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The Challenge of FDA Clearance

Posted on March 16, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

As I’ve talked to 100s of companies creating devices for healthcare, there’s inevitably the question: “Are you FDA cleared?” There answer usually tells me a lot about the company and what their goals are for the product. Generally, it’s a question of if they’re going to go after the consumer space (ie. no FDA clearance) or after the medical market (ie. FDA clearance preferred).

In a few cases, I’ve talked to companies like EarlySense that have an FDA cleared product for hospital beds and a non-FDA cleared product for consumers. It was interesting to hear the reasons why they chose to release a non-FDA cleared product for consumers since they already knew they had the capability to go through the FDA clearance process. Their answer to me was instructive.

The core of their response was that FDA clearance is not a one time event and so this limits their ability to iterate and release product updates.

For anyone working in the startup world, it runs completely counter to the startup culture. The idea of iterating quickly and often is part of the mantra of most startup companies in silicon valley and now around the world. The FDA’s clearance process runs almost completely counter to this idea.

With this type of restriction, it makes sense why so many companies would avoid FDA clearance and just create a direct to consumer product that doesn’t require FDA clearance. The ongoing FDA clearance requirements can be a bear. What company wouldn’t want to bypass it and just iterate as they please?

The challenge with this approach is that there are reasons that FDA clearance is so challenging. First, it searches to provide a level of safety as far as what’s being implemented and the results of the device actually being tested and confirmed. Second, it creates a trust that most doctors (and their malpractice and insurance companies) want to see before using it.

Certainly, we could argue about how effective the FDA clearance is about ensuring safety and results, but that’s a topic for another day. If nothing else, it requires many organizations to think deeply about what the safety of the patients that are impacted by the device and consider the promises they make to customers. Those are two things that are missing in my consumer health devices and apps.

It’s a tough balance and I don’t think we’ve fully figured it out. How do you ensure safety and efficacy while still allowing the entrepreneurial spirit of innovation to thrive?

Digital Therapeutics

Posted on May 22, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Here’s a new term for you to consider: digital therapeutics. I guess I could add it to the list I polled about earlier: Digital Health, Connected Health, Wireless Health, Mobile Health, and Telehealth. By the way, the poll results are showing a mix basket when it comes to using these terms. Digital Health leads the way with mobile health following pretty closely behind and connected health with quite a few votes.

I don’t think adding digital therapeutics to the ring helps to clear up the confusion of terms, but I think it can open us open to a new way of thinking when it comes to how we use digital in healthcare. I’ve long loved the idea of prescribing an app and digital therapeutics is along those same lines. Can we prescribe a digital therapy that will help improve a patient?

Since we’re throwing out new terms that stretch our thinking, how about the ideas of digital chemistry and digital biology. I like these because they suggest a rigor in their study and understanding like you might see in chemistry and biology. I think it’s fair to say that the very best healthcare IT companies are going to be digging into the digital chemistry and digital biology world.

Once you start digging into these areas though, you better be ready for the FDA regulation that comes with therapeutics. I’ve written quite a bit about EHR and FDA regulation and this is why I don’t think EHR vendors will be digging into this type of digital therapeutics. Instead, I think the EHR will stick to being the database of healthcare.

In a recent video interview I did with Alan Portela, he made a really good point about the transition to really smart mobile health technologies that start to suggest treatment (some might call that a shift to digital therapeutics). The problem with many mobile health technologies that have avoided FDA clearance is that they won’t be able to do digital therapeutics. It will take a company that’s FDA cleared and understands that process to put these type of digital “treatments” into place.

I’m excited about the potential for digital therapeutics (or whatever word you prefer). This will change the way we look at healthcare and that will be a very good thing.