Pediatric Device Consortium UCSF Mission Bay February 15, 2011.

Pediatric Device ConsortiumUCSF Mission Bay

February 15, 2011

INTRODUCTION

OBJECTIVE/AGENDA

• Objective:– Introduction to California MedTech– Insights into outsourced product development and manufacturing

• California MedTech– Clients– Services – Products

• ODM/CM Overview – Definitions– Other considerations

• Why California MedTech

COMPANY OVERVIEW

COMPANY OVERVIEW - CLIENTS

• Profitable Every Year• Employee Owned• Founded 1998• Self-funded• No Debt

COMPANY OVERVIEW – FINANCIALS

Development Capabilities• 16 Full-Time Engineers

• Electrical Engineering• Software Development• Mechanical Design• Fluidics Engineering*

• Photonics Engineering*

• Industrial Design*

* Supplier network - contracted services

COMPANY OVERVIEW

Design Transfer Capabilities

• Manufacturing Engineering• Process Development• Verification & Validation• Compliance Testing• Regulatory Support

COMPANY OVERVIEW

COMPANY OVERVIEW

Manufacturing Capabilities:•High-Level Box Build •San Diego – Partners Tijuana & China•All locations ISO 13485 Certified

Fulfillment Services:•Finished Goods Inventory •Drop Shipment – US/OUS•Complete In-House Service Depot

PRODUCT EXPERIENCE

TIBION BIONIC LEG

The Tibion Bionic Leg is the first wearable, battery operated, robotic rehabilitation tool to provide stroke patients with the possibility of regaining significant use of their impaired leg.

California MedTech provides:•Design Tx.•Production scale-up•Service•Order fulfillment

GENOMICS

Personal Genome Machine sequencer weighs less than 50 pounds and has a foot print that’s no bigger than a desktop printer, so it can fit in any lab.

Extracts samples from 384-well microtiter plates and places nanoliter droplets onto a SmartChip for genomics analysis.

SURGICAL

PEAK SURGICAL: A plasma-based, high-frequency tissue dissection system that provides the exacting control of a scalpel with the bleeding control of electro-surgery.

“ULTHERA RECEIVES FIRST-EVER FDA CLEARANCE TO MARKET ULTRASOUND TECHNOLOGY FOR FACIAL AESTHETIC IMPROVEMENT”

PHILIPS MEDICAL - INNERCOOL

Temperature Modulation Therapy encompasses inducing, maintaining, and reversing hypothermia, as well as maintaining normal body temperature or normothermia.

California MedTech provides:•Design & Design Tx.•Full scale production •Service•Order fulfillment

OTHER PRODUCTSDeveloped the NeuroVision® evoked-response nerve monitoring system for use with minimally-invasive spinal surgery. Manufactured three generations of the system.

Eye Scanner and Pupillometer: designed a handheld instrument to measure pupil and iris diameter under various lighting conditions, as well as curvature of the cornea. Project included PC application software for image archiving and post-processing.

OUTSOURCING

DEFINITIONS

• Electronics Manufacturing Services (EMS) (ECM)– design, test, manufacture, distribute, and provide return/repair

services for electronic components and assemblies typically for OEMs. Also referred to as Electronic Contract Manufacturing (ECM).

• Original Design Manufacturer (ODM)**– a company which designs and manufactures a product which is

specified and eventually branded by another firm for sale. A primary attribute of this business model is that the ODM owns and/or designs in-house the products that are branded by the buying firm.

• Contract Manufacturer (CM)**– acts as the hiring firm's factory, producing and shipping units of the

design on behalf of the hiring firm.

** California MedTech, LLC

SELECTION CONSIDERATIONS• Experience with similar products and processes• Ownership – Development through manufacturing• Business model:

– High vs. low complexity– High vs. low volume (+1,000,000/year)

• Intellectual property ownership/restrictions• Stickiness - embedded proprietary hardware/software• Transparency• Capacity• Location• Track record• Crown jewels?

MULTI PRODUCT DEVELOPMENT

• Benefits of multiple product lines and continuous development.– Learning curve effects– Maintaining critical skills

Contract Manufacturer

- C

ost

/Tim

e -

- Cumulative volume -

Self – 1st Self – 2nd

MULTI-PRODUCT DEVELOPMENT-

% L

abo

r -

- Development Time/Phase -

• Resource management:– Motivation– Resource utilization • competing projects• Minimize tail effects

OTHER ADVANTAGES – ODM/CM

• Startup Business – long development cycles– CM reallocation of resources

• Minimize downside impact of “Forecast Error”• No delays with build out of manufacturing infrastructure

- N

um

ber

of

Un

its

-

Animal

FIH

Commercial

- Time/Project Phase -

CALIFORNIA MEDTECH

• Experience – as a trusted outsourcing partner, we’ve designed and manufactured some of the most successful life science products and medical devices in the industry generating over $2 Billion in value.

• We make complicated things without making things complicated. We can build and service your product reliably and cost effectively.

• Full service product development and manufacturing partner.

• FDA registered, CA State licensed and ISO-9001/13485.

• Skills and resources to take products from concept to commercialization, and beyond.

Complete ODM/CM Solution Provider for Challenging Medical ProductsFDA Registered, CA Licensed, ISO-13485 Certified

Track Record of On-Time, In-Spec, On-Budget Delivery

Bill WrightVP Business Development – Northern California

Menlo Park650-799-0680