Pedi Slideshare

1,363 views

Published on

Injection Molding for the Medical Device Industry

Published in: Business, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,363
On SlideShare
0
From Embeds
0
Number of Embeds
7
Actions
Shares
0
Downloads
20
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Pedi Slideshare

  1. 1. Injection Molding & Manufacturing<br />
  2. 2. <ul><li>1985 Plastic Engineering and Development, Inc. (“PEDI”) is formed in Carlsbad, California
  3. 3. 1989 R. Witchey purchases the assets of PEDI via Witco (C-Corp).
  4. 4. 1996 Company relocates operations to current building – design built specifically for plastics manufacturing
  5. 5. 1996 PEDI achieves ISO 9001 certification
  6. 6. 2001 J. Sparacio hired as President and CEO
  7. 7. 2003 Facility registers as Medical Device Establishment with the U.S. Food and Drug Administration
  8. 8. 2004 PEDI achieves ISO 13485 certification
  9. 9. 2009 Acquires Emergent production assets and signs proprietary manufacturing, distribution and servicing agreement with Bound Tree Medical, LLC
  10. 10. 2010 Providien, LLC, funded by Endeavor Capital, acquires PEDI</li></ul>PEDI Timeline<br />
  11. 11. <ul><li>A Phoenix, AZ based holding company focused on acquiring small companies that provide contract manufacturing of medical devices.
  12. 12. External funding by Endeavor Capital a Portland, OR based company and has committed $75 million to Providien
  13. 13. Acquired to date
  14. 14. Specialty Manufacturing, Inc. a pressure former of plastics based in San Diego, CA
  15. 15. PEDI a plastic molder contract manufacturing based in Carlsbad, CA.
  16. 16. Providien is managed by Jeffrey Goble and Charles Stroupe.
  17. 17. C. Stroupe was CEO and J. Goble, President of Medegen, LLC an Ontario, CA based company of disposable intravenous therapy products
  18. 18. Medgen was acquired by Carefusion Corp., a San Diego, CA based company for $225 million in April, 2010.</li></ul>PROVIDIEN<br />
  19. 19. Management Team<br /><ul><li>Jack W. Sparacio – President – Business Development - 25 years experience in healthcare. Formerly with J & J, American Hospital, served as General Manager of V. Mueller, Executive V.P. of Advanced Technology Labs, President & CEO of IMED Corporation and Lang Manufacturing.
  20. 20. James Bennett – Vice President Operations - 30 years of various and progressive operational experiences in Plastics and Medical Manufacturing firms. Experience includes management in Administration, Manufacturing, Regulatory Affairs/Quality Assurance, Equipment-Facilities Maintenance, and Tooling. Directive responsibilities also include Engineering, Warehousing, Distribution, Assembly, and Human Resources.
  21. 21. Dick Manson - Sales Manager - 25 years experience in plastic and metal injection molding sales and marketing. VP of Sales & Marketing for Guest Supply Inc., Director of Marketing, Cairns Brothers, Inc. and VP of Sales with Injectamax Injection in Escondido, Ca.</li></li></ul><li>Management Team<br /><ul><li>James O’Connor - Engineering Manager- 20 years experience in engineering, quality, engineering design and product development for Cubic Defense, Easton Sports and Sanyo Energy.
  22. 22. Rob Gilman - Plant Manager- 25 years of tooling, manufacturing, and injection molding experience.BSE Degree, Cal State Poly and AA degree in machine tool technology. Certified Toolmaker. Formerly, Engineering and Operations Manager for Trademark Plastics.
  23. 23. Bob DePew – Senior Account Manager - Over 25 years of manufacturing and injection molding experience, featuring PCB Contract Assembly, Sheet Metal Fabrication, CNC Machining, Fiberglass & Composite Molding, Prototyping and Pre-Production Services as well as Operations experience.</li></li></ul><li><ul><li>Fully Collaborative Manufacturing Partner
  24. 24. From Concept to Distribution
  25. 25. Highly Competent Engineering Capability – consult on product design, FDA qualification, tooling design and cost reduction strategies for customers
  26. 26. Tooling design and outsourcing of tooling fabrication both foreign and domestic
  27. 27. Ability to Solve Tough Product Issues: examples are work with exotic resins (PEEK), tight tolerances (Aurora) and Emergent with roughly 150 components in final product that must be tested before shipment</li></ul>General Capabilities<br />
  28. 28. General Capabilities (cont.)<br /><ul><li>Full logistics capability – warehousing of product, maintaining SKU’s and direct shipments e.g. Emergent, Kirby, Ivera Medical
  29. 29. Collaborative relationship with Integra Bio in Tijuana, MX for outsourcing of high labor content assembly
  30. 30. PEDI is the virtual manufacturing and warehouse company for medical start-ups such as Ivera, Auroa, Venetec, and Access Scientific
  31. 31. Aftermarket services - testing and warranty work for Emergent CPAP devices</li></li></ul><li>Systems and Infrastructure<br /><ul><li>Operations Supported by Quality Certification and Registrations
  32. 32. ISO 13485:2003 (medical devices)
  33. 33. FDA and State of California registered production facility
  34. 34. Class 8 (100K) Cleanroom and White Room Product Environments
  35. 35. Ancillary Operations to Complement the Manufacture of Plastic Components – automation and robotics</li></li></ul><li><ul><li>Medical
  36. 36. Biotech
  37. 37. Life Sciences
  38. 38. Recreation
  39. 39. Connectors
  40. 40. Pro Audio
  41. 41. Aerospace
  42. 42. Industrial
  43. 43. Electronic
  44. 44. Irrigation</li></ul>Industries Served<br />
  45. 45. Our Facility<br /><ul><li>50,000 sq.ft. custom designed injection- molding facility (ample room for expansion)
  46. 46. 5,000 sq.ft. Class 8 clean room
  47. 47. Clean room assembly and packaging area
  48. 48. Custom Customer Cells
  49. 49. White Room Assembly and Manufacturing
  50. 50. 28 Toyo, Sumitomo & Toshiba injection-molding presses, 18 ton to 500 ton, 10 in clean room
  51. 51. Vacuum-fed material handling system
  52. 52. Video CMM</li></li></ul><li>19 Molding machines with mobile enclosures for added cleanliness<br />Commercial molding floor<br />
  53. 53. White room assembly facility with testing<br />Our modular assembly facility can be configured to meet customer manufacturing requirements<br />
  54. 54. Clean Room Molding with assembly automation<br />
  55. 55. Clean Room Production<br />Automation reduces operator interface<br />5,000 square foot Class 8 Clean Room<br />
  56. 56. Operators check the parts against the quality requirements<br />Clean Room Molding Cell<br />
  57. 57. <ul><li>Product Design Assistance
  58. 58. 3-D Solid Modeling
  59. 59. Mold Design
  60. 60. Mold Flow Analysis
  61. 61. Mold Construction and Project Coordination
  62. 62. Electronic File Transfer
  63. 63. Material Selection
  64. 64. Product & Process Validation</li></ul>Full CAD Engineering<br />
  65. 65. Mold Types<br /><ul><li>SPE/SPI
  66. 66. Class 101, 102
  67. 67. Hot Runner
  68. 68. Runnerless
  69. 69. Sub-Gates
  70. 70. Automatic
  71. 71. Prototype & Low Volume
  72. 72. Single & Multi Cavity</li></li></ul><li><ul><li>CNC Machining Centers
  73. 73. CNC Turning Centers
  74. 74. Surface Grinders
  75. 75. Ram EDMs
  76. 76. Vertical Mills
  77. 77. Horizontal Mills
  78. 78. Lathes</li></ul>In House Tooling Capability<br />
  79. 79. <ul><li>Process Control Plans
  80. 80. Validation - IQ/OQ/PQ
  81. 81. Risk Assessment - Failure Modes and Effects Analysis (FMEA)
  82. 82. Statistical Process Control (SPC)
  83. 83. Automated Inspection
  84. 84. Preventive Maintenance Program</li></ul>QC Operations<br />
  85. 85. <ul><li>ISO 13485:2003 Certified
  86. 86. CA Device Manufacturing License
  87. 87. FDA Registered – Class 2 listings
  88. 88. UL Recognized
  89. 89. cGMP (Good Manufacturing Practices)
  90. 90. Accredited membership in SPE, SPI, and ASQC
  91. 91. Members of Biocom and Octane</li></ul>Certifications<br />
  92. 92. Molding Specialties<br /><ul><li>Inserts</li></ul>Rigids, Connectors, Filters, Flexibles, and Floating<br /><ul><li>Elastomeric Molding
  93. 93. Implantable
  94. 94. Two Shot Molding
  95. 95. Optical lens
  96. 96. Unscrewing connectors
  97. 97. Reeled overmolding
  98. 98. In Mold Decorating
  99. 99. Micromolding</li></li></ul><li>Production Examples<br />From the very very small parts<br />
  100. 100. Production Examples<br />Valve Assembly<br />Urological Assembly<br />
  101. 101. Medical Production Examples<br />
  102. 102. Medical Production Examples<br />
  103. 103. Medical Production ExamplesTyvek Bag Packaging<br />
  104. 104. Production Examples<br /><ul><li>From the very small
  105. 105. To the very large</li></li></ul><li><ul><li>Polypropylene
  106. 106. HDPE
  107. 107. LDPE/LLDPE
  108. 108. TPO/TPE
  109. 109. PET
  110. 110. PBT
  111. 111. Acrylic
  112. 112. PVC
  113. 113. Acetal
  114. 114. Nylon
  115. 115. Polycarbonate
  116. 116. Polystyrene
  117. 117. ABS
  118. 118. SAN
  119. 119. LCP
  120. 120. PEEK</li></ul>Materials<br />
  121. 121. <ul><li>Molding small and large parts
  122. 122. Insert and over molding
  123. 123. Clean room molding
  124. 124. Complex assembly
  125. 125. Automation assembly
  126. 126. Assembly done at the machine
  127. 127. Packaging at the machine
  128. 128. Experienced with engineered plastics
  129. 129. Contract assembly medical devices
  130. 130. Experienced with automation in assembly</li></ul>Production Summary<br />
  131. 131. <ul><li>Kanban
  132. 132. Vendor Managed Inventory (VMI)
  133. 133. Year-Over-Year Cost Reduction Program
  134. 134. Just In Time (JIT) Inventory
  135. 135. Electronic Data Interchange (EDI)
  136. 136. Product Bar Coding (Shipping/Packaging Labels)
  137. 137. Packaging, order and shipping fulfillment
  138. 138. Mold consolidation and materials purchasing advantages</li></ul>Customer Services<br />
  139. 139. Secondary Services<br />Production<br /><ul><li>Hot stamping
  140. 140. Ultrasonic welding
  141. 141. Machining/tapping/ drilling/inserting
  142. 142. Assembly
  143. 143. Access to Mexico assembly facility</li></ul>Finishing<br /><ul><li>PAD printing
  144. 144. Painting/silk screening
  145. 145. Coating
  146. 146. EMI shielding
  147. 147. Bar coding</li></li></ul><li>Packaging and Fulfillment<br /><ul><li>Heat sealing
  148. 148. Bar Code labeling
  149. 149. Customized packaging
  150. 150. Located near airport and international border
  151. 151. Company-owned delivery trucks</li>

×