Injection Molding for the Medical Device Industry

1. Injection Molding & Manufacturing

3. 1989 R. Witchey purchases the assets of PEDI via Witco (C-Corp).

4. 1996 Company relocates operations to current building – design built specifically for plastics manufacturing

5. 1996 PEDI achieves ISO 9001 certification

6. 2001 J. Sparacio hired as President and CEO

7. 2003 Facility registers as Medical Device Establishment with the U.S. Food and Drug Administration

8. 2004 PEDI achieves ISO 13485 certification

9. 2009 Acquires Emergent production assets and signs proprietary manufacturing, distribution and servicing agreement with Bound Tree Medical, LLC

10. 2010 Providien, LLC, funded by Endeavor Capital, acquires PEDIPEDI Timeline

12. External funding by Endeavor Capital a Portland, OR based company and has committed $75 million to Providien

13. Acquired to date

14. Specialty Manufacturing, Inc. a pressure former of plastics based in San Diego, CA

15. PEDI a plastic molder contract manufacturing based in Carlsbad, CA.

16. Providien is managed by Jeffrey Goble and Charles Stroupe.

17. C. Stroupe was CEO and J. Goble, President of Medegen, LLC an Ontario, CA based company of disposable intravenous therapy products

18. Medgen was acquired by Carefusion Corp., a San Diego, CA based company for $225 million in April, 2010.PROVIDIEN

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.

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.

24. From Concept to Distribution

25. Highly Competent Engineering Capability – consult on product design, FDA qualification, tooling design and cost reduction strategies for customers

26. Tooling design and outsourcing of tooling fabrication both foreign and domestic

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 shipmentGeneral Capabilities

29. Collaborative relationship with Integra Bio in Tijuana, MX for outsourcing of high labor content assembly

30. PEDI is the virtual manufacturing and warehouse company for medical start-ups such as Ivera, Auroa, Venetec, and Access Scientific

32. ISO 13485:2003 (medical devices)

33. FDA and State of California registered production facility

34. Class 8 (100K) Cleanroom and White Room Product Environments

36. Biotech

37. Life Sciences

38. Recreation

39. Connectors

40. Pro Audio

41. Aerospace

42. Industrial

43. Electronic

44. IrrigationIndustries Served

46. 5,000 sq.ft. Class 8 clean room

47. Clean room assembly and packaging area

48. Custom Customer Cells

49. White Room Assembly and Manufacturing

50. 28 Toyo, Sumitomo & Toshiba injection-molding presses, 18 ton to 500 ton, 10 in clean room

51. Vacuum-fed material handling system

53. White room assembly facility with testing Our modular assembly facility can be configured to meet customer manufacturing requirements

54. Clean Room Molding with assembly automation

55. Clean Room Production Automation reduces operator interface 5,000 square foot Class 8 Clean Room

56. Operators check the parts against the quality requirements Clean Room Molding Cell

58. 3-D Solid Modeling

59. Mold Design

60. Mold Flow Analysis

61. Mold Construction and Project Coordination

62. Electronic File Transfer

63. Material Selection

64. Product & Process ValidationFull CAD Engineering

66. Class 101, 102

67. Hot Runner

68. Runnerless

69. Sub-Gates

70. Automatic

71. Prototype & Low Volume

73. CNC Turning Centers

74. Surface Grinders

75. Ram EDMs

76. Vertical Mills

77. Horizontal Mills

78. LathesIn House Tooling Capability

80. Validation - IQ/OQ/PQ

81. Risk Assessment - Failure Modes and Effects Analysis (FMEA)

82. Statistical Process Control (SPC)

83. Automated Inspection

84. Preventive Maintenance ProgramQC Operations

86. CA Device Manufacturing License

87. FDA Registered – Class 2 listings

88. UL Recognized

89. cGMP (Good Manufacturing Practices)

90. Accredited membership in SPE, SPI, and ASQC

91. Members of Biocom and OctaneCertifications

93. Implantable

94. Two Shot Molding

95. Optical lens

96. Unscrewing connectors

97. Reeled overmolding

98. In Mold Decorating

100. Production Examples Valve Assembly Urological Assembly

101. Medical Production Examples

102. Medical Production Examples

103. Medical Production ExamplesTyvek Bag Packaging

106. HDPE

107. LDPE/LLDPE

108. TPO/TPE

109. PET

110. PBT

111. Acrylic

112. PVC

113. Acetal

114. Nylon

115. Polycarbonate

116. Polystyrene

117. ABS

118. SAN

119. LCP

120. PEEKMaterials

122. Insert and over molding

123. Clean room molding

124. Complex assembly

125. Automation assembly

126. Assembly done at the machine

127. Packaging at the machine

128. Experienced with engineered plastics

129. Contract assembly medical devices

130. Experienced with automation in assemblyProduction Summary

132. Vendor Managed Inventory (VMI)

133. Year-Over-Year Cost Reduction Program

134. Just In Time (JIT) Inventory

135. Electronic Data Interchange (EDI)

136. Product Bar Coding (Shipping/Packaging Labels)

137. Packaging, order and shipping fulfillment

138. Mold consolidation and materials purchasing advantagesCustomer Services

140. Ultrasonic welding

141. Machining/tapping/ drilling/inserting

142. Assembly

144. Painting/silk screening

145. Coating

146. EMI shielding

148. Bar Code labeling

149. Customized packaging

150. Located near airport and international border

151. Company-owned delivery trucks