The bar for approval of medical devices is too low. There is no reason we shouldn’t require, as we almost always do for drugs, a randomized placebo-controlled trial showing improvements in “hard” outcomes like mortality before approving them - Haider Warraich
image by: masha_tace
Last week, waiting for my iced coffee at Starbucks, I enviously observed the girl in front of me paying with her phone. Fast forward 30 seconds and boom! Iced coffee in hand, I took a few minutes to peruse the app and see what it actually provided -- besides the ability to get more iced coffee no matter where I left my wallet. Turns out, it had the whole menu, with ample nutritional data, a store locator, a gifting feature, and the ability to share on social media.
Information. Education. Sharing.
According to the Pew Research Center, 64 percent of adults now carry a smartphone of some kind -- nearly double the 35 percent prevalence just four years ago. We also know that smartphone users do much more than make telephone calls -- in fact, 62 percent have used their phone to look up a medical condition in the past year. Now consider that every year in the United States hundreds of thousands of cardiac devices are implanted into patients during procedures or surgeries. These interventions are performed to open heart arteries, replace valves, or keep the heart beating, and all come at a significant cost to the patient -- financially and emotionally. Each of these implantable devices are accompanied by their own set of rules to follow: lifestyle changes, new medications, follow up visits, and important information about their device that is essential to their health and medical follow-up during visits or hospitalizations. However, while buying a four-dollar iced coffee can be made easier with a beautiful free app, these very expensive and lifesaving cardiac devices do not offer the same luxury.
What better use for an app, which you carry with you constantly, than to provide information about a device that is implanted in you permanently? For the nearly 100,000 valve replacement patients (and their health care providers), the yet to be developed MyValve app could show the size, model, and manufacturer of the valve, in addition to the implanting institution, name of the surgeon, reason for valve replacement (or repair), and information about their disease. There is already tons of information about the devices on these companies' websites so why not allow them to read it on their phone or tablet? Perhaps patients could connect to others who had, or will have, similar surgeries and share their experiences about their own diagnosis and recovery. #MyNewValve
Apps could serve similar roles for the estimated 500,000 coronary artery stents and tens of thousands of pacemakers, providing vitally important information and education to a new generation of patients who will be more informed about their treatment and have all the information about their own device at their fingertips, all the time. A "frequently asked questions" feature that addresses common concerns of patients after the procedure seems like something that should have been done long ago. Even simply having the name of the company who makes the pacemaker on someone's phone saves an inordinate amount of time and effort, since no one other than the patient and implanting physician possess that information.
The use of mobile devices and health-related apps have exploded over the past decade with the realization that smartphones have the ability to make our lives (and our health care) more efficient, safer, and more informed. However, those who undergo surgery today and leave the hospital with new valves, stents, or pacemakers do not receive an app. They do not even receive a DVD. Nope, with that incredibly sophisticated implantable device that may have saved their life, they receive a paper card for their wallet. A slightly thicker-than-normal-paper, wallet-sized card -- almost guaranteed to disappear during the discharge shuffle, never making it to its expected slot between the unused gift card and old frayed receipts. No reference material, no answers to frequently asked questions, not even general contact information in case of emergency. No helpful reminders that medication compliance is critical to survival. No ability to share with others that they just got a new valve or a stent or a pacemaker. #Unacceptable
So why do these apps not currently exist? The leading device companies gross billions of dollars annually and a quick search of the app store shows that they are making apps -- dozens actually, but very few made for the education of patients about their implant. Beyond the benefits to physicians and patients, an app that is stored on a patient's phone would have numerous benefits for the manufacturer as well. It would allow these companies to track patient data of all their customers, giving them a direct line of communication to market to them for future device needs or pharma partnerships. It also seems like a smart public relations move for your brand to be known as the company that cares about its patients and makes the extra step to provide additional educational support. Seems like a win-win.
So why not create apps for patients to keep track of their own device? The best answer seems to be that there is not a clear way to profit from it. Is it better for patients? Without a doubt. Does it make healthcare more efficient and safer? Absolutely. Would it empower patients and allow them more insight into their own care? Totally. But does it make money? Probably not, as I discovered when I brought this idea to all of my business-minded friends. Implantable devices are found in nearly every specialty and subspecialty. From the more than two million IUDs to the 700,000 knee joints, and every organ system in between, apps for implants need to be developed. (2)
So this is my call out to the cardiac device companies. The pacemaker manufacturers, the stent creators, the valve industry. It is time to meet the needs of patients and healthcare providers and it's time to do what is right for patients and health care providers and catch up to Starbucks. Discard the worthless pieces of paper in exchange for informative and empowering apps that measure up to the research and technology of today's implanted devices. Allow patients to share their experiences and build networks and learn about what is now a part of their body. Help healthcare practitioners feel more secure in their decisions to start or stop medications and spend more time on treatment and less time on chasing down old medical records from outside hospitals. Help patients remember that they need to take their medications every day and schedule their office appointments; empower device recipients by educating them about how their procedure was performed and what they can expect. This is not complex or farfetched, it is taking advantage of technology that already exists and content that's already there. It may not yield a direct profit but it will yield a healthier, more educated, more empowered society.
Source: Jordan Safirstein, MD, What the Medical Device Industry Can Learn From Starbucks, Life, HuffPost, December 6, 2017.