Interesting and insightful comments, Victor. Here are my thought thus far:
When it comes to "innovative" versus "disruptive" or "game-changing," there are forces at play in the broader tech environment that have apparently found it in their interests to define very minor changes as "innovative," and slightly more aggressive changes as "disruptive" or "game changing." (Think how often you have seen the advertising tag line, "This changes everything" attached to a product that really changes very little, e.g. version 1.111113 of a cell phone.)
Those forces are also at play within the medtech industry, where it sometimes seems that "innovative" can carry about the same meaning as "new and improved" on box of detergent. The point here seems to be to have something new to promote in a market that has saturated and gone flat, not really to improve much of anything. (If it succeeds in kick-starting sales, then I guess that could be considered "disrupting" the status quo of flat sales, but I'm doubtful that this is what you have in mind.) I think this form of "innovation" and the typical "me too" 510(k) process are a perfect match for each other.
Until recently, there was another crowd within the industry, laboring to develop "disruptive" (a little or a lot) devices. These efforts were being increasingly "held back" by the regulations, which offered them a choice between a rock (the 510(k) path) or a hard place (the PMA path).
If you want to talk about a regulatory "game changer," I think that would be the new "direct to De novo" process. It has freed the crowd that wants to "disrupt" from having to struggle to pound a square peg into a round hole. I expect it will ultimately reshape the medical device industry. I think it will also reshape our profession, with those steeped in the traditional "me too" 510(k) mindset going one way (or perhaps simply "away," since there is really not much "regulatory" to be found here), and those grounded in the mindset of novel devices another.
------------------------------
Julie Omohundro, ex-RAC (US, EU), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 26-May-2016 08:29
From: Victor Mencarelli
Subject: Is There Innovation in Regulatory Affairs?
Hi Lena.
Maybe I look at this too simplistically by I have always looked at innovation as anything that disrupts the status quo. That disruption does not need to be a "violent" disruption (like a new mega-regulation coming out of FDA [sort of like the new nutrition facts labeling rule]) but it can be anything that forces thought processes to move in one direction or the other.
I happen to like a few of the comments that you have gotten already on this topic and I plan to introduce some of the mindset that some other have already detailed within my own organization to try to change the way we, as regulatory professionals, are viewed within my own business. But I do think that the mindset of the business plays a huge role in how innovative the regulatory team can be. For example, where you have people who can only seem to think in yes/no Boolean terms, innovation is going to have a hard time getting a foothold because they don't understand or have no desire to be taught the level of nuance in the industry and even in regulatory issues. Where people are more open to discussion, negotiation, risk/benefit, etc. (whatever you want to term it) then regulatory has a real opportunity to provide that challenge to the status quo.
Regulatory, by its very basic and not-fully understood definition of the profession, could be seen as the antithesis to innovation. Let's be honest, we have all been in situations where there is a "playbook" on how to get things done and no one ever questions the playbook because it has always "been OK" or "worked" to get the job done. I can provide an example from my own experience. In the past I have been involved with companies who use Excel spreadsheets to manage their formulation development. Now obviously none of the Excel spreadsheets met 21 CFR 11 in any way, shape or form so the company needed to manage multiple systems and scientific books, and signatures and counter-signatures along with all of the stuff they already were doing. When I came in there had been some discussion of obtaining funding from the company to purchase a formulation tracking software that could comply with 21 CFR 11 and also could provide other modules that would allow for Quality, Operations, Package Engineering, etc. to also obtain benefit of a fully functional data management system all in one place. My predecessor in the position wanted to hear nothing of it because the other system "worked just fine the way it was set up". Oh, and I should mention that this person routinely worked 12-13 hour days because the system "worked just fine". My first project when I took over the position fully was to bring that discussion back to the table. Thankfully some other folks had also been hired in the same time period as I and they also understood the power of the use of such a system to streamline processes. So it was a bit simpler because they understood as users what the system might afford them in terms of efficiency, simplicity and searchability that they weren't able to get from Excel.
I personally think that there is a need for innovation in every aspect of corporate life. Let's be honest here - those who stagnate typically will die. So a company needs to be able to come up with new ways to improve things. Innovation in my mind can be used to improve process, improve culture, improve costs, improve the bottom line, and all of these things ultimately improve the company and its ability to do business. The only people I have ever truly heard arguing that they didn't need to consider new ideas or new ways to manage things were those who were so far along in their careers that they had truly forgotten just how important all these things are or who were so young in their careers that they simply didn't understand the basic truth that not all things are created equal in business and there are different ways to approach any issue to solve a problem [Note - I do count myself as one of the latter earlier in my own career!]. Being realistic, when the profession first started there was a need for some limited understanding of business principles simply to understand where the arguments might arise from upper management. Now, I don't know of many regulatory professionals who have either been on the "business" (operational) side of the world or who have specifically tried to obtain further education in business principles (such as the Executive Development program sponsored and run by RAPS) to understand what the business needs from the regulatory team and then to also be able to discuss regulatory issues in a language that business-people can comprehend.
And , no, EMPHATICALLY NO, regulations do not hold back the profession from being innovative. As some have stated already in many instances the same regulator that some fear will frown on the innovative approach have been among the people and colleagues who have been the most vocally positive of the changes that have occurred. Have there been instances where someone unfairly or unnecessarily questioned innovative ideas? I am certain there have. But I am equally convinced that there have been far more situations where someone (regulator) has seen the innovation and brought it up to their team as a possible best practice. Is every innovation good? That depends on the definition of "good" in this instance. Will every innovation work the way it was planned without any issues? NO. But any innovation is good in my mind for the simple fact that someone chose to try to make a CHANGE in how we think, work, etc. Change is good because it forces further discussion of what is going well and what is going poorly. And discussion can never, in my mind, be a bad thing.
------------------------------
Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States