Ginger, I have to smile at your last line; my initial reaction is, yes, and that's to throw *them* out the door. My other reaction was, Well, darn, Ginger, and here I was trying to keep my response relatively brief, for once. There are quite a number of different scenarios that could fit under this umbrella.
I have found that it is usually 1) and 2), rather than 1) or 2). "What's the minimum we can do?" is practically the motto of the VC-driven start-up. In the interest of brevity, I decided to leave start-ups out of it, because Tina asked about a regulatory team, and most start-ups are too small to have a regulatory team.
But you can certainly find this mentality inside an established device company as well. Sometimes it's just one or a few teams, but sometimes that mentality goes all the way to the top of the organization. In the latter case, I don't think there is much to be done, other than decide if you really want to work there. In the former, a lot depends on the company's product development processes. If you are lucky, regulatory must be brought in early, so you have the opportunity to educate the team before it has taken too many shortcuts. If not, then often you end up being the belated bearer of bad news and unhappy director of a salvage operation. Small consolation is that at least they will know better next time.
Another bleak scenario is a simple struggle for control. Some people aren't cut out for a team environment, nor for a regulated environment. They resent the whole idea that they can't do their job however they please. I don't know of any happy solutions to this one, either.
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Julie Omohundro, ex-RAC (US, GS), 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-Jul-2016 10:27
From: Ginger Glaser
Subject: Establishing trust and value-add for your team
Julie,
I found your comments on executive management vs product development teams interesting. I agree that exec management discussions need to be about helping meet business goals. However, I have seen project teams at two different ends of the spectrum. The first, as you describe, are very dedicated to getting their product right, with the right compliance etc. They do well if you explain the "why" to them. Conversely, I have worked with teams that are ONLY about "how fast can we throw this out the door" and "what is the absolute minimum we can do." Typically these teams either 1) have the idea that medical device development is done by throwing out a prototype and then iterating based on feedback from the field, or 2) are very inexperienced and don't quite understand the need for what RA is requesting. These types of teams require somewhat different approaches than the first type.
Ginger
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
Original Message:
Sent: 22-Jul-2016 17:13
From: Julie Omohundro
Subject: Establishing trust and value-add for your team
By and large...what Glenda said.
Although I probably would have interpreted your question differently. Everyone seems to be offering excellent suggestions for RA when working with others in the company. Because you said "business," I initially thought you were talking about executive management. I think everyone else probably got it right, but I will go ahead and comment on the difference in my strategies when dealing with the execs versus coworkers.
When I talk to the execs, it is all about the business goals and how regulatory is helping to achieve them. This usually means go fast, but don't get us into trouble. :)
Otherwise, I normally work with product development teams. They tend to be naturally more committed to their product. They do want to move forward at a satisfying pace, but they also tend to be more interested in "getting it right." They also don't want to end up being embarrassed by a lot of questions from the FDA that would seem to suggest they didn't do a very good job of developing it. So I focus on how to assure that the FDA review goes smoothly and also what is likely to assure the product is successful post-market.
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Julie Omohundro, ex-RAC (US, GS), 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: 20-Jul-2016 10:15
From: Tina O'Brien
Subject: Establishing trust and value-add for your team
What are some of your best practices related to establishing trust and demonstrating expertise and value-add for your Regulatory team? It doesn't matter how experienced the team is if the business doesn't believe in their value to the success of the organization.
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Tina O'Brien RAC, MS
Sr. Regulatory Affairs Specialist
Fisher & Paykel Healthcare
Auckland
New Zealand
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