A Newly Candid FDA on the Future Of Medical Device Regulation

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something called ‘key bounce,’ where you push a button and you would think if I hit the button for a number the number gets pressed once. Say I’m going to give 20ml of some drug every hour and I hit 2 and 0, it should be 20, but in a number of instances you’d hit 2 and 0 and it wasn’t 20, it was 200. If you’re dealing with a drug that in higher concentrations has significant safety concerns, like the blood thinner heparin, you’ve put that patient at significant risk.

Normally our standard operating procedure would have been that we’d identify problems and we’d go back to the manufacturer and say “Your problem, you figure out what to do and then come back and talk to us.” Here we said “We’re going to come out and make our expertise available to work with you to solve this problem.” And that’s very different.

SW: How so?

JS: We have worked with the University of Pennsylvania to develop a generic infusion pump software code so a manufacturer can take that software and build on it to make its own device or they can use it as a benchmark for their own software to try to avoid common problems.

Also, we are offering to perform what is called static analysis, where we use software to look for some of the most common problems and go back to the manufacturer and say “We identified this problem, you should fix that now.” We’ve offered to perform this at any time in the life cycle of the product, so a manufacturer can come to us as they’re developing the device. Normally they would come to us with a submission of data when they’re done with the device and they’ve analyzed and assessed it and they’re asking us to review this information to determine whether or not to approve it. Now we’re willing to do a diagnostic on their technology while they’re developing it, so this potentially could help some manufacturers save a lot of time and effort. We have not done this before.

SW: Is this unprecedented for the agency to be coming in and giving manufacturers a specific path to product design? It seems very unique to me that you’re coming in and saying “This is how everybody should design their pumps,” and that some of the changes are geared towards working around the possibility that an operator might make a mistake.

JS: You are exactly right, it is unique. This idea that you have to design around the way people behave is exactly on target. It’s one of the reasons why we came back and said that for many pumps, before they can come on the market, they have to test them in the environment in which they will be used, or simulate an environment in which they will be used, with the people who would be using them. It’s what we call usability testing, so you can assess whether it was designed in a way that’s going to lead to problems with how people use it.

SW: If you had your pick of something you don’t have and you’d like to get right now for the FDA and for your office what would that be?

JS: One of the challenges that I face is that if have an expert in an area, particularly in the medical disciplines, I may at best have one expert and in some cases I may have none. That creates a challenge for our ability to stay on top of the science, particularly for cutting-edge science. If you want to understand the technology you need to have people who understand the technology itself and then you need to understand how it interfaces with the body.

One of the things that’s a priority for us is setting up what we call a network of experts so that we can more readily tap into people outside of the agency who are knowledgeable in critical areas to help us answer scientific questions. This is different from how we use our advisory panels. There are times when we need to pose a question to an expert to try to understand a new technology. The challenge, of course, is setting this up in a way where we’ve identified the experts and we understand their relationship to the technology and the makers of the technology, so we’ve looked at potential conflicts. Then we need to assure we have the right experts in the agency who can, if you will, talk the talk. So for example I’m a neurologist; you aren’t going to send me in to have discussions on orthopedics. I’ll understand it but I’m not going to understand it in the same way that another orthopedist would, and vice versa.

SW: So you would hope to maybe recruit more people within various areas of expertise?

JS: We’re looking at several options. It is one of the things that we will be assessing.

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Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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2 responses to “A Newly Candid FDA on the Future Of Medical Device Regulation”

  1. Ruthie says:

    The 510(k) process and the FDA have been broken from the start and will continue to fail as we see time and time again.
    As a part of the TMJ Implant Disaster the FDA and the 510(k) failed so many innocent people. In the end it is all about $$$$ and the rats that were experimented on by the cockroaches are left running on a wheel with no answers, protection, or help. Rats and cockroaches both survived the nuclear bomb…but will all have to face our maker in the end.
    The FDA and Congressional Hearings are a waste of tax payers time and money. How did the government fix the complaints of long waits at the post office??? They took the clocks off the walls!!! Quit wasting our time and money. True honor, integrity, and character are lost to the evil $…God help us all!