Regulatory Impact on Medical Devices

In his current position, Mr. Sidebottom is responsible for Medtronic's corporate standards program. He represents Medtronic at national and international standards organizations on standards matters affecting the medical device industry. Heavily involved in international standards work since 1987, Mr. Sidebottom serves as Secretary to the International Electrotechnical Commission (IEC) subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice, Secretary of International Standards Organization (ISO) subcommittee ISO/TC 150/SC 5, Osteosynthesis and spinal devices, and is the Secretary of ASTM Committee F04. He is the author of the book International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic products

Gerald Clarke:          Chuck, could you give us a little bit of background as to your history in the field?

Chuck Sidebottom:    I've been involved in medical device standards for about the last 25 years, and have been pretty much dedicated to the standards work for the last 20 years with Medtronic. At our company, standards are a part of our global regulatory operation, so I'm a part of the regulatory group here at Medtronic.

Clarke:          What do you see as being the most important regulatory changes in recent years and how are they affecting the industry?

Sidebottom:    I think probably the most important trend that I have seen in the last 15 years has been the increasing move to a risk-based regulatory system. I think that's really been a fundamental change that's affected the industry and the regulators; moving from a very prescribed set of requirements to applying a risk methodology to the regulatory process.

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Clarke:          How is that change in focus affecting the industry?

Sidebottom:    I think that a risk-based system really requires both the industry and the regulators to move up to the next level in terms of their sophistication in the process, moving away from checklist-type mentality to really thinking about what are the risks associated with a particular device or a particular therapy. And then figuring out how to manage those risks effectively has required a greater sophistication, both on the part of the manufacturer, but also on the part of the regulator that is having to look at the results of the work the manufacturers are doing.

Clarke:          What changes do you foresee coming in the next few years?

Sidebottom:    I think we're continuing to work our way through the whole transition, if you will, from prescribed requirements to a risk-based methodology, and both industry and regulators are still working our way through that process. Of course, regulation is continuing to involve and increase, so we are seeing more countries and areas around the globe bringing in medical device regulation or increasing their level of oversight of medical devices. That whole process of trying to do that and to harmonise so that we have some consistency in the way that a regulation is being applied around the globe is a big challenge, and I think we're going to continue to have to work on that and really strive to achieve greater harmonisation of regulatory requirements, because that has a very important effect on both access of patients to the devices that they need but also the cost of those devices in the marketplace. Complying with regulatory requirements is a very significant financial burden which, of course, gets then passed on to the ultimate consumer of the devices.

Clarke:          Keeping tracking of these regulatory changes in an evolving field is very difficult and doing so while operating globally is even more so; how can companies keep track?

Sidebottom:    That is, as we say, the $64,000 question that every manufacturer around the globe is wrestling with. As the regulatory systems continue to evolve and as more countries either add or notch up their regulatory requirements keeping track of all those is a major challenge for every manufacturer, but particularly for small and medium-size manufacturers that maybe don't have the resources that are in-country to keep track. Larger companies, at Medtronic we have people in many of the major markets whose job it is to keep track of the requirements and their geographies and then feed that information back into a centralised system that tries to keep up to date with all of these global changes. As I say, I think that's a really big challenge for the small and medium-size enterprises that don't have the people resources to have folks' boots on the ground, as we would say, in the countries, trying to keep up with regulation. Of course, it's now a real opportunity for consultants that provide those kinds of services that manufacturers can contract with to do that work where they don't have in-country resources. There's a real expanding marketplace I think for those people who are working to keep up with their local area and then sell those resources to companies around the globe that need to track them.

Clarke:          Many companies are working out of multiple offices; how can they ensure a compliance culture is in place across these multiple teams?

Sidebottom:    That of course is one of the big challenges in managing a distributed development environment where you have teams working in different locations and different time zones and different continents; maintaining a compliance culture is just one more of the things that the manufacturer has to do. I think the way they need to do it is just through both good practices and policies that they've established that foster a culture of compliance and then putting in place the tools, the technologies that help support that working together. It's just another aspect of managing a development activity that's spread out amongst multiple teams in multiple locations.

Clarke:          In what ways can organisations work more closely with their Dev teams to ensure effective embedded environment?

Sidebottom:    I think again it's a corporate culture thing. You have to build a culture that is focused on the compliance culture – the thing that we were just talking about – so that the teams know – and have that held up in front of them constantly – that compliance is something that everybody is responsible for. And then, again, it's having the communications technologies and the infrastructure that allows for ready access and communication between the members of these distributed teams. You need the corporate culture that makes sure that the compliance is a top priority, and then the infrastructure that helps the teams stay connected and to deal with any compliance issues that come up as they appear, and to make sure that they're dealt with effectively.

Clarke:          Thank you very much, Chuck, for sharing your insights and your time with us today. We look forward to hearing more from you at the Software Design for Medical Devices event.

Sidebottom:    Thank you. It was a pleasure, and also I'm looking forward to the upcoming conference this January.

Clarke:          If you would like to find out more about this topic and the Software Design for Medical Devices Europe conference in January 27-30 in Munich, Germany, visit us at www.sdmdeurope.com.

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