Production Tracker

· Production progress and remaining work for the Lumimed pilot and planned builds.

Production Summary

The next step is a 30-unit pilot to check housing fit, assembly and packaging before building the balance. Eastek has confirmed material for the pilot; the revised orders and final build documents are needed to schedule it.

Key Production Components

1. Orders & Schedule

The first 1,000 units retain the earlier price of about $118 each. Later orders follow the updated quote and selected annual volume.

  • Finalize the two Rev A orders, including deposit credits and payment terms, then confirm the pilot and balance delivery dates. (Avery)
  • Confirm purchasing status and obtain the updated parts and lead-time list.
  • Reconcile contacts held by SmartShape or already shipped before ordering replacements.

2. Housing & Quality

The pilot will check fit and defects in the existing housings before production proceeds with the balance.

  • Review pilot results and decide whether future housings need tooling, snap-fit or adhesive changes. (Mark Cartellone)
  • Document fit acceptance criteria and the pilot defect count. Verify the sharp-edge tool correction and affected lots.
  • Confirm assembly and work instructions before building the balance.
  • Confirm the product-specific SGS audit alongside the first production build.

3. Packaging & Markings

Updated Direction A artwork is prepared.

  • Finalize the imagery and printer proof. (Adam)
  • Check box opening and the white corrugated insert during the pilot.
  • Finish manual formatting, labels, serial numbers and date-code markings before build approval.

4. Regulatory & Battery

Done: keep the current battery and its higher minimum order quantity.

The FDA pre-submission filing has not yet been verified.

  • Confirm the FDA pre-submission filing and receipt. (Avery)
  • Keep the pilot for internal evaluation. Commercial release remains subject to regulatory clearance.

Related pages: Market launch planning · Open item checklist · Parts shortage list · Shortage workbook

Inventory Management

Summary of Key Critical Parts and Status

Material is available for the 30-unit pilot. The June 9 shortage figures below are historical, measured against the original 500-unit build; current stock and committed arrival dates still need confirmation. Label quantities reflect component demand, not finished-unit count.

PartComponentJune 9 Shortage / StockStatus / Next Step
IMM0055Cone cap, white molded500 short; 0 on handReconcile the earlier 400+ housing-set stock report; confirm usable balance and whether a SmartShape mold run is needed.
MHW0075Heatsink, white molded425 short; 75 on handReconcile the earlier housing stock report and confirm the usable balance after the pilot.
LPL0007Light pipe, white molded12 short; 488 on handEarlier plan: draw from SmartShape buffer. Confirm buffer availability and balance supply.
IMM0057Charger base, white molded6 short; 494 on handConfirm stock against the current revision and the delivery date for any remaining shortage.
IMM0056Charger base bottom, molded6 shortConfirm current stock; include any remaining shortage in the next mold run.
IMM0048Cover cap, white molded5 shortCheck pilot fit and stock; include any remaining shortage in the next mold run.
BAT0002Battery, lithium manganese500 short; 0 on handEarlier Pytes end-of-life notice led to a BFN alternative proposal. Later decision: retain the current battery at its higher minimum order quantity; confirm supply.
PCBA0008-1Main board, SMT420 short; 80 builtComplete remaining boards as parts arrive. Confirm pilot assembly/test results and balance supply.
CON0007Connector FFC 4-pos 1mm432 shortConfirm spot-buy availability or a suitable equivalent, and a committed arrival date.
INS0004Owner's manual500 shortEarlier artwork pack supplied to Eastek. Content prepared; finish formatting and release approval.
LBL0009Charger information label1,000 shortEarlier artwork pack supplied. Confirm current label/marking revision and release approval.
BOX0109Top/bottom set-up box500 shortQuote and die cuts were on file with a 6-8 day lead time. Reconfirm timing after final artwork, opening-fit check and printer proof.