Marjan Chinnanpour is an Aurotech contractor for the FDA Innovation Lab. She is a mission-focused MBA professional with biomedical engineering background and over ten years of proven skills in managing special projects. During ACT-IAC 2018 Health Innovation Day Chinnanpour had the opportunity to demo the latest prototype designed for the FDA's Center for Devices and Radiological Health (CDRH). Chinnanpour joined Anton E. Dmitriev, Ph.D. (Division Director, Office of Science and Engineering Laboratories, CDRH) during his presentation to demo the IRMD Mobile Application (Image Recognition of Medical Devices).
What is your day to day like as a project manager for the Innovation Lab?
My day to day as a project manager... I'd say busy if I want to put it in one word. Under the FDA's Innovation lab project, we work on many prototypes. It’s called a project, but it’s more like a program with a lot of smaller projects which we do at prototype level. This project consists of doing Large and small prototypes, creating whitepapers, technology surveillance on emerging technologies, and lab support and operations. We help the FDA's Innovation Lab in holding workshops, Ask- the- Experts events, and special events such as "Innovate Today" and "Women in Innovation". My job is to manage all the tasks under this project to make sure the deliverables are getting delivered on time, keep the team happy, and the clients happy.
ACT-IAC 2018 Health Innovation Day Presentation Summary:
CDRH recognized the stakeholder’s concern around the technological challenges in bringing Unique Device Identification (UDI) to point of use for non-sterile implant devices and reached out to FDA Innovation Lab and requested development of a functioning prototype using image recognition.
The mobile app has the ability to scan and record surgical non-sterile implants and upload the implants’ UDI number(s) into the database (which can be integrated into Patient’s Electronic Health Record or EHR) at the time of loading the tray before surgery and reloading the tray after surgery. The mobile app uses machine learning to identify and record surgical non-sterile implants that are no longer present in the tray after surgery and provides a report of missing implants with their UDI number(s) and location. This report can be later integrated into patient's EHR and a copy can be submitted to the billing department of the healthcare facility. The mobile app also has a workflow for the tray assembler enabling the healthcare professional or vendor to scan each implant at the time of filling a tray before surgery and re-filling the tray after surgery and upload the implants’ UDI and location to a database which can be integrated into patient’s EHR.
What is the biggest challenge you ran into with this project?
Since this was a prototype, there were many challenges we had to face. The biggest challenge we had to resolve was perhaps getting the machine learning algorithm to an acceptable accuracy. Right now the algorithm is at 99.2% accuracy. In phase one, we were not able to reach this, but we succeeded in phase two.
The whole point of attending Health Innovation day is that we want to move this prototype to production. We would like to find partners in the healthcare space that would be interested in continued joint development of this project. If anyone would like to learn more, please contact Marjan Chinnanpour and she can facilitate an introduction with Dr. Dmitriev, CDRH primary investigator on the project, to go over more details. Marjan Chinnanpour can be reached at Marjan.Chinnanpour@aurotechcorp.com.
Learn more about the Benefits of IRMD Prototype below:
- Capture images of a loaded surgical tray before and after surgeryUse machine learning to detect the difference of the implants from the tray pre and post-surgery
- Provide a robust platform to capture images, because health care facilities vary and the setups are very dissimilar
- Provide a service to upload the Device Identifier information to the Patient’s Electronic Health Record (EHR)
- Scan each implant at the time of filling a tray before surgery and re-filling the tray after surgery and upload the implants’ UDI and location to database which can be integrated into patient’s EHR
Source: 4/27/2018 Phone Interview with Marjan Chinnanpour, Project Manager- Contractor for FDA Innovation Lab designed for Center for Devices and Radiological Health (CDRH) - the product owner.