Wednesday, October 1, 2014

Collaborating to Meet Global Regulatory Challenges

An interview with
Elisabeth George
Vice President of Global Government Affairs, Regulations and Standards
Philips Healthcare

Interviewed by Sam Narisi

Medical technology companies often struggle to balance the need to bring new products and innovations to market quickly with the ever changing   regulations and standards. That is an especially big challenge for companies working globally due to the difference in the laws of different countries.

In her role at Philips Healthcare, Elisabeth George is responsible for both helping shape healthcare regulations around the world, as well as making sure her company can strategically adapt to the shifting rules. Frost & Sullivan recent spoke with Elisabeth about some of the strategies companies can use to navigate the complex global regulatory environment.

Describe your role with Philips Healthcare.

I’m responsible, from a global perspective, for interface with government affairs, regulations and standards. I’m working from a strategic perspective toward future regulations and standards. When a regulator starts developing a guidance document or a new regulation, I’m a focal point for our company. I work with our different businesses within our company as well as interact with the different stakeholders  to evaluate those proposals and represent the company back to the regulatory authority, explaining either why I disagree or agree with what they’ve defined.

Then once a new regulation or guidance document comes out, my team puts together the training and deploys it across the company. We also participate around the world  in a number of standards organizations as well as industry organizations including as a board member or a chairperson of committees.

What are some of the trends you see developing in the regulatory landscape?

There a couple of things. First off, every country that has a regulation seems to be changing them, and every country that doesn’t have a regulation seems to be defining and implementing one. So that’s a big challenge. Another change that is somewhat on the positive side is that a number of the larger regulatory regions –  US, Japan, China, Russia, Brazil, and Europe – are all working together toward some aspect of convergence on regulations through IMDRF (the International Medical Device Regulators Forum). They are realizing that the world is getting smaller and if they all have different ways of doing things it impacts time to market, availability to patients, and potentially patient care.

Another new area is anything having to do with the use of IT, including medical apps on phones and the use of software in the clinical environment. Everything that used to be mechanical is becoming much more electronic and software-based. There’s also the whole Big Data aspect, where there’s a desire to collect information and for people to use that information in all sorts of decisions including financial, clinical and environmental. There are questions around who owns the data and how they’re allowed to use it, as well as concerns regarding privacy and the accuracy of the data. With all of health IT, there is also the challenge of cyber security.

One big challenge in medicine is that the regulations typically don’t evolve as fast as the technology changes. What are some things companies can do about that?

That’s a problem everywhere in the world. Some of the emerging countries that are just starting to implement regulations have very slow burdensome processes that require very significant testing, even for products that have been used in the US for several years. So that’s a challenge, and I think one of the ways to work on that is to spend a lot of time with the regulators to help them understand what regulations are in place elsewhere. Try to get those regulators talking to regulators from the other countries. Offer to educate them, and if possible, instead of sending the product to them to test it, offer to have regulators come and see the product in use in a hospital or bring them into the factories.

When dealing with regulations in the US, again the way to help overcome these challenges is to work with the regulators. The FDA has people involved in the standards process so they can partner with industry on standards development. It’s important not to be afraid of regulators and to work with them either directly or indirectly by joining an industry group.  The FDA has an Experiential Learning Program (ELP) that industry should reach out to the FDA to engage them in learning about new technology.

Companies can also reach out to consultants, and make use of opportunities like Frost & Sullivan events to network and find out what other people are doing. Don’t assume that there’s only one way. It’s a moving target, so never assume that if you analyzed something yesterday that it will have exactly the same answer today. There are a lot of inputs that regulators are getting every day, from competitors of your company, from post-market complaints and failures, and from patients. Regulators realize they have to change, and agencies are willing to have open door discussions, and they’re willing to take risks with us as well.  Companies must use the Benefit Risk thought process when making decisions.

Given how constantly things are changing, what advice do you have for staying current, especially when dealing with regulations globally?

One way is what I call “feet on the street,” which is having people physically in the region that communicate with regulators and stay on top of local regulations. There are also different organizations that publish updates to regulations and offer pointers. Again, it helps also to be a part of a local industry organization, such as AdvaMed  or MITA in the US. Even if you can’t actively participate in all of the committees they have, you can be on their email list so you get updates to see what’s changing. It’s also important is spend time surfing the web for information. And again, whenever you can, network.

None of these are perfect, and to be honest we do all of them and don’t always find out about every change. But when we’re caught off guard, we try to find out why we were caught off guard. The good news is most of time it’s one of those weird regulations or requirements that’s maybe only applicable to one small slice of our product line. We’re not usually caught off guard when it’s a major change.

What are some of the differences in introducing products in emerging markets such as India or Latin America, for example, compared to the US or Europe?

If I look at India specifically, fortunately for us, most of our products are not on their medical list that requires those products to go through an extra-burdensome process. What they require is that the country of origin regulatory submission has been done. They do happen to have more  burdensome radiation requirements, so for our imaging products, we took some of our radiation specialists there and scheduled meetings with the people who work on those regulations. We went through some general training and shared the practices we go through to ensure safety and effective performance and all of that. That allowed us to integrate what the regulators needed into our design process so it added next to no effort on our part. We also helped introduce them to people in the radiation area of the FDA, so they understood what they were doing in the US. Those relationships are very valuable.

Another example I’ll use is Brazil. A number of years ago, Brazil had no regulations. One thing we did early on before they started to develop regulations was to visit them with the US State Department and try to educate them on the many different regulatory schemes that were already out there. I was part of that group, but it wasn’t just me. It was part of an industry group effort. Let’s say you don’t know what’s going on in that country and you’re not really sure how to find out. You can find the medical device industry group in that area, and the other medical device manufacturers in that area. Even if they’re only doing band-aids and you’re doing an MRI machine, at least you can talk to them and find out about the oversight process, what’s expected, and who you can talk to.

Especially if you’re a small company and you don’t know what to do, find some local networking opportunities. Regulatory people aren’t like the R&D people and design engineers who don’t want to share general perspectives information with competitors because it may be proprietary. I’m not going to share the dirty details of my regulatory submission with other companies, but I can tell them who they may be able to call for help, or I can  reach out and ask a question to one of my contacts.

1 comment:

  1. Excellent blog. I’m glad I discovered it because I love great food and I enjoyed all these great comments. Keep it going!