Expert Guide to FDA Approval for Healthcare IIoT Solutions

An Interview with Tracy Rausch, CEO of DocBox

During a recent Object Management Group event in Boston focused on End‑to‑End Quality Management in Healthcare, I had the opportunity to speak with Tracy Rausch, the CEO of DocBox. Over the past decade, DocBox has championed efficiency in healthcare by democratizing data through a blend of hardware, software, and analytics. Their journey from concept to commercial product offers valuable insights into navigating regulatory compliance in today’s connected‑health landscape.

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

Regulatory Landscape: Hardware, Software, and the FDA

David: When developing a product for FDA submission, it needs to be a complete system—hardware, drivers, and software. DocBox and others are moving toward app‑based solutions that can run on various platforms. How will the FDA handle this shift?

Tracy: The FDA has been accepting off‑the‑shelf computing devices for over a decade. Historically, you needed to set and meet hardware requirements to gain approval. The new Mobile Medical Applications guidance now decouples software from hardware, allowing FDA approval of the app independent of the device, provided the hardware was already approved.

David: What is the name of this guidance document?

Tracy: It’s called the Mobile Medical Applications guidance. It’s the first document that separates application software from the platform. Decades of work, including a 2010 de novo filing by Partners Healthcare and MD PnP, led to this guidance. The FDA’s responses to pre‑submissions are publicly available and offer a clear roadmap.

The FDA’s mandate is to prove your application is safe. There is no rigid checklist; the agency evaluates risk and efficacy. Guidance documents help shape your approach, but ultimately you decide how to demonstrate safety.

Pre‑Submission: The Key to a Smooth Approval Process

David: Any advice for the RTI development community on FDA approval?

Tracy: Engage the FDA early through the pre‑submission process—a free, structured dialogue that lets you align your project with regulatory expectations. Most companies miss this opportunity. At DocBox, we conducted three pre‑submissions, openly sharing our regulatory plan and design rationale. While the FDA may challenge your assumptions, their feedback is invaluable for ensuring safety and effectiveness.

Prepare a robust regulatory plan before the meeting; the pre‑submission is not a brainstorming session but a chance for targeted feedback. Approach it with an open mind, and you’ll leave with a clearer path to compliance.

Speed of Innovation vs. Regulatory Rigor

David: In consumer apps, updates happen every 3–6 months. In healthcare, the cycle is slower. How can companies accelerate their release timelines?

Tracy: The FDA isn’t a barrier but a safeguard. By building a solid quality system and engineering safety from the outset, you reduce rework and streamline testing. While typical refresh cycles may be 6–12 months for medical devices, a well‑structured process can approach the agility of consumer markets.

Key Takeaway

“If you take advantage of the systems that help build good software, maintain a strong quality system, and engineer safety from the beginning, you won’t encounter major obstacles,” Tracy emphasized.

For more details on DocBox, see the RTI Customer Snapshot. To learn more about RTI or Connext DDS, visit RTI Healthcare.