2. Glossary of NPI Terms
PET Positron Emission Tomography; type of medical imaging used to observe
metabolic processes
Linac Linear Particle Accelerator; beam that kills the cancer
CT Computed Tomography; type of medical imaging that utilizes X-rays
NCR Non Conformance Reports; stores inventory discrepancies
DHR Device History Records; documents any work done on the Alphas
PCBA Printed Circuit Board Assembly
Alpha # Actual working machines that are used for testing; currently 5 Alphas
Arena Computer program that helps organize product information
3. What is refleXion?
-Innovative medical device company located
in Hayward, CA
-Around 150 employees
-Has three buildings
-Utilizes biology guided radiotherapy (Bgrt)
-Combines PET, Linac, and CT
-Treats cancer real time
-Effectively treats cancer at any stage
Suite 275
4. Our Roles and Responsibilities
-Shadowing and working with the NPI (New Product Introduction) Team
-Seated on the manufacturing floor
-Working with PET scanner
-Construction of machine parts
-Documentation of inventory
-Reviewing over Device History Records
5. dosimetry badge
(required to wear for
radiation protection)
where we walk in every morninguse our badges to
enter all the buildings
In the Morning
6. Where We Sit
-Sit in our own cubicles (we are neighbors) in the manufacturing building
-Received mug, books, t-shirt, notebook, pens, water bottle on first day
-Received our own laptop computers
-Received a cute little bamboo plant to water daily
8. The Machine
-Diagnostic tool for cancer treatment
using PET, Linac, and CT
-Locates hard to find tumors using specific
radiotracers
-Not yet commercialized
-Goal: to be in every cancer treating hospital
across the country
9. Alpha 1 in comparison to a
human.
Fun Fact: The Alpha machines
weigh about 15,000 lbs.
10. PET Scanner
- Deconstructed an old PET Scanner used in one of the machines (Alpha 1)
-Grounded ourselves with wrist straps for protection from damaging the
computer boards with our human electric charge
-Took off wires, screws, nuts, bolts, and large metal components
-Reconstructed the PET Scanner with new wires and electrical tape
-Learned more about what the PET Scanner role and location in the machine
and how it detects the radiation on the patient
12. Ray-Gen Interface
-Followed instructions on how to build the box
- Wrote our signature after completing a procedure on traveler
-Put PCBA, nuts, screws together while using Loctite (glue) and a torque driver
-Looked for any mistakes in the directions that need to be revised to make it
simple for someone who has never built this part before
-Once completed, handed box off to a QA (quality assurance) person
15. Inventory
-Checked inventory stock
-Made sure part numbers were in order
-Noted down the inventory in our notebooks that was
low and needed to be restocked
-Relabeled any boxes with missing part number labels
-Emailed the senior buyer/planner of inventory stock
to order new parts
storage cart
16. Device History Records (DHR)
-Reviewing DHR from 2017
-Comparing to DHR that was recently made
-Worked on Alpha 1, 2, 3, 4, and 5 binders
-Updating part numbers/information in Arena and Excel
-Creating a table of contents for Alpha 1, 3, 4, and 5
using PCIR and hardware configuration tables
17. NCR (Non Conformance Report)
-Stores records of inventory stock with their status (completed, intransaction,
etc..)
-Use Arena to look up certain inventory
-Copy and paste information (supplier name, cause code, area of
nonconformance occurrence, initial defect code,primarily deposition, final
disposition, date created, date closed) into Excel spreadsheet
-Email completion to manager of QA (quality assurance)
18. Other Activities Trainings
Assisting an IT intern -New hire orientation
-Used drills, drivers, nuts, and bolts -SNMMI Lunch and learn
to hang up clocks and whiteboards in -FDA lunch and learn
the new conference rooms -Radiation safety lunch and learn
Team Lunches -DHR training
Witness Machine Testings -NCR training
Ice Cream and Chocolate Parties -Arena training
RefleXion’s Welcome Summer Picnic Listening in on Meetings
Learned where our colleagues went to school and what they majored in
19. Special Thanks to
Abraham Mendoza
Jessica Porter
Mercedes Tolliver
Marcus Bellini
and the whole NPI Team
snack cart raid!!
