Ask the CMO: How do you choose the best device for your patient?

This article is part of our Ask the CMO series, where Cook Medical’s chief medical officer, Dr. John Kaufman, answers questions. Learn more about Dr. Kaufman in his Meet Our Leaders bio. 

Q: What are some disease states and interventional therapies that would greatly benefit from iMRI technology?

Dr. Kaufman: Interventional MRI will have the biggest impact in cancer treatment, musculoskeletal disorders, pediatric care, and cardiac interventions.

Cancer is probably one of the biggest areas for contribution for iMRI. Currently MRI is used extensively in the diagnosis, staging and follow-up of patients with cancer, for example liver, prostate, and soft tissue tumors. There are some interventions that are performed on cancer patients under MRI, but because of the technical limitations, it’s really not been pursued on a large scale. Our collaboration with Siemens Healthineers and our development of iMRI-compatible devices could unlock a huge range of cancer therapies for patients that have been previously unavailable.

MRI is a particularly great imaging modality for musculoskeletal diseases because of the ability to differentiate the many soft tissues such as muscles, tendons, cartilage, nerves, and the linings of joints. Biopsies, ablations (thermal destruction of tissue), nerve blocks, and perhaps even spine interventions may be ideal for iMRI.

In keeping with our commitment to find solutions for all patients in need, the potential pediatric applications are very exciting. Interventional MRI could be very impactful for kids who have chronic diseases that that currently require multiple repeat procedures with ionizing radiation. If you can do these procedures in MRI, it may be beneficial in the long term. While we always want to keep x-ray exposure as low as possible, we are less concerned about one or two exposures in adults. But in some children who are getting imaging and image-guided procedures on almost a monthly basis, this can be a big deal.

Additionally, the cardiac world is very interested in iMRI. Cook is not currently deeply involved in the cardiac space, but this may lead us in a new direction. So, these are just a few of the early areas where iMRI could significantly change current procedures. Once we have iMRI tools in everyone’s hands, it will be really exciting to see all the different places it gets applied.

Q: What are some challenges with iMRI?

Dr. Kaufman: Interventional MRI has some technical, procedural, and some logistical challenges.

Technical challenges

The major technical issue is that it is a completely different environment than most interventionalists are used to working in. There is a very strong magnetic field, and everything needs to be compatible with this. You must have dedicated tools that are not attracted to the magnetic field, don’t create a lot of artifact, but that you can still see with MRI. This creates a lot of challenges in terms of creating devices, including some of the standard accessories that you need when you are doing an intervention like monitors and ultrasound machines. All tools need to be specially designed to work in this environment.

Now, that being said, everyone should understand that there is already a a lot of patient support equipment that is designed for more powerful MRI machines than the 0.55T interventional MRI. It is very common, particularly for children, to have MRIs under sedation or general anesthesia. There are already ultrasound machines that work in this environment. It may sound like a daunting challenge to create iMRI-compatible medical devices, but it is really not as great as you might think. Right now, it’s primarily the procedural tools and devices that have led to the limited adoption of iMRI.

Procedural challenges

It’s also difficult procedure-wise to figure out the configuration of working in an MRI. It’s a small space. It has typically been a very confined environment. However, the iMRI machines have a larger bore, and we are working on those tools that will allow them to be easily manipulated in that environment.

Logistical challenges

The logistical challenges are also daunting. There are different safety requirements around MRIs. Patients have to be screened in a different way than they are for other procedures.

Additionally, getting physicians the necessary time on diagnostic magnets for procedures is challenging in most places unless they have a dedicated MRI for intervention. However, the training needed for running the magnets for both intervention and diagnostic components are all things that Cook has planned for and can provide.

How Cook Medical is solving these iMRI challenges

We’re rethinking the way the whole iMRI suite works and solving challenges with iMRI-conditional devices, training modules, installation support, redesigned MRI machines, and more. Pete Polverini, the vice president of Cook’s iMRI division, has viewed these challenges and opportunities in a holistic way. He’s thinking beyond the idea of finding a device that works in a magnet–he’s thinking about this entire environment and what is needed to make this successful. We’re excited to continue working with Siemens Healthineers on creating that environment that overcomes the logistical, procedural, and technical challenges.

This article is part of our Ask the CMO series, where Cook Medical’s chief medical officer, Dr. John Kaufman, answers questions. Learn more about Dr. Kaufman in his Meet Our Leaders bio. 

Q: You have worked with many other medical device companies and many people in the industry, such as sales reps, trainers, product managers, and regulatory scientists. From a physician’s perspective, how did Cook differentiate itself? 

Dr. Kaufman: The reason that I was so excited to join Cook is that for my entire career I always felt that anyone that I worked with from Cook is more of a partner with aligned interests toward doing the best thing for the patient than a transactional relationship. I’ve never felt with Cook that there was a pressure to use something that somebody needed to fill a quota for or convince me to switch to something. It was never that way. It is always with Cook that I felt aligned, to the extent that I could trust anyone from Cook to say, “We don’t have the thing you are looking for, but this other company does.” When I first then began investigating or meeting people as potentially becoming part of Cook that culture was very clear.

What is different about Cook is that, although that culture may be present at other companies, it is such a strong presence throughout all of Cook. There is a shared alignment of goals between those of us who are taking care of people and trying to do the best thing for the person in front of us regardless of other factors. Overall, that is how Cook operates.

Obviously, we are a company, we have to somehow make enough money to stay afloat and make enough money to take care of the people who work for us as well. So, decisions can’t always be purely altruistic. We do have to make some of those decisions, but that is always in the framework of is this really the right thing to do, not just for us but for the patients of physicians.

What is an area that could potentially be improved on?

What could we do better? I think everyone has a different answer based on their own perspective, and as Cook customer it would be great if we could get new or updated devices through the pipeline and into clinical practice as fast as possible. We have so much fantastic stuff in the wings and I want it now! On a serious note, we also need to focus on preserving our unique culture and relationships with physicians as we navigate the complex and highly regulated world that we now operate in. These two things have been drivers for Cook from the beginning and are in a sense timeless.

This article is part of our Ask the CMO series, where Cook Medical’s chief medical officer, Dr. John Kaufman, answers questions. Learn more about Dr. Kaufman in his Meet Our Leaders bio. 

Q: How do you balance your connection with Cook with what is the best option or device for your patient? 

Dr. Kaufman: I do love working for Cook. It is one of the best things that has ever happened to me professionally, if not the best thing. And I also love taking care of patients and I so appreciate the ability to do both things at the same time. It is not a thing I take for granted at all, but it is an incredible privilege.

The culture at Cook and the culture of medicine are very similar: You do what is best for the patient in front of you.

Don’t do what is best for you or what might be best for your friend or the company you work for or the hospital you are working for or the professional organization that you are a member of. You do what is right for the person in front of you and that guides you all the time. 

That prevents really any issue from arising of, “Should I be using a Cook catheter or a non-Cook catheter?” Cook catheters are the best catheters — they just are. So, I don’t have any qualms about using what I think is the best device. There are other devices that other people do better than us and I will use them because I think it is the right thing. I’m glad that it is evident that I am excited to work for Cook as it is an awesome group of people and an awesome organization.