There has been a great deal of discussion lately about regulation stifling innovation in the medical device sector. Much of it strikes me as misguided or a discussion of something unrelated. Instead, it is my opinion that efforts to avoid regulation are an important contributor to stifling innovation of safe and effective medical devices. Let’s begin by defining our terms:
•Invention is the act of creating, or improving, something that is new.
•Innovation is the act of successfully commercializing something that has been invented; it will be successful, if it has real (utilitarian) or perceived (aesthetic) value. This definition is consistent with the over half century of published work on diffusion of innovation. Innovation cannot include commercializing dangerous or defective products. If you want to protect your profitability, make sure your products are safe (each won’t cause harm) and effective (each will do what you claim).
•Regulation (in the medical device sector) is a control mechanism for protecting the public (health).
Yes, regulation can impact invention. If there is little or no opportunity to benefit from your intellectual property, then it is likely that you will focus your energies elsewhere. Regulation can also impact innovation; in fact, that is exactly FDA’s congressionally-mandated mission. Congress established that FDA regulates manufacturers—not inventors, practitioners, or consumers. Practitioners are regulated by each individual state. Congress charged FDA with protecting the health of consumers.
FDA regulation, like everything else in life, has its preferred attributes and disliked attributes. For example, from the manufacturer’s point of view, FDA regulation’s preferred attributes include shielding from civil liability when a product is approved (but not if it is administratively cleared via 510(k)), protecting proprietary design and manufacturing information, and dramatically reducing competition; not just any firm can jump into the medical device sector. On the other hand, it demands modern engineering practices (including design controls and risk management for hardware, software, and human factors), it demands accountability (such as complaint handling and medical device reporting), and it is believed to be slow to complete clearances and approvals.
From the consumer’s point of view, FDA regulation’s preferred attributes include requiring best practices and accountability from manufacturers and its disliked attributes include shielding manufacturers from civil liability, not divulging critical proprietary information related to design and manufacturing flaws, limiting the possible number of manufacturers available to innovate (due to the high barrier imposed by regulation), not vigorously enforcing accountability, and being too quick to complete clearances (in other words, without clinical trials). Yes, that’s right: what one side likes, the other side dislikes.
From the regulator’s perspective, it is constrained by federal law and historically promulgated regulations, it is constrained by congressionally-mandated budgets, and it can be whipsawed by the push and pull of manufacturers, practitioners, consumers, and their political allies. Yes, of course, it is a bureaucracy: just like every other unit of federal, state, and local government and most units of large corporations.
The Institute of Medicine’s (IOM) recent recommendation essentially to dismantle the 510(k) premarket notification system, a central FDA/CDRH program, was certainly scientifically and technically correct, based upon the specific questions they were asked (Is the 510(k) process optimal and, if not, what should be done?); but from a managerial, commercial, and consumer perspective, it was totally untenable. We already knew it was not optimal; suggesting it be replaced, rather than offering how to transform it, seems to me to be counterproductive. Bureaucracies just aren’t that agile and likely never will be.
This article gives the detailed views of an industry expert who has actually built products and done hands-on work—not just another consultant/pundit—and much of it is contrary to conventional, generally accepted wisdom.
To read the entire article, which first appeared at sibling publication MD+DI (Medical Device and Diagnostic Industry), click here.
About the author
GM Samaras is a biomedical scientist and engineer at Samaras & Associates Inc. (Pueblo, CO). Trained as an electrical engineer, he has doctorates in physiology and industrial engineering and is a licensed professional engineer, board-certified human factors engineer, and an ASQ-certified quality engineer. He has a number of biomedical patents and publications in physiology and engineering (hardware, software, human factors, and quality). He has worked at the FDA/CDRH as a reviewer and manager, was a medical school and engineering graduate school professor, and founded an engineering firm that he ran for a decade.
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