Manufacturing Implementation
Technology The Zif syringe is designed to be manufactured on existing syringe equipment. Thus, Zif will use the following existing technologies to manufacture syringes: Clean room manufacturing environment Plastic Injection Molding Vertical continuous-motion rotary syringe barrel printing High speed spring winding Continuous motion rotary syringe assembly Horizontal continuous packaging equipment
Zif Medical Devices
Zif will work with contractors and/or licensees to integrate these technologies into a streamlined manufacturing process that will make use of Just-In-Time principles. This arrangement is proven to provide the greatest quality at the lowest cost. Additionally, this process will allow Zif and its partners to operate with very low inventory levels, low overhead costs, and with excellent space utilization. Syringe manufacturing is a complicated, but well established in its field. Six individual pieces, as shown below, must be manufactured or sourced, then printed, assembled and packaged in an efficient manner. Buy/Source Decisions The specific part buy/source decisions are as follows: Plunger Tip, and needle: purchased parts Barrel, Sheath, Plunger: purchase molds and use custom molder Spring: purchase spring winding machine to integrate w/assembly Printing: leverage w/existing player Assembly: leverage existing player's equipment Distribution: partnership
Project Implementation The manufacturing plan will be implemented in three phases (also refer to Timeline page 18): Phase I : Prototype, Patent, and Apply for FDA Approval (Options #1 and #2) This includes filing for patent protection, applying for FDA approval, and developing small scale production for field testing and promotions. Upon completion of Phase I, managers and investors will determine whether to pursue the licensing option (Option #1) or continue on to Phase II. Phase II : 3cc Production Line (Option #2 Only) This phase is designed to begin full-line production with a minimal capital investment. This includes the purchase of specialty spring winding equipment, and plastic injection molds for the syringe barrel, sheath, and plunger. The plastic molding of the syringe parts will be contracted out to a custom molding company. The printing and assembly of the syringe will also be contracted out. Zif will work as the management tie between the contract manufacturing, and the distribution partner(s).
Phase III : 1cc Production Line (Option #2 Only) Positive cash flow from the first line will be reinvested into line #2. This phase duplicates previous efforts to develop and commercialize a 1cc version of the Zif safety syringe. See timeline for details.