Non-Invasive Device for Early Detection Of Alzheimer’s
Delays in Development Put Clinical Trials Milestone at Risk
Medical technology company required full SDLC support to develop advanced diagnostic system to aid in early detection of Alzheimer’s disease.
The unique combination of MedAcuity’s technical expertise in design and implementation of complex software for embedded systems and understanding of workflow ensured client’s new device was ready for clinical trial submission.
project snapshot
SITUATION
- Small start-up company looking to develop a non-invasive laser scanning device for the early-detection and diagnosis of Alzheimer’s disease
- Developing a camera-like device to produce high quality images capable of detecting the amount of beta-amyloid in a patient’s eye
Challenges
- Lack of proven expertise internally in developing complex software that is safe, secure and reliable while also meeting stringent FDA regulations
- Identify the root causes contributing to poor image quality and uncover required features to improve image quality
SOLUTION
- Comprehensive experiments on various camera features resulted in implementing new brightness and contrast features to the device’s settings library
- MedAcuity engineers completed hazard analysis, refined architecture and design, performed software implementation and system verification
Results
- MedTech company went to clinical trials and collected usable images on which to conduct scans
- From the scans, data could be collected and analyzed in order to detect the beta-amyloid measurements in patients who have signs and symptoms consistent with Alzheimer’s disease
- To date, the beginning stages of the project have been successful, and development is ongoing to further improve the promise of this new device for the early detection of Alzheimer’s