In 2014, a wildly popular MedTech app called the Instant Blood Pressure (IBP) app hit the market to huge success. Users downloaded this $4.99 app over 900 times a day for months, and rated it as one of the top 5 apps on the market consistently. IBP had users put their mobile phone on their chest while placing their finger on the camera to measure systolic blood pressure, which is one of the most basic and effective medical statistics to predict potential heart disease and stroke risks.
Problem was, it wasn’t accurate. In fact, this study reported that it was almost 80% wrong in standardized testing, and when this hit the news cycles and got the attention of the Federal Trade Commission (FTC), the app was quickly removed from the market the following year, and the founders were successfully sued by the FTC to what amounted to a total loss of all profit. Strangely enough, this isn’t the end of the story.
Another report released a year later sought to measure the satisfaction level of IBP users, even when they were aware of its inaccuracies. Many participants continued to approve of the app, citing ease of this medical app use as a plus. More tellingly, this app throughout its run consistently under-reported users blood pressure level; in other words, it gave the user the perception that they were healthier than they actually were. Despite the obvious danger presented to users who thought their blood pressure level was in a safe range, surveyed users showed far more satisfaction with these lower numbers, even when they knew they weren’t right. False good news was preferable to accurate higher levels, which is very disturbing to see.
It’s important to remember these approval ratings aren’t about a time-killing game or a news site; these refer to a crucial medical assessment that quite possibly could mean the difference between life or death. While this potentially harmful app was quickly shut down once its functionality was discredited, there are hundreds of thousands of MedTech mobile apps competing fiercely in the market. While there are many aspects of these apps to consider before development, accuracy and transparency need to be at the forefront of any development strategy. Here’s why.
MedTech App Compliance
When MedTech app developers hear the word “compliance”, the first response is HIPAA. Patient data security and privacy is highly regulated and protected on a federal level, so this is obviously a top priority. However, based on the IPB story reported on above, there must certainly be formal regulation on the accuracy and viability of these apps by now, right?
Well, not exactly. This release from the American Medical Association shows that while the medical community is definitely concerned about the quality and accuracy of all of these multiple apps on the market, they aren’t exactly able to precisely assess and regulate them. One quote from their report says, “While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns”. This is telling, because while the Food and Drug Administration’s exacting standards can reward MedTech mobile apps with valuable approvals, they simply don’t have the bandwidth to examine more than a few apps a year.
And while statements by the AMA that proclaim that new apps should “have a high-quality clinical evidence base to support their use in order to ensure mHealth app safety and effectiveness”, there’s still no comprehensive way to ensure quality and accuracy. App developers that go above and beyond to test and prove their product in a similar way that the FDA would demand should be recognized, and they would do well to promote and market them as such.
Trust and Quality When it Comes to Medical Apps
It could be argued that today’s app user is a bit more savvy and exacting than they were even four or five years ago when this IBP scandal broke. Any in-app experience that comes through as disingenuous or misleading can turn off plenty of users, no matter what niche it falls under. MedTech apps are no exception here, and if the app contains some sort of diagnostic tool, direct advice, or other expert feature, it needs to be vetted, tested, and approved before it hits the market.
Quality assurance should always be front and center to developing any type of app, as has been firmly established over and over. In addition to the general technical and UX performance of an app, special features unique to MedTech apps need to be examined and tested in a clinical setting to ensure its functionality. If you can get some major accredited professional association to approve and endorse your app, you enter the marketplace several steps ahead of the competition on credibility and reputation alone. Developers should start to connect with these organizations and foster and nurture these relationships carefully.
There’s a reason that trust and quality are in the same category here in this post. These two characteristics reinforce and support each other, one building off the other in a successful development and operational strategy. The difference is that quality can be assured and executed, especially with well-funded and concise development. Trust can’t be bought or formulated; it all depends on a quality product that’s accurate and tested, along with honest and transparent communication with users and professional organizations.
What’s the Takeaway?
The IBP case, and the resulting studies and findings, certainly presents several lessons to internalize. The immediate takeaway here is to make sure your leading feature has been extensively tested, approved by professionals, and works the way it should. The temptation to highlight positive results at the expense of accuracy is a real thing, but ultimately will do more harm than good.
Accuracy, trust, and quality are three aspects of a MedTech mobile app that should never be compromised or ignored. Make sure your app development partner appreciates and values these parts of an app as much as you do, and your strategy will be guided successfully.
Here at Koombea, we are experts at creating compliant MedTech apps. Reach out today for a free consultation!
