Improving Diagnostic Techniques in the Middle Ear
For PhotoniCare
Testimonial
Innolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance. The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.
Project Description
PhotoniCare has developed the first method to non-invasively visualize the middle ear, where the infections live. Their TOMi™ Scope has embedded software that provides doctors with a simple, easily used device that internally implements advanced signal processing and real time imaging.
Because of safety and regulatory concerns, developing firmware for medical devices requires a tight, visible, and well documented engineering process. At the same time developing a new product for a new company retains all the needs for quick, flexible, and robust solutions to problems as they appear. We have met that challenge with PhotoniCare, assisting them with several aspects of their device.
The user interface was designed with an iterative process that honed in on a final design that was both easy to use and fully functional. The instrument has two displays, a base unit and a handheld unit. We designed the user interface for both, making sure they worked smoothly together. We used our medical experience to ensure the device would allow doctors to keep a smooth work flow. The pediatricians and ENTs involved with trials have been enthusiastic about the design and are eager to use it in their clinics.
A user interface is more than just the displays, and includes manuals and labeling. We also contributed to the TOMi™ Scope user manual.
A key feature of the TOMi™ Scope is its ability to see behind the ear drum into the middle ear. The desired information is embedded in the data flowing back from the handheld instrument. But extracting the information is a non-trivial process. We helped in the design and testing of the extraction algorithm. We also put together a user interface to allow factory technicians to calibrate and tune each instrument to best performance.
Proper process and documentation are needed to meet regulatory requirements. We have developed a documentation generation tool that has greatly assisted us. (See Regulatory Documentation Manager). We architected the PhotoniCare firmware and provided complete design control documentation. This enabled us to:
- Provide a regulatory strategy with regards to HIPAA compliance.
- Develop the device using ISO62304 compliant software development processes.
- Handle cyber security concerns (both for HIPAA and to meet FDA Guidance documents).
- Help perform software risk assessment to comply with ISO14971.
- Streamline the documentation generation process.
We helped develop a software development process that was appropriate for PhotoniCare’s size, keeping the regulatory burden down to a minimum.
Testing is always critical with embedded systems. In addition to safety concerns, discovering an untested flaw means having to update shipped systems. That both burdens the user and potentially damages the company reputation. To reduce the likelihood of that, we put together an automated testing system. The C++ UI framework we used did not provide a streamlined end-to-end testing framework, so we developed our own framework that simulates a user stepping through various work flows. These work flows are then checked for compliance with design specifications. The system can also capture screen shots from the tests for use in documentation. In addition the automated testing system also includes substantial unit testing to verify that the building blocks of the design all work as intended. We augmented the automated test system with manual tests that flow into regulatory compliance documentation.
We also put together a software update system that will allow field update of instruments while retaining their factory calibration. The system has to be available to end users while not introducing cyber security risks.
Our team has a wide range of experience with software and medical technologies. For this project we leveraged our understanding of tools and languages such as C++, Cmake, SWUpdate, Bash, and googletest. We leveraged our understanding of operating system internals to properly configure the embedded firmware to meet design requirements.
