Dr Jaffar Khan gets to the heart of why innovation is so important in healthcare.
In every aspect of life, role models are critical. This is the same for clinicians wanting to be involved in medical innovation. It can be a demanding space, one that is often lonely, with no clear path and many hurdles. The early days of the true clinical academic were no doubt similar. It is therefore a great honour, in this innovation-themed issue of the Bulletin, to be able to hear from a young clinician who is truly leading in the field of medical innovation. Jaffar Khan is an interventional cardiologist and director of cardiac innovation at St Francis Hospital and Heart Center in New York. For someone who is only at the beginning of their career, he has been pushing innovation forwards in the field of interventional cardiology, with a number of new devices to his name.
TD: FROM THE UNIVERSITY OF OXFORD TO THE US, TELL US HOW YOU GOT TO WHERE YOU ARE TODAY.
JK: When I was exploring options for my PhD degree, I visited the National Institutes of Health (NIH) in America. I scrubbed in with the research fellow there while he inserted a large bore sheath through a pig’s back and into the left atrium, then withdrew the sheath and closed the atriotomy with a nitinol plug. He did this under real-time magnetic resonance imaging guidance. He said this was the straightest way to the mitral valve. I decided this is where I wanted to be.
TD: I CAN SEE WHY THAT WAS INSPIRING! HAVE YOU ALWAYS BEEN AN INNOVATOR?
JK: We are all innovators, we just need to nurture this side of us. We need time to think creatively and we then need opportunities to test our creative ideas. I was given this time and these opportunities at the animal lab at the NIH. I also benefitted greatly from a mentor who supported and guided me through the creative process.
TD: YOU’VE CREATED A NUMBER OF INTERVENTIONAL CARDIAC DEVICES. CAN YOU TELL US ABOUT THESE?
JK: They are mostly procedures with funny names: LAMPOON, which is anterior mitral valve leaflet laceration to prevent left ventricular outflow tract obstruction from transcatheter mitral valve replacement; BASILICA, a similar procedure to prevent coronary obstruction from transcatheter aortic valve replacement; ELASTA-Clip, to cut out a failed MitraClip™ device; PASTA and Antepasta, both tricuspid repair procedures; and SESAME, a transcatheter myotomy. I’ve also been involved in the development of three devices that have entered early feasibility studies in the US: a transcaval closure device, a mitral cerclage device for mitral regurgitation and heart failure, and the TELLTALE electrosurgery guidewire system.
TD: WOW! IT’S AN IMPRESSIVE COLLECTION OF ADVANCEMENTS THAT HAVEN’T GONE UNNOTICED BY YOUR PEERS. HOW DID YOU COME UP WITH THE IDEA FOR ALL THESE DEVICES?
JK: The team I am part of are close friends who are dedicated physicians and creative thinkers. Together, we spend time thinking about problems that occur in clinical practice and play around with ideas to fix them. We also have access to an animal lab and a group of biomedical engineers so we can readily test our ideas.
TD: WHAT WAS THE PROCESS FOR GOING FROM IDEA TO PATIENT-APPROVED PRODUCT?
JK: First, you have to honestly ask yourself whether it’s a good idea. Then, find out if it is novel. If you’re on to something, find a team of engineers who will make a prototype. The device will need to go through simulation, benchtop and animal testing, and then to the US Food and Drug Administration (FDA) or equivalent in your country (the Medicines and Healthcare products Regulatory Agency in the UK) for an early feasibility study. That’s how to get a device into humans. Getting an approved product then requires a pivotal study and submission to the FDA.
TD: DO YOU THINK THIS WAS EASIER IN THE US THAN IT WOULD BE IN THE UK?
JK: I think the NIH is a unique place. Historically, device approval has lagged behind in the US compared with Europe but it looks like this may be changing with some helpful recent device development pathways from the FDA.
TD: IF YOU WERE TO DO IT AGAIN, WHAT WOULD YOU DO DIFFERENTLY?
JK: I would have loved a less convoluted path to the Certificate of Completion of Training in the UK. Despite completing the training curriculum, I was booted out of the programme because I had spent too long abroad. I ended up pasting my completed e-portfolio into a Certificate of Eligibility for Specialist Registration application. Then, after two years of painful back-and-forth, I got on to the specialist register. And they wonder why they can’t retain talent.
TD: DO YOU THINK THE REGULATORY FRAMEWORK ALLOWS SAFE BUT EFFICIENT INNOVATION, OR IS THERE ANYTHING YOU WOULD CHANGE ABOUT IT?
JK: Our group has performed all our first-in-human procedures in the US, which has some of the highest standards and regulations for patient protection. I am really proud of that.
TD: THE COVID-19 PANDEMIC CERTAINLY SPED UP OF SOME OF THOSE REGULATORY PROCESSES. HOW DO YOU THINK THE PANDEMIC HAS AFFECTED INNOVATION GENERALLY?
JK: COVID-19 produced the greatest innovation in medicine in our lifetime: mRNA vaccines. There was suddenly a great need, some free time and lots of resources thrown at a problem. Development in other areas, however, definitely suffered but it may have boosted our spirit of innovation.
TD: WHAT ADVICE WOULD YOU GIVE OTHER CLINICIANS LOOKING TO INNOVATE IN THEIR FIELD?
JK: We have a tendency to think that if things are hard or if they go wrong, we need to do better. But we are all highly trained, intelligent, hardworking and caring doctors. The problem is probably not us but the process, or system, or device, or contemporary practice. Recognise them as problems. Then, just think about the problem for days. I guarantee you’ll find some interesting solutions.
Thanks once again for your thoughts on innovation in medicine. Your last point is exactly the reason we need enthusiastic role models like you! When things are getting difficult, it’s inspiring to see people who have achieved innovative change.
Information & Authors
The Bulletin of the Royal College of Surgeons of England