested in taking a medical device from personal inspiration to market would do well to seek out a partnership with an experienced party or device manufacturer as early in the process as possible, advised Janet E. Trunzo in an interview earlier this year. As the senior vice president for global regulatory affairs for the Advanced Medical Technology Association, known as AdvaMed, she is in a position to know.
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Once a device has matured and gained supportive preclinical testing, it is ready to be considered for large, prospective clinical trials. The clinical trials typically include a safety trial followed by an efficacy trial. During this portion of the development process, the U.S. Food and Drug Administration will need to be engaged in order to ensure that the trials are designed to their specifications and that all relevant questions which they anticipate regarding the device are answered. Once the device has completed clinical trials, a final application process for approval with the FDA is undertaken. This often is an iterative process which may generate additional study and data generation before approval. Instances where a novel device meets a clinical need critical to patient outcome or safety may qualify for a priority review process to expedite final FDA approval.
One characteristic of the process from inspiration to product introduction is that the timeline can vary greatly from very short to very long, according to Trunzo. The timeline for a simple, non-implantable device which is made of materials that are known to be biocompatible could be very short; an example of such a device might be an external temperature sensor or a tongue depressor. On the other hand, a device intended for implantation (defined by the FDA as remaining in the body longer than 30 days) and made from materials which have not been previously established as biocompatible may take substantially longer to complete the process successfully.
It is this variability that often affects the willingness of companies to pursue development and introduction of innovations. The specific estimates regarding the difficulty getting through the regulatory process and achieving a successful product introduction will, of necessity, be weighed against the market opportunity and the potential return that a device manufacturer could reasonably expect. Despite this reality, products are being introduced at an ever-increasing pace in the medical realm. As Trunzo views it, this makes the medical device industry unique, interesting, and exciting. In fact when a new device is introduced, a new model can be expected to make its market debut within a span of only 18 months. This quick cycling is due in part to the FDA’s 510(k) approval process, which allows relatively fast approval if it can be shown that a device is substantially equivalent to an existing device.
Cost is an issue which seems to draw a lot of critical attention to the process of new product development. Many neurosurgeons realize that the implants they use routinely generate licensing, manufacturing and marketing profit margins which summed are possibly greater than the remuneration they receive for surgical services. While this seems paradoxical, it is at least partially justified by the large upfront capital investment necessary to get a product through the FDA process. However, it is not possible to discern a precise profit margin for any given product with publicly available information.
Surprisingly, device manufacturers do not enjoy the same level of patent protection for their intellectual material and design concepts as pharmaceutical manufacturers, Trunzo said. Such market realities may impact the potential revenue estimates of new products, as there is a likelihood of imitation and “fast-follower” products designed for similar indications which will erode the original innovator’s opportunity. This encourages manufacturers to try to reach financial targets over a short time, which further escalates prices.
To prevent an otherwise worthy inspiration from being lost in one of the many pitfalls that accompany such a complex, highly regulated, and cost-laden system, Janet Trunzo’s advice to seek partnership early in the process seems quite appropriate.
Patrick W. McCormick, MD, is a neurosurgeon with Neurosurgical Network Inc. Toledo, Ohio.