Posted on September 28, 2017
It shouldn't come as a surprise that software, not just "dumb" devices, will play a significant part in shaping the future of healthcare.
Earlier this year, the FDA announced that they were creating a pre-certification pilot program under its Digital Health Innovation Action Plan and would announce a select group of companies who would pilot the program.
During his keynote at the AdvaMed MedTech Conference, FDA Commissioner, Scott Gottlieb, M.D. announced the 9 companies chosen to be part of the pilot program out of over 100 applicants.
- Johnson & Johnson
What is goal of the program?
The FDA has had an image problem when it comes to approval timelines. With the iterative nature of software development, slow approval would be prohibitive to many companies, like Apple, who have the ability to develop life changing products for consumers. Therefore, a change to the FDA processes was necessary in order to fuel healthcare innovation with digital software.
The companies participating in the pilot program are going to help the FDA make these necessary changes and narrow down "key metrics and performance indicators for precertification" with regard to a company's digital health software.
Some of the key metrics and indicators looked at under the pilot are to inspect pilot companies facilities to ensure they meet quality standards and have the capabilities to adequately track their products once on the market. Once these companies pass the agency audits, they would be pre-certified and would face a less stringent approval process or potentially not have to go through the FDA approval process at all.
“Our team will be spending the rest of the year working closely with these companies to deepen our understanding of their technologies and their operations and methodologies,” Gottlieb told attendees during his keynote. “This collaboration is a key part of establishing the proper regulatory framework.”
"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb. "We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
What this means for consumers
Many of us already use wearable devices and apps that track heart rate, yet most of these devices do not have the FDA stamp of approval.
While most of the apps on the market do not require FDA approval, more sophisticated software that allows consumers to track more specific medical conditions will need oversight. This program will allow the FDA to get out in front of a coming wave of software development to monitor and asses medical conditions.
Software is key to this program because the FDA isn't looking at individual devices made by these participating companies. Rather, the FDA will consult with Apple, Fitbit, and others about what aspects should be included in a company's digital health software in order for it to be "pre-certified."
The future of medical devices in healthcare is less about physical products and more about software. The FDA should be applauded for recognizing this.
What this means for companies like Apple?
For one, Apple and other companies will be motivated to develop software now that the process will be more defined.
The motivation wasn't always there for companies like Apple.
For example, Tim Cook previously said that the lengthy FDA approval process was one reason for letting their app partners create more complex medical tracking with the Apple Watch.
"We don’t want to put the watch through the Food and Drug Administration (FDA) process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else.”
With a program now in place, a company like Apple can deploy, or hire, software engineers to tackle different medical conditions.
They are already off to a quick start.
Apple recently announced an upcoming study with Stanford University to test whether the Apple Watch can detect cardiac abnormalities like atrial fibrillation. Additionally, their new WatchOS 4 has advanced heart monitoring that alerts you if you have an elevated heart rate but don't appear to be active.
In an interview with Fortune, Cook stated:
"We started working on the Apple Watch several years ago," he said, and one goal was "performing some measurements of your health that people were not measuring, at least continually. Like your heart. Very few people wore heart monitors. We're extremely interested in this area. And yes it is a business opportunity."
Programs like this change the mindset of companies like Apple who have the intellectual capabilities in place to create significant software applications for devices they currently manufacture.
The discussion has very much revolved around traditional software companies like Google and Apple but there are also companies in the pilot program like Johnson & Johnson and Roche who are not thought of as software companies.
This digital revolution will only benefit consumers as traditional medical device and pharmaceutical companies will now be forced to compete to attract and hire talented software engineers to pave the road in digital health. Companies like Medtronic and Apple will compete, but there will also be exciting collaborations, such as the Google and Johnson & Johnson partnership, Verb Surgical.
There is a revolution in healthcare coming and it is exciting.