Professional Documents
Culture Documents
15x4 +
4 16x4
No Updates to our Design Specifications
Specification Metric
Cost of Development < $10,000
Number of Available Recording
64 channels per PCB - 512 for 8 stacked PCBs
Channels
Channel Functionality 64/64 channels function properly per PCB
# of PCBs that can be stacked 8 PCBs with one headstage (512 channels total)
Any redesigned PCB must remain compatible with the current
Headstage compatibility
stackable HS-640 E-cube headstage system
Time to manufacture 1 functional PCB
< 1 hour
(64 channels)
Single PCB mass < 5 grams
Single PCB length < 10.4 mm
Single PCB width < 10.9 mm
Single PCB height < .68 mm
Electrode Biological Response No glial scarring around carbon electrodes
Electrode Functional Time Course Electrodes must be able to record properly for longer than 1 year
No Updates to Gantt Chart
Updates to our Team Roles
FDA, U., & Food and Drug Administration. (2018). CFR-Code of Federal
Regulations Title 21. Chapter I, Sec, 312, 21.
PVA Fiber Coating Validation Plan
Assay measuring the improved handling of the fibers during insertion into the
alignment grid and/or PCB.
Qualitative assessment based on testimony from Hengen lab members.
If technicians cannot differentiate between the handling of coated and uncoated
fibers, then the PVA coating will be abandoned
Rules and Regulations
Title 21 Article 3 of FDA codes: PVA can be used as a coating up to 6%
Our coating is only 5% and will not be used in Humans so our PVA can be used
without concern for regulations.
Platinum (in our PCB) does have special regulations as per FDA Title
21.
Small amount used in our PCB does not qualify for regulation
Additionally, our PCBs are not for use in humans
“Straight from manufacturer to bench”
Our CFMEAs are not for human use so this limits the regulations we must follow
FDA, U., & Food and Drug Administration. (2018). CFR-Code of Federal
Regulations Title 21. Chapter I, Sec, 312, 21.
Other Proof of Concept Testing
Deep Reactive Ion Etching (DRIE) of Grid
adapted from Maharbiz et al.
500 µm thick wafer was trialed at the WashU
Clean room
Only 193.8 µm were cut away
However, low precision, slow speeds, and high
cost of DRIE led us to choose 3D printing as
primary fabrication method
Patel, P. R., Na, K., Zhang, H., Kozai, T. D. Y., Kotov, N. A., Yoon, E., & Chestek, C. A.
(2015). Insertion of linear 8.4μm diameter 16 channel carbon fiber electrode
arrays for single unit recordings. Journal of Neural Engineering, 12(4), 046009. doi:
10.1088/1741-2560/12/4/046009
Maharbiz, Michel M, et al. “A High-Density Carbon Fiber Neural Recording Array
Technology.” BioRxiv, Cold Spring Harbor Laboratory, 1 Jan. 2018,
www.biorxiv.org/content/10.1101/320937v1.
https://www.mdpi.com/2072-666X/9/9/430/html
FDA, U., & Food and Drug Administration. (2018). CFR-Code of Federal Regulations
Title 21. Chapter I, Sec, 312, 21.
Questions?