Boston Device Blog

Medical Device Prototypes Need to Adhere to High Standards

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When considering medical devices for clinical use, to think of a product as a “prototype” can be misleading and detrimental to the development cycle.  Unlike prototypes created for commercial use outside of the healthcare field, clinical trials for medical device prototypes must produce results identical to those intended for the final release product.  Essentially, there is no “back to the drawing board”—medical prototypes must produce statistically consistent results over differing clinical environments.

Consequently, is better to think of the first clinical trial as not really a trial at all, but instead, as the first commercial use of the device.  

Clinical trails are a key milestone in the approval process of a device and often future funding of the project depends on the results of such trials.  It is therefore important that the prototype pass regulatory safety standards as quickly as possible.  The change-control process must be rigorous and record keeping meticulous.  Any delays in approval of clinical trials can cost companies dearly in terms of funding, marketing, and competitive edge.  The idea is to get the product to market as quickly and efficiently as possible.  When going before an institutional review board (IRB), companies must be ready to prove that the device has already arrived at safety benchmarks that comply with the IRB committee’s requirements as to the welfare of the intended participants of device trials.  If the IRB is unconvinced--due to prototypes that are imperfect or need future revision--valuable time and money is lost.

It is also crucial to ensure that users can realistically expect the same results throughout the full lifecycle of the device.  Unlike other, non-medical, prototypes that can be brought to the trial phase looking or acting nearly the same as what you expect the final release to look and act like, medical prototypes must, for all practical purposes, be undifferentiated from the final product. The prototype will not perform or function any differently from the product that is brought to market. For these reasons, it is better to think of medical device prototypes for clinical use instead as a preliminary manufactured product.