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4 min read

Navigating Regulatory Approval for Healthcare IIoT

Navigating Regulatory Approval for Healthcare IIoT

An Interview with Tracy Rausch, CEO, DocBox

Recently, I attended an event in Boston produced by the Object Management Group on the topic of End-to-End Quality Management in Healthcare. While at the conference I was able to connect with Tracy Rausch, CEO of DocBox. For the past 10 years, DocBox’s mission has been to drive efficiency in healthcare through the democratization of data. Their combination of hardware, software and analytics aims to arm healthcare providers with more actionable information than ever before. As a part of the journey from concept to commercial product, Tracy and the DocBox team have learned a lot about the regulatory process. This blog shares their lessons learned for regulatory compliance in the age of connected healthcare.

NOTE: The content below is a transcript of our conversation (edited with permission for length and clarity).

David: In my experience, when you’re developing a product and looking to submit it to the FDA, it needs to be submitted as a complete system. Hardware, lower level drivers, application software, the complete system. DocBox and others are now taking the medical device world down a path we have seen in many other industries already: A world that is app based. A world where these apps can live on a variety of hardware platforms. Do you have any idea how the FDA is going to handle this direction? Or is that another challenge to overcome?

Tracy: The FDA has accepted off-the-shelf computing devices for a decade now. Historically for acceptance, you had to set requirements and show that you met those requirements as a solution. If you completed this process, generally the FDA had no issue. The mobile medical app guidance is the first piece of guidance that actually decouples hardware and software and allows FDA approval of software independent of hardware as long as the hardware was previously approved.

David: What is this guidance document called?

Tracy: It’s the Mobile Medical Applications document. As I mentioned earlier, it is the first guidance that actually decouples application software from a platform. There has been substantial work on this over the past 10 years. Dr. Julian Goldman of Partners Healthcare / MD PnP actually worked with MDIS and others for a community-wide de novo admission after an FDA meeting in 2010 about device interoperability. They went through a de novo filing of a platform-based medical device as a research project. They filed pre-submissions, held formal meetings, and received a positive response from the FDA. It is all publicly available and provides valuable information for a better understanding of what is required.

The FDA requires you to prove that your application is safe. The FDA doesn't have a template - nor should they - that says ‘check these five boxes and you are approved’. The FDA is looking at risk, they're looking at efficacy of the solution. The FDA provides guidance documents to help guide your thinking, but one thing that has not changed is that it's really up to you on how you want to prove to them that your solution is safe.

David: That’s great information to know Tracy! Any other advice you have for the RTI development community with regard to developing a healthcare application and getting it approved by the FDA?

Tracy: I think the biggest thing I encourage companies to do, is to have an open dialogue with the FDA via the FDA pre-submission process. I am constantly amazed how few people take advantage of this free process that allows you to discuss your application with members of the FDA prior to starting your project. This will ensure that you are looking at your application from the view of the regulators before you get too far down a path. I have to warn you: Be prepared, you may not like what they have to tell you, but they're going to tell you what you should do and how it should go forward.

At DocBox, we’ve been through three pre-submissions with the FDA. We went in and said, “Is this what you meant? Is this what you wanted to look at? This is how this is going to work, and here is our approach to doing this going forward.” We were open and transparent, which is not always the approach most organizations take with the FDA.

If you want to take full advantage of the pre-cert system, come to the meeting with a regulatory plan. Do not show up and expect to design a regulatory plan on the spot. This is a place to get feedback, not hours of free consulting. Come with an open mind and listen. I guarantee you will leave with a better understanding of answering, “how to make sure this is safe for the public and how to ensure it is effective. ”

David: That's some pretty solid advice for any software products, apps or even hardware devices going to market. The pre-submission process sounds exceptionally useful.

Another topic I wanted to get your thoughts on is the speed of refresh cycles in healthcare as opposed to other industries. It is common to update consumer-focused apps every three to six months. In healthcare as I know it, that is not the case. Do you see any process improvements at the FDA that will allow companies focused on apps to speed their time to market and make it easier to update their app on a more regular basis?

Tracy: Everyone believes that the FDA has always been the barrier to entry, but that's really not the case. If you take advantage of the systems put in place to help build good software, under a good quality system, and engineer safety into the system from the beginning, you really won’t have any problems. Yes, it takes longer and yes, there is more testing required, but you have to remember these are medical devices. So, we may not get to typical three-month refresh cycles, but six- to twelve-month cycles are reasonable.

David: Tracy, I really appreciate the advice you shared today, which is invaluable to the RTI Connext Community and to the extended healthcare market.

I hope you enjoyed hearing directly from the CEO of DocBox, Tracy Rausch, about how she and her team approach the development of a regulated medical device. Tracy summed it up best when she said, “If you take advantage of the systems put in place to help build good software, under a good quality system, and engineer safety into the system from the beginning, you really won’t have any problems.” If you would like to learn more about DocBox, check out the RTI Customer Snapshot here.

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